What is Azulfidine?

Azulfidine is used to treat ulcerative colitis (UC), and to decrease the frequency of UC attacks. This medicine will not cure ulcerative colitis, but it can reduce the number of attacks you have.

Azulfidine is also used to treat rheumatoid arthritis in children and adults who have used other arthritis medicines that did not work or have stopped working.

Azulfidine may also be used for purposes not listed in this medication guide.

Azulfidine side effects

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;
• mouth sores, red or swollen gums;
• pale skin, easy bruising, unusual bleeding; or
• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• fever with headache, rash, and vomiting;
• a skin rash, no matter how mild;
• severe nausea or vomiting when you first start taking Azulfidine;
• little or no urination, urine that looks foamy;
• puffy eyes, swelling in your ankles or feet, weight gain; or
• liver problems–loss of appetite, stomach pain (upper right side), dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of Azulfidine may include:

• nausea, vomiting, upset stomach, loss of appetite;
• headache;
• rash; or
• low sperm count in men.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

You should not use Azulfidine if you have porphyria, a blockage in your bladder or intestines, or if you are allergic to sulfa drugs, aspirin, or similar medicines called salicylates.

Before taking this medicine

You should not use Azulfidine if you are allergic to it, or if you have:

• a blockage in your bladder or intestines;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• an allergy to sulfa drugs; or
• an allergy to aspirin or other salicylates (such as Nuprin Backache Caplet, Kaopectate, KneeRelief, Pamprin Cramp Formula, Pepto-Bismol, Tricosal, Trilisate, and others).

Tell your doctor if you have ever had:

• frequent infections;
• asthma;
• low blood cell counts; or
• liver or kidney disease.

Tell your doctor if you are pregnant. Taking Azulfidine can make it harder for your body to absorb folic acid, and folic acid helps prevent major birth defects of the baby’s brain or spine. You may need to take folic acid supplements if you take this medicine during pregnancy. Follow your doctor’s instructions.

Sulfasalazine can pass into breast milk and may cause diarrhea or bloody stools in a nursing baby. Tell your doctor if you are breast-feeding.

Azulfidine is not approved for use by anyone younger than 2 years old.

How should I take Azulfidine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Azulfidine after a meal.

Swallow the tablet whole and do not crush, chew, or break it.

You will need frequent medical tests.

Drink plenty of liquids to keep your kidneys working properly while you are taking Azulfidine.

Azulfidine can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Azulfidine may cause your skin or urine to appear orange-yellow in color. Call your doctor if you also have yellowing of your eyes, brown urine, or stomach pain. These may be signs of liver problems.

If you are treating arthritis, do not stop using any of your other arthritis medicines until your doctor tells you to. Azulfidine may not improve your symptoms right away, and you may still need your other medicines for awhile.

Azulfidine is only part of a complete treatment for rheumatoid arthritis that may also include rest and physical therapy. Follow your doctor’s instructions very closely.

What is azathioprine?

Azathioprine weakens your body’s immune system, to help keep it from “rejecting” a transplanted organ such as a kidney. Organ rejection happens when the immune system treats the new organ as an invader and attacks it.

Azathioprine is used to prevent your body from rejecting a transplanted kidney. Azathioprine is also used to treat symptoms of rheumatoid arthritis.

Azathioprine may also be used for purposes not listed in this medication guide.

Azathioprine side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Azathioprine may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.

Stop using azathioprine and call your doctor right away if you have any of these symptoms of lymphoma:

• fever, swollen glands, body aches, night sweats, not feeling well;
• pale skin, rash, easy bruising or bleeding;
• cold hands and feet, feeling light-headed or short of breath;
• pain in your upper stomach that may spread to your shoulder; or
• feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• signs of infection (fever, chills, weakness, flu symptoms, sore throat, cough, pain or burning when you urinate);
• severe nausea, vomiting, or diarrhea;
• easy bruising, unusual bleeding;
• rapid heartbeats, shortness of breath;
• pale skin, cold hands and feet; or
• dark urine, jaundice (yellowing of the skin or eyes).

Common side effects of azathioprine may include:

• nausea, diarrhea, stomach pain;
• hair loss; or
• skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis.

Before taking this medicine

You should not take azathioprine if you are allergic to azathioprine.

You should not use azathioprine to treat rheumatoid arthritis if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy while using this medicine.

Azathioprine may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

While taking azathioprine, you may have a higher risk of developing skin cancer. Ask your doctor about skin symptoms to watch for.

Tell your doctor if you have ever had:

• kidney disease, or a kidney transplant (if you are using azathioprine for rheumatoid arthritis);
• any type of viral, bacterial, or fungal infection;
• liver disease; or
• chemotherapy with medications like cyclophosphamide, chlorambucil, melphalan, busulfan, and others.

You should not breast-feed while you are using azathioprine.

How should I take azathioprine?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using azathioprine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

When given for kidney transplant, azathioprine is usually given right before or on the day of transplant. For rheumatoid arthritis, azathioprine is taken on a daily basis.

It may take up to 8 weeks before your symptoms improve. Keep using azathioprine as directed and tell your doctor if your symptoms have not improved after 12 weeks of use.

Take with food if azathioprine upsets your stomach.

You may not be able to continue taking other arthritis medications together with azathioprine. Do not change your dose or dosing schedule without your doctor’s advice.

Azathioprine affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking azathioprine?

Avoid sunlight or tanning beds. Azathioprine can increase your risk of developing skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What is Humira?

Humira is used to treat many inflammatory conditions in adults, such as rheumatoid arthritis (RA), psoriatic arthritis (PA), ankylosing spondylitis (AS), plaque psoriasis, and a skin condition called hidradenitis suppurativa.

Humira is also used in adults and children to treat Crohn’s disease, juvenile idiopathic arthritis, ulcerative colitis, and uveitis.

Humira’s mechanism of action involves specifically targeting and blocking tumor necrosis factor (TNF)-alpha, a key inflammatory protein in the immune system. This interrupts immune system signals that cause excessive inflammation. Humira belongs to the drug class tumor necrosis factor (TNF) blockers and is also called a biologic.  

Humira gained FDA approval on December 31, 2002. There are several Humira generics (more correctly called biosimilars).

What are the Humira biosimilars?

There are 10 biosimilars of Humira. Some are fully interchangeable, others have mixed interchangeability, and others are not interchangeable.

• Abrilada is a fully interchangeable biosimilar of Humira (all strengths). An interchangeable biosimilar can automatically substituted by a pharmacist for Humira, with individual state laws controlling how and whether physicians will be notified.
• For Amjevita, the following strengths are interchangeable: prefilled syringe, 20mg/0.4mL, 40mg/0.8mL, 10mg/0.2mL; autoinjector 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe 20mg/0.2mL, 40mg/0.4mL, 80mg/0.8mL; autoinjector 40mg/0.4mL, 80mg/0.8mL.
• For Cyltezo, the following strengths are interchangeable: prefilled syringe, 40mg/0.8mL, 20mg/0.4mL, 10mg/0.2mL; autoinjector 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe/autoinjector 40mg/0.4mL.
• For Hadlima, the following strengths are interchangeable: prefilled syringe/single-dose vial 40mg/0.8mL.  The following strengths are not interchangeable: prefilled syringe/autoinjector 40mg/0.4mL, autoinjector 40mg/0.8mL.
• For Hyrimoz, the following strengths are interchangeable: prefilled syringe, 40mg/0.8mL, 80mg/0.8mL, 20mg/0.4mL, 20mg/0.2mL, 10mg/0.2mL, 10mg/0.1mL. The following strengths are not interchangeable: prefilled syringe 40mg/0.4mL; autoinjector 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL. 
• For Simlandi, the following strengths are interchangeable: prefilled syringe/autoinjector, 40mg/0.8mL. The following strengths are not interchangeable: prefilled syringe 20mg/0.2mL, 80mg/0.8mL.
• Hulio, Idacio, Yuflyma, and Yusimry, are also biosimilars of Humira, but they are not interchangeable. This means they can only be dispensed in place of Humira if the healthcare provider specifically prescribes the biosimilar product by name. 

Humira uses

Humira is used to treat:

• moderate to severe RA in adults. Humira can be used alone, with methotrexate, or with certain other medicines
• moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. Humira can be used alone or with methotrexate
• psoriatic arthritis (PsA) in adults. Humira can be used alone or with certain other medicines
• ankylosing spondylitis (AS) in adults
• moderate to severe hidradenitis suppurativa (HS) in people 12 years and older
• moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older
• moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. It is not known if Humira is effective in people who stopped responding to or could not tolerate TNF-blocker medicines
• moderate to severe chronic (lasting a long time) plaque psoriasis in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)
• non-infectious intermediate, posterior, and panuveitis in adults and children 2 years of age and older.

Humira side effects

The most common side effects of Humira include:

• injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually go away within a few days. Call your doctor right away if you have pain, redness, or swelling around the injection site that does not go away within a few days or gets worse
• upper respiratory infections (including sinus infections)
• headaches
• rash.

Serious side effects and warnings

Humira is a medicine that affects your immune system and has a Boxed Warning for serious infections and cancer.

Serious infections. Humira can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Humira. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections.

• Your doctor should test you for TB before starting Humira.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Humira.
• You should not start taking Humira if you have any kind of infection unless your doctor says it is okay.

After starting Humira, call your doctor right away if you have an infection or any signs of an infection. Humira can make you more likely to get infections or worsen any infection you may have.

Cancer. For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including Humira, the chances of getting cancer may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers.

• People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• If you use TNF blockers including Humira your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin). These types of cancer are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that does not heal.
• Some people receiving TNF blockers including Humira developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP).

Tuberculosis (TB). Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Humira and during treatment with Humira. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Humira. People who had a negative TB skin test before receiving Humira have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Humira:

• cough that does not go away
• low-grade fever
• weight loss
• loss of body fat and muscle (wasting).

Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Humira. Your doctor should do blood tests before you start treatment, while you are using Humira, and for several months after you stop treatment with Humira. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:

• muscle aches
• feel very tired
• dark urine
• skin or eyes look yellow
• little or no appetite
• vomiting
• clay-colored bowel movements
• fever
• chills
• stomach discomfort
• skin rash.

Allergic reactions. Allergic reactions can happen in people who use Humira. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:

• hives
• trouble breathing
• swelling of your face, eyes, lips, or mouth.

Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.

Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new worsening symptoms of heart failure while taking Humira, including:

• shortness of breath
• sudden weight gain
• swelling of your ankles or feet.

Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on your cheeks or arms that get worse in the sun. Symptoms may improve when you stop Humira.

Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:

• feel very tired
• skin or eyes look yellow
• poor appetite or vomiting
• pain on the right side of your stomach (abdomen).

Psoriasis. Some people using Humira had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Humira. Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Humira may be stopped.

Call your doctor right away if you:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis – confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems – body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome – joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems – numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis – fever with ongoing cough, weight loss (fat or muscle).

What is hydroxychloroquine?

Hydroxychloroquine is a quinoline medicine used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito. Malaria is common in areas such as Africa, South America, and Southern Asia. This medicine is not effective against all strains of malaria.

Hydroxychloroquine is not effective against all strains of malaria, or against malaria in areas where the infection has been resistant to a similar drug called chloroquine.

Hydroxychloroquine is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.

Warnings

Hydroxychloroquine can cause dangerous effects on your heart, especially if you also use certain other medicines including the antibiotic azithromycin (Z-Pak). Seek emergency medical attention if you have fast or pounding heartbeats and sudden dizziness (like you might pass out).

Taking hydroxychloroquine long-term or at high doses may cause irreversible damage to the retina of your eye that could progress to permanent vision problems.

Stop taking hydroxychloroquine and call your doctor at once if you have blurred vision, trouble focusing, distorted vision, blind spots, trouble reading, changes in your color vision, increased sensitivity to light.

Before taking this medicine

You should not use hydroxychloroquine if you are allergic to hydroxychloroquine or chloroquine.

High doses or long-term use of hydroxychloroquine may cause irreversible damage to your retina (the membrane layer inside your eye that helps produce vision). This could progress to permanent vision problems. The risk of retinal damage is higher in people with pre-existing eye problems, kidney disease, or people who also take tamoxifen.

To make sure hydroxychloroquine is safe for you, tell your doctor if you have ever had:

• vision changes or damage to your retina caused by an anti-malaria medication;
• heart disease, heart rhythm disorder (such as long QT syndrome);
• diabetes;
• a stomach disorder;
• an allergy to quinine;
• liver or kidney disease;
• psoriasis;
• alcoholism;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Tell your doctor if you are pregnant or plan to become pregnant. Malaria is more likely to cause serious illness or death in a pregnant woman. Having malaria during pregnancy may also increase the risk of miscarriage, stillbirth, premature delivery, and low birth weight.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of hydroxychloroquine on the baby.

It is not known whether hydroxychloroquine will harm an unborn baby. If you are pregnant, ask your doctor about the risks of traveling to areas where malaria is common (such as Africa, South America, and Southern Asia).

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Hydroxychloroquine is not approved for treating lupus or rheumatoid arthritis in anyone younger than 18 years old.

How should I take hydroxychloroquine?

Take hydroxychloroquine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take hydroxychloroquine with a meal or a glass of milk unless your doctor tells you otherwise.

Do not crush or break a hydroxychloroquine tablet.

To treat lupus or arthritis, hydroxychloroquine is usually taken daily.

To prevent malaria: Hydroxychloroquine is usually taken once per week on the same day each week. Start taking the medicine 2 weeks before entering an area where malaria is common. Keep taking the medicine during your stay and for at least 4 weeks after you leave the area.

To treat malaria: Hydroxychloroquine is usually given as one high dose followed by smaller doses during the next 2 days in a row.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

No medication is 100% effective in treating or preventing all types of malaria. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

While using hydroxychloroquine, you may need frequent medical tests and vision exams.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Malaria Prophylaxis:

400 mg salt (310 mg base) orally once a week

Weight-based dosing: 6.5 mg/kg salt (5 mg/kg base) orally once a week
-Maximum dose: 400 mg salt (310 mg base)/dose

Comments:
-This drug should be administered on the same day of each week.
-Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area.

Use: For the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

US CDC Recommendations: 310 mg base (400 mg salt) orally once a week

Comments:
-An alternative to chloroquine for prophylaxis only in areas with chloroquine-sensitive malaria
-Prophylaxis should start 1 to 2 weeks before travel to malarious areas; should continue weekly (same day each week) while in malarious areas and for 4 weeks after leaving such areas
-If malaria develops while using this drug for chemoprophylaxis, it should not be used as part of the treatment regimen.
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Malaria:

800 mg salt (620 mg base) orally as an initial dose, followed by 400 mg salt (310 mg base) at 6, 24, and 48 hours after the initial dose
Total dose: 2000 mg salt (1550 mg base)

Weight-based dosing:
-First dose: 13 mg/kg salt (10 mg/kg base) orally
-Second dose (6 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
-Third dose (24 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
-Fourth dose (48 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally

Maximum Dose:
-First dose: 800 mg salt (620 mg base)/dose
-Second, third, and fourth dose: 400 mg salt (310 mg base)/dose

Comments:
-Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of Plasmodium vivax and P ovale infections.

Use: For the treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

US CDC Recommendations: 620 mg base (800 mg salt) orally at once, followed by 310 mg base (400 mg salt) orally at 6, 24, and 48 hours
Total dose: 1550 mg base (2000 mg salt)

Comments:
-Recommended for uncomplicated malaria (P falciparum or species not identified) in regions with chloroquine sensitivity
-Recommended for uncomplicated malaria (P malariae, P knowlesi, P vivax [unless chloroquine-resistant P vivax suspected], or P ovale) in all regions; if treating P vivax or P ovale infections, concomitant treatment with primaquine (after quantitative testing to rule out glucose-6-phosphate dehydrogenase [G6PD] deficiency) is recommended.
-Recommended for uncomplicated malaria treatment for pregnant women in regions with chloroquine sensitivity
-Current guidelines should be consulted for additional information.

Usual Adult Dose for Systemic Lupus Erythematosus:

200 to 400 mg salt (155 to 310 mg base)/day orally divided in 1 or 2 doses

Comments:
-Doses above 400 mg/day are not recommended.
-Higher incidence of retinopathy reported when this maintenance dose is exceeded.

Uses: For the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus

Usual Adult Dose for Rheumatoid Arthritis:

Initial dose: 400 to 600 mg salt (310 to 465 mg base)/day orally divided in 1 or 2 doses
Maintenance dose: 200 to 400 mg salt (155 to 310 mg base)/day orally divided in 1 or 2 doses
Maximum dose: 600 mg salt (465 mg base)/day or 6.5 mg/kg salt (5 mg/kg base)/day, whichever is lower

Comments:
-The action of this drug is cumulative and may require weeks to months to achieve the maximum therapeutic effect.
-When a good response is obtained, the initial dose may be reduced by 50% and continued at a maintenance dose.
-Higher incidence of retinopathy reported when this maintenance dose is exceeded; 600 mg salt (465 mg base) or 6.5 mg/kg salt (5 mg/kg base), whichever is lower, should not be exceed per day.
-Corticosteroids and salicylates may be used with this drug, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of this drug has been achieved.

Use: For the treatment of acute and chronic rheumatoid arthritis

Usual Pediatric Dose for Malaria Prophylaxis:

6.5 mg/kg salt (5 mg/kg base) orally once a week
Maximum dose: 400 mg salt (310 mg base)/dose

Comments:
-This drug should be administered on the same day of each week.
-Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area.

Use: For the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

US CDC Recommendations: 5 mg/kg base (6.5 mg/kg salt) orally once a week
Maximum dose: 310 mg base (400 mg salt)/dose

Comments:
-An alternative to chloroquine for prophylaxis only in areas with chloroquine-sensitive malaria
-Prophylaxis should start 1 to 2 weeks before travel to malarious areas; should continue weekly (same day each week) while in malarious areas and for 4 weeks after leaving such areas
-If malaria develops while using this drug for chemoprophylaxis, it should not be used as part of the treatment regimen.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose for Malaria:

First dose: 13 mg/kg salt (10 mg/kg base) orally
Second dose (6 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
Third dose (24 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
Fourth dose (48 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally

Maximum Dose:
-First dose: 800 mg salt (620 mg base)/dose
-Second, third, and fourth dose: 400 mg salt (310 mg base)/dose

Comments:
-Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of P vivax and P ovale infections.

Use: For the treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

US CDC Recommendations: 10 mg/kg base orally at once, followed by 5 mg/kg base orally at 6, 24, and 48 hours
Total dose: 25 mg/kg base

Comments:
-Pediatric dose should never exceed adult dose.
-Recommended for uncomplicated malaria (P falciparum or species not identified) in regions with chloroquine sensitivity
-Recommended for uncomplicated malaria (P malariae, P knowlesi, P vivax [unless chloroquine-resistant P vivax suspected], or P ovale) in all regions; if treating P vivax or P ovale infections, concomitant treatment with primaquine (after quantitative testing to rule out G6PD deficiency) is recommended.
-Current guidelines should be consulted for additional information.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of hydroxychloroquine can be fatal, and must be treated quickly.

Overdose symptoms may include drowsiness, vision changes, seizure, slow heart rate, weak pulse, pounding heartbeats, sudden dizziness, fainting, shortness of breath, or slow breathing (breathing may stop).

Keep hydroxychloroquine out of the reach of children. A hydroxychloroquine overdose can be fatal to a child who accidentally swallows this medicine.

What to avoid

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid taking an antacid or Kaopectate (kaolin-pectin) within 4 hours before or 4 hours after you take hydroxychloroquine.

Hydroxychloroquine side effects

Get emergency medical help if you have signs of an allergic reaction to hydroxychloroquine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Also seek emergency medical attention if you have symptoms of a serious heart problem: fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

Hydroxychloroquine may cause serious side effects. Call your doctor at once if you have:

• a seizure;
• yellowing of your eyes;
• ringing in your ears, trouble hearing;
• unusual mood changes;
• severe muscle weakness, loss of coordination, underactive reflexes;
• any sudden changes in mood or behavior, or thoughts about suicide;
• low blood cell counts – fever, chills, tiredness, sore throat, mouth sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• a serious drug reaction that can affect many parts of your body – skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Taking hydroxychloroquine long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking hydroxychloroquine and tell your doctor if you have:

• blurred vision, trouble focusing, trouble reading;
• distorted vision, blind spots;
• changes in your color vision;
• hazy or cloudy vision;
• seeing light flashes or streaks, seeing halos around lights; or
• increased sensitivity to light.

Common side effects of hydroxychloroquine may include:

• headache;
• dizziness;
• nausea or vomiting;
• stomach pain;
• loss of appetite;
• weight loss;
• feeling nervous or irritable;
• skin rash or itching; or
• hair loss.

What is Kevzara?

Kevzara (sarilumab) is used to treat rheumatoid arthritis (RA) and polymyalgia rheumatica (PMR) in certain adults, and also active polyarticular juvenile idiopathic arthritis (pJIA) to help reduce pain, stiffness, swelling, and other symptoms.

Kevzara works by blocking the effects of a protein called interleukin-6 (IL-6), which is involved in causing inflammation, by blocking IL-6 reduces the inflammatory process and improves symptoms. Kevzara belongs to the class of medicines known as interleukin-6 receptor antagonists (also called IL-6 inhibitors) and is a type of biologic.

Kevzara is often given after other medications have been tried without successful treatment of symptoms, depending on the condition being treated. It is sometimes given together with other arthritis medicines.

Who can use Kevzara?

Kevzara FDA approval was received on May 22, 2017. It is now FDA approved to treat:

• active rheumatoid arthritis (moderate to severe) in adults who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs).
• polymyalgia rheumatica in adults who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
• active polyarticular juvenile idiopathic arthritis in patients who weigh 63 kg or greater.

Kevzara side effects

Common Kevzara side effects

Common Kevzara side effects may include runny or stuffy nose, sinus pain, sore throat, abnormal liver function tests, painful urination, or skin redness where an injection was given.

Serious Kevzara side effects

Get emergency medical help if you have signs of an allergic reaction to Kevzara: hives; chest pain, difficult breathing, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Kevzara. Stop using this medicine and call your doctor right away if you have signs of infection such as:

• fever, chills, sweating, body aches;
• cough with bloody mucus;
• feeling short of breath;
• diarrhea, stomach pain, weight loss;
• sores on your skin;
• pain or burning when you urinate; or
• feeling very tired.

Also call your doctor at once if you have signs of perforation (a hole or tear) in your stomach or intestines:

• fever;
• ongoing stomach pain; or
• a change in bowel habits.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Kevzara affects your immune system. You may get infections more easily, even serious or fatal infections. Tell your doctor if you have a fever, chills, tiredness, cough, diarrhea, stomach pain, weight loss, skin sores, or painful urination.

Kevzara may cause you to have a tear in your stomach or intestines. This is more likely if you have diverticulitis or a stomach ulcer, or if you also take steroids, methotrexate, or an NSAID (nonsteroidal anti-inflammatory drug). Call your doctor right away if you have a fever and ongoing stomach pain.

Before and during your treatment with Kevzara, you will need frequent blood tests. Your treatment may be delayed or stopped based on the results of these tests.

This medicine may increase your risk of certain cancers by changing the way your immune system works. Tell your healthcare provider if you have ever had any type of cancer.

Before taking this medicine

You should not use Kevzara if you are allergic to sarilumab.

Tell your doctor if you have ever had tuberculosis or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure Kevzara is safe for you, tell your doctor if you have ever had:

• an active or chronic infection;
• diabetes;
• HIV or AIDS;
• a weak immune system;
• hepatitis or other liver problems;
• stomach pain, diverticulitis, or stomach or intestinal ulcers;
• cancer; or
• if you have received or are scheduled to receive any vaccines.

Using Kevzara may increase your risk of developing certain types of cancers. Ask your doctor about this risk.

It is not known whether sarilumab will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of sarilumab on the baby.

You should not breast-feed while using Kevzara.

How should I take Kevzara?

Kevzara is injected under the skin, usually given once every 2 weeks. A healthcare provider may teach you how to properly use the medication by yourself.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy or has particles in it. Call your pharmacist for new medicine.

Kevzara affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store this medicine in its original container in a refrigerator. Protect from light. Do not shake or freeze the medicine. Keep Kevzara cold even while traveling.

Before injecting your dose, take the medicine out of the refrigerator and let it reach room temperature (for 30 minutes if using the prefilled syringe, or for 60 minutes if using the injection pen). Once at room temperature, the medicine must be used within 14 days.

Each prefilled syringe or injection pen is for one use only. Throw it away after one use, even if there is still medicine left inside.

• Place used needles, syringes, or injection pens in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Adult Kevzara Dose for Rheumatoid Arthritis:

Usual recommended dose: 200 mg subcutaneously every 2 weeks

Comments:

• This drug may be used as monotherapy or in combination with methotrexate (MTX) or other conventional DMARDs.
• Test patients for latent tuberculosis (TB); if positive, consider treating for TB prior to initiating therapy.
• Avoid using this drug with biological DMARDs because of the possibility of increased immunosuppression and increased risk of infection; concurrent use with biological DMARDs such as TNF antagonists, IL-1R antagonists, anti-CD20 monoclonal antibodies and selective co-stimulation modulators has not been studied.
• Avoid use in patients with active infections.

Adult Kevzara Dose for Polymyalgia Rheumatica:

Usual recommended dose: 200 mg subcutaneously every 2 weeks

Comments:

• This drug is recommended to be used in combination with a tapering course of corticosteroids. It can be used as monotherapy following discontinuation of corticosteroids.

Kevzara Dose active polyarticular juvenile idiopathic arthritis

Usual recommended dose: 200 mg given subcutaneously once every 2 weeks for pJIA patients who weigh 63 kg or greater using the 200 mg/1.14 mL pre-filled syringe.

Comments:

• Can be used as monotherapy or in combination with conventional DMARDs.

Dose Modification

Dosage Modifications are required for cytopenias, abnormal liver enzymes, and infections. Click on the link below for more detailed dosage information.

Kevzara Dosage Forms

Single-dose pre-filled syringe injection: 150 mg/1.14 mL and 200 mg/1.14 mL.

Single-dose pre-filled pen injection: 150 mg/1.14 mL and 200 mg/1.14 mL.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using Kevzara, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Kevzara?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can interact with sarilumab, especially:

• any other medicines to treat rheumatoid arthritis, such as abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, tocilizumab, or tofacitinib.

This list is not complete and many other drugs may affect Kevzara. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

• Refrigerate at 36°F to 46°F (2°C to 8°C) in original carton to protect from light.
• If needed, patients/caregivers may store this medicine at room temperature up to 77°F (25°C) up to 14 days in the outer carton. Do not store above 77°F (25°C). After removal from the refrigerator, use KEVZARA within 14 days or discard.
• Do not freeze.
• Do not shake.

Ingredients

Active Ingredient: sarilumab

Inactive Ingredients: arginine, histidine, polysorbate 20, sucrose, and Water for Injection, USP.

Company

Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807, A SANOFI COMPANY U.S. License # 1752.

Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591)

Registered trademark: Sanofi Biotechnology ©2024 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC

Kevzara Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kevzara.Kevzara (sarilumab) – Sanofi-Aventis U.S. LLC

What is Kineret?

Kineret is a FDA approved medicine used to treat moderate to severe rheumatoid arthritis in adults, neonatal onset multisystem inflammatory disease (NOMID) in newborn babies, and deficiency of interleukin-1 receptor antagonist (DIRA) in adults and children.
Kineret also has emergency use authorization (EUA) for the treatment of COVID-19 in specific hospitalized patients.

Kineret works to reduce the body’s immune response and inflammation by blocking the IL-1 receptor as it is an interleukin-1 (IL-1) receptor antagonist. 

Kineret is given as a subcutaneous injection daily or sometimes twice daily.

Kineret (anakinra) is used to control symptoms in: 

• Active rheumatoid arthritis that is moderate to severe, in adult patients who have tried disease modifying antirheumatic drugs (DMARDs) and they have not worked.
• Neonatal-onset multisystem inflammatory disease (NOMID) in new born babies. NOMID is a rare genetic condition that is a form of cryopyrin-associated periodic syndromes (CAPS). NOMID causes uncontrolled inflammation in many parts of the body, including the skin, joints, and central nervous system.
• Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in adults and children. DIRA is a very rare genetic condition that causes a severe inflammatory reaction during the first days of life and can lead to organ failure throughout the body.
• The US Food and Drug Administration (FDA) has authorized emergency use of anakinra for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

Warnings

The US Food and Drug Administration (FDA) has authorized emergency use of Kineret for the treatment of COVID-19 in hospitalized adults who tested positive for COVID-19 with pneumonia requiring supplemental oxygen, who are at risk of having severe respiratory failure, and are likely to have an increased risk of worsening of the disease (measured by abnormal blood levels of a certain protein).

You should not use Kineret if you are allergic to medicines that contain E. coli bacteria proteins, or if you have an active infection.

Before using Kineret, tell your doctor if you have asthma, kidney disease, a latex allergy, a weak immune system, an active or chronic infection, or signs of infection such as fever, chills, or open sores on your skin.

Kineret can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Stop using this medicine and call your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, mouth sores, weight loss, or feeling tired or short of breath.

You may have a higher risk of infection if you are also using adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), adalimumab (Humira), cancer medicines, steroids, or medicines to prevent organ transplant rejection.

Do not give Kineret to anyone under 18 years old without medical advic

Before taking this medicine

You should not use Kineret if you are allergic to anakinra or if you have:

• an active infection; or
• an allergy to any medicine that contains E. coli bacteria proteins.

To make sure Kineret is safe for you, tell your doctor if you have:

• kidney disease;
• an active or chronic infection;
• fever, chills, or open sores on your skin;
• a weak immune system (caused by disease or by using certain medicines):
• asthma;
• tuberculosis; or
• if you are scheduled to receive a vaccine.

Tell your doctor if you are pregnant or plan to become pregnant. Having rheumatoid arthritis or CAPS during pregnancy may increase the risk of premature birth or low birth weight. The benefit of treating rheumatoid arthritis or CAPS may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Do not give this medicine to a child without medical advice. Kineret is not approved to treat rheumatoid arthritis in anyone younger than 18 years old.

How should I use Kineret?

Use Kineret exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Kineret is injected under the skin. A healthcare provider may teach you how to properly use the medication by yourself.

Kineret is given either once per day or once every other day. Follow your doctor’s dosing instructions very carefully. Inject your dose at the same time of day when you use the medicine.

Your healthcare provider will show you where on your body to inject Kineret. Use a different place each time you give an injection. Each injection should be given at least 1 inch away from where you last injected the medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all instructions.

Do not shake the prefilled syringe or you may ruin the medicine.

Prepare an injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Call your doctor if your arthritis symptoms do not improve, or if they get worse while using Kineret.

Anakinra affects your immune system. You may get infections more easily. You will need frequent medical tests before and while using Kineret and for several months after you stop using it.

Store in the refrigerator, do not freeze. Protect from light. Throw away any unused medicine after the expiration date on the label has passed.

Each prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once and then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Dosing information

Usual Adult Dose of Kineret for Rheumatoid Arthritis:

100 mg subcutaneously once daily at approximately the same time each day

Comments:
-Alternating the injection site is recommended to avoid discomfort at the site of injection.

Use: To reduce symptoms and slow the progression of structural damage in moderately to severely active rheumatoid arthritis (RA) in patients who have failed 1 or more disease modifying antirheumatic drugs (DMARDs)

Usual Adult Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Usual Pediatric Dose of Kineret for Cryopyrin-Associated Periodic Syndrome:

Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily
NOTE: Once daily administration is generally recommended, but the dose may be split into twice daily administrations.

Comments:
-The therapeutic response is primarily reflected by reduction in symptoms such as fever, rash, joint pain, and headache, but also in inflammatory serum markers (CRP/SAA levels), or occurrence of flares.

Use: Cryopyrin-Associated Periodic Syndromes (CAPS): Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

Usual Pediatric Dose of Kineret for Interleukin-1 Receptor Antagonist Deficiency:

1 month and older:
Initial dose: 1 to 2 mg/kg subcutaneously daily
Dose escalation: Adjust doses in 0.5 to 1 mg/kg increments
Maximum dose: 8 mg/kg subcutaneously daily

Use: For the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) in children 1 month and older

Usual dose of Kineret for adults with COVID-19:

Recommended dosage of Kineret is 100 mg administered daily by subcutaneous injection for 10 days.

Dose for patients with severe renal insufficiency or end stage renal disease  (creatinine clearance < 30 mL/min, estimated from serum creatinine levels) consider a dose of 100 mg of Kineret administered every other day for 5 total doses over 10 days.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Kineret?

Do not receive a “live” vaccine while using Kineret, or you could develop an infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Kineret side effects

Get emergency medical help if you have signs of an allergic reaction to Kineret: hives, sweating, severe itching; wheezing, difficult breathing; fast or pounding heartbeats; dizziness, fainting; swelling of your face, lips, tongue, or throat.

If you are using Kineret for DIRA, you may have an increased risk of allergic reactions, especially in the first weeks of treatment.

Call your doctor at once if you have:

• fever or chills;
• low white blood cell counts – mouth sores, skin sores, sore throat; or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired.

Common Kineret side effects may include:

• abnormal liver function tests;
• rash;
• worsening arthritis symptoms;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• joint pain;
• flu symptoms;
• cold symptoms such as stuffy nose, sneezing, sore throat; or
• redness, bruising, itching, stinging, or swelling where the injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

What other drugs will affect Kineret?

You may have a higher risk of infection from Kineret if you are also using:

• certolizumab;
• etanercept;
• golimumab;
• infliximab;
• adalimumab; or
• cancer medicines, steroids, or medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may interact with anakinra, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Kineret Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Kineret.Kineret (anakinra) – Swedish Orphan Biovitrum AB (publ)

What is leflunomide?

Leflunomide affects the immune system and reduces swelling and inflammation in the body.

Leflunomide is used to treat the symptoms of rheumatoid arthritis.

Leflunomide may also be used for purposes not listed in this medication guide.

Leflunomide side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Leflunomide may cause serious side effects. Call your doctor at once if you have:

• signs of infection–sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, red or swollen gums, trouble swallowing;
• sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• numbness, tingling, or burning pain in your hands or feet;
• liver problems–nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of leflunomide may include:

• nausea, diarrhea, stomach pain;
• headache;
• abnormal liver function tests;
• thinning hair;
• back pain;
• weakness;
• rash; or
• high blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Warnings

Do not use leflunomide if you are pregnant, and stop taking leflunomide if you think you might be pregnant. Use birth control to prevent pregnancy while you are taking leflunomide, and until you complete a “drug elimination” procedure.

Leflunomide can cause severe or fatal liver damage. Tell your doctor if you have a history of liver disease or if you also use other medicines such as: pain or arthritis medicine (including aspirin, Tylenol, and Advil/Motrin), medicines to treat tuberculosis or other infections, seizure medication, hormonal birth control or hormone replacement therapy, chemotherapy, cholesterol-lowering medicine, heart medication, or blood pressure medicine.

Your liver function will need to be tested often, and you may need to stop taking leflunomide based on the results of these tests.

Before taking this medicine

You should not use this medicine if you are allergic to leflunomide or teriflunomide, or if:

• you are pregnant (you will need to have a negative pregnancy test before starting this treatment);
• you have severe liver disease; or
• you are also using teriflunomide.

Do not use leflunomide if you are pregnant or may become pregnant. Avoid getting pregnant until after you stop taking leflunomide and undergo a “drug elimination” procedure to help rid your body of this medicine. Stop taking leflunomide and call your doctor right away if you miss a period or think you might be pregnant.

To make sure leflunomide is safe for you, tell your doctor if you have:

• a history of liver disease or hepatitis (leflunomide can cause severe liver problems);
• a severe or uncontrolled infection;
• kidney disease;
• nerve problems, such as neuropathy caused by diabetes;
• a history of tuberculosis;
• a weak immune system or bone marrow disorder; or
• if you are using any drugs that weaken your immune system (such as cancer medicine or steroids).

Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking leflunomide, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

Ask your doctor if you should use a barrier form of birth control (condom or diaphragm with spermicide). Using hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may increase your risk of liver damage while taking leflunomide.

It is not known whether leflunomide passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take leflunomide?

Before you start treatment with leflunomide, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use leflunomide in larger or smaller amounts or for longer than recommended.

Your blood pressure will need to be checked often.

Leflunomide can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your leflunomide treatment may be stopped for a short time based on the results of these tests.

Your liver function will also need to be tested often, and you may need to stop taking leflunomide based on the results of these tests.

After you stop taking leflunomide, you may need to be treated with other medicines to help your body eliminate leflunomide quickly. If you do not undergo this drug elimination procedure, leflunomide could stay in your body for up to 2 years. Follow your doctor’s instructions.

You will also need to go through this drug elimination procedure if you plan to become pregnant after you stop taking leflunomide.

Arthritis is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor’s advice.

Store at room temperature away from moisture, heat, and light.

Leflunomide dosing information

Usual Adult Dose for Rheumatoid Arthritis:

Loading dose: 100 mg orally once a day for 3 days
Maintenance: 20 mg orally once a day (If not well tolerated, the dose may be decreased to 10 mg orally once a day)

Comment:
-Hematology parameters and liver enzymes should be monitored.

Use:
For the treatment of active rheumatoid arthritis (RA):
-To reduce signs and symptoms
-To inhibit structural damage as evidenced by X-ray erosions and joint space narrowing
-To improve physical function

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include diarrhea, stomach pain, pale skin, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).

What should I avoid while taking leflunomide?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using leflunomide, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect leflunomide?

Leflunomide can cause severe or fatal liver damage. This effect is increased when you also use certain other medicines, including:

• acetaminophen (Tylenol), aspirin, gout or arthritis medication (including gold injections); an NSAID (non-steroidal anti-inflammatory drug)–ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;
• an antibiotic, antifungal medicine, or sulfa drug; tuberculosis medicine; antiviral or HIV/AIDS medication; medicine to treat mental illness; seizure medication–carbamazepine, phenytoin, valproic acid, and others;
• birth control pills or hormone replacement therapy; anabolic steroids–methyltestosterone, “performance-enhancing drugs”; cancer medication; or
• cholesterol-lowering medication–Crestor, Lipitor, Vytorin, Zocor, and others; heart or blood pressure medication.

What is methotrexate?

Methotrexate interferes with the growth of certain cells of the body, especially cells that reproduce quickly, such as cancer cells, bone marrow cells, and skin cells.

Methotrexate is used to treat leukemia and certain types of cancer of the breast, skin, head and neck, lung, or uterus.

Methotrexate is also used to treat severe psoriasis and rheumatoid arthritis in adults. It is also used to treat active polyarticular-course juvenile rheumatoid arthritis in children.

Methotrexate is sometimes given when other medicines have not been effective.

Methotrexate side effects

Common side effects of methotrexate

Common methotrexate side effects may include:

• fever, chills, tiredness, not feeling well;
• low blood cell counts;
• mouth sores;
• nausea, stomach pain;
• abnormal liver function tests;
• hair loss;
• burning skin lesions; or
• being more sensitive to light.

Serious methotrexate side effects

Get emergency medical help if you have signs of an allergic reaction to methotrexate: (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

• sudden chest pain, wheezing, dry cough, cough with mucus, chest pain, feeling short of breath;
• fever, chills, swollen lymph glands, night sweats, weight loss;
• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• vomiting, diarrhea, blood in your urine or stools;
• skin changes such as redness, warmth, swelling, or oozing;
• low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• kidney problems – little or no urination, swelling in your feet or ankles;
• liver problems – swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• nerve problems – confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
• signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

This is not a complete list of side effects and others may occur.

Warnings

Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. Methotrexate is sometimes used to treat cancer during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant.

Do not use this medicine to treat psoriasis or rheumatoid arthritis if you have low blood cell counts, a weak immune system, alcoholism or chronic liver disease, or if you are breastfeeding.

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. Some people have died after incorrectly taking methotrexate every day. You must use the correct dose for your condition.

Methotrexate can cause serious or fatal side effects. Tell your doctor if you have diarrhea, mouth sores, cough, shortness of breath, upper stomach pain, dark urine, numbness or tingling, muscle weakness, confusion, seizure, or skin rash that spreads and causes blistering and peeling.

Before taking this medicine

You should not use methotrexate if you are allergic to it. You may not be able to take this medicine if you have:

• alcoholism, cirrhosis, or chronic liver disease;
• low blood cell counts;
• a weak immune system or bone marrow disorder; or
• if you are pregnant or breastfeeding.

Methotrexate is sometimes used to treat cancer in people who have a condition listed above. Your doctor will decide if this treatment is right for you.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• liver problems, especially fluid in your stomach (ascites);
• kidney disease;
• lung problems, especially fluid in the lungs (pleural effusion);
• radiation treatments; or
• a stomach ulcer or ulcerative colitis.

Tell your doctor if you are pregnant or plan to become pregnant. Methotrexate may cause injury or death to an unborn baby and should not be used during pregnancy to treat arthritis or psoriasis. However, methotrexate is sometimes used to treat cancer during pregnancy.

Methotrexate can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, you may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using methotrexate and for at least 6 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using methotrexate.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because methotrexate may harm the baby if a pregnancy does occur.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Do not give this medicine to a child without the advice of a doctor.

How should I take methotrexate?

YOU MAY NOT NEED TO TAKE METHOTREXATE EVERY DAY. This medicine is sometimes taken only once per week, or 2 to 4 times per week. Some conditions are treated daily for just a few days followed by a rest period of 1 week or longer before taking the medicine again.

You must use the correct dose. Some people have died after incorrectly taking methotrexate every day.

Take methotrexate exactly as it was prescribed for you. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Methotrexate can be toxic to your organs, and may lower your blood cell counts. You will need frequent medical tests, and you may need an occasional liver biopsy or chest X-ray. Your cancer treatments may be delayed based on the results.

If you need to be sedated for dental work, tell your dentist you currently use methotrexate.

Store methotrexate at room temperature away from moisture, heat, and light.

You may store Xatmep in a refrigerator or at room temperature. Avoid freezing or high heat. Throw away any unused Xatmep after 60 days if kept at room temperature.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of methotrexate.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of methotrexate can be fatal.

Overdose symptoms may include bruising or unusual bleeding, mouth sores, vomiting, little or no urination, bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

What to avoid

Avoid drinking alcohol. It may increase your risk of liver damage.

Do not receive a “live” vaccine while using methotrexate, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Methotrexate could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What is Orencia?

Orencia (abatacept) is a type of biologic that is given by intravenous infusion or subcutaneous (under the skin) injection which helps prevent your body’s immune system from attacking healthy joints and other tissues and is approved for:

• adults with moderately to severely active rheumatoid arthritis
• patients aged 2 years and older with moderately to severely active polyarticular juvenile idiopathic arthritis
• patients aged 2 years and older with active psoriatic arthritis
• the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and children aged 2 years and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

Orencia works by helping to block T-cell activation in the immune system and belongs to the class of medicines known as selective T-cell costimulation modulators. Blocking T-cell activation interrupts the cycle that can lead to joint inflammation, pain, and destruction in certain forms of arthritis and acute graft versus host disease. T-cells are part of the immune system that helps to protect you from certain infections and cancers. It is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Orencia was first FDA-approved on 23 December 2005.

Warnings

Hypersensitivity reactions, including anaphylaxis, have occurred.

Orencia carries a risk of serious infections. People with a history of recurrent infections or with underlying conditions that predispose them to infections (such as a weakened immune system, COPD, or diabetes) are more at risk. Using Orencia with a TNF antagonist can increase your infection risk.

Your doctor should screen you for viral hepatitis and latent TB infection before starting treatment with Orencia. If you test positive for TB your doctor will initiate TB treatment.

All your childhood vaccinations and other age-appropriate vaccinations should be up to date before starting Orencia. Live vaccines should not be given concurrently or within 3 months of discontinuation. Orencia may blunt the effectiveness of some immunizations.

The risk of respiratory side effects may be more common in patients with COPD (Chronic Obstructive Pulmonary Disease). There is a risk of cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) reactivation in patients treated for aGVHD prophylaxis.

It is not known if Orencia is safe and effective in children less than two years of age.

Before taking

You should not use Orencia if you are allergic to Orencia, abatacept, or any of the components of the intravenous or subcutaneous injection.

Before you receive or use Orencia, tell your healthcare provider about all of your medical conditions, including if you have:

• any kind of infection even if it is small (such as an open cut or sore), or an infection that is in your whole body (such as the flu)
• an infection that will not go away, an infection that keeps coming back, or inflammation of your liver due to an infection (viral hepatitis)
• had a lung infection called tuberculosis (TB), a positive skin test for TB, or you recently have been in close contact with someone who has had TB. Symptoms of TB may include:
  • a cough that does not go away
  • fever
  • weight loss
  • night sweats.
• a history of Epstein-Barr Virus (EBV) or Cytomegalovirus (CMV) if you are receiving Orencia for the preventative treatment of aGVHD during HSCT from an unrelated donor
• been scheduled to have surgery
• recently received a vaccination or are scheduled for a vaccination
• a history of a breathing problem called chronic obstructive pulmonary disease (COPD)
• have diabetes and use a blood glucose monitor to check your blood sugar (blood glucose) levels
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Some people treated with Orencia have developed skin cancer. Tell your healthcare provider if you have a family or personal history of skin cancer, or if you see any growths or changes in the appearance of your skin during or after treatment.

Pregnancy and breastfeeding

It is not known if Orencia can harm an unborn baby. If you inadvertently become pregnant while taking Orencia, register with the pregnancy registry by calling 1-877-311-8972. When your baby is born talk to your healthcare provider before your baby receives any vaccines.

It is not known if Orencia passes into breast milk. Talk to your healthcare provider about the best way to feed your baby.

How will I receive Orencia?

Orencia is usually injected as an infusion into the vein initially, and, depending on your condition, it can be self-administered at home as an injection under the skin. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

For the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and psoriatic arthritis

The first dose of Orencia may be given by a healthcare provider through a vein in your arm (intravenous infusion).

• The infusion takes about 30 minutes.
• The next dose will be 2 weeks later, then 4 weeks after the first dose, and then every 4 weeks thereafter.
• Intravenous administration of Orencia is not approved for pediatric patients with psoriatic arthritis. Orencia is injected under the skin when given to a child between 2 and 6 years old.

You may also receive Orencia as an injection under your skin (subcutaneous).

• For home use, Orencia comes in a prefilled syringe or a prefilled ClickJect autoinjector.
• If you want to self-administer Orencia your healthcare provider will train you or your caregiver on the right way to prepare and inject Orencia. Do not try to inject it until you have been shown the right way to do so.
• Your healthcare provider will advise you of the dose.

For the preventative treatment of aGVHD

Orencia is given by a healthcare provider through a vein in your arm over 60 minutes on the day before transplantation (Day 1).

• You will then receive ORENCIA on Days 5, 14, and 28 after transplantation.
• Your healthcare provider may give you antiviral medicines before, during, and after your transplantation to help prevent Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) infections.

What happens if I miss a dose?

Call your doctor for instructions if you miss your Orencia dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Orencia?

Do not receive a “live” vaccine while using Orencia, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What are the side effects of Orencia?

Get emergency medical help if you have signs of an allergic reaction to Orencia such as hives; difficulty breathing; or swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

Orencia may cause serious side effects, including:

• infections which may be serious or fatal. Call your healthcare provider right away if you have any symptoms of an infection, such as:
  • fever
  • flu-like symptoms
  • feeling very tired
  • warm, red, or painful skin
  • a cough
  • pain, or burning when you urinate.
• hepatitis B infection in people who carry the virus in their blood. Your healthcare provider may do a blood test before you start treatment
• breathing problems in people with Chronic Obstructive Pulmonary Disease (COPD). You may get certain respiratory problems more often if you receive ORENCIA and have COPD. Symptoms of respiratory problems include COPD that becomes worse, difficulty breathing, or a cough
• cancer (malignancies). Certain kinds of cancer have been reported in people using Orencia, including skin cancers. It is not known if Orencia increases your chance of getting cancer
• Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) infections in people receiving preventative treatment of aGVHD during unrelated HSCT. Your healthcare provider will monitor you for 6 months after transplantation and may treat you with medicines to help prevent CMV and EBV infection if needed.

The most common side effects of Orencia include:

• headache
• sore throat
• upper respiratory tract infection
• nausea.

In children and adolescents, other side effects may include:

• diarrhea
• fever
• cough
• abdominal pain.

The most common side effects of Orencia in the prevention of aGVHD include:

• low red blood cell count
• nosebleeds
• high blood pressure
• decreased CD4 lymphocytes
• CMV infection
• increased levels of magnesium in the blood
• fever
• kidney problems
• pneumonia.

These are not all the possible side effects of Orencia. Call your doctor for medical advice about side effects.

What other drugs will affect Orencia?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Orencia may affect the way other medicines work, and other medicines may affect the way it works causing serious side effects.

You may have a higher chance of getting a serious infection if you take ORENCIA with other biologic medicines that may affect your immune system. Especially tell your healthcare provider if you take other biologic medicines that may affect your immune system, such as:

• adalimumab
• anakinra
• certolizumab
• etanercept
• golimumab
• infliximab
• rituximab
• tocilizumab.

Orencia can cause false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way to test your blood sugar.

Orencia for intravenous infusion contains maltose, a type of sugar, that can give false high blood sugar readings with certain types of blood glucose monitors on the day of the infusion. Your healthcare provider may tell you to use a different way to monitor your blood sugar levels. Orencia for subcutaneous injection does not contain maltose.

This list is not complete. Other drugs may interact with abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Store in the refrigerator at 36°F to 46°F (2°C to 8°C) in its original package (protected from light). Do not freeze.

The prefilled syringe or autoinjector can be left out of the refrigerator for up to 6 hours (without light protection) if the temperature remains between 46°F to 77°F (8°C to 25°C).

Ingredients

Active: abatacept.

Intravenous, inactive: maltose, monobasic sodium phosphate, sodium chloride for administration.

Subcutaneous, inactive: sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, water for injection.

Manufacturer

Bristol-Myers Squibb Company.

Orencia Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Orencia.Orencia (abatacept) – Bristol-Myers Squibb Company

What is Otezla?

Otezla (apremilast) is used to treat plaque psoriasis, psoriatic arthritis, and mouth ulcers in Behcet’s disease. Otezla improves plaque psoriasis symptoms of scaling, itching, and skin redness, and reduces nail and scalp psoriasis symptoms. When used for psoriatic arthritis, Otezla improves inflammation, joint swelling, and pain.

Otezla works by blocking an enzyme called PDE4 that drives inflammation and the processes that cause plaque psoriasis, psoriatic arthritis symptoms, and Behcet’s disease mouth ulcers.

Otezla is an oral phosphodiesterase-4 (PDE-4) inhibitor; it is a selective immunosuppressant agent and is considered a class of immunomodulatory or immunosuppressive medication. It is not a biologic or steroid.

Otezla tablets are usually taken twice a day, after an initial dose increase over 5 days.

Otezla received FDA approval on March 21, 2014, for psoriatic arthritis. Since then, it has also been FDA-approved to treat types of plaque psoriasis and Behcet’s disease in specific patients. It is not available as a generic medicine.

Otezla Uses

• Plaque Psoriasis in adult patients with plaque psoriasis who require systemic therapy or light treatment (phototherapy).
  It can also be used for pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
• Psoriatic Arthritis in adult patients with active psoriatic arthritis.
• Behçet’s Disease for Oral Ulcers in adult patients.

How does Otezla work?

Otezla mechanism of action is by inhibiting phosphodiesterase 4 (PDE4), leading to an increase in intracellular cAMP levels, which is thought to reduce inflammatory proteins (cytokines) and increase anti-inflammatory mediators. This results in clinical improvements for the conditions being treated.

Otezla side effects

Common Otezla side effects

Common Otezla side effects are nausea, diarrhea, headache, vomiting, upper respiratory tract infection, upper abdominal pain, and cold symptoms such as a stuffy nose, sneezing, and sore throat.

These were the side effects that occurred for Otezla 30mg twice daily from day 6 to day 112 in the psoriatic arthritis clinical trials PsA-1 (NCT01172938), PsA-2 (NCT01212757), and PsA-3 (NCT01212770). Side effects that caused patients to stop taking tablets during the trials included nausea (1.8%), diarrhea (1.8%), and headache (1.2%).

Gastrointestinal side effects can occur when first starting therapy. To help reduce these side effects, the dose is started low and increased over the first 5 days. Otezla starter packs are available with the first 5 days of tablets, which makes initial dosing easy and convenient.

Serious Otezla side effects

Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Otezla may cause other serious side effects. Call your doctor at once if you have:

• severe diarrhea, nausea, and vomiting;
• unexplained weight loss, or if you lose a lot of weight;
• mood changes, new or worsening depression; or
• thoughts of suicide or hurting yourself.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects.

Warnings

Depression: Some people have thoughts about suicide while taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor. Carefully weigh the risks and benefits of treatment in patients with a history of depression and/or suicidal thoughts or behavior.

Nausea, vomiting, and diarrhea can be a severe complication of Otezla, and patients should contact their doctor if this occurs.

Hypersensitivity: Cases of swelling (angioedema) and anaphylaxis have been reported. Do not use this medicine in patients with known hypersensitivity to apremilast or any of the inactive ingredients:

Otezla weight loss: Otezla may cause weight loss. Monitor weight regularly. If clinically significant or unexpected weight loss occurs, evaluate the reason for weight loss and consider stopping this medicine.

Drug interactions: Medications that are strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) are not recommended because loss of efficacy may occur. See the Interactions section below.

What is the cost of Otezla?

With the Otezla copay card, you may pay as little as $0 if you have private or commercial insurance and meet the criteria. You can enrol in the Otezla copay program .

The cost of prescription drugs varies depending on your insurance plan, whether you have insurance, and which pharmacy you use. For more information on cost, which covers prices with or without insurance.

Before taking this medicine

You should not use Otezla if you are allergic to the active ingredient apremilast or any of the inactive ingredients.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• kidney disease; or
• depression or suicidal thoughts or actions.

Pregnancy:

Otezla may harm an unborn baby. It is important to use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of apremilast on the baby.

Breastfeeding:

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How should I take Otezla?

Otezla tablets should be swallowed whole; do not crush, chew, or break the tablet.
This medicine can be taken with or without food.

The Otezla dose is usually slowly increased over the first week to reduce gastrointestinal symptoms that may occur when this medication is first started. You may be given a Treatment Initiation Pack, with your starting doses pre-packed.

Take this medicine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Dosing information

Usual Adult Otezla Dose for Psoriatic Arthritis, Plaque Psoriasis, and Behcet’s disease

Adult starting dose:

• Day 1: 10 mg once a day in the morning
• Day 2: 10 mg twice a day (morning and evening)
• Day 3: 10 mg in the morning and 20 mg in the evening
• Day 4: 20 mg twice a day (morning and evening)
• Day 5: 20 mg in the morning and 30 mg in the evening, then maintenance dose.

Adult maintenance dose:

• 30 mg orally twice a day (morning and evening)

Usual Otezla Dose for Pediatric Patients

For Moderate to Severe Plaque Psoriasis who are 6 Years of Age and Older and Weighing at Least 20kg.

Starting dose for pediatric patients (20kg to less than 50 kg):

• Day 1: 10 mg once a day in the morning
• Day 2: 10 mg twice a day (morning and evening)
• Day 3: 10 mg in the morning and 20 mg in the evening
• Day 4: 20 mg twice a day (morning and evening), then maintenance dose.

Maintenance dose pediatric patients (20kg to less than 50 kg):

• 20 mg twice a day (morning and evening)

Starting dose for pediatric patients (50 kg or more):

• Day 1: 10 mg once a day in the morning
• Day 2: 10 mg twice a day (morning and evening)
• Day 3: 10 mg in the morning and 20 mg in the evening
• Day 4: 20 mg twice a day (morning and evening)
• Day 5: 20 mg in the morning and 30 mg in the evening, then maintenance dose.

Maintenance dose for pediatric patients (50 kg or more):

• 30 mg orally twice a day (morning and evening).

Otezla starter pack

Otezla starter packs contain the tablets required for the 5-day titration period, making initial dosing easier, but it is still important to follow your doctor’s instructions carefully.

General Dosing Comments

Keep track of your body weight while you are taking this medicine, and tell your doctor about any major weight loss.

Dosage adjustments are required in renal impairment.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect Otezla?

Sometimes, it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

When you are taking Otezla it is important to tell your doctor about all your current medicines and any medicine you start or stop using. It is especially important that your healthcare professional knows if you are taking any of the medications in the list below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using Otezla with any of the following medicines may not be recommended but may be necessary in some cases. If both medicines are to be used together, your doctor may change the dose or how often you use one or both of the medicines.

• Carbamazepine
• Enzalutamide
• Fosphenytoin
• Mitotane
• Phenytoin
• Primidone
• Rifabutin
• Rifampin
• Rifapentine
• St John’s Wort
• Tofacitinib

This list is not complete, and many other drugs can interact with Otezla. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you. Click the link below to check for interactions with this medication.

Does Otezla interact with my other drugs?

Enter medications to view a detailed interaction report .Drug nameAdd a drug to check interactionsAdd

Ingredients

Active ingredient: apremilast

Inactive ingredients:

10mg tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol (unspecified), titanium dioxide, polyethylene glycol (unspecified), talc, ferric oxide red.

20mg tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol (unspecified), titanium dioxide, polyethylene glycol (unspecified), talc, ferric oxide red, ferric oxide yellow.

30mg tablet: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, polyvinyl alcohol (unspecified), titanium dioxide, polyethylene glycol (unspecified), talc, ferric oxide red, ferric oxide yellow, ferrosoferric oxide.

What is Plaquenil?

Plaquenil is used to treat or prevent malaria, a disease caused by parasites that enter the body through the bite of a mosquito. Hydroxychloroquine is not effective against all strains of malaria, or against malaria in areas where the infection has been resistant to a similar drug called chloroquine.

Plaquenil is also used to treat symptoms of rheumatoid arthritis and discoid or systemic lupus erythematosus.

Warnings

Plaquenil can cause dangerous effects on your heart, especially if you also use certain other medicines including the antibiotic azithromycin (Z-Pak). Seek emergency medical attention if you have fast or pounding heartbeats and sudden dizziness (like you might pass out).

Taking Plaquenil long-term or at high doses may cause irreversible damage to the retina of your eye that could progress to permanent vision problems.

Stop taking Plaquenil and call your doctor at once if you have blurred vision, trouble focusing, distorted vision, blind spots, trouble reading, changes in your color vision, increased sensitivity to light.

Before taking this medicine

You should not use Plaquenil if you are allergic to hydroxychloroquine or chloroquine.

High doses or long-term use of Plaquenil may cause irreversible damage to your retina (the membrane layer inside your eye that helps produce vision). This could progress to permanent vision problems. The risk of retinal damage is higher in people with pre-existing eye problems, kidney disease, or people who also take tamoxifen.

To make sure Plaquenil is safe for you, tell your doctor if you have ever had:

• vision changes or damage to your retina caused by an anti-malaria medication;
• heart disease, heart rhythm disorder (such as long QT syndrome);
• diabetes;
• a stomach disorder;
• an allergy to quinine;
• liver or kidney disease;
• psoriasis;
• alcoholism;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system); or
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Tell your doctor if you are pregnant or plan to become pregnant. Malaria is more likely to cause serious illness or death in a pregnant woman. Having malaria during pregnancy may also increase the risk of miscarriage, stillbirth, premature delivery, and low birth weight.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of hydroxychloroquine on the baby.

It is not known whether hydroxychloroquine will harm an unborn baby. If you are pregnant, ask your doctor about the risks of traveling to areas where malaria is common (such as Africa, South America, and Southern Asia).

It may not be safe to breastfeed while using Plaquenil. Ask your doctor about any risk.

Plaquenil is not approved for treating lupus or rheumatoid arthritis in anyone younger than 18 years old.

How should I take Plaquenil?

Take Plaquenil exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take Plaquenil with a meal or a glass of milk unless your doctor tells you otherwise.

Do not crush or break a Plaquenil tablet.

To treat lupus or arthritis, Plaquenil is usually taken daily.

To prevent malaria: Plaquenil is usually taken once per week on the same day each week. Start taking the medicine 2 weeks before entering an area where malaria is common. Keep taking the medicine during your stay and for at least 4 weeks after you leave the area.

To treat malaria: Plaquenil is usually given as one high dose followed by smaller doses during the next 2 days in a row.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve.

Call your doctor as soon as possible if you have been exposed to malaria, or if you have fever or other symptoms of illness during or after a stay in an area where malaria is common.

Use protective clothing, insect repellents, and mosquito netting around your bed to further prevent mosquito bites that could cause malaria.

No medication is 100% effective in treating or preventing all types of malaria. Talk with your doctor if you have fever, vomiting, or diarrhea during your treatment.

While using Plaquenil, you may need frequent medical tests and vision exams.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose of Plaquenil for Malaria Prophylaxis:

400 mg salt (310 mg base) orally once a week

Weight-based dosing: 6.5 mg/kg salt (5 mg/kg base) orally once a week
-Maximum dose: 400 mg salt (310 mg base)/dose

Comments:
-This drug should be administered on the same day of each week.
-Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area.

Use: For the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

US CDC Recommendations: 310 mg base (400 mg salt) orally once a week

Comments:
-An alternative to chloroquine for prophylaxis only in areas with chloroquine-sensitive malaria
-Prophylaxis should start 1 to 2 weeks before travel to malarious areas; should continue weekly (same day each week) while in malarious areas and for 4 weeks after leaving such areas
-If malaria develops while using this drug for chemoprophylaxis, it should not be used as part of the treatment regimen.
-Current guidelines should be consulted for additional information.

Usual Adult Dose of Plaquenil for Malaria:

800 mg salt (620 mg base) orally as an initial dose, followed by 400 mg salt (310 mg base) at 6, 24, and 48 hours after the initial dose
Total dose: 2000 mg salt (1550 mg base)

Weight-based dosing:
-First dose: 13 mg/kg salt (10 mg/kg base) orally
-Second dose (6 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
-Third dose (24 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
-Fourth dose (48 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally

Maximum Dose:
-First dose: 800 mg salt (620 mg base)/dose
-Second, third, and fourth dose: 400 mg salt (310 mg base)/dose

Comments:
-Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of Plasmodium vivax and P ovale infections.

Use: For the treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

US CDC Recommendations: 620 mg base (800 mg salt) orally at once, followed by 310 mg base (400 mg salt) orally at 6, 24, and 48 hours
Total dose: 1550 mg base (2000 mg salt)

Comments:
-Recommended for uncomplicated malaria (P falciparum or species not identified) in regions with chloroquine sensitivity
-Recommended for uncomplicated malaria (P malariae, P knowlesi, P vivax [unless chloroquine-resistant P vivax suspected], or P ovale) in all regions; if treating P vivax or P ovale infections, concomitant treatment with primaquine (after quantitative testing to rule out glucose-6-phosphate dehydrogenase [G6PD] deficiency) is recommended.
-Recommended for uncomplicated malaria treatment for pregnant women in regions with chloroquine sensitivity
-Current guidelines should be consulted for additional information.

Usual Adult Dose of Plaquenil for Systemic Lupus Erythematosus:

200 to 400 mg salt (155 to 310 mg base)/day orally divided in 1 or 2 doses

Comments:
-Doses above 400 mg/day are not recommended.

Uses: For the treatment of chronic discoid lupus erythematosus and systemic lupus erythematosus

Usual Adult Dose of Plaquenil or Rheumatoid Arthritis:

Initial dose: 400 to 600 mg salt (310 to 465 mg base)/day orally divided in 1 or 2 doses
Maintenance dose: 200 to 400 mg salt (155 to 310 mg base)/day orally divided in 1 or 2 doses

Comments:
-The action of this drug is cumulative and may require weeks to months to achieve the maximum therapeutic effect.
-When a good response is obtained, the initial dose may be reduced by 50% and continued at a maintenance dose.
-Corticosteroids and salicylates may be used with this drug, and they can generally be decreased gradually in dosage or eliminated after a maintenance dose of this drug has been achieved.

Use: For the treatment of acute and chronic rheumatoid arthritis

Usual Pediatric Dose of Plaquenil for Malaria Prophylaxis:

6.5 mg/kg salt (5 mg/kg base) orally once a week
Maximum dose: 400 mg salt (310 mg base)/dose

Comments:
-This drug should be administered on the same day of each week.
-Suppressive therapy should begin 2 weeks prior to exposure and should continue for 4 weeks after leaving the endemic area.

Use: For the prophylaxis of malaria in geographic areas where chloroquine resistance is not reported

US CDC Recommendations: 5 mg/kg base (6.5 mg/kg salt) orally once a week
Maximum dose: 310 mg base (400 mg salt)/dose

Comments:
-An alternative to chloroquine for prophylaxis only in areas with chloroquine-sensitive malaria
-Prophylaxis should start 1 to 2 weeks before travel to malarious areas; should continue weekly (same day each week) while in malarious areas and for 4 weeks after leaving such areas
-If malaria develops while using this drug for chemoprophylaxis, it should not be used as part of the treatment regimen.
-Current guidelines should be consulted for additional information.

Usual Pediatric Dose of Plaquenil for Malaria:

First dose: 13 mg/kg salt (10 mg/kg base) orally
Second dose (6 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
Third dose (24 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally
Fourth dose (48 hours after first dose): 6.5 mg/kg salt (5 mg/kg base) orally

Maximum Dose:
-First dose: 800 mg salt (620 mg base)/dose
-Second, third, and fourth dose: 400 mg salt (310 mg base)/dose

Comments:
-Concomitant therapy with an 8-aminoquinoline compound is necessary for radical cure of P vivax and P ovale infections.

Use: For the treatment of uncomplicated malaria due to P falciparum, P malariae, P ovale, and P vivax

US CDC Recommendations: 10 mg/kg base orally at once, followed by 5 mg/kg base orally at 6, 24, and 48 hours
Total dose: 25 mg/kg base

Comments:
-Pediatric dose should never exceed adult dose.
-Recommended for uncomplicated malaria (P falciparum or species not identified) in regions with chloroquine sensitivity
-Recommended for uncomplicated malaria (P malariae, P knowlesi, P vivax [unless chloroquine-resistant P vivax suspected], or P ovale) in all regions; if treating P vivax or P ovale infections, concomitant treatment with primaquine (after quantitative testing to rule out G6PD deficiency) is recommended.
-Current guidelines should be consulted for additional information.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line . An overdose of hydroxychloroquine can be fatal, and must be treated quickly.

Overdose symptoms may include drowsiness, vision changes, seizure, slow heart rate, weak pulse, pounding heartbeats, sudden dizziness, fainting, shortness of breath, or slow breathing (breathing may stop).

Keep this medicine out of the reach of children. A hydroxychloroquine overdose can be fatal to a child who accidentally swallows this medicine.

What to avoid

This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Avoid taking an antacid or Kaopectate (kaolin-pectin) within 4 hours before or 4 hours after you take Plaquenil.

Plaquenil side effects

Get emergency medical help if you have signs of an allergic reaction to Plaquenil (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Also seek emergency medical attention if you have symptoms of a serious heart problem: fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).

Call your doctor at once if you have:

• a seizure;
• yellowing of your eyes;
• ringing in your ears, trouble hearing;
• unusual mood changes;
• severe muscle weakness, loss of coordination, underactive reflexes;
• any sudden changes in mood or behavior, or thoughts about suicide;
• low blood cell counts – fever, chills, tiredness, sore throat, mouth sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• low blood sugar – headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; or
• a serious drug reaction that can affect many parts of your body – skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Taking Plaquenil long-term or at high doses may cause irreversible damage to the retina of your eye. Stop taking Plaquenil and tell your doctor if you have:

• blurred vision, trouble focusing, trouble reading;
• distorted vision, blind spots;
• changes in your color vision;
• hazy or cloudy vision;
• seeing light flashes or streaks, seeing halos around lights; or
• increased sensitivity to light.

Common Plaquenil side effects may include:

• headache, dizziness;
• nausea, vomiting, stomach pain;
• loss of appetite, weight loss;
• feeling nervous or irritable;
• skin rash or itching; or
• hair loss.

What is Remicade?

Remicade reduces the effects of a substance in the body that can cause inflammation.

Remicade is used to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and severe or disabling plaque psoriasis in adults.

Remicade is also used to treat ulcerative colitis and Crohn’s disease in adults and children at least 6 years old.

Infliximab is often used when other medicines have not been effective.

Warnings

You should not use Remicade if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia).

Using Remicade may increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal. Ask your doctor about your specific risk.

Remicade affects your immune system. You may get infections more easily, even serious or fatal infections. Before you start using Remicade, your doctor may perform tests to make sure you do not have certain infections. Call your doctor if you have a fever, tiredness, flu symptoms, cough, or skin pain.

Before taking this medicine

Tell your doctor if you have ever had tuberculosis (TB), or anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

To make sure Remicade is safe for you, tell your doctor if you have ever had:

• heart failure or other heart problems;
• an active infection (fever, cough, flu symptoms, open sores or skin wounds);
• diabetes;
• liver failure, hepatitis B, or other liver problems;
• chronic obstructive pulmonary disease (COPD);
• heart problems;
• cancer;
• a weak immune system;
• seizures;
• numbness or tingling anywhere in your body;
• a nerve-muscle disorder, such as multiple sclerosis or Guillain-Barré syndrome;
• phototherapy for psoriasis;
• vaccination with BCG (Bacille Calmette-Guérin); or
• if you are scheduled to receive any vaccines.

Make sure your child is current on all vaccines before he or she starts treatment with Remicade.

Remicade may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Remicade may cause other types of cancer, such as skin cancer or cancer of the cervix. Ask your doctor about this risk.

If you use infliximab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to infliximab in the womb could affect your baby’s vaccination schedule during the first 6 months of life.

You should not breastfeed while you are receiving infliximab.

Remicade is not for use in children younger than 6 years old.

How is Remicade given?

Before you start treatment with Remicade, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Remicade is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 2 hours to complete.

You may be watched closely after receiving infliximab, to make sure the medicine has not caused any serious side effects.

Infliximab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis, and you may need frequent TB tests.

Serious infections may be more likely in older adults.

If you need surgery, tell the surgeon ahead of time that you are using Remicade.

If you’ve ever had hepatitis B, using infliximab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your Remicade injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Remicade?

Avoid activities that may increase your risk of bleeding injury.

Do not receive a “live” vaccine while using infliximab, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, and varicella (chickenpox).

Remicade side effects

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy or tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

Get emergency medical help if you have signs of an allergic reaction to Remicade: hives; chest pain, difficult breathing; fever, chills, severe dizziness; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with Remicade. Call your doctor right away if you have signs of infection such as: fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, warmth, or redness).

Also call your doctor if you have:

• skin changes, new growths on the skin;
• pale skin, easy bruising or bleeding;
• delayed allergic reaction (up to 12 days after receiving Remicade) – fever, sore throat, trouble swallowing, headache, joint or muscle pain, skin rash, or swelling in your face or hands;
• liver problems – right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes (jaundice), and not feeling well;
• lupus-like syndrome – joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);
• nerve problems – numbness or tingling, problems with vision, weakness in your arms or legs, seizure;
• new or worsening psoriasis – skin redness or scaly patches, raised bumps filled with pus;
• signs of heart failure – shortness of breath with swelling of your ankles or feet, rapid weight gain;
• signs of a stroke – sudden numbness or weakness, trouble speaking or understanding what is said to you, problems with vision or balance, severe headache;
• signs of lymphoma – fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin); or
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

Serious infections may be more likely in adults who are 65 years or older.

Common Remicade side effects may include:

• stuffy nose, sinus pain;
• fever, chills, sore throat;
• cough, chest pain, shortness of breath;
• high or low blood pressure;
• headache, feeling light-headed;
• rash, itching; or
• stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What other drugs will affect Remicade?

Tell your doctor about all your other medicines, especially:

• abatacept;
• anakinra;
• tocilizumab;
• any “biologic” medications to treat your condition – adalimumab, certolizumab, etanercept, golimumab, natalizumab, rituximab, and others; or
• any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis.

This list is not complete. Other drugs may interact with infliximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Remicade Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There are 2 for Remicade.Remicade (infliximab) – Janssen Biotech, Inc.

What is Rinvoq?

Rinvoq (upadacitinib) is an oral Janus kinase (JAK) inhibitor that may be used alone or in combination with other medications to treat several conditions that have inflammation as a characteristic symptom. It works by decreasing the activity of the immune system. Rinvoq is used to treat:

• Rheumatoid arthritis in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s)
• Psoriatic arthritis (a condition that causes joint pain and swelling, and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s)
• Symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years and older who cannot use other medications for their condition, or whose eczema has not responded to other medications
• Ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults who cannot take or who did not respond to one or more TNF inhibitor medication(s)
• Ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Giant cell arteritis (an inflammatory condition of the temporal arteries) in adults
• Active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling), but without changes seen on X-ray, in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Active polyarticular juvenile idiopathic arthritis in children 2 years and older who have had an inadequate response or intolerance to one or more TNF blockers.

There are two formulations of Rinvoq: Rinvoq extended-release tablets and Rinvoq LQ liquid solution. These two formulations are not interchangeable. Rinvoq is not a substitute for Rinvoq LQ.

• Rinvoq is not recommended in combination with other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine.

Rinvoq was FDA approved on August 16, 2019, and Rinvoq LQ was approved on April 26, 2024. 

What is the cost of Rinvoq?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of Rinvoq.

You may also be eligible for a Rinvoq savings card or Rinvoq coupon. Ask your doctor or pharmacist if you qualify.

Rinvoq side effects

Get emergency medical help if you have signs of an allergic reaction to Rinvoq: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Upadacitinib affects your immune system and may cause certain white blood cells to grow out of control. Call your doctor right away if you have:

• fever, swollen glands, night sweats;
• vomiting, diarrhea, weight loss;
• a new skin lesion, or a mole that has changed in size or color;
• weakness on one side of your body, problems with speech or vision;
• changes in your mental state;
• blood in your urine, burning when you urinate, little or no urination; or
• tenderness near the transplanted kidney.

Some people taking Rinvoq have developed heart attacks, strokes, or serious blood clots. Seek emergency medical attention if you have:

• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke – sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung – chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or
• signs of a blood clot deep in the body – pain, swelling, or warmth in one leg.

Rinvoq may cause serious side effects. Call your doctor at once if you have:

• wheezing, trouble breathing, severe or worsening cough;
• increased urination, pain, or burning when you urinate;
• fever, chills, cough with mucus, chest pain, feeling short of breath;
• abnormal blood tests;
• signs of tuberculosis – fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired;
• signs of shingles – flu-like symptoms, tingly or painful blistering rash on one side of your body;
• symptoms of herpes virus – cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;
• signs of infection – fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;
• a hole (perforation) in your digestive tract – fever, severe stomach pain, change in bowel habits; or
• signs of hepatitis – loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common Rinvoq side effects may include:

• flu symptoms or fever;
• nausea;
• acne or a rash;
• headache;
• stomach pain;
• weight gain;
• muscle pain;
• folliculitis (redness or crusting around your hair follicles);
• cold symptoms such as stuffy nose, sneezing, sore throat;
• low white blood cell counts – fever, mouth sores, skin sores, sore throat, cough; or
• low red blood cells (anemia) – pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. Y

Warnings

Rinvoq carries a Boxed Warning for serious infections, mortality, cancer, major adverse cardiovascular events, and thrombosis.

Taking Rinvoq may increase your risk of life-threatening medical problems, including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer. A higher rate of serious infections was observed with Rinvoq 30 mg tablets compared to 15 mg tablets.

Call your doctor right away if you have a fever, night sweats, constant tiredness, weight loss, stomach pain, diarrhea, or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.

Seek emergency medical attention if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea, severe dizziness, a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.

If you’ve had hepatitis B, it may come back or get worse. Tell your doctor if you don’t feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not take Rinvoq if you are allergic to upadacitinib, Rinvoq, or any excipients in the tablets or oral solution.

Before you start taking Rinvoq, tell your doctor if you have any signs of infection, such as fever, sweating, chills, cough, body aches, tiredness, open sores or skin wounds, shortness of breath, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

To make sure Rinvoq is safe for you, tell your doctor if you have ever had:

• a weak immune system or HIV;
• an active or chronic infection;
• tuberculosis (or if anyone in your household has tuberculosis);
• herpes zoster (also called shingles);
• any type of cancer;
• diverticulitis, an ulcer in your stomach or intestines, or unexplained stomach pain;
• heart problems, heart attack, stroke, or blood clot;
• high cholesterol;
• chronic lung disease;
• eye problems (especially a problem with your retina);
• diabetes;
• low red or white blood cell counts;
• recently received or scheduled to receive any vaccine;
• are a current or past smoker;
• liver disease (especially hepatitis B or C); or
• kidney disease
• are pregnant or intending to become pregnant
• are breastfeeding.

Make sure you are current on all vaccines before you start using Rinvoq.

Using Rinvoq may increase your risk of developing certain cancers, such as lymphoma, lung cancer, or skin cancer. Ask your doctor about this risk.

Pregnancy

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Use effective birth control while using Rinvoq and for at least 4 weeks after your last dose. Tell your doctor if you become pregnant.

There is a pregnancy surveillance program for Rinvoq. The program’s purpose is to collect information about your and your baby’s health.

Breastfeeding

Do not breastfeed while using this medicine, and for at least 6 days after your last dose.

How should I take Rinvoq?

Take Rinvoq exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Rinvoq tablets

Rinvoq tablets are usually taken once per day, with or without food.

• Swallow the tablet whole and do not crush, chew, or break a tablet.
• Call your doctor if you see part of the Rinvoq tablet in your stool.
• You may need frequent medical tests before and while taking Rinvoq.

Store this medicine in the original container at room temperature away from moisture and heat.

Rinvoq LQ

Rinvoq LQ is not the same as Rinvoq tablets. Do not switch between Rinvoq LQ and Rinvoq tablets.

Your healthcare provider will tell you what dose to give. This is based on you or your child’s weight. The dosage is usually given twice daily.

• Only use the syringe provided. Do not share with other people or use with other medicines. The syringe should be clean and dry before use.
• The first time you use a new bottle of Rinvoq LQ, you will need to insert the syringe adapter. Once inserted, do not remove.
• Insert the syringe tip into the adapter, then turn the bottle upside down.
• Pull the plunger down and flick the syringe to remove large air bubbles. Small air bubbles are normal.
• Measure the dose. Move the plunger until it is even with the marking for the dose.
• Turn the bottle upright, carefully remove the syringe, and place the lid back on the bottle.
• Check that the dose is correct. If correct, place the syringe against the inside of your child’s cheek and push the plunger to give the entire dose into the child’s mouth. The solution must be given within 1 hour of filling the syringe.
• Give the child a drink of water.
• Remove the plunger from the syringe and rinse both parts in water, then leave to dry.

Dosing Information

Dose of Rinvoq for Rheumatoid Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis (Adults)

• 15 mg orally once a day

Rinvoq may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

• Not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) of less than 1000 cells/mm³, or hemoglobin level of less than 8 g/dL.

Dose of Rinvoq for Psoriatic Arthritis

• Adults: 15 mg orally once daily
• Children aged 2 to less than 18 years weighing at least 10 kg: the dosage is based on body weight.

Dose of Rinvoq for Atopic Dermatitis

• Adults less than 65 years and children 12 years and older weighing at least 40kg:
  • Initiation dose: 15 mg orally once daily
  • Maximum dose: 30 mg orally once daily (if no response with the initial dose).
• Adults 65 years and older: 15 mg once daily.
• Severe renal impairment: 15 mg once daily. 

Use the lowest dose to maintain the response.

• Not recommended to use in combination with other JAK inhibitors, biological immunomodulators, or other immunosuppressants.

Dose of Rinvoq for Ulcerative Colitis (Adults)

• Induction dose: 45 mg once daily for 8 weeks.
• Maintenance dose: 15 mg once daily.
  • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
  • Dosage modification may be needed for kidney or liver impairment, or with
    drug interactions. 

Dose of Rinvoq for Crohn’s Disease (Adults)

• Induction dose: 45 mg once daily for 12 weeks.
• Maintenance dose: 15 mg once daily.
  • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
  • Dosage modification may be needed for kidney or liver impairment or with
    drug interactions. 

Dose of Rinvoq for Polyarticular Juvenile Idiopathic Arthritis

• The recommended dosage is based on body weight.

Dose of Rinvoq for Giant Cell Arteritis (Adults)

• Adults: 15 mg orally once daily in combination with a tapering dose of corticosteroids.
• Can be used as monotherapy following discontinuation of corticosteroids.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

 If you take too much Rinvoq/Rinvoq LQ, call your healthcare provider or Poison Help line or go to the nearest hospital emergency room. 

What should I avoid while taking Rinvoq?

Avoid receiving a “live” vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

What is Rituxan?

Rituxan is used to treat certain leukemias and lymphomas and some non-cancer conditions, such as rheumatoid arthritis, polyangiitis, and pemphigus vulgaris. It is given by IV infusion (an infusion into a vein) by a healthcare provider.

Rituxan infusion is not chemotherapy; it is a type of immunotherapy called a targeted cancer treatment.

Rituxan (rituximab) gained FDA approval on November 26, 1997. Rituxan has 3 biosimilars: Riabni, Ruxience, and Truxima. A biosimilar is a biological product that is similar to a reference biologic (usually the originally approved product) and for which there are no clinically meaningful differences in terms of safety, purity, and potency.

FDA approvals and indications

Rituxan is approved to treat:

• Non-Hodgkin’s lymphoma (NHL) in adults.
  • Relapsed or refractory, low-grade or follicular, CD20-positive B-cell NHL as a single agent, or
  • Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy, or
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy, or
  • Previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens.
• Mature B-cell Non-Hodgkin’s lymphoma (NHL) and mature B-cell acute leukemia (B-AL) in children 6 months and older.
  • Previously untreated, advanced-stage, CD20-positive, diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL), or mature B-cell acute leukemia (B-AL) in combination with chemotherapy.
• Chronic lymphocytic leukemia in adults.
  • Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC).
• Rheumatoid arthritis (RA) in combination with methotrexate in adult patients with moderately to severely active RA who have inadequate response to one or more TNF antagonist therapies.
• Granulomatosis with Polyangiitis (GPA, Wegener’s granulomatosis) and Microscopic Polyangiitis (MPA) in adults and children 2 years and older, in combination with glucocorticoids.
• Moderate to severe Pemphigus Vulgaris (PV) in adults.

Rituxan is not approved for:

• Children aged less than 2 years with GPA or MPA
• Children less than 6 months of age with mature B-cell NHL and B-AL
• Children with conditions other than GPA, MPA, B-cell NHL, and B-AL.

How Rituxan works

Rituxan is a targeted therapy that attaches to CD20, a protein found on the surface of B cells. As a type of white blood cell in your immune system, B cells normally help fight infections, but they can also contribute to certain diseases. When Rituxan binds to the CD20 protein, it triggers two key mechanisms to destroy these B cells:

1. It activates your body’s complement system, which directly attacks and eliminates the B cells
2. It flags the B cells for destruction by other immune cells in a process called antibody-dependent cell-mediated cytotoxicity.

This targeted elimination of B cells makes Rituxan effective for treating various conditions where B cells play a harmful role, including:

• B-cell cancers such as Non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL)
• Autoimmune disorders such as rheumatoid arthritis, where B cells contribute to inflammation and joint damage.

By precisely targeting problematic B cells, rituximab helps control these conditions while minimizing impact on other parts of the immune system.

Side effects

The most common side effects of Rituxan infusion are:

• infusion-related reactions
• infections (may include fever, chills)
• body aches
• tiredness
• nausea.

In adults with GPA or MPA, the most common side effects of Rituxan also include:

• low white and red blood cells
• swelling
• diarrhea
• muscle spasms.

In children with B-cell NHL or B-AL who receive Rituxan with chemotherapy, the most common side effects are:

• decreased white blood cells with fever
• mouth sores
• inflammation of the upper intestine
• serious infection throughout the body and organs (sepsis)
• changes in liver function blood tests
• low level of potassium in the blood

Other side effects of Rituxan are:

• aching joints during or within hours of receiving an infusion
• more frequent upper respiratory tract infections.

These are not all of the possible side effects of Rituxan. Call your doctor for medical advice about side effects. You may report side effects to the FDA .

Serious side effects and warnings

Rituxan carries a Boxed Warning for fatal infusion-related reactions, severe skin reactions, hepatitis B virus reactivation, and a rare brain condition called progressive multifocal leukoencephalopathy (PML).

Rituxan can cause the following serious side effects:

• Infusion-related reactions. These are a common side effect of R. Serious infusion-related reactions can happen during your or your child’s infusion or within 24 hours after. Your healthcare provider should give you or your child medicines before your Rituxan infusion to decrease the chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you or your child gets any of these symptoms during or after an infusion:
  • hives (red itchy welts) or rash
  • shortness of breath, difficulty breathing, or wheezing
  • itching
  • weakness
  • swelling of your lips, tongue, throat, or face
  • dizziness or feeling faint
  • sudden cough
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain.
• Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you or your child gets any of these symptoms at any time during your treatment with Rituxan:
  • painful sores or ulcers on your skin, lips, or in your mouth
  • blisters
  • peeling skin
  • rash
  • pustules.
• Hepatitis B virus (HBV) reactivation. Before you or your child receives Rituxan treatment, your healthcare provider will do blood tests to check for HBV infection. If you or your child has had hepatitis B or is a carrier of the hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You or your child should not receive Rituxan if you or your child has active hepatitis B liver disease. Your healthcare provider will monitor you or your child for hepatitis B infection during and for several months after you or your child stops receiving Rituxan. Tell your healthcare provider immediately if you or your child gets worsening tiredness, or yellowing of your or your child’s skin or white part of your eyes, during treatment.
• Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you or your child has any new or worsening symptoms or if anyone close to you notices these symptoms:
  • confusion
  • dizziness or loss of balance
  • decreased strength or weakness on one side of your body
  • difficulty walking or talking
  • vision problems.
• Tumor Lysis Syndrome (TLS). TLS is caused by the rapid breakdown of cancer cells. TLS can cause you or your child to have:
  • kidney failure and need dialysis treatment
  • an abnormal heart rhythm.

TLS can happen within 12 to 24 hours after an infusion of Rituxan. Your healthcare provider may do blood tests to check you or your child for TLS. Your healthcare provider may give you or your child medicine to help prevent TLS. Tell your healthcare provider right away if you or your child has any of the following signs or symptoms of TLS:

• • nausea
  • diarrhea
  • vomiting
  • lack of energy.
• Serious infections. Serious infections can happen during and after treatment with Rituxan, and can lead to death. Rituxan can increase your or your child’s risk of getting infections and can lower the ability of your or your child’s immune system to fight infections. Types of serious infections that can happen with Rituxan include bacterial, fungal, and viral infections. After receiving Rituxan, some people have developed low levels of certain antibodies in their blood for a long period (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive Rituxan. Tell your healthcare provider right away if you or your child has any symptoms of infection:
  • fever
  • cold symptoms, such as a runny nose or sore throat that do not go away
  • flu symptoms, such as cough, tiredness, and body aches
  • earache or headache
  • pain during urination
  • cold sores in the mouth or throat
  • cuts, scrapes, or incisions that are red, warm, swollen, or painful.
• Heart problems. Rituxan may cause chest pain, irregular heartbeats, and a heart attack. Your healthcare provider may monitor your or your child’s heart during and after treatment with Rituxan if you or your child has symptoms or heart problems or has a history of heart problems. Tell your healthcare provider right away if you or your child has chest pain or irregular heartbeats during treatment with Rituxan.
• Kidney problems, especially if you or your child are receiving Rituxan for NHL. Rituxan can cause severe kidney problems that can lead to death. Your healthcare provider should do blood tests to check how well your or your child’s kidneys are working.
• Stomach and serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel, can happen if you or your child receives Rituxan with chemotherapy medicines. Tell your healthcare provider right away if you or your child has any severe stomach-area (abdomen) pain or repeated vomiting during treatment with Rituxan.

Your healthcare provider will stop treatment with Rituxan if you have severe, serious, or life-threatening side effects.

Get emergency medical help if you have signs of an allergic reaction to Rituxan, such as hives, difficulty breathing, swelling in your face or throat, or a severe skin reaction (symptoms may include fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

These are not all of the possible side effects of Rituxan. Call your doctor for medical advice about side effects.

Before taking this medicine

Before you or your child receives Rituxan, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• have had a severe reaction to Rituxan or a rituximab product
• have a history of heart problems, irregular heartbeat, or chest pain
• have lung, liver, or kidney problems
• have an infection or a weakened immune system
• have or have had any severe infections, including:
  • Hepatitis B virus (HBV)
  • Parvovirus B19
  • Hepatitis C virus (HCV)
  • Varicella zoster virus (chickenpox or shingles)
  • Cytomegalovirus (CMV)
  • West Nile Virus
  • Herpes simplex virus (HSV).
• have had a recent vaccination or are scheduled to receive vaccinations. You or your child should not receive certain vaccines before or during treatment with Rituxan. You should be up-to-date on any needed immunizations before starting treatment with Rituxan.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Rituxan may harm an unborn baby. Talk to your healthcare provider about the risks to an unborn baby if you or someone you are caring for receives Rituxan during pregnancy. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test to check for pregnancy before starting Rituxan.

Effective birth control (contraception) should be used during treatment with Rituxan and for 12 months after the last dose. Talk to your healthcare provider about effective birth control.

Tell your healthcare provider right away if you or your child becomes pregnant or think you may be pregnant during treatment with Rituxan.

Breastfeeding

Rituxan may pass into your breast milk. It is not safe to breastfeed a baby while you are using this medicine. Do not breastfeed during treatment and for 6 months after your or your child’s last dose of Rituxan.

How is Rituxan administered?

Rituxan is given by infusion through your or your child’s central catheter or a needle placed in a vein (intravenous infusion), in you or your child’s arm. A healthcare provider will give you this injection.

• Your healthcare provider may prescribe medicines before each infusion of Rituxan to reduce infusion side effects such as fever and chills.
• Rituxan is not given daily. Your Rituxan dosing schedule will depend on the condition being treated. Follow your doctor’s dosing instructions very carefully.
• Your healthcare provider should do blood tests regularly to check for side effects of Rituxan.
• Before each Rituxan treatment, your healthcare provider or nurse will ask you questions about your or your child’s general health. Tell your healthcare provider or nurse about any new symptoms.

If you need surgery, tell the surgeon beforehand that you are using this medicine.

Call your doctor at once if you have any of these other side effects, even if they occur several months after you receive Rituxan, or after your treatment ends.

• painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus;
• redness, warmth, or swelling of the skin;
• severe stomach pain, vomiting, constipation, bloody or tarry stools;
• irregular heartbeats, chest pain or pressure, pain spreading to your jaw or shoulder;
• tiredness or jaundice (yellowing of the skin or eyes);
• signs of infection – fever, chills, cold or flu symptoms, cough, sore throat, mouth sores, headache, earache, pain or burning when you urinate; or
• signs of tumor cell breakdown – confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet, or around your mouth.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your Rituxan infusion.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving Rituxan?

Do not receive a “live” vaccine while receiving Rituxan, and avoid coming into contact with anyone who has recently received a live vaccine.

There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and the nasal flu (influenza) vaccine.

What other drugs will affect Rituxan?

Tell your healthcare provider about all the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you or your child takes or has taken:

• a Tumor Necrosis Factor (TNF) inhibitor medicine such as adalimumab, certolizumab, etanercept, or golimumab, infliximab
• a Disease Modifying Anti-Rheumatic Drug (DMARD) such as leflunomide, methotrexate, or sulfasalazine
• chemotherapy drugs, especially cisplatin.

If you are not sure if your or your child’s medicine is one listed above, ask your healthcare provider. This list is not complete. Other drugs may interact with Rituxan, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Rituxan infusion ingredients

Active ingredient: rituximab
Inactive ingredients: polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP.

Available as Rituxan injection for infusion, 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution in single-dose vials.

Manufacturer

Rituxan (rituximab) is jointly marketed by two pharmaceutical companies, Genentech (a member of the Roche Group) and Biogen.

• Genentech’s headquarters are located in South San Francisco, California, USA.
• Biogen’s headquarters are located in Cambridge, Massachusetts, USA.

The drug was originally developed through a collaboration between these two companies, and they continue to co-market it in the United States, while Roche markets rituximab internationally under various brand names, including MabThera in many countries.

Rituxan Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Rituxan.Rituxan (rituximab) – Genentech, Inc.

What is rituximab?

Rituximab infusion is used to treat certain leukemias and lymphomas and some non-cancer conditions, such as rheumatoid arthritis, polyangiitis, and pemphigus vulgaris, depending on the brand. Brand names include Rituxan, Riabni, Ruxience, and Truxima. Rituximab is given by IV infusion (an infusion into a vein) by a healthcare provider.

Rituximab is not chemotherapy, it is a type of immunotherapy called a targeted cancer treatment.

Rituximab gained FDA approval on November 26, 1997, under the brand name Rituxan. Biosimilars to Rituxan followed, with:

• Truxima (rituximab-abbs), approved on November 28, 2018
• Ruxience (rituximab-pvvr), approved on July 23, 2019
• Riabni (rituximab-arrx), approved on December 17, 2020.

Truxima, Ruxience, and Riabni are not approved for use in children or for pemphigus vulgaris. Only Rituxan can be used in children or for pemphigus vulgaris.

FDA approvals and indications

Rituximab (Rituxan, Truxima, Ruxience, Riabri) is approved to treat:

• Non-Hodgkin’s lymphoma in adults alone or with other chemotherapy medicines
• Chronic lymphocytic leukemia in adults, in combination with the chemotherapy medicines fludarabine and cyclophosphamide
• Rheumatoid arthritis (RA) in adults, in combination with methotrexate, to reduce signs and symptoms of moderate to severely active RA after an inadequate response to treatment with a Tumor Necrosis Factor (TNF) antagonist
• Granulomatosis with Polyangiitis (GPA, Wegener’s granulomatosis) and Microscopic Polyangiitis (MPA) in adults, in combination with glucocorticoids.

The Rituxan brand of rituximab is also approved to treat:

• Mature B-cell Non-Hodgkin’s lymphoma (NHL) and mature B-cell acute leukemia (B-AL) in children 6 months and older, in combination with chemotherapy medicines
• Granulomatosis with Polyangiitis (GPA, Wegener’s granulomatosis) and Microscopic Polyangiitis (MPA) in children 2 years and older, in combination with glucocorticoids
• Moderate to severe pemphigus vulgaris in adults.

Rituximab is not approved for:

• Children aged less than 2 years with GPA or MPA
• Children less than 6 months of age with mature B-cell NHL and B-AL
• Children with conditions other than GPA, MPA, B-cell NHL, and B-AL.

How rituximab works

Rituximab is a targeted therapy that attaches to CD20, a protein found on the surface of B cells. As a type of white blood cell in your immune system, B cells normally help fight infections, but they can also contribute to certain diseases. When rituximab binds to the CD20 protein, it triggers two key mechanisms to destroy these B cells:

1. It activates your body’s complement system, which directly attacks and eliminates the B cells
2. It flags the B cells for destruction by other immune cells in a process called antibody-dependent cell-mediated cytotoxicity.

This targeted elimination of B cells makes rituximab effective for treating various conditions where B cells play a harmful role, including:

• B-cell cancers such as Non-Hodgkin lymphoma and chronic lymphocytic leukemia (CLL)
• Autoimmune disorders like rheumatoid arthritis, where B cells contribute to inflammation and joint damage.

By precisely targeting problematic B cells, rituximab helps control these conditions while minimizing impact on other parts of the immune system.

Side effects

The most common side effects of rituximab are:

• infusion-related reactions
• infections (may include fever, chills)
• body aches
• tiredness
• nausea.

In adults with GPA or MPA, the most common side effects of rituximab also include:

• low white and red blood cells
• swelling
• diarrhea
• muscle spasms.

In children with B-cell NHL or B-AL who receive rituximab with chemotherapy, the most common side effects are:

• decreased white blood cells with fever
• mouth sores
• inflammation of the upper intestine
• serious infection throughout the body and organs (sepsis)
• changes in liver function blood tests
• low level of potassium in the blood

Other side effects of rituximab are:

• aching joints during or within hours of receiving an infusion
• more frequent upper respiratory tract infections.

These are not all of the possible side effects of rituximab. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Serious side effects and warnings

Rituximab carries a Boxed Warning for fatal infusion-related reactions, severe skin reactions, hepatitis B virus reactivation, and a rare brain condition called progressive multifocal leukoencephalopathy (PML).

Rituximab can cause the following serious side effects:

• Infusion-related reactions. These are very common side effects of rituximab treatment. Serious infusion-related reactions can happen during your or your child’s infusion or within 24 hours after. Your healthcare provider should give you or your child medicines before your rituximab infusion to decrease the chance of having a severe infusion-related reaction. Tell your healthcare provider or get medical help right away if you or your child gets any of these symptoms during or after an infusion:
  • hives (red itchy welts) or rash
  • shortness of breath, difficulty breathing, or wheezing
  • itching
  • weakness
  • swelling of your lips, tongue, throat, or face
  • dizziness or feeling faint
  • sudden cough
  • palpitations (feel like your heart is racing or fluttering)
  • chest pain.
• Severe skin and mouth reactions. Tell your healthcare provider or get medical help right away if you or your child gets any of these symptoms at any time during your treatment with rituximab:
  • painful sores or ulcers on your skin, lips, or in your mouth
  • blisters
  • peeling skin
  • rash
  • pustules.
• Hepatitis B virus (HBV) reactivation. Before you or your child receives rituximab treatment, your healthcare provider will do blood tests to check for HBV infection. If you or your child has had hepatitis B or is a carrier of the hepatitis B virus, receiving rituximab could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You or your child should not receive rituximab if you or your child has active hepatitis B liver disease. Your healthcare provider will monitor you or your child for hepatitis B infection during and for several months after you or your child stops receiving rituximab. Tell your healthcare provider immediately if you or your child gets worsening tiredness, or yellowing of your or your child’s skin or white part of your eyes, during treatment.
• Progressive Multifocal Leukoencephalopathy (PML). PML is a rare, serious brain infection caused by a virus that can happen in people who receive rituximab. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Tell your healthcare provider right away if you or your child has any new or worsening symptoms or if anyone close to you notices these symptoms:
  • confusion
  • dizziness or loss of balance
  • decreased strength or weakness on one side of your body
  • difficulty walking or talking
  • vision problems.
• Tumor Lysis Syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause you or your child to have:
  • kidney failure and need dialysis treatment
  • an abnormal heart rhythm.

TLS can happen within 12 to 24 hours after an infusion of rituximab. Your healthcare provider may do blood tests to check you or your child for TLS. Your healthcare provider may give you or your child medicine to help prevent TLS. Tell your healthcare provider right away if you or your child has any of the following signs or symptoms of TLS:

• • nausea
  • diarrhea
  • vomiting
  • lack of energy.
• Serious infections. Serious infections can happen during and after treatment with rituximab, and can lead to death. Rituximab can increase your or your child’s risk of getting infections and can lower the ability of your or your child’s immune system to fight infections. Types of serious infections that can happen with rituximab include bacterial, fungal, and viral infections. After receiving rituximab, some people have developed low levels of certain antibodies in their blood for a long period (longer than 11 months). Some of these people with low antibody levels developed infections. People with serious infections should not receive rituximab. Tell your healthcare provider right away if you or your child has any symptoms of infection:
  • fever
  • cold symptoms, such as a runny nose or sore throat, that do not go away
  • flu symptoms, such as cough, tiredness, and body aches
  • earache or headache
  • pain during urination
  • cold sores in the mouth or throat
  • cuts, scrapes, or incisions that are red, warm, swollen, or painful.
• Heart problems. Rituximab may cause chest pain, irregular heartbeats, and a heart attack. Your healthcare provider may monitor your or your child’s heart during and after treatment with rituximab if you or your child has symptoms or heart problems or has a history of heart problems. Tell your healthcare provider right away if you or your child has chest pain or irregular heartbeats during treatment with rituximab.
• Kidney problems, especially if you or your child is receiving rituximab for NHL. Rituximab can cause severe kidney problems that can lead to death. Your healthcare provider should do blood tests to check how well your or your child’s kidneys are working.
• Stomach and serious bowel problems that can sometimes lead to death. Bowel problems, including blockage or tears in the bowel, can happen if you or your child receives rituximab with chemotherapy medicines. Tell your healthcare provider right away if you or your child has any severe stomach-area (abdomen) pain or repeated vomiting during treatment with rituximab.

Your healthcare provider will stop treatment with rituximab if you have severe, serious, or life-threatening side effects.

Get emergency medical help if you have signs of an allergic reaction to rituximab, such as hives, difficulty breathing, swelling in your face or throat, or a severe skin reaction (symptoms may include fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

These are not all of the possible side effects of rituximab. Call your doctor for medical advice about side effects.

Before taking this medicine

Before you or your child receives rituximab, tell your healthcare provider about all of your or your child’s medical conditions, including if you or your child:

• have had a severe reaction to rituximab, Rituxan, Riabni, Ruxience, Truxima, or any ingredients in the injection
• have a history of heart problems, irregular heartbeat, or chest pain
• have lung, liver, or kidney problems
• have an infection or a weakened immune system
• have or have had any severe infections, including:
  • Hepatitis B virus (HBV)
  • Parvovirus B19
  • Hepatitis C virus (HCV)
  • Varicella zoster virus (chickenpox or shingles)
  • Cytomegalovirus (CMV)
  • West Nile Virus
  • Herpes simplex virus (HSV).
• have had a recent vaccination or are scheduled to receive vaccinations. You or your child should not receive certain vaccines before or during treatment with rituximab. You should be up-to-date on any needed immunizations before starting treatment with rituximab.
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Rituximab may harm an unborn baby. Talk to your healthcare provider about the risks to an unborn baby if you or someone you are caring for receives rituximab during pregnancy. If you are a female who can become pregnant, your healthcare provider should do a pregnancy test to check for pregnancy before starting rituximab.

Effective birth control (contraception) should be used during treatment with rituximab and for 12 months after the last dose. Talk to your healthcare provider about effective birth control.

Tell your healthcare provider right away if you or your child becomes pregnant or think you may be pregnant during treatment with rituximab.

Breastfeeding

Rituximab may pass into your breast milk. It is not safe to breastfeed a baby while you are using this medicine. Do not breastfeed during treatment and for 6 months after your or your child’s last dose of rituximab.

How is rituximab administered?

Rituximab is given by infusion through your or your child’s central catheter or a needle placed in a vein (intravenous infusion), in your arm or your child’s arm. A healthcare provider will give you this injection.

• Your healthcare provider may prescribe medicines before each infusion of rituximab to reduce infusion side effects such as fever and chills.
• Rituximab is not given daily. Your rituximab dosing schedule will depend on the condition being treated. Follow your doctor’s dosing instructions very carefully.
• Your healthcare provider should do blood tests regularly to check for side effects of rituximab.
• Before each rituximab treatment, your healthcare provider or nurse will ask you questions about your or your child’s general health. Tell your healthcare provider or nurse about any new symptoms.

If you need surgery, tell the surgeon beforehand that you are using this medicine.

Call your doctor at once if you have any of these other side effects, even if they occur several months after you receive rituximab, or after your treatment ends.

• painful skin or mouth sores, or a severe skin rash with blistering, peeling, or pus
• redness, warmth, or swelling of the skin
• severe stomach pain, vomiting, constipation, bloody or tarry stools
• irregular heartbeats, chest pain or pressure, pain spreading to your jaw or shoulder
• tiredness or jaundice (yellowing of the skin or eyes)
• signs of infection – fever, chills, cold or flu symptoms, cough, sore throat, mouth sores, headache, earache, pain or burning when you urinate
• signs of tumor cell breakdown – confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet, or around your mouth.

What happens if I miss a dose?

Call your doctor if you miss an appointment for your rituximab infusion.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving rituximab?

Do not receive a “live” vaccine while receiving rituximab, and avoid coming into contact with anyone who has recently received a live vaccine.

There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and the nasal flu (influenza) vaccine.

What other drugs will affect rituximab?

Tell your healthcare provider about all the medicines you or your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you or your child takes or has taken:

• a Tumor Necrosis Factor (TNF) inhibitor medicine such as adalimumab, certolizumab, etanercept, or golimumab, infliximab
• a Disease Modifying Anti-Rheumatic Drug (DMARD) such as leflunomide, methotrexate, or sulfasalazine
• chemotherapy drugs, especially cisplatin.

If you are not sure if your or your child’s medicine is one listed above, ask your healthcare provider. This list is not complete. Other drugs may interact with rituximab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Ingredients

Available as an injection for infusion, 100 mg/10 mL (10 mg/mL) and 500 mg/50 mL (10 mg/mL) solution in single-dose vials.

Rituxan

Active ingredient: rituximab
Inactive ingredients: polysorbate 80, sodium chloride, sodium citrate dihydrate, and water for injection, USP.

Truxima

Active ingredient: rituximab-abbs

Inactive ingredients: polysorbate 80, sodium chloride, tri-sodium citrate dihydrate, and Water for Injection, USP.

Ruxience

Active ingredient: rituximab-pvvr

Inactive ingredients: edetate disodium dihydrate, L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection.

Riabni

Active ingredient: rituximab-arrx

Inactive ingredients: polysorbate 80, sodium chloride, sodium citrate dihydrate, and Water for Injection, USP.
Hydrochloric acid is used to adjust the buffer solution pH.

Manufacturer

Manufacturers of rituximab and its biosimilars are:

• Rituxan: Jointly marketed by Genentech (San Francisco, CA) and Biogen (Cambridge, MA)
• Truxima: Celltrion, Inc., Yeonsu-gu, Incheon, Republic of Korea
• Ruxience: Pfizer Ireland Pharmaceuticals, Cork, Ireland 
• Riabni: Amgen, Inc., One Amgen Center Drive, Thousand Oaks, CA.

Rituximab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for rituximab.Rituxan (rituximab) – Genentech, Inc.

What is adalimumab?

Adalimumab (Humira and others) is used to treat plaque psoriasis (Ps), Crohn’s disease, ulcerative colitis, rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis, ankylosing spondylitis, and uveitis. Adalimumab works to reduce pain, inflammation, and skin symptoms in chronic autoimmune conditions. Adalimumab works by blocking a protein called tumor necrosis factor (TNF) that can cause inflammation, pain, or other autoimmune symptoms. Adalimumab is from a class of medicine called TNF alfa inhibitor. 

There are 10 biosimilars of Humira, the brand names are Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Idacio, Simlandi, Yufyma and Yusimry.

All Abrilada products are interchangeable. 

Amjevita, Cyltezo, Hadlima, Hyrimoz and Simlandi have some interchangeable products and some are biosimilars.

Hulio, Idacio, Yuflyma and Yusimry are biosimilars.

Humira was approved by the FDA on December 31, 2002. Humira was the first brand of adalimumab, so it is called the reference product. Biosimilars of Humira are now also available, see below for a full list of adalimumab biosimilars, indications, and companies.

A biosimilar is a biologic medicine that is a very close copy of the original product made by another company.  An interchangeable biosimilar has undergone an additional Interchangeability Study, meaning that patients can be confident in the safety and effectiveness of the interchangeable biosimilar product, just as they would be for the FDA-approved original product, in this case, Humira.

Adalimumab pronunciation

Adalimumab pronunciation is a dal aye’ mu mab.

How does adalimumab work?

Normally, your immune system defends your body against diseases by fighting harmful bacteria or viruses. However, in autoimmune disorders, the immune system becomes hyperactive and mistakenly attacks its own tissues, leading to symptoms of the autoimmune condition. Tumor necrosis factor (TNF) is a protein that is involved in causing inflammation. Adalimumab is a TNF blocker that inhibits TNF, helping to reduce pain, inflammation, and skin symptoms. Adalimumab is a recombinant human monoclonal antibody.

Brand names of Humira biosimilars

Humira is the original brand of adalimumab, other brands of adalimumab are biosimilars.

What is adalimumab used for?

Adalimumab is used to reduce pain, inflammation, and skin symptoms in many chronic conditions.  Each brand of adalimumab may be FDA-approved to treat different conditions and different patient groups.  

Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. 

Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.

Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS.

Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in patients 6 years of age and older.

Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults for all brands except  Humira brand, which is patients 5 years of age and older. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. 

Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older for Humira. Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Yusimry, and Yuflyma can be used for adults with HS.

Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis patients 2 years of age and older, for Humira brand only. Abrilada, Amjevita, Cyltezo, Hadlima, Hulio, Hyrimoz, Yusimry, Idacio Simlandi, and Yuflyma can be used in adults with uvelitis.

Adalimumab Biosimilar Brands and Indications

Adalimumab side effects

Common adalimumab side effects of may include:

• headache;
• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat;
• rash; or
• redness, bruising, itching, or swelling where the injection was given.

Serious adalimumab side effects of may include:

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor right away if you have any symptoms of lymphoma:

• fever, swollen glands, night sweats, general feeling of illness;
• joint and muscle pain, skin rash, easy bruising or bleeding;
• pale skin, feeling light-headed or short of breath, cold hands and feet;
• pain in your upper stomach that may spread to your shoulder; or
• loss of appetite, feeling full after eating only a small amount, weight loss.

Also call your doctor at once if you have:

• new or worsening psoriasis (raised, silvery flaking of the skin);
• a sore or bump on your skin that does not heal;
• symptoms of sepsis – confusion, chills, severe drowsiness, fast heartbeats, rapid breathing, feeling very ill;
• liver problems – body aches, tiredness, stomach pain, right-sided upper stomach pain, vomiting, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• lupus-like syndrome – joint pain or swelling, chest pain, shortness of breath, patchy skin color that worsens in sunlight;
• nerve problems – numbness, tingling, dizziness, vision problems, weakness in your arms or legs; or
• signs of tuberculosis – ever with ongoing cough, weight loss (fat or muscle).

Older adults may be more likely to develop infections or cancer while using adalimumab.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings

Adalimumab affects your immune system. You may get infections more easily, even serious or fatal infections.

Before or during treatment with adalimumab, tell your doctor if you have signs of infection such as fever, chills, aches, tiredness, cough, skin sores, diarrhea, or burning when you urinate.

Your doctor should test you for tuberculosis (TB) before you start taking adalimumab and also monitor you closely for signs and symptoms of TB during treatment.

The chances of getting cancer may be increased for children and adults taking TNF-blockers.

Before taking this medicine

Before you start using adalimumab, tell your doctor if you have signs of infection – fever, chills, sweats, muscle aches, tiredness, cough, bloody mucus, skin sores, diarrhea, burning when you urinate, or feeling constantly tired.

Adalimumab should only be given to children if the brand is indicated for their condition and age group. Children using adalimumab should be current on all childhood immunizations before starting treatment.

Tell your doctor if you have ever had:

• tuberculosis (or if anyone in your household has tuberculosis);
• a chronic infection;
• cancer;
• hepatitis B (adalimumab can cause hepatitis B to come back or get worse);
• diabetes;
• heart failure;
• any numbness or tingling, or a nerve-muscle disorder such as multiple sclerosis or Guillain-Barre syndrome;
• an allergy to latex rubber;
• if you are scheduled to have major surgery; or
• if you have recently received or are scheduled to receive any vaccine.

Tell your doctor where you live and if you have recently traveled or plan to travel. You may be exposed to infections that are common to certain areas of the world.

Adalimumab may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn’s disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Pregnancy

It is not known whether adalimumab will harm an unborn baby. Tell your doctor if you are pregnant or planning a pregnancy. Make sure any doctor caring for your newborn baby knows if you used adalimumab while you were pregnant, and especially before your baby receives any vaccines.

Breastfeeding

It may not be safe to breastfeed a baby while you are using adalimumab. Ask your doctor about any risks and the best way to feed your baby while on this medicine.

How should I use adalimumab?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Adalimumab is injected under the skin (subcutaneous injection) using an autoinjector or a prefilled syringe. A healthcare provider will teach you how to properly use this injection by yourself.

Do not start using adalimumab if you have any signs of an infection. Call your doctor for instructions.

The dose schedule for adalimumab is highly variable and depends on the condition you are treating. Follow your doctor’s dosing instructions very carefully.

Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed color, or has particles in it. Call your pharmacist for new medicine.

Leave the adalimumab auto-injector or prefilled syringe at room temperature for 15 to 30 minutes to allow it to warm up.  Do not warm the prefilled syringe using heat sources such as hot water or a microwave. Discard any adalimumab that has become frozen

Choose an injection site. You may inject into the front of your thighs, and your abdomen except for the 2 in (5 cm) around the belly button (navel). Rotate the injection site each time you give an injection. Each new injection site should be at least 1.2 in (3 cm) away from the injection site you used before.

Do not inject into skin that is red, hard, tender, damaged, bruised, or scarred, and do NOT inject through your clothes.

Adalimumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

Store this medicine in its original carton in a refrigerator. Do not freeze. If you are traveling, carefully follow all patient instructions for storing your medicine during travel. Avoid extreme heat or cold.

Dosing information

Different brands of adalimumab are available in different dosage forms and strengths, these are the approved forms and strengths for each brand.

Humira is available as:

• Humira Pen 80mg/0.8 mL, 40mg/0.8 mL, 40mg/0.4 mL

• Humira Prefilled Syringe 80mg/0.8 mL, 40mg/0.8 mL, 40mg/0.4 mL, 20mg/0.4 mL, 20mg/0.2 mL, 10mg/0.2 mL, 10mg/0.1 mL
• Humira Single-Dose Institutional Use Vial  40mg/0.8 mL

Abrilada is available as: 

• Abrilada Pen 40 mg/0.8 mL 
• Abrilada Prefilled Syringe Injection: 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL 
• Abrilada Single-Dose Institutional Use Vial Injection 40 mg/0.8 mL

Amjevita is available as:

• Amjevita SureClick Autoinjector 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL 
• Amjevita Prefilled Syringe 80 mg/0.8 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 20 mg/0.2 mL, 10 mg/0.2 mL 

Cyltezo  is available as:

• Cyltezo Pen 40 mg/0.8 mL, 40 mg/0.4 mL 
• Cyltezo Prefilled Syringe 40 mg/0.8 mL, 40 mg/0.4 mL, 20 mg/0.4 mL, 10 mg/0.2 mL 

Hadlima is available as:

• Hadlima PushTouch autoinjector  40 mg/ 0.8 mL,  40 mg/ 0.4 mL
• Hadlima Prefilled Syringe 40 mg/0.8 mL, 40 mg/0.4 mL
• Hadlima Single-Dose Institutional Use Vial Injection 40 mg/0.8 mL

Hulio is available as: 

• Hulio Pen 40 mg/0.8 mL
• Hulio prefilled plastic syringe 40 mg/0.8 mL, 20 mg/0.4 mL

Hyrimoz  is available as: 

• Hyrimoz Sensoready Pen 40 mg/0.8 mL, 40 mg/0.4 mL, 80 mg/0.8 mL
• Hyrimoz Single-dose prefilled glass syringe with BD UltraSafe Passiv Needle 20 mg/0.4 mL, 40 mg/0.8 mL, 40 mg/0.4 mL, 80 mg/0.8 mL
• Hyrimoz glass syringe 10 mg/0.2 mL, 10 mg/0.1 mL, 20 mg/0.2 mL

Idacio is available as: 

• Idacio 40 mg/0.8 mL
• Idacio Prefilled Syringe 40 mg/0.8 mL

Simlandi is available as:

•  Simlandi single-dose autoinjector 40 mg/0.4 mL

Yuflyma is available as:

• Yuflyma Prefilled Auto-injector (Yuflyma AI) 40 mg/0.4 mL
• Yuflyma Prefilled syringe with safety guard 40 mg/0.4 mL 
• Yuflyma Prefilled Syringe 40 mg/0.8 mL

Yusimry is available as: 

• Yusimry Pen Injection 40 mg/0.8 mL 
• Yusimry Prefilled Glass Syringe 40 mg/0.8 mL.

The dose and frequency of adalimumab given is dependent on age, severity, and condition treated. For more information on specific dosing schedules click the link below.

What happens if I miss a dose?

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up for the missed dose.

What should I avoid while using adalimumab?

Do not inject adalimumab into skin that is bruised, red, tender, or hard.

While using this medicine avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a “live” vaccine while using adalimumab. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), or zoster (shingles).

What other drugs will affect adalimumab?

Some drugs should not be used together with adalimumab. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with adalimumab, especially:

• abatacept, etanercept;
• anakinra;
• azathioprine, 6-mercaptopurine; or
• certolizumab, golimumab, infliximab, rituximab.

This list is not complete. Other drugs may interact with adalimumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Does adalimumab interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Adalimumab Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for adalimumab.Humira (adalimumab) – AbbVie Inc.

Humira interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.Abrilada (adalimumab-afzb) – Pfizer Inc.

View Abrilada information in detail.Amjevita (adalimumab-atto) – Amgen Inc.

View Amjevita information in detail.Cyltezo (adalimumab-adbm) – Boehringer Ingelheim Pharmaceuticals, Inc.

View Cyltezo information in detail.Hadlima (adalimumab-bwwd) – Samsung Bioepis Co., Ltd.

View Hadlima information in detail.Hyrimoz (adalimumab-adaz) – Sandoz Inc.

View Hyrimoz information in detail.Simlandi (adalimumab-ryvk) – Alvotech USA Inc.

View Simlandi information in detail.

Humira biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by stateAmjevita (adalimumab-atto) – Amgen Inc.

View Amjevita information in detail.Cyltezo (adalimumab-adbm) – Boehringer Ingelheim Pharmaceuticals, Inc.

View Cyltezo information in detail.Hadlima (adalimumab-bwwd) – Samsung Bioepis Co., Ltd.

View Hadlima information in detail.Hulio (adalimumab-fkjp) – Biocon Biologics Inc.

View Hulio information in detail.Hyrimoz (adalimumab-adaz) – Sandoz Inc.

View Hyrimoz information in detail.Idacio (adalimumab-aacf) – Fresenius Kabi USA, LLC

View Idacio information in detail.Simlandi (adalimumab-ryvk) – Alvotech USA Inc.

View Simlandi information in detail.Yuflyma (adalimumab-aaty) – CELLTRION, Inc.

View Yuflyma information in detail.Yusimry (adalimumab-aqvh) – Hong Kong King-Friend Industrial Company Limited

What is abatacept?

Abatacept (Orencia) is used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA), which are autoimmune disorders, and is also used to prevent acute graft versus host disease (aGVHD). Abatacept works by preventing your body’s immune system from attacking healthy tissues or graft tissues. The immune system helps your body fight infections. In people with autoimmune disorders, the immune system mistakes the body’s own cells for invaders and attacks them.

Abatacept is a selective T-cell costimulation modulator.

T cells (T lymphocytes) are a type of white blood cell that is part of the immune system, activated T cells are involved in autoimmune disorders such as RA, pJIA, and PsA. Abatacept blocks T cells from becoming activated by binding to proteins on the cell surface called CD80 and CD86, which block interaction with a protein called CD28. This means the T cells are not fully activated, so helps relieve symptoms of  RA, pJIA, PsA, and acute graft versus host disease. 

Abatacept is not a cure for any autoimmune disorder and will only treat the symptoms of your condition.

Abatacept became an FDA-approved medicine on December 23, 2005.

Who can use abatacept?

Abatacept is FDA-approved to be used for:

• adult patients with moderately to severely active rheumatoid arthritis (RA)
• patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).
• adult patients with active psoriatic arthritis (PsA)
• the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

Abatacept side effects

Common abatacept side effects

• fever
• nausea, diarrhea, stomach pain
• headache
• cold symptoms such as stuffy nose, sneezing, sore throat, or cough.

Serious abatacept side effects

Get emergency medical help if you have signs of an allergic reaction hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as

• fever, chills, night sweats, flu symptoms, weight loss
• feeling very tired
• dry cough, sore throat, or
• warmth, pain, or redness of your skin.

Call your doctor at once if you have any of these other serious side effects:

• trouble breathing;
• stabbing chest pain, wheezing, cough with yellow or green mucus;
• pain or burning when you urinate; or
• signs of skin infection such as itching, swelling, warmth, redness, or oozing.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Warnings 

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Using abatacept with a TNF antagonist, other biologic RA/PsA therapy, or JAK Inhibitors can increase the risk of infections and serious infections. 

Hypersensitivity and anaphylaxis have occurred. 

Serious infections have been reported. Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections. Discontinue if a serious infection develops. 

Screen for latent tuberculosis (TB) infection before starting abatacept therapy. Patients testing positive should be treated for TB  before starting abatacept treatment. 

You should be screened for viral hepatitis before starting abatacept.

Update vaccinations before starting treatment. Live vaccines should not be given concurrently or within 3 months of discontinuation. Abatacept may blunt the effectiveness of some immunizations. 

Chronic obstructive pulmonary disease (COPD) patients may develop more frequent respiratory adverse events. 

Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) reactivation in patients treated for aGVHD prophylaxis. 

Before taking this medicine

You should not use abatacept if you are allergic to it or any of the in

Before using abatacept, tell your doctor if you have ever had tuberculosis if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

Tell your doctor if you have ever had:

• a weak immune system;
• any type of infection, including a skin infection or open sores;
• infections that go away and come back;
• COPD (chronic obstructive pulmonary disease);
• diabetes;
• hepatitis; or
• if you are scheduled to receive any vaccines.

Using abatacept may increase your risk of developing certain types of cancer such as lymphoma (cancer of the lymph nodes). This risk may be greater in older adults. Talk to your doctor about your specific risk.

Children using abatacept should be current on all childhood immunizations before starting treatment.

Pregnancy

Tell your healthcare provider if you are pregnant, become pregnant, or plan to become pregnant, as it is not known if abatacept can harm your unborn baby.  If you take abatacept during pregnancy, your name may be listed on a pregnancy registry to track the effects of abatacept on the baby.

Breastfeeding

Tell your doctor if you are pregnant or breastfeeding. It is not known if abatacept passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use abatacept

How should I use abatacept?

Before you start treatment with abatacept, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

For treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), and polyarticular juvenile idiopathic arthritis (pJIA)

IV infusion: Abatacept may be given by a healthcare provider through a vein in your arm (intravenous infusion), this takes about 30 minutes to give you the full dose of medicine. You will then receive your next abatacept dose at 2 weeks and 4 weeks after the first dose, and then every 4 weeks.

Subcutaneous injection: Abatacept may also be given as an injection under your skin (subcutaneous). The abatacept is available as a prefilled syringe or ClickJect autoinjector for home use. Your healthcare provider will prescribe the type that is best for you. If your healthcare provider decides that you or a caregiver can give your injections of abatacept prefilled syringes or abatacept ClickJect autoinjectors at home, you or your caregiver should receive training on preparing and injecting this medicine. Do not try to inject this medicine until you have been shown the right way to give the injections by your healthcare provider.

Your healthcare provider will tell you how much abatacept to use and when to use it.

For preventative treatment of aGVHD:

You will receive abatacept by a healthcare provider through a vein in your arm (intravenous infusion) over 60 minutes on the day before transplantation (Day -1). You will then receive abatacept on Days 5, 14, and 28 after transplantation.
Your healthcare provider may give you antiviral medicines before, during, and after transplant to help prevent Epstein-Barr Virus (EBV) and Cytomegalovirus (CMV) infections.

General administration information

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don’t understand all the instructions.

Prepare an injection only when you are ready to give it. Gently swirl but do not shake the medication bottle. Do not use it if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

Each vial (bottle) or prefilled syringe is for one use only. Throw it away after one use, even if there is still medicine left inside.

Use a needle and syringe only once, then place them in a puncture-proof “sharps” container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

If you need surgery, tell the surgeon beforehand you are using abatacept.

If you’ve ever had hepatitis B, using abatacept can cause this virus to become active or worsen. You may need frequent liver function tests while using this medicine and for several months after you stop.

Abatacept can cause false results with certain blood glucose tests, showing high blood sugar readings. If you have diabetes, talk to your doctor about the best way you should test your blood sugar.

Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor’s advice.

Dosing Information

Usual Adult Dose for Rheumatoid Arthritis:

IV Dosing Regimen:
Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter.
Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter.
Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter.
Subcutaneous Dosing Regimen:
Optional IV loading dose:

• Weight less than 60 kg: 500 mg IV once.
• Weight 60 to 100 kg: 750 mg IV once.
• Weight more than 100 kg: 1000 mg IV once

Subcutaneous injection: 125 mg subcutaneously once a week
Comments:
This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDS), such as tumor necrosis factor (TNF) antagonists.
The IV infusion should be administered over 30 minutes.
Before the first subcutaneous dose, an optional loading dose may be administered as a single IV infusion; if an IV loading dose is used, the first subcutaneous injection should be administered within 1 day of the infusion.
For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.
Use: For the treatment of patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Psoriatic Arthritis:

IV Dosing Regimen:
Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Subcutaneous Dosing Regimen: 125 mg subcutaneously once a week
Comments:
This drug may be used with or without nonbiologic DMARDs.
The IV infusion should be administered over 30 minutes.
For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.
Use: For the treatment of patients with active psoriatic arthritis

Usual Adult Dose for Graft Versus Host Disease – Prophylaxis:

10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose
Comments:
Before administering this drug, recommended antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation should be administered and continued for 6 months after hematopoietic stem cell transplantation (HSCT); additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
The IV infusion should be administered over 60 minutes.
Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft versus host disease (aGVHD) in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

IV Dosing Regimen:
6 years or older:
Weight less than 75 kg: 10 mg/kg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight 75 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Maximum dose: 1000 mg/dose
Subcutaneous Dosing Regimen:
2 years or older:
Weight 10 to less than 25 kg: 50 mg subcutaneously once a week
Weight 25 to less than 50 kg: 87.5 mg subcutaneously once a week
Weight at least 50 kg: 125 mg subcutaneously once a week
Comments:
This drug may be used as monotherapy or concomitantly with methotrexate.
The IV infusion should be administered over 30 minutes.
Subcutaneous administration: Patients may self-inject or the patient’s caregiver may administer this drug if both the health care provider and parent/legal guardian decides it is appropriate; the ability of pediatric patients to self-inject with the autoinjector has not been tested.
Use: For the treatment of patients with moderately to severely active polyarticular juvenile idiopathic arthritis

Usual Pediatric Dose for Graft Versus Host Disease – Prophylaxis:

2 to less than 6 years: 15 mg/kg IV on the day before transplantation (Day -1), then 12 mg/kg IV on Days 5, 14, and 28 after transplantation
6 years or older: 10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose
Comments:
Before administering this drug, recommended antiviral prophylaxis for EBV reactivation should be administered and continued for 6 months after HSCT; additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
The IV infusion should be administered over 60 minutes.
Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of aGVHD in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor.

What happens if I miss a dose?

Call your doctor for instructions if you miss your abatacept dose.

What should I avoid while using abatacept?

Do not receive a “live” vaccine while using abatacept, and for at least 3 months after your treatment ends. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

What other drugs will affect abatacept?

Tell your doctor about all your other medicines, especially:

• adalimumab;
• anakinra;
• certolizumab;
• etanercept;
• golimumab;
• infliximab;
• rituximab; or
• tocilizumab.

This list is not complete. Other drugs may affect abatacept, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Does abatacept interact with my other drugs?

Enter medications to view a detailed interaction report using our Drug Interaction Checker.Drug nameAdd a drug to check interactionsAdd

Ingredients

Active ingredient: abatacept.

Intravenous inactive ingredients: maltose, monobasic sodium phosphate, and sodium chloride for administration.

Subcutaneous inactive ingredients: sucrose, poloxamer 188, monobasic sodium phosphate monohydrate, dibasic sodium phosphate anhydrous, water for injection.

Storage

Store in the original carton in a refrigerator. Protect from light and do not freeze. Do not use it after the expiration date on the medicine label has passed.

If you need to travel with your medicine, place the syringes in a cooler with ice packs.

Abatacept mixed with a diluent may be stored in a refrigerator or at room temperature and must be used within 24 hours.

Company

Bristol-Myers Squibb Company, Princeton, NJ 08543 USA, U.S. License Number 1713.

Abatacept Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for abatacept.Orencia (abatacept) – Bristol-Myers Squibb Company