Cimzia injection is used to treat Crohn’s disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, and non-radiographic axial spondyloarthritis in certain patients. Cimzia works to reduce inflammation and improve symptoms by blocking a protein called TNFα (tumor necrosis factor alpha).  Cimzia (certolizumab  pegol) belongs to the drug class TNF alfa inhibitors.

In autoimmune conditions, like Crohn’s disease, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis inflammation can be caused or worsened when TNF is released in the body. By Cimzia blocking TNFα there is less inflammation so symptoms of the condition improve.

Cimzia first received FDA approval on April 22, 2008, for moderate to severe active Crohn’s disease in adults who have an inadequate response to conventional therapy to reduce signs and symptoms of the disease and to maintain clinical response. Since then, it has also been approved for specific adult patients with rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and non-radiographic axial spondyloarthritis.

Cimzia Indications

Cimzia FDA-approved indications for adults are 

• Crohn’s disease for reducing signs and symptoms and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
• active rheumatoid arthritis  that is moderate to severe
• active psoriatic arthritis
• active ankylosing spondylitis 
• active non-radiographic axial spondyloarthritis with objective signs of inflammation
• plaque psoriasis that is moderate to severe in patients who are candidates for systemic therapy or phototherapy.

Cimzia FDA-approved indication for patients 2 years of age and older is 

• active polyarticular juvenile idiopathic arthritis (pJIA)

Cimzia side effects

Common Cimzia side effects may include rash, pain or burning when you urinate, and cold symptoms such as stuffy nose, sneezing, and a sore throat.

Serious Cimzia side effects

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

Serious and sometimes fatal infections may occur during treatment with Cimzia. Tell your doctor if you have signs of infection, such as fever, chills, cough, sweating, muscle pain, open sores or skin wounds, unusual tiredness, feeling short of breath, painful urination, diarrhea, or weight loss.

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

• chest pain, cough, feeling short of breath;
• swelling in your neck, underarm, or groin (this swelling may come and go);
• fever, night sweats, itching, weight loss, feeling tired;
• feeling full after eating only a small amount; or
• pain in your upper stomach that may spread to your back or shoulder.

Stop using Cimzia and call your doctor at once if you have Cimzia side effect symptoms of:

• shortness of breath (even with mild exertion), swelling, rapid weight gain;
• pale skin, easy bruising or bleeding;
• a new growth on your skin (may be red or purple), or any change in the size or color of a mole, freckle, or bump on your skin;
• nerve problems – vision problems, dizziness, numbness or tingly feeling, muscle weakness in your arms or legs;
• liver problems – loss of appetite, right-sided stomach pain, tiredness, jaundice (yellowing of the skin or eyes); or
• new or worsening symptoms of lupus – joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

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

Warnings

Cimzia affects your immune system. Serious and sometimes fatal infections may occur.

Your risk of infection may be higher if you have diabetes, HIV, a weak immune system, hepatitis B, chronic infections, if you use certain medications, or if you live in or travel to certain areas.

Call your doctor at once if you have symptoms such as fever, chills, cough, diarrhea, night sweats, flu symptoms, or skin sores.

Using Cimzia may also increase your risk of developing certain types of cancer, including a rare fast-growing type of lymphoma that can be fatal.

Do not receive a “live” vaccine while you are being treated with Cimzia.

Do NOT use this medicine if you have had a serious hypersensitivity reaction to certolizumab pegol or to any of the inactive ingredients. 

Before taking this medicine

You should not use Cimzia if you are allergic to certolizumab. You may not be able to use Cimzia if you have symptoms of an infection such as fever, chills, cough, skin sores, shortness of breath, weight loss, diarrhea, or painful urination.

Tell your doctor if you have ever had tuberculosis, 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.

Cimzia 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.

Tell your doctor if you have ever had:

• a chronic infection;
• hepatitis B (or if you are a carrier of the virus);
• lymphoma or other types of cancer;
• a blood cell disorder;
• congestive heart failure;
• a seizure;
• an allergy to latex;
• numbness or tingling, or a nervous system disorder such as multiple sclerosis; or
• if you are scheduled to receive any vaccines, or have recently been vaccinated with BCG (Bacille Calmette-Guerin).

It is not known whether Cimzia will harm an unborn baby. Tell your doctor if you are pregnant. Your name may be listed on a pregnancy registry to track the effects of Cimzia on the baby.

It may not be safe to breast-feed a baby while you are using this medicine. Ask your doctor about any risks.

Cimzia is not approved for use by anyone younger than 18 years old.

How is Cimzia given?

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

Cimzia is usually given every 2 to 4 weeks. You may need to use more than 1 injection to get a full dose. Follow your doctor’s dosing instructions very carefully.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Cimzia if you don’t understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your 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.

Cimzia can increase your risk of bleeding or infection by changing the way your immune system works. You will need frequent medical tests.

Store Cimzia in its original carton in the refrigerator. Protect from light and do not freeze.

Take the syringe out of the refrigerator and let it reach room temperature before injecting your dose.

Unopened prefilled syringes may also be stored at room temperature for up to 7 days, away from heat and light. Throw away any prefilled syringe not used within 7 days. Do not put it back in the refrigerator.

Each prefilled syringe is for one use only. Throw 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.

If you’ve ever had hepatitis B, using Cimzia 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.

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

Dosing information

Usual Adult Cimzia Dose for Rheumatoid Arthritis

Initial Cimzia dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Maintenance Cimzia dose: 400 mg subcutaneously every 4 weeks can be considered
Use: For the treatment of adults with moderately to severely active rheumatoid arthritis (RA)

Usual Adult Cimzia Dose for Psoriatic Arthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every other week
Use: For the treatment of adult patients with active psoriatic arthritis (PsA)

Usual Adult Dose for Ankylosing Spondylitis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks
Use: For the treatment of adults with active ankylosing spondylitis

Usual Adult Cimzia Dose for Crohn’s Disease

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4
Maintenance dose: 400 mg subcutaneously every 4 weeks
Use: For reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy

Usual Adult Dose for Plaque Psoriasis

Initial dose: 400 mg subcutaneously (given as 2 subcutaneous injections or 200 mg) every other week
For certain patients with body weight <=90 kg: 400 mg (given as 2 subcutaneous injections or 200 mg) at weeks 0, 2, and 4 followed by 200 mg every other week can be considered
Use: For the treatment of adults with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

Usual Adult Dose for Non-Radiographic Axial Spondyloarthritis

Initial dose: 400 mg subcutaneously (given as two subcutaneous injections of 200 mg) at weeks 0, 2, and 4, followed by 200 mg subcutaneously every 2 weeks or 400 mg subcutaneously every 4 weeks
Use: For the treatment of adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.

Usual dose for Polyarticular Juvenile Idiopathic Arthritis  patients 2 years of age and older)

Dose is weight dependant, every other week:

10 kg (22 lbs) to less than 20 kg (44 lbs): dose 100 mg initially and at week 2 and 4, followed by maintenance dose of 50 mg every other week
20 kg (44 lbs) to less than 40 kg (88 lbs): dose 200 mg initially and at week 2 and 4, followed by a maintenance dose of 100 mg every other week
Greater than or equal to 40 kg (88 lbs): dose 400 mg initially and at week 2 and 4, followed by  a maintenance dose of 200 mg every other week 

General Cimzia Dosing Information

• Rotate injection sites.
• Do not inject into skin that is tender, bruised, red, or hard.
• When a 400 mg dose is needed (given as 2 subcutaneous injections of 200 mg), injections should occur at separate sites in the thigh or abdomen.
• This drug can be given as monotherapy or concomitantly with non-biological disease modifying anti-rheumatic drugs (DMARDs).
• The use of this drug in combination with biological DMARDs or another tumor necrosis factor (TNF) blocker therapy is not recommended.

Cimzia is available as 200 mg lyophilized powder in a single-dose vial and 200 mg/mL solution in a single-dose prefilled syringe

Withdrawal from Cimzia

Your healthcare profession will guide you on how long you will use Cimzia.
Withdrawal from Cimzia may be required if you have severe allergic reactions.  Clinical trials have also studied reducing the dose of Cimza and stopping Cimza after sustained low disease activity in treating rheumatoid arthritis. However, the NCT01521923 clinical study failed to meet its primary endpoint.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while receiving Cimzia?

Avoid injecting Cimzia into scars or stretch marks, or into skin that is red, bruised, swollen, hard, or tender.

Ask your doctor before receiving any vaccine while you are being treated with Cimzia.

Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

What is golimumab?

Golimumab is used to treat rheumatoid arthritis and ankylosing spondylitis in adults.

Golimumab is also used alone or in combination with other medicines to treat psoriatic arthritis and polyarticular juvenile idiopathic arthritis in adults and children at least 2 years old.

Golimumab is also used alone or in combination with other medicines to treat ulcerative colitis in adults when other medicines have not worked or could not be tolerated.

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

Golimumab 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.

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, sweating, muscle aches, feeling very tired;
• cough, bloody mucus, shortness of breath;
• weight loss;
• painful skin sores, warmth, or redness;
• diarrhea, stomach pain; or
• increased urination, or burning when you urinate.

Also call your doctor at once if you have:

• skin growths or changes in skin appearance;
• swelling in your lower legs;
• vision changes;
• numbness or tingly feeling, weakness in your arms or legs;
• heart problems–swelling, rapid weight gain, feeling short of breath;
• 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;
• liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• new or worsening symptoms of lupus–joint pain, and a skin rash on your cheeks or arms that worsens in sunlight; or
• signs of psoriasis–red or scaly patches of skin, flaking, pus.

Common side effects of golimumab may include:

• cold symptoms such as stuffy nose, sneezing, sore throat;
• abnormal liver function tests;
• high blood pressure;
• skin rash;
• low blood cell counts; or
• pain, itching, redness, bruising, tingling or swelling where the medicine was injected.

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

You may get infections more easily, even serious or fatal infections. Call your doctor if you have flu symptoms, cough, night sweats, neck stiffness, confusion, or vision problems.

If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start golimumab. Your doctor may need to monitor you for signs and symptoms during treatment.

Before taking this medicine

You should not use golimumab if you are allergic to rubber or latex.

Tell your doctor if you have or ever had:

• an active or chronic infection;
• a nerve-muscle disorder such as multiple sclerosis or Guillain-Barré syndrome;
• cancer or lymphoma;
• congestive heart failure;
• psoriasis; or
• recently received or scheduled to receive a live vaccine.

Tell your doctor if you’ve had or been exposed to tuberculosis, or if you recently traveled. Some infections are more common in certain parts of the world, and you may have been exposed during travel.

Using golimumab may increase your risk of developing other cancers. Ask your doctor about this risk.

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

Tell your baby’s doctor if you used golimumab during pregnancy. It could affect your baby’s vaccination schedule during the first 6 months of life.

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I use golimumab?

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

If you have ever had tuberculosis or hepatitis B, golimumab can cause these conditions to come back or get worse. You should be tested for these conditions before you start golimumab. Your doctor may need to monitor you for signs and symptoms during treatment. 

Golimumab is sometimes given as an infusion into a vein. A healthcare provider will give you this type of injection once every 4 to 8 weeks.

Golimumab may also be injected under the skin once every 2 to 4 weeks. You may be able to give this injection to yourself.

Your healthcare provider will show you where to inject golimumab. Do not inject into the same place two times in a row.

Ask your doctor or pharmacist if you don’t understand how to use an injection.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Golimumab can weaken your immune system. Your blood will need to be tested often.

Store this medicine in its original container in the refrigerator, do not freeze. Protect from light.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before using. Do not warm the medicine with hot water, sunlight, or a microwave.

Throw away a prefilled syringe or auto-injector after one use, even if there is still medicine left inside.

Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

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 golimumab?

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 other drugs will affect golimumab?

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

Tell your doctor about all your other medicines, especially:

• anakinra;
• abatacept, etanercept; or
• adalimumab, certolizumab, infliximab, rituximab, or tocilizumab.

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

Golimumab 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 golimumab.Simponi (golimumab) – Janssen Biotech, Inc.

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 Inflectra?

Inflectra (infliximab-dyyb) is a monocloncal antibody used to treat a range of inflammatory autoimmune diseases.

Inflectra is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilar of Remicade are highly similar to it and are designed to have the same effect, but they are not identical.

Inflectra works in the same way as the other versions of infliximab, by blocking the damage that results from too much tumor necrosis factor-alpha (TNF-alpha). Inflectra binds to TNF-alpha, which stops it from interacting with its receptors and certain activating processes.

TNF-alpha is a protein and inflammatory cytokine which plays a key role in your normal immune response. It is involved in your inflammatory response and also helps to fight off infection and cancer. Some people, however, produce too much TNF-alpha and this can cause an autoimmune disease to develop.

Inflectra was approved by the US Food and Drug Administration (FDA) in 2016, 18 years after the original version of infliximab was introduced. It was the first biosimilar of Remicade to be approved.

What is Inflectra used for?

Inflectra is a prescription medicine that is approved for patients with:

• Rheumatoid Arthritis – adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
• Crohn’s Disease – children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
• Ankylosing Spondylitis in adults
• Psoriatic Arthritis in adults
• Plaque Psoriasis – adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
• Ulcerative Colitis – children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

It is not known if Inflectra is safe and effective in children under 6 years of age.

Important information

Inflectra may cause serious side effects, including:

1. Risk of infection

Inflectra is a medicine that affects your immune system. Inflectra can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Inflectra. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting Inflectra.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with Inflectra.

Before starting Inflectra, tell your doctor if you:

• think you have an infection. You should not start receiving Inflectra if you have any kind of infection.
• are being treated for an infection.
• have signs of an infection, such as a fever, cough, flu-like symptoms.
• have any open cuts or sores on your body.
• get a lot of infections or have infections that keep coming back.
• have diabetes or an immune system problem. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive Inflectra. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B.
• use the medicines Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics used to treat the same conditions as Inflectra.

After starting Inflectra, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Inflectra can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

• There have been cases of unusual cancers in children and teenage patients using TNF-blocker medicines, such as Inflectra.
• For children and adults receiving TNF-blocker medicines, including Inflectra, the chances of getting lymphoma or other cancers may increase.
• Some people receiving TNF-blockers, including Inflectra, 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 a TNF-blocker and another medicine called azathioprine or 6-mercaptopurine.
• People who have been treated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
• Some people treated with infliximab products, such as Inflectra, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Inflectra, tell your doctor.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with Inflectra.
• Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Inflectra, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

See the section “What are the possible side effects of Inflectra?” below for more information.

Who should not receive Inflectra?

You should not receive Inflectra if you have:

• heart failure, unless your doctor has examined you and decided that you are able to receive Inflectra. Talk to your doctor about your heart failure.
• had an allergic reaction to infliximab products, or any of the other ingredients in Inflectra. See below for a complete list of ingredients in Inflectra.

What should I tell my doctor before receiving Inflectra?

Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions, including if you:

• have an infection (see “Important information” above).
• have other liver problems including liver failure.
• have heart failure or other heart conditions. If you have heart failure, it may get worse while you take Inflectra.
• have or have had any type of cancer.
• have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving Inflectra.
• have COPD. Patients with COPD may have an increased risk of getting cancer while receiving Inflectra.
• have or have had a condition that affects your nervous system such as:
  • multiple sclerosis, or Guillain-Barré syndrome, or
  • if you experience any numbness or tingling, or
  • if you have had a seizure.
• have recently received or are scheduled to receive a vaccine. Adults and children receiving Inflectra should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Children should have all of their vaccines brought up to date before starting treatment with Inflectra.

How should I receive Inflectra?

• You will be given Inflectra through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Your doctor may decide to give you medicine before starting the Inflectra infusion to prevent or lessen side effects.
• Only a healthcare professional should prepare the medicine and administer it to you.
• Inflectra will be given to you over a period of about 2 hours.
• If you have side effects, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
• A healthcare professional will monitor you during the infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving Inflectra to monitor you for side effects and to see how well you respond to the treatment.
• Your doctor will determine the right dose for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.

What should I avoid while receiving Inflectra?

Do not take Inflectra together with medicines such as Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics that are used to treat the same conditions as this medication.

Dosing information

Inflectra is administered by intravenous infusion for at least 2 hours.

• Crohn’s Disease
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
• Pediatric Crohn’s Disease (≥ 6 years old)
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Ulcerative Colitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Pediatric Ulcerative Colitis (≥ 6 years old)
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Rheumatoid Arthritis
  • In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
• Ankylosing Spondylitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
• Psoriatic Arthritis and Plaque Psoriasis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

What are the side effects of Inflectra?

Serious side effects of Inflectra include:

• See “Important information” above.
• Serious Infections
  • Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Inflectra. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Inflectra your doctor will treat your infection and may need to stop your Inflectra treatment.
  • Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Inflectra:
    • a fever
    • feel very tired
    • have a cough
    • have flu-like symptoms
    • warm, red, or painful skin
  • 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 Inflectra and during treatment with Inflectra.
  • Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Inflectra. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
  • If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Inflectra. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Inflectra and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
    • feel unwell
    • tiredness (fatigue)
    • poor appetite
    • fever, skin rash, or joint pain
• Heart Failure
  If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Inflectra. Your congestive heart failure may get worse while you are receiving Inflectra. Be sure to tell your doctor of any new or worse symptoms including:
  • shortness of breath
  • swelling of ankles or feet
  • sudden weight gain
    Treatment with Inflectra may need to be stopped if you get new or worse congestive heart failure.
• Other Heart Problems
  Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of an infliximab product. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
• Liver Injury
  Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
  • jaundice (skin and eyes turning yellow)
  • dark brown-colored urine
  • pain on the right side of your stomach area (right-sided abdominal pain)
  • fever
  • extreme tiredness (severe fatigue)
• Blood Problems
  In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:
  • have a fever that does not go away
  • bruise or bleed very easily
  • look very pale
• Nervous System Disorders
  Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:
  • changes in your vision
  • numbness or tingling in any part of your body
  • weakness in your arms or legs
  • seizures
    Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
• Allergic Reactions
  Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Inflectra treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Inflectra and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:
  • hives (red, raised, itchy patches of skin)
  • difficulty breathing
  • chest pain
  • high or low blood pressure
  • fever
  • chills
    Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with an infliximab product. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Inflectra:
    • fever
    • rash
    • headache
    • sore throat
    • muscle or joint pain
    • swelling of the face and hands
    • difficulty swallowing
• Lupus-like Syndrome
  Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Inflectra.
  • chest discomfort or pain that does not go away
  • shortness of breath
  • joint pain
  • rash on the cheeks or arms that gets worse in the sun
• Psoriasis
  Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Inflectra.

The most common side effects of infliximab products include:

• respiratory infections, such as sinus infections and sore throat
• headache
• coughing
• stomach pain

Infusion reactions can happen up to 2 hours after your infusion of Inflectra. Symptoms of infusion reactions may include:

• fever
• chills
• chest pain
• low blood pressure or high blood pressure
• shortness of breath
• rash
• itching

Children with Crohn’s disease showed some differences in side effects of treatment compared with adults with Crohn’s disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who took infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with Inflectra. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA .

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.

Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Inflectra harms your unborn baby. Inflectra should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Inflectra if you are pregnant or plan to become pregnant.

If you have a baby and you were receiving Inflectra during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Inflectra use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received Inflectra while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed. You and your doctor should decide if you should receive Inflectra while breastfeeding.

Storage

Store unopened Inflectra vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

Do not use Inflectra beyond the expiration date (Exp) located on the carton and the vial. This product contains no preservative.

What are the ingredients in Inflectra?

Active ingredient: infliximab-dyyb.

Inactive ingredients: : dibasic sodium phosphate dihydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Inflectra is manufactured by Celltrion, Inc. 23, Academy-ro, Yeonsu-gu, Incheon, 22014, Republic of Korea and distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017

Inflectra 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 Inflectra.Remicade (infliximab) – Janssen Biotech, Inc.

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 Renflexis?

Renflexis (infliximab-abda) is a monocloncal antibody used to treat a range of inflammatory autoimmune diseases.

Renflexis is a biological drug and one of four biosimilars of Remicade (infliximab). Biosimilar of Remicade are highly similar versions of the drug, which are designed to have the same effect, but which are not identical.

Renflexis works in the same way as the other versions of infliximab, by blocking the damage that results from too much tumor necrosis factor-alpha (TNF-alpha). Renflexis binds to TNF-alpha, which stops it from interacting with its receptors and activating certain processes.

TNF-alpha is a protein and inflammatory cytokine which plays a key role in your normal immune response. It is involved in your inflammatory response and also helps to fight off infection and cancer. Some people, however, produce too much TNF-alpha and this can cause an autoimmune disease to develop.

Renflexis was approved by the US Food and Drug Administration (FDA) in 2017, almost 20 years after the original version of infliximab started being used.

What is Renflexis used for?

Renflexis is a prescription medicine that is approved for patients with:

• Rheumatoid Arthritis – adults with moderately to severely active rheumatoid arthritis, along with the medicine methotrexate.
• Crohn’s Disease – children 6 years and older and adults with Crohn’s disease who have not responded well to other medicines.
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Plaque Psoriasis – adult patients with plaque psoriasis that is chronic (does not go away), severe, extensive, and/or disabling.
• Ulcerative Colitis – children 6 years and older and adults with moderately to severely active ulcerative colitis who have not responded well to other medicines.

Important information

Renflexis may cause serious side effects, including:

1. Risk of infection

Renflexis is a medicine that affects your immune system. Renflexis can lower the ability of your immune system to fight infections. Serious infections have happened in patients receiving Renflexis. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting Renflexis.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with Renflexis.

Before starting Renflexis, tell your doctor if you:

• think you have an infection. You should not start receiving Renflexis if you have any kind of infection.
• are being treated for an infection.
• have signs of an infection, such as a fever, cough, flu-like symptoms.
• have any open cuts or sores on your body.
• get a lot of infections or have infections that keep coming back.
• have diabetes or an immune system problem. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may develop or become more severe if you receive Renflexis. If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B.
• use the medicines Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics used to treat the same conditions as Renflexis.

After starting Renflexis, if you have an infection, any sign of an infection including a fever, cough, flu-like symptoms, or have open cuts or sores on your body, call your doctor right away. Renflexis can make you more likely to get infections or make any infection that you have worse.

2. Risk of Cancer

• There have been cases of unusual cancers in children and teenage patients using TNF-blocker medicines, such as Renflexis.
• For children and adults receiving TNF-blocker medicines, including Renflexis, the chances of getting lymphoma or other cancers may increase.
• Some people receiving TNF-blockers, including Renflexis, 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 a TNF-blocker and another medicine called azathioprine or 6-mercaptopurine.
• People who have been treated for rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis for a long time may be more likely to develop lymphoma. This is especially true for people with very active disease.
• Some people treated with infliximab products, such as Renflexis, have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Renflexis, tell your doctor.
• Patients with Chronic Obstructive Pulmonary Disease (COPD), a specific type of lung disease, may have an increased risk for getting cancer while being treated with Renflexis.
• Some women being treated for rheumatoid arthritis with infliximab products have developed cervical cancer. For women receiving Renflexis, including those over 60 years of age, your doctor may recommend that you continue to be regularly screened for cervical cancer.
• Tell your doctor if you have ever had any type of cancer. Discuss with your doctor any need to adjust medicines you may be taking.

See the section “What are the possible side effects of Renflexis?” below for more information.

Who should not receive Renflexis?

You should not receive Renflexis if you have:

• heart failure, unless your doctor has examined you and decided that you are able to receive Renflexis. Talk to your doctor about your heart failure.
• had an allergic reaction to infliximab products, or any of the other ingredients in Renflexis. See below for a complete list of ingredients in Renflexis.

What should I tell my doctor before receiving Renflexis?

Your doctor will assess your health before each treatment. Tell your doctor about all of your medical conditions, including if you:

• have an infection (see “Important information” above).
• have other liver problems including liver failure.
• have heart failure or other heart conditions. If you have heart failure, it may get worse while you take Renflexis.
• have or have had any type of cancer.
• have had phototherapy (treatment with ultraviolet light or sunlight along with a medicine to make your skin sensitive to light) for psoriasis. You may have a higher chance of getting skin cancer while receiving Renflexis.
• have COPD. Patients with COPD may have an increased risk of getting cancer while receiving Renflexis.
• have or have had a condition that affects your nervous system such as:
  • multiple sclerosis, or Guillain-Barré syndrome, or
  • if you experience any numbness or tingling, or
  • if you have had a seizure.
• have recently received or are scheduled to receive a vaccine. Adults and children receiving Renflexis should not receive live vaccines (for example, the Bacille Calmette-Guérin [BCG] vaccine) or treatment with a weakened bacteria (such as BCG for bladder cancer). Children should have all of their vaccines brought up to date before starting treatment with Renflexis.

How should I receive Renflexis?

• You will be given Renflexis through a needle placed in a vein (IV or intravenous infusion) in your arm.
• Your doctor may decide to give you medicine before starting the Renflexis infusion to prevent or lessen side effects.
• Only a healthcare professional should prepare the medicine and administer it to you.
• Renflexis will be given to you over a period of about 2 hours.
• If you have side effects, the infusion may need to be adjusted or stopped. In addition, your healthcare professional may decide to treat your symptoms.
• A healthcare professional will monitor you during the infusion and for a period of time afterward for side effects. Your doctor may do certain tests while you are receiving Renflexis to monitor you for side effects and to see how well you respond to the treatment.
• Your doctor will determine the right dose for you and how often you should receive it. Make sure to discuss with your doctor when you will receive infusions and to come in for all your infusions and follow-up appointments.

What should I avoid while receiving Renflexis?

Do not take Renflexis together with medicines such as Kineret (anakinra), Orencia (abatacept), Actemra (tocilizumab), or other medicines called biologics that are used to treat the same conditions as this medication.

Dosing information

Renflexis is administered by intravenous infusion over a period of not less than 2 hours.

• Crohn’s Disease
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.
• Pediatric Crohn’s Disease
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Ulcerative Colitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Pediatric Ulcerative Colitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
• Rheumatoid Arthritis
  • In conjunction with methotrexate, 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every 4 weeks.
• Ankylosing Spondylitis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 6 weeks.
• Psoriatic Arthritis and Plaque Psoriasis
  • 5 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.

What are the side effects of Renflexis?

Serious side effects of Renflexis include:

• See “Important information” above.
• Serious Infections
  • Some patients, especially those 65 years and older have had serious infections while receiving infliximab products, such as Renflexis. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with Renflexis your doctor will treat your infection and may need to stop your Renflexis treatment.
  • Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving Renflexis:
    • a fever
    • feel very tired
    • have a cough
    • have flu-like symptoms
    • warm, red, or painful skin
  • 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 Renflexis and during treatment with Renflexis.
  • Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving Renflexis. Patients who had a negative TB skin test before receiving infliximab products have developed active TB.
  • If you are a chronic carrier of the hepatitis B virus, the virus can become active while you are being treated with Renflexis. In some cases, patients have died as a result of hepatitis B virus being reactivated. Your doctor should do a blood test for hepatitis B virus before you start treatment with Renflexis and occasionally while you are being treated. Tell your doctor if you have any of the following symptoms:
    • feel unwell
    • tiredness (fatigue)
    • poor appetite
    • fever, skin rash, or joint pain
• Heart Failure
  If you have a heart problem called congestive heart failure, your doctor should check you closely while you are receiving Renflexis. Your congestive heart failure may get worse while you are receiving Renflexis. Be sure to tell your doctor of any new or worse symptoms including:
  • shortness of breath
  • swelling of ankles or feet
  • sudden weight gain
    Treatment with Renflexis may need to be stopped if you get new or worse congestive heart failure.
• Other Heart Problems
  Some patients have experienced a heart attack (some of which led to death), low blood flow to the heart, or abnormal heart rhythm within 24 hours of beginning their infusion of an infliximab product. Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Tell your doctor right away if you have any of these symptoms.
• Liver Injury
  Some patients receiving infliximab products have developed serious liver problems. Tell your doctor if you have:
  • jaundice (skin and eyes turning yellow)
  • dark brown-colored urine
  • pain on the right side of your stomach area (right-sided abdominal pain)
  • fever
  • extreme tiredness (severe fatigue)
• Blood Problems
  In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding. Tell your doctor if you:
  • have a fever that does not go away
  • bruise or bleed very easily
  • look very pale
• Nervous System Disorders
  Some patients receiving infliximab products have developed problems with their nervous system. Tell your doctor if you have:
  • changes in your vision
  • numbness or tingling in any part of your body
  • weakness in your arms or legs
  • seizures
    Some patients have experienced a stroke within approximately 24 hours of their infusion with infliximab products. Tell your doctor right away if you have symptoms of a stroke which may include: numbness or weakness of the face, arm or leg, especially on one side of the body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes, sudden trouble walking, dizziness, loss of balance or coordination or a sudden, severe headache.
• Allergic Reactions
  Some patients have had allergic reactions to infliximab products. Some of these reactions were severe. These reactions can happen while you are getting your Renflexis treatment or shortly afterward. Your doctor may need to stop or pause your treatment with Renflexis and may give you medicines to treat the allergic reaction. Signs of an allergic reaction can include:
  • hives (red, raised, itchy patches of skin)
  • difficulty breathing
  • chest pain
  • high or low blood pressure
  • fever
  • chills
    Some patients treated with infliximab products have had delayed allergic reactions. The delayed reactions occurred 3 to 12 days after receiving treatment with an infliximab product. Tell your doctor right away if you have any of these signs of delayed allergic reaction to Renflexis:
    • fever
    • rash
    • headache
    • sore throat
    • muscle or joint pain
    • swelling of the face and hands
    • difficulty swallowing
• Lupus-like Syndrome
  Some patients have developed symptoms that are like the symptoms of Lupus. If you develop any of the following symptoms, your doctor may decide to stop your treatment with Renflexis.
  • chest discomfort or pain that does not go away
  • shortness of breath
  • joint pain
  • rash on the cheeks or arms that gets worse in the sun
• Psoriasis
  Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps on the skin that are filled with pus. Your doctor may decide to stop your treatment with Renflexis.

The most common side effects of infliximab products include:

• respiratory infections, such as sinus infections and sore throat
• headache
• coughing
• stomach pain

Infusion reactions can happen up to 2 hours after your infusion of Renflexis. Symptoms of infusion reactions may include:

• fever
• chills
• chest pain
• low blood pressure or high blood pressure
• shortness of breath
• rash
• itching

Children with Crohn’s disease showed some differences in side effects of treatment compared with adults with Crohn’s disease. The side effects that happened more in children were: anemia (low red blood cells), leukopenia (low white blood cells), flushing (redness or blushing), viral infections, neutropenia (low neutrophils, the white blood cells that fight infection), bone fracture, bacterial infection and allergic reactions of the breathing tract. Among patients who took infliximab for ulcerative colitis in clinical studies, more children had infections as compared with adults.

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the side effects with Renflexis. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. These include any other medicines to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis.

Know the medicines you take. Keep a list of your medicines and show them to your doctor and pharmacist when you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Renflexis harms your unborn baby. Renflexis should be given to a pregnant woman only if clearly needed. Talk to your doctor about stopping Renflexis if you are pregnant or plan to become pregnant.

If you have a baby and you were receiving Renflexis during your pregnancy, it is important to tell your baby’s doctor and other health care professionals about your Renflexis use so they can decide when your baby should receive any vaccine. Certain vaccinations can cause infections.

If you received Renflexis while you were pregnant, your baby may be at higher risk for getting an infection. If your baby receives a live vaccine within 6 months after birth, your baby may develop infections with serious complications that can lead to death. This includes live vaccines such as the BCG, rotavirus, or any other live vaccines. For other types of vaccines, talk with your doctor.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether Renflexis passes into your breast milk. Talk to your doctor about the best way to feed your baby while receiving Renflexis. You should not breast-feed while receiving Renflexis.

Storage

Store unopened Renflexis vials in a refrigerator at 2ºC to 8ºC (36ºF to 46ºF).

If needed, unopened Renflexis vials may be stored at room temperatures up to a maximum of 30ºC (86°F) for a single period of up to 6 months but not exceeding the original expiration date. Once removed from the refrigerator, Renflexis cannot be returned to the refrigerator.

What are the ingredients in Renflexis?

Active ingredient: infliximab-abda.

Inactive ingredients: dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, polysorbate 80, and sucrose. No preservatives are present.

Renflexis is manufactured by Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic of Korea.

Renflexis 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 Renflexis.Remicade (infliximab) – Janssen Biotech, 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