Benlysta is used to treat active systemic lupus erythematosus (SLE) or lupus nephritis (LN) in people 5 years and older, who weigh at least 15 kg (33 lb), and are receiving standard therapy. Benlysta is a monoclonal antibody given by injection every 2 to 4 weeks. Clinical trials show that when Benlysta is combined with other lupus medicines, it reduces disease activity more effectively than other medicines alone.

• Benlysta is not recommended for severe active central nervous system lupus because it has not been studied in this population.

Benlysta (belimumab) first gained FDA approval on March 9, 2011, and was the first lupus treatment specifically designed to target the underlying autoimmune process that causes lupus. 

How Does Benlysta Work? Mechanism of Action

Benlysta is a BLyS-specific inhibitor that works by blocking the BLyS protein that keeps harmful B-cells alive and active. This reduces B-cell survival and decreases autoantibody production, reducing the overactive immune response behind lupus flares and symptoms such as fatigue and joint pain.

Unlike broad immunosuppressants that affect your entire immune system, Benlysta specifically targets the cells and proteins involved in lupus.

Benlysta (belimumab) belongs to the drug class called B-lymphocyte stimulator (BLyS)-specific inhibitors.

What is the cost of Benlysta?

The list price for Benlysta injection is just over $1,200 per single dose (sold in a 4-pack for just over $4,800), while Benlysta infusion pricing varies based on patient weight.

Most insurance plans cover Benlysta, with over 95% of lupus patients nationwide having coverage.

Eligible commercially insured patients may qualify for the Benlysta Copay program, which can reduce out-of-pocket costs to as little as $0, with up to $9,450 in annual assistance. 

Benlysta Side Effects

Common Side Effects

The most common side effects of Benlysta are:

• Nausea
• Diarrhea
• Fever
• Stuffy or runny nose and sore throat (nasopharyngitis)
• Persistent cough (bronchitis)
• Trouble sleeping (insomnia)
• Leg or arm pain
• Depression
• Headache (migraine)
• Pain, redness, itching, or swelling at the site of the injection (when given subcutaneously).

Serious Side Effects

Benlysta can cause serious side effects, including:

• Progressive multifocal leukoencephalopathy (PML). This is a serious and life-threatening brain infection. Your chance of getting PML may be higher if you are treated with medicines that weaken your immune system, including Benlysta. PML can result in death or severe disability. If you notice any new or worsening medical problems such as those below, tell your healthcare provider right away:
  • memory loss
  • trouble thinking
  • dizziness or loss of balance
  • difficulty talking or walking
  • loss of vision.
• Cancer. Benlysta may reduce the activity of your immune system. Medicines that affect the immune system may increase your risk of certain cancers.

See also Warnings below.

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

Warnings

Immunosuppressive agents, including Benlysta, can cause serious side effects. Some of these side effects may cause death. 

Benlysta may increase the risk of infection, some of which may be serious, leading to hospitalization or death. Benlysta should be used with caution in patients with severe or chronic infections. Your healthcare provider may withhold your treatment with Benlysta if you develop a new infection during treatment. Tell your healthcare provider right away if you have any of the following symptoms of an infection:

• Fever
• Urinating often
• Chills
• Coughing up mucus
• Pain or burning with urination
• Warm, red, or painful skin or sores on your body.

Should not be given to people with a history of serious hypersensitivity reactions to Benlysta, belimumab, or any of the ingredients in the formulation. Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, can happen on the day of, or in the days after, receiving Benlysta and may cause death. Your healthcare provider will watch you closely while you are receiving Benlysta intravenously and after your infusion for signs of a reaction. Allergic reactions can sometimes be delayed. Tell your healthcare provider right away if you have any of the following symptoms of an allergic reaction following a benlysta infusion:

• Itching
• Low blood pressure
• Swelling of the face, lips, mouth, tongue, or throat
• Dizziness or fainting
• Headache
• Trouble breathing
• Nausea
• Anxiousness
• Skin rash.

Symptoms of mental health problems, including suicidal thoughts and actions, can occur with Benlysta. Tell your healthcare provider right away if you have any of the following symptoms:

• Thoughts of suicide or dying
• New or worse depression
• Attempt to commit suicide
• Acting on dangerous impulses
• Trouble sleeping (insomnia)
• Other unusual changes in your behavior or mood
• New or worse anxiety
• Thoughts of hurting yourself or others.

Before Receiving Benlysta

Absolute Contraindications

Do not receive Benlysta if you have previously had an anaphylactic reaction to Benlysta.

Caution Needed

Before you receive Benlysta, tell your healthcare provider about all of your medical conditions, including if you:

• Think you have an infection or have infections that keep coming back. You should not receive Benlysta if you have an infection unless your healthcare provider tells you to.
• Have or have had mental health problems such as depression or thoughts of suicide
• Have recently received a vaccination, or if you think you may need a vaccination. If you are receiving Benlysta, you should not receive live vaccines
• Are allergic to other medicines
• Are receiving other biologic medicines or monoclonal antibodies
• Have or have had any type of cancer
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Benlysta will harm an unborn baby. You should talk to your healthcare provider about whether to prevent pregnancy while on Benlysta.

If you choose to prevent pregnancy, you should use an effective method of birth control while receiving Benlysta and for at least 4 months after the final dose of Benlysta.

• Tell your healthcare provider right away if you become pregnant during your treatment with Benlysta or if you think you may be pregnant.
• If you become pregnant while receiving Benlysta, talk to your healthcare provider about enrolling in the Benlysta Pregnancy Registry.
• The purpose of this registry is to collect information about the health of you and your baby.

Breastfeeding

It is not known if Benlysta passes into your breast milk. You and your healthcare provider should talk about whether or not you should receive Benlysta and breastfeed.

How will I receive Benlysta?

Benlysta is available as IV infusions at a healthcare facility every 2-4 weeks, or subcutaneous injections for home use weekly or fortnightly.

• Both are equally effective; your doctor will recommend the best option.

How is a Benlysta infusion given?

You will be given Benlysta by a healthcare provider through a needle placed in a vein (IV infusion).

• It takes about 1 hour to give you the full dose of Benlysta.
• Your healthcare provider will tell you how often you should receive Benlysta.
• Your healthcare provider may give you medicines before you receive Benlysta to help reduce your chance of having a reaction. A healthcare provider will watch you closely while you are receiving Benlysta and after your infusion for signs of a reaction. A healthcare provider will review the signs and symptoms of possible allergic reactions that could happen after your infusion.

How is a Benlysta injection given?

Your healthcare provider will tell you how often and how much of Benlysta you should use. Use Benlysta exactly as your healthcare provider tells you to.

• Read the Instructions for Use that comes with your medicine for instructions about the right way to give Benlysta injections at home.
• Benlysta may be prescribed as a single-dose autoinjector or as a single-dose prefilled syringe.
  • The single-dose autoinjector is for use in adults and children 5 years of age and older.
  • The single-dose prefilled syringe is for use in adults 18 years of age and older.
  • For children under 10 years of age, Benlysta must be given by a healthcare provider or a trained caregiver.
• Remove from the refrigerator and allow it to reach room temperature for 30 minutes.
• Benlysta is injected under the skin (subcutaneously) of your stomach (abdomen) or thigh.
• Rotate injection sites
• Avoid skin that is bruised, tender, red, or hard.
• Use Benlysta on the same day each week or the same day every 2 weeks, as your healthcare provider tells you.

Before you use Benlysta, your healthcare provider will show you or your caregiver how to give the injections and review the signs and symptoms of possible allergic reactions.

What Happens if I Miss a Dose?

If you miss your subcutaneous dose of Benlysta on your planned day, inject a dose as soon as you remember. Then, inject your next dose at your regularly scheduled time or continue dosing based on the new day injected. In case you are not sure when to inject Benlysta, call your healthcare provider.

Call your doctor for instructions if you miss an appointment for your IV Benlysta infusion.

Dosing Information

Intravenous Dosing of Benlysta for Active SLE or Lupus Nephritis

• 10 mg/kg at 2-week intervals for the first 3 doses and at 4-week intervals thereafter.
• Administer over 1 hour.
• Consider prophylactic premedications for infusion reactions and hypersensitivity reactions.

Subcutaneous Dosing of Benlysta for Active SLE or Lupus Nephritis

Active SLE:

• Adults: 200 mg once weekly
• Pediatric patients (≥40 kg): 200 mg once weekly
• Pediatric patients (15 kg to <40 kg): 200 mg every 2 weeks.

Active Lupus Nephritis:

• Adults: 400 mg once weekly for 4 doses, then 200 mg once weekly
• Pediatric patients (≥40 kg): 400 mg once weekly for 4 doses, then 200 mg once weekly
• Pediatric patients (15 kg to <40 kg): 200 mg once weekly for 4 doses, then 200 mg every 2 weeks.

Note: The 400 mg dose requires two 200 mg injections. Prefilled syringes have not been studied in children under 18 years.

How Long Until Benlysta Works?

Most patients improve within 2-6 months, though responses vary:

• Some notice reduced fatigue and joint pain as early as 8 weeks
• Most begin seeing improvements in lupus symptoms within 2-6 months
• Full benefits may take up to 12 months to develop

Continue treatment as prescribed, even without immediate results, because Benlysta works gradually to suppress your overactive immune response.

What to Avoid While Taking Benlysta

Live Vaccines

Do not receive live vaccines while taking Benlysta, as they may not work properly and could cause infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, chickenpox, shingles, and the nasal flu vaccine. Inactivated vaccines like the flu injection are generally safe and recommended. Always discuss vaccination plans with your healthcare provider.

Sick Contacts

Avoid close contact with people who are sick or have infections, as Benlysta may weaken your immune system.

Drug Interactions

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

• Other biologics, such as rituximab. Research does not support using Benlysta with other biologics due to increased risk of serious infections and reactions.

Know the medicines you take. Keep a list of your medicines with you to show to your healthcare provider and
pharmacist when you get a new medicine.

Benlysta J Code

Benlysta J code is J0490 (Injection, belimumab, 10 mg).

Storage Instructions

Store autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C) until use and keep in their original carton to protect from light until use.

• Do not freeze
• Do not shake
• Avoid exposure to heat

Do not use Benlysta if it has been left out of the refrigerator for more than 12 hours.

Benlysta Ingredients

Active ingredient: belimumab

Inactive ingredients (IV): citric acid, polysorbate 80, sodium citrate, sucrose

Inactive ingredients (SC): L-arginine hydrochloride, L-histidine, L-histidine monohydrochloride, polysorbate 80, sodium chloride

Available as:

• Intravenous (IV): Single-dose vial: 120 mg or 400 mg lyophilized powder for reconstitution
• Subcutaneous (SC): Prefilled syringe: 200 mg/mL (adults 18+) and autoinjector: 200 mg/mL (ages 5+)

Manufacturer

Benlysta is made by GlaxoSmithKline LLC, Philadelphia, PA 19104.

Frequently Asked Questions

Is Benlysta a chemotherapy drug?

No. Benlysta is a targeted biologic therapy that specifically blocks the BLyS protein involved in lupus. Unlike chemotherapy drugs that kill rapidly dividing cells throughout the body, Benlysta selectively reduces overactive B-cells without the widespread cellular damage associated with chemotherapy.

Can I travel while taking Benlysta?

Yes, you can travel while receiving Benlysta, but you will need to plan ahead. 

• Subcutaneous Benlysta injections:
  • Bring enough medication plus extra for delays
  • Pack in carry-on luggage with a cooling pack (not frozen)
  • Bring a prescription and a doctor’s letter
  • Research medication import requirements for international destinations.
• Intravenous Benlysta Infusions:
  • Coordinate with a healthcare provider to find infusion centers at your destination
  • Consider adjusting the dosing schedule around travel dates.

Will Benlysta cure my lupus?

No, Benlysta will not cure Lupus. However, Benlysta can significantly help manage lupus by reducing disease activity, decreasing frequency and severity of flares, improving symptoms like fatigue and joint pain, potentially slowing organ damage, and improving quality of life.

Can I drink alcohol while taking Benlysta?

There are no specific restrictions on alcohol with Benlysta. However, other lupus medications (like methotrexate or NSAIDs) that you may be taking may interact with alcohol. Alcohol can also worsen lupus symptoms such as fatigue and depression and impair immune function, increasing infection risk.

Talk to your healthcare provider about drinking alcohol with Benlysta. 

Benlysta 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 Benlysta.Benlysta (belimumab) – GlaxoSmithKline LLC

What is Aubagio?

Aubagio is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease). Aubagio may help reduce the relapse rate, slow disability progression, and also slow lesion size growth, compared to placebo treatment. Aubagio tablets are taken once daily with or without food.

Aubagio affects the immune system and reduces swelling and inflammation in the nervous system. Aubagio works by lowering the number of lymphocytes that cause inflammation and damage to the nerves. This helps to slow the progression of RRMS and reduce the relapse rate.

In RRMS, a type of white blood cell called lymphocytes mistakenly attacks the protective coating (myelin) that surrounds your neurons, which causes inflammation of the neurons and loss of myelin. The neurons are unable to work properly, causing the symptoms of RRMS.

Aubagio is not a cure for MS; it helps slow disease progression and reduces relapse rate.

Aubagio received FDA approval on September 12, 2012. The generic for Aubagio is called teriflunomide and is also now available.

Aubagio side effects

Common Aubagio side effects may include:

• headache;
• nausea, diarrhea;
• thinning hair; or
• abnormal liver function tests.

Serious Abagio side effects

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

Stop using this medicine and call your doctor at once if you have:

• numbness or tingling in your hands or feet that feels different from your MS symptoms;
• trouble breathing, new or worsening cough with or without fever;
• signs of infection – fever, chills, body aches, nausea, vomiting, feeling tired, or
• liver problems – upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).

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

Warnings

Do not use Aubagio if you are pregnant or may become pregnant. You will need to have a negative pregnancy test before starting this treatment. Tell your doctor right away if you become pregnant during treatment or within 2 years after your treatment ends.

Teriflunomide can cause severe liver problems. You should not use this medicine if you have severe liver disease or if you are also taking leflunomide (Arava). Tell your doctor if you have a history of liver disease.

Call your doctor at once if you have signs of liver problems: upper stomach pain, loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

Your doctor may need to test your liver function up to 6 months before you start taking Aubagio and then every month when you first start taking this medicine.

Teriflunomide can lower blood cells that help your body fight infections. This can make it easier for you to get sick from being around others who are ill. While using Aubagio, you may need blood tests every 6 months. Your blood pressure will also need to be checked often.

After you stop taking Aubagio, the drug could stay in your body for up to 2 years. You may need to be treated with other medications to help your body eliminate teriflunomide quickly. Follow your doctor’s instructions.

Before taking this medicine

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

• you have severe liver disease or
• you are also taking leflunomide (Arava).

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

• liver or kidney disease;
• high blood sugar;
• high blood pressure;
• skin problems when taking medicines;
• a fever, or uncontrolled infections;
• breathing problems;
• tuberculosis; or
• nerve problems, such as neuropathy.

Pregnancy

Do not use Aubagio if you are pregnant or may become pregnant You will need to have a negative pregnancy test before starting this treatment. Use birth control to prevent pregnancy while you are taking this medicine. After you stop taking Aubagio, continue using birth control until you have received blood tests to make sure the drug has been eliminated from your body.

Avoid getting pregnant until after you stop taking this medicine and undergo a “drug elimination” procedure to help rid your body of this medicine. Stop taking Aubagio and call your doctor right away if you miss a period or think you might be pregnant. If you inadvertently become pregnant while receiving Aubagio or within 2 years of stopping it, there is a pregnancy surveillance program for Aubagio. You or your healthcare provider can report the pregnancy by calling 1-800-745- 4447. This is to track the outcome of the pregnancy and to evaluate any effects of teriflunomide on the baby.

If you are a man, use effective birth control to prevent pregnancy if your sex partner is able to get pregnant. After your treatment ends, keep using birth control until you have received the medications to help your body eliminate teriflunomide.

Breastfeeding

You should not breastfeed while using this medicine.

How should I take Aubagio?

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

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

You may take Aubagio with or without food.

Your blood pressure will need to be checked often.

Teriflunomide can lower your blood cell counts. Your blood will need to be tested often. Your treatment may be delayed based on the results.

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

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

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

7 mg or 14 mg orally once a day

Use: Treatment of patients with relapsing forms of multiple sclerosis.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What to avoid

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

Do not receive a “live” vaccine while using Aubagio, and for at least 6 months after you stop taking it. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

What other drugs will affect Aubagio?

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

Your doctor may need to adjust the doses of any other medicines you take on a regular basis.

Many drugs can interact with teriflunomide. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Kesimpta?

Kesimpta (ofatumumab) is an FDA-approved medicine used to slow the progression and risk of relapses for specific forms of relapsing multiple sclerosis (MS). It is a once-a-month injection given under the skin (subcutaneously) that you can self-administer in your own home.

Kesimpta’s mechanism of action is thought to involve binding to and decreasing numbers of B cells. These are a type of white blood cell called B-lymphocytes that produce antibodies and are more abundant in people with MS, particularly those with active disease. Kesimpta binds to CD20, a protein on the surface of pre-B and mature B cells, triggering the destruction of the cell. Kesimpta will not cure MS but clinical trials show it slows its progression and reduces the rate of relapse.

Kesimpta belongs to the drug class called CD20 monoclonal antibodies. Kesimpta may also be called a selective immunosuppressant.

Kesimpta gained FDA approval on October 26, 2009. There is no Kesimpta generic (more correctly called a biosimilar). 

What is Kesimpta used for?

Kesimpta is used in adults with specific types of relapsing forms of multiple sclerosis (MS) including:

• clinically isolated syndrome (CIS)
• relapsing-remitting MS (RRMS)
• active secondary progressive disease (active SPMS).

Clinical trials have shown Kesimpta starts to work to lower B cells within a week. Symptoms of MS may take a bit longer to resolve.

Important Note:  Arzerra Vs Kesimpta

Although Arzerra contains the same active ingredient as Kesimpta (ofatumumab), they are NOT interchangeable.

• They are used to treat different conditions (Arzerra is used for CLL and Kesimpta is used for MS).
• They are given by different routes of administration (Arzerra is given by intravenous infusion and Kesimpta is given by subcutaneous injection).

Kesimpta side effects

The most common side effects of Kesimpta are:

• upper respiratory tract infections (these are typically viral infections that cause sneezing, nasal congestion, a headache, and a sore throat)
• headache.

Serious side effects and warnings

Kesimpta can cause the following serious side effects.

Infections. Clinical trials have reported serious infections associated with Kesimpta. If you have an active infection, your healthcare provider should delay your treatment until your infection is gone. Kesimpta taken before or after other medicines that weaken the immune system may increase your risk of getting infections. Tell your healthcare provider right away if you have any infections or get any symptoms, including painful and frequent urination, nasal congestion, runny nose, sore throat, fever, chills, cough, or body aches.

Hepatitis B virus (HBV) reactivation. Before starting treatment, your healthcare provider will do blood tests to check for HBV. If you have ever had an HBV infection, the HBV may become active again during or after treatment. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems, including liver failure or death. You should not receive this medicine if you have active hepatitis B liver disease. Your healthcare provider will monitor you for HBV infection during and after you stop using this medicine. Tell your healthcare provider right away if you get worsening tiredness or yellowing of your skin or white part of your eyes during treatment.

Progressive Multifocal Leukoencephalopathy (PML). PML may happen with this medicine. PML is a rare, serious brain infection caused by a virus that may get worse over days or weeks. PML can result in death or severe disability. Tell your healthcare provider right away if you have any new or worsening neurologic signs or symptoms. These may include weakness on one side of your body, loss of coordination in arms and legs, vision problems, and changes in thinking and memory which may lead to confusion and personality changes.

Weakened immune system. Kesimpta taken before or after other medicines that weaken the immune system could increase your risk of getting infections.

Injection-related reactions. Injection-related reactions are a common side effect of Kesimpta. These can happen within 24 hours (1 day) following the first injection and with later injections. There are 2 kinds of reactions:

• at or near the injection site: redness of the skin, swelling, itching and pain. Talk with your healthcare
  provider if you have any of these signs and symptoms.
• those that may happen when certain substances are released in your body: fever, headache, pain in the muscles, chills, tiredness, rash, hives, trouble breathing, swelling of the face, eyelids, lips, mouth, tongue and throat, and feeling faint, or chest tightness. Contact your healthcare provider right away if you experience any of these signs and symptoms, especially if they become worse or you have new severe signs of reactions after subsequent injections. It could be a sign of an allergic reaction, which can be serious.

Low immunoglobulins. Kesimpta may cause a decrease in some types of antibodies. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.

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

Before using Kesimpta

Do not use Kesimpta if you:

• have an active hepatitis B virus infection
• have had an allergic reaction to ofatumumab or a life-threatening injection-related reaction to Kesimpta.

Before using this medicine, tell your healthcare provider about all of your medical conditions, including if you:

• have or think you have an infection including HBV or PML
• have ever taken, currently take, or plan to take medicines that affect your immune system. These medicines could increase your risk of getting an infection
• have had a recent vaccination or are scheduled to receive any vaccinations.
  • You should receive any required ‘live’ or ‘live-attenuated’ vaccines at least 4 weeks before you start treatment. You should not receive ‘live’ or ‘live-attenuated’ vaccines while you are being treated with this medicine and until your healthcare provider tells you that your immune system is no longer weakened.
  • Whenever possible, you should receive any ‘non-live’ vaccines at least 2 weeks before you start treatment with Kesimpta.
  • Talk to your healthcare provider about vaccinations for your baby if you used Kesimpta during your pregnancy.
• are pregnant, think you might be pregnant, or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if this medicine will harm your unborn baby. Females who can become pregnant should use birth control (contraception) during treatment with this medicine and for 6 months after your last treatment. Talk with your healthcare provider about what birth control method is right for you during this time.

Breastfeeding

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

How should I use Kesimpta?

See the detailed Instructions for Use that come with the Kesimpta Package Insert for information about how to prepare and inject a dose of this medicine and how to properly throw away (dispose of) used pens or prefilled syringes.

• Use Kesimpta exactly as your healthcare provider tells you to use it.
• Kesimpta is given as an injection under your skin (subcutaneous injection), in your thigh or stomach area (abdomen) by you or a caregiver. A caregiver may also give you an injection in your upper outer arm. See Where and how is Kesimpta injected? for more information.
• Your healthcare provider will show you how to prepare and inject this medicine the right way before you use it for the first time.
• Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with moles, scars, or stretch marks.

Kesimpta dosing

• Initial dosing: Kesimpta 20 mg of Kesimpta given by subcutaneous injection at Weeks 0, 1, and 2.
• Subsequent dosing: Kesimpta 20 mg administered monthly starting at week 4.
• There is no injection at Week 3.

What happens if I miss a dose?

If you miss a monthly injection, give it as soon as possible without waiting until the next scheduled dose. After that, use your injections a month apart.

What other drugs will affect Kesimpta?

Tell your doctor about all your other medicines, especially drugs that weaken the immune system such as

• cancer medicine
• steroids
• medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect Kesimpta, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal  supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I store Kesimpta?

Store Kesimpta in a refrigerator between 36°F to 46°F (2°C to 8°C). Keep it in the original carton until ready for use to protect it from light.

If needed, Kesimpta may be stored for up to 7 days at room temperature, up to 86°F (30°C ). Write the date taken out of the refrigerator in the space provided on the carton.

If stored below 86°F (30°C), unused Kesimpta may be returned to the refrigerator and must be used within the next 7 days. If this Kesimpta is not used within those 7 days, then discard the medicine.

Do not freeze. Do not shake.

Keep Kesimpta and all medicines out of the reach of children.

What are the ingredients in Kesimpta?

Active ingredient: ofatumumab
Inactive ingredients: Sensoready pen and prefilled syringe: arginine, disodium edetate, polysorbate 80, sodium acetate trihydrate, sodium chloride, and Water for Injection. Hydrochloric acid may be added.

Available as Kesimpta 20 mg/0.4 mL solution in a single-dose prefilled Sensoready Pen and Kesimpta 20 mg/0.4 mL solution in a single-dose prefilled syringe.

Who makes Kesimpta?

Kesimpta is made by Novartis, a multinational pharmaceutical company headquartered in Basel, Switzerland. Novartis was founded in 1996 through the merger of Ciba-Geigy and Sandoz. Some of Novartis’s other notable medications include:

• Entresto (for heart failure)
• Cosentyx (for psoriasis and arthritis)
• Gilenya (for multiple sclerosis)
• Zolgensma (for spinal muscular atrophy)
• Leqvio (for cholesterol management)
• Xolair (for asthma and allergic conditions)
• Tasigna (for leukemia)
• Tafinlar (for melanoma)
• Promacta (for blood disorders)
• Kisqali (for breast cancer).

What is leflunomide?

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

Leflunomide is used to treat the symptoms of rheumatoid arthritis.

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

Leflunomide side effects

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

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

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

Common side effects of leflunomide may include:

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

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

Warnings

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

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

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

Before taking this medicine

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

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

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

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

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

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

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

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

How should I take leflunomide?

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

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

Your blood pressure will need to be checked often.

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

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

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

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

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

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

Leflunomide dosing information

Usual Adult Dose for Rheumatoid Arthritis:

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

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

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

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

What should I avoid while taking leflunomide?

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

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

What other drugs will affect leflunomide?

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

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

What is Mayzent?

Mayzent (siponimod) belongs to a class of medications called sphingosine l-phosphate receptor modulators.

Mayzent is used to prevent episodes of symptoms and slow the worsening of disability in adults with relapsing-remitting forms (course of disease where symptoms flare up from time to time) of multiple sclerosis (MS); a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control).

Mayzent works by decreasing the action of immune cells that may cause nerve damage. It is only used if you have a specific genotype. Your doctor will test you for this genotype.

Mayzent was FDA-approved on March 26, 2019.

Mayzent side effects

Common Mayzent side effects may include:

• headache;
• increased blood pressure; or
• abnormal liver function tests.

Serious side effects

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

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

• slow or irregular heartbeats;
• vision problems such as increased sensitivity to light, blurred vision, eye pain, having a blind spot or shadows in the center of your vision, or unusual color to your vision (vision problems may occur 1 to 4 months after you start taking Mayzent). S1P receptor modulators, including Mayzent, have been associated with an increased risk of macular edema. Your healthcare provider should send you for an eye examination before starting treatment, 3 to 4 months into treatment, periodically thereafter, and any time there is a vision change. Patients with diabetes or a history of uveitis are more at risk;
• headache, confusion, change in mental status;
• a seizure;
• sores in your mouth and throat, cold sores, sores on your genital or anal area;
• skin changes, unusual moles that change in color or size;
• shortness of breath;
• liver problems – nausea, vomiting, upper stomach pain, tiredness, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes); or
• symptoms of meningitis – fever, chills, body aches, tiredness, nausea and vomiting, neck stiffness, increased sensitivity to light.

Longer treatment durations of Mayzent (more than 18 months) increase the risk of developing progressive multifocal leukoencephalopathy (PML), a rare brain infection.

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 the FDA

Warnings

You should not use Mayzent if you have a serious heart condition such as “sick sinus syndrome” or “AV block” (unless you have a pacemaker), or if you’ve recently had heart block, heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke.

Mayzent can slow your heart rate when you start taking it. You may receive your first dose in a setting where your heart rhythm can be monitored. If you miss any doses, you may need to restart taking this medicine under medical observation.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, vomiting, confusion, neck stiffness, or problems with coordination, thought, vision, or muscle movement. Your risk of infection could last for 3 to 4 weeks after you stop taking this medicine.

You may have increased sensitivity to light, blurred vision, eye pain, or have a blind spot or shadows in the center of your vision, unusual color to your vision, or other vision problems while you are taking Mayzent, which may occur 1 to 4 months after your first dose.

You should not use Mayzent if you have a specific genotype. Your doctor will perform tests to make sure this medicine is the right treatment for you.

Before taking this medicine

You should not use Mayzent if you are allergic to siponimod or any of the ingredients in Mayzent tablets, or if you have:

• a specific genotype;
• “AV block” (2nd or 3rd degree);
• irregular or abnormal heart rhythm (unless you have a pacemaker); or
• recent (within the past 6 months) heart failure, heart attack, stroke, ‘mini-stroke’ or TIA, chest pain (unstable angina), or other serious heart problem.

Some heart rhythm medications can cause unwanted or dangerous effects when used with Mayzent. Your doctor may change your treatment plan if you also use: amiodarone, disopyramide, dofetilide, dronedarone, flecainide, ibutilide, procainamide, propafenone, quinidine, or sotalol.

Before you take Mayzent, tell your doctor if you have never had chickenpox or if you have never received a varicella vaccine. You may need to receive the vaccine and then wait 1 month before taking Mayzent.

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

• weak immune system (caused by disease or by using certain medicines);
• fever or an active or chronic infection;
• high blood pressure;
• slow or irregular heart beats;
• heart problems, a heart attack, a stroke, or chest pain;
• asthma, sleep apnea (breathing stops during sleep), or other breathing disorder;
• skin cancer (melanoma);
• an eye condition called uveitis;
• diabetes; or
• liver disease.

Tell your doctor if you have recently received a vaccine, or if you are scheduled to receive a vaccine.

Siponimod may harm an unborn baby. Use effective birth control while using Mayzent and for at least 10 days after your last dose. Tell your doctor if you become pregnant .

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

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

How should I take Mayzent?

Take Mayzent exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your dose will be increased gradually during the first 5 to 6 days of taking Mayzent.

You may need medical tests before you start taking Mayzent including blood tests, ECG, eye evaluation, heart and liver function tests, and skin exam.

Siponimod can slow your heart rate when you start taking it. You may receive your first dose in a medical setting. Your blood pressure and heart rate may be constantly monitored for at least 6 hours after your first dose of Mayzent.

Siponimod 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. Your risk of infection could last 3 to 4 weeks after you stop taking this medicine.

Always ask your doctor before you stop taking Mayzent for any reason. When you stop taking Mayzent, your MS symptoms may return. In rare cases, some people who stopped taking Mayzent had MS symptoms that were worse than before or during treatment with this medicine.

If you stop taking Mayzent, do not start taking it again without asking your doctor. You may need to be under medical observation when you restart this medication.

Do not crush, break, or split a Mayzent tablet. Swallow the tablet whole.

You may take Mayzent with or without food.

Store unopened tablets in the refrigerator, do not freeze.

After opening, store Mayzent in the original container at room temperature away from moisture and heat for up to 3 months.

If you stop taking this medicine, watch for signs of worsening MS, and call your doctor right away if any new or worsening symptoms appear.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

CYP450 2C9 Genotype *1/*1, *1/*2, or *2/*2:
-Titration regimen: 0.25 mg orally once daily on Days 1 and 2, then 0.5 mg orally once daily on Day 3, then 0.75 mg orally once daily on Day 4, then 1.25 mg orally once daily on Day 5
-Maintenance dose: 2 mg orally once daily beginning on Day 6
NOTE: Use a starter pack for patients who will be titrated to the 2 mg maintenance dose.

CYP450 2C9 Genotype *1/*3 or *2/*3:
-Titration regimen: 0.25 mg orally once daily on Days 1 and 2, then 0.5 mg orally once daily on Day 3, then 0.75 mg orally once daily on Day 4
-Maintenance dose: 1 mg orally once daily beginning on Day 5
NOTE: Do not use the starter pack for patients who will be titrated to the 1 mg maintenance dose.
-If one titration dose is missed for more than 24 hours, therapy needs to be reinitiated with Day 1 of the titration regimen.

Comments:
-If one titration dose is missed for more than 24 hours, therapy needs to be reinitiated with Day 1 of the titration regimen.
-First-dose monitoring is recommended for patients with sinus bradycardia, first- or second-degree atrioventricular (AV) block, or a history of myocardial infarction or heart failure.
-Administer the first dose in a setting equipped to manage symptomatic bradycardia.
-Monitor patients for 6 hours after the first dose for bradycardia with hourly pulse and blood pressure measurements. Obtain an ECG in these patients at the end of Day 1.
-If any of the following abnormalities are present after 6 hours (even in the absence of symptoms), continue monitoring until the abnormality resolves: the heart rate 6 hours post dose is less than 45 bpm; the heart rate 6 hours post dose is at the lowest value post dose, suggesting that the maximum pharmacodynamic effect on the heart may not have occurred; the ECG 6 hours post
dose shows new onset second-degree or higher AV block.
-If post dose symptomatic bradycardia, bradyarrhythmia, or conduction related symptoms occur, or if ECG 6 hours post dose shows new onset second degree or higher AV block or QTc greater than or equal to 500 msec, initiate management, begin continuous ECG monitoring, and continue monitoring until the symptoms have resolved if no treatment is required. If treatment is required, continue monitoring overnight and repeat 6-hour monitoring after the second dose.
-After the initial titration is complete, if treatment is interrupted for 4 or more consecutive daily doses, reinitiate therapy with Day 1 of the titration regimen; also complete first-dose monitoring in patients for whom it is recommended.

Use: For relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

What happens if I miss a dose?

Call your doctor for instructions. If you miss 1 or more of your first doses, or 4 or more of your maintenance doses, you may need to take your next dose under medical observation in a medical setting.

Get your prescription refilled before you run out of medicine completely.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line.

What should I avoid while taking Mayzent?

Avoid receiving a vaccine without asking your doctor. The vaccine may not work as well while you are using Mayzent. Receiving a “live” vaccine while using Mayzent may cause you to develop an infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

If you need to receive a vaccine, you should stop taking Mayzent for at least 1 week ahead of time. After receiving the vaccine, you should wait another 4 weeks before you start taking Mayzent again. Do not stop taking this medicine without your doctor’s advice.

Oral route(Capsule;Tablet;Powder for Suspension)

Embryofetal Toxicity, Malignancies and Serious Infections

Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning.

Increased risk of development of lymphoma and other malignancies, particularly of the skin.

Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes .

Uses for mycophenolate mofetil

Mycophenolate belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines (eg, cyclosporine, steroid medicine) to lower the body’s natural immunity in patients who receive organ transplants (eg, kidney, heart, or liver).

When a patient receives an organ transplant, the body’s white blood cells will try to get rid of (reject) the transplanted organ. Mycophenolate prevents the white blood cells from rejecting the transplanted organ.

This medicine is available only with your doctor’s prescription.

Before using mycophenolate mofetil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate capsules, suspension, or tablets in children receiving kidney transplants. However, safety and efficacy have not been established in infants younger than 3 months of age.

Appropriate studies have not been performed on the relationship of age to the effects of mycophenolate capsules, suspension, or tabletsin children receiving heart or liver transplants. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of mycophenolate delayed-release tablets in children receiving kidney transplants. However, safety and efficacy have not been established in children younger than 5 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of mycophenolate in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving mycophenolate.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amoxicillin
• Azathioprine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholestyramine
• Ciprofloxacin
• Clavulanic Acid
• Colesevelam
• Colestipol
• Cyclosporine
• Dengue Tetravalent Vaccine, Live
• Desogestrel
• Dexlansoprazole
• Dienogest
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Drospirenone
• Esomeprazole
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etonogestrel
• Gestodene
• Influenza Virus Vaccine, Live
• Isavuconazonium Sulfate
• Lansoprazole
• Levonorgestrel
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Measles Virus Vaccine, Live
• Medroxyprogesterone
• Mercaptopurine
• Mestranol
• Metronidazole
• Mumps Virus Vaccine, Live
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Omeprazole
• Pantoprazole
• Poliovirus Vaccine, Live
• Rabeprazole
• Rifampin
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Segesterone
• Smallpox Vaccine
• Tacrolimus
• Telmisartan
• Typhoid Vaccine, Live
• Ulipristal
• Varicella Virus Vaccine, Live
• Yellow Fever Vaccine
• Zoster Vaccine, Live

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iron
• Lanthanum Carbonate
• Sevelamer

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bone marrow problems (eg, neutropenia) or
• Hepatitis B or C infection or
• Stomach or bowel problems (eg, ulcers, bleeding)—Use with caution. May make these conditions worse.
• Infection (eg, bacteria, fungus, or virus), active—May decrease your body’s ability to fight an infection.

• Kelley-Seegmiller syndrome (rare genetic disease) or
• Lesch-Nyhan syndrome (rare genetic disease)—Should not be used in patients with these conditions.
• Kidney disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
• Phenylketonuria (PKU)—The oral suspension contains aspartame (phenylalanine), which can make this condition worse.

Proper use of mycophenolate mofetil

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much may increase the chance of side effects, while taking too little may lead to rejection of your transplanted organ.

This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take this medicine on an empty stomach, either 1 hour before or 2 hours after meals, unless your doctor tells you otherwise.

Mycophenolate capsules, delayed-release tablets, and tablets should be swallowed whole. Do not break, crush, cut, open, or chew them.

It is important that you handle this medicine with care. Avoid inhaling the powder from the capsule or allowing the powder or the oral liquid to touch your skin or eyes. If the medicine gets on your skin, wash it thoroughly with soap and water. If the medicine gets in your eyes, wash them with plain water. Should a spill occur, wipe it up using paper towels wetted with water to remove the powder or liquid.

Measure the oral liquid medicine with the oral dispenser. Do not mix with any other medicine. Ask your doctor or pharmacist if you have any questions about this.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

If you are also using antacids that contain aluminum or magnesium (eg, Maalox® or Mylanta®), do not use them at the same time as mycophenolate. Use them 2 hours after your dose. If you have questions, talk with your doctor about the best times to use your medicines.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules, suspension, or tablets):
  • To prevent heart transplant rejection:
    • Adults—1.5 grams (g) 2 times a day.
    • Children—Use and dose must be determined by your doctor.
  • To prevent kidney transplant rejection:
    • Adults—1 gram (g) 2 times a day.
    • Children 3 months of age and older—Dose is based on body surface area (BSA) and must be determined by the doctor. The suspension dose is 600 milligrams (mg) per square meter [m(2)] 2 times a day. The capsules and tablets are given as 750 mg to 1 gram two times a day.
    • Children younger than 3 months of age—Use and dose must be determined by your doctor.
  • To prevent liver transplant rejection:
    • Adults—1.5 grams (g) 2 times a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage forms (delayed-release tablets):
  • To prevent kidney transplant rejection:
    • Adults—720 milligrams (mg) 2 times a day.
    • Children 5 years of age and older (at least 6 months after the transplant)—Dose is based on body surface area (BSA) and must be determined by the doctor. The dose is 400 mg per square meter [m(2)] 2 times a day. Dose is usually not more than 720 mg 2 times a day.
    • Children younger than 5 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 2 hours from your next scheduled dose, skip the missed dose and return to your regular schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The oral suspension can also be kept in the refrigerator. Throw away any unused suspension after 60 days.

Precautions while using mycophenolate mofetil

It is very important that your doctor check your progress at regular visits. Your doctor will do blood tests to make sure that mycophenolate is working properly and to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby or cause a miscarriage during the first 3 months. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Your birth control pills may not work as well while you are using this medicine. You must use two forms of birth control together for 1 month before starting this medicine, for the entire time that you are being treated, and for 6 weeks after you receive your last dose of this medicine. Use birth control pills together with another form of birth control, including a condom, diaphragm, or contraceptive foam or jelly. Male patients with female partners should use an effective form of birth control during treatment and for at least 90 days after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

Do not donate sperm during treatment and for at least 90 days after the last dose.

Using this medicine may increase your risk of getting skin cancer or cancer of the lymph system (lymphoma). Talk to your doctor if you have concerns about this risk.

Use sunscreen or sunblock lotions with a sun protection factor (SPF) of at least 30 on a regular basis when you are outdoors. Wear protective clothing and hats and stay out of direct sunlight, especially between the hours of 10 am. and 3 pm. Avoid sunlamps and tanning beds.

Mycophenolate can temporarily lower the number of white blood cells in your blood, which increases the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Mycophenolate may cause pure red cell aplasia (PRCA). This is a very rare condition where the body no longer makes red blood cells and the patient has severe anemia. Check with your doctor right away if you have a fever and sore throat, pale skin, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may increase your risk of developing a serious and rare brain infection called progressive multifocal leukoencephalopathy (PML). Check with your doctor right away if you have vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs.

This medicine may increase your risk of developing rare and serious virus infections, including shingles, herpes, cytomegalovirus (CMV) infection, polyomavirus associated nephropathy (PVAN), BK virus-associated nephropathy (BKVAN), or SARS-CoV-2 (COVID-19) infection. The BK virus may affect how your kidneys work and cause a transplanted kidney to fail. Check with your doctor right away if you have bloody urine, a decreased frequency or amount of urine, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain.

This medicine may cause reactivation of hepatitis B or C infection. Check with your doctor right away if you have dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

Check with your doctor right away if you have difficulty in moving, fever, muscle pain or stiffness, or pain, swelling, or redness in the joints. These may be symptoms of acute inflammatory (swelling) syndrome.

While you are using mycophenolate, and after you stop, do not have any immunizations (vaccinations) without your doctor’s approval. Mycophenolate will lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent.

This medicine may cause serious stomach or bowel problems (eg, ulcers, bleeding). Check with your doctor right away if you have black, tarry stools, constipation, diarrhea, heartburn, indigestion, nausea, stomach pain, cramping, or burning, trouble breathing, or vomiting of blood or material that looks like coffee grounds.

This medicine may inhibit the ability to drive and use machines. Avoid driving or using machines if confusion, dizziness, fainting, lightheadedness, sleepiness, or trembling or shaking of the hands or feet occur during treatment.

Do not stop taking this medicine without checking first with your doctor. Doing so may cause rejection of your transplanted organ. Your doctor will decide how long you should take this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of mycophenolate mofetil

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• bloody or cloudy urine
• blurred vision
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chest pain or tightness
• confusion
• cough or hoarseness
• decreased urine
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty in moving
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast, slow, pounding, or irregular heartbeat or pulse
• fever or chills
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• headache
• heartburn
• increased hunger
• increased thirst
• increased urination
• irregular heartbeats
• irregular pulse
• irritability
• lightheadedness
• loss of appetite
• loss of strength or energy
• lower back or side pain
• muscle cramps in the hands, arms, feet, legs, or face
• muscle pain, stiffness, cramps, or weakness
• muscle spasms (tetany) or twitching
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain in the joints
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid weight gain
• rapid, shallow breathing
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach cramps, pain, and bloating
• sweating
• swollen glands
• tingling of the hands or feet
• trembling
• tremor
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• weakness or heaviness of the legs

Incidence not known

• Back pain
• bloody, black, tarry stools
• constipation
• coughing or spitting up blood
• darkened urine
• general feeling of illness
• indigestion
• night sweats
• pain
• pains in the stomach, side, or abdomen, possibly radiating to the back
• severe headache
• sudden high fever or low-grade fever for months
• tenderness
• watery or bloody diarrhea
• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

What is omalizumab?

Omalizumab (Xolair) injection is used to reduce the risk of severe food allergy reactions (anaphylaxis) and help improve allergic asthma, nasal polyps, and chronic hives symptoms. Omalizumab works by targeting specific proteins in the immune system to reduce allergy symptoms.

Omalizumab is given as an injection under the skin every 2 to 4 weeks and can be self-injected using a pen (autoinjector) or a prefilled syringe.

Omalizumab is an anti-IgE antibody that works by blocking a protein (IgE ) that plays a key role in allergic responses. Omalizumab is a preventative medicine that reduces symptoms caused by allergies; it does not treat acute asthma or emergency allergic reactions, including anaphylaxis.

Omalizumab FDA approval was granted on June 20, 2003, for Genentech and Novartis Pharmaceuticals.

Omalizumab brand name is Xolair.

What is omalizumab used for?

Omalizumab is used to treat:

• food allergies to reduce allergic reactions including anaphylaxis after accidentally eating food you are allergic to. Omalizumab can be used for IgE-mediated food allergy in adults and children aged 1 year and older. May be given repeatedly and should be used in conjunction with food allergen avoidance. It should not be used for the emergency treatment of allergic reactions, including anaphylaxis.
• moderate to severe asthma that is caused by allergies for adults and children who are at least 6 years old. It can be used if asthma symptoms are not controlled by asthma-inhaled steroid medicine. It is not a rescue medicine for treating an asthma attack.
• chronic hives with no known cause (chronic spontaneous urticaria) in adults and children who are at least 12 years old. It can should only be used if antihistamine medicines have been tried but were not successful. It should not be used for other forms of hives.
• nasal polyps in people 18 years of age and older as an add-on medicine if medicines called nasal corticosteroids have not worked well

How does omalizumab work?

If you have allergies, your overactive immune system produces antibodies called Immunoglobulin E (IgE) which bind to receptors on cells in the immune system (mast cells). When you are exposed to the allergen (food, dust, grass) the allergen binds to IgE on the cells which sets off an allergic reaction triggering the release of chemicals like histamine, which causes the allergic reaction.

Omalizumab mechanism of action is by blocking the binding of IgE to receptors on cells, which in turn stops the release of the chemicals responsible for allergy symptoms. Omalizumab also reduces the number of IgE receptors on cells, resulting in further improvement of allergy symptoms.

Omalizumab side effects

Common omalizumab side effects

Common omalizumab side effects include: 

• fever;
• rash;
• nausea, vomiting, diarrhea, stomach pain;
• Itching or a skin rash;
• headache;
• dizziness; 
• joint pain usually in arms or legs, bone fractures;
• ear pain, ear infection;
• Swelling in sinuses, nose or throat;
• Throat infection
• nose bleeds
• injection site reaction with pain, bruising, swelling, or irritation where the medicine was injected; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, cough, sore throat.

The common omalizumab side effects vary depending on the condition being treated and the age group of the patient. 

Serious omalizumab side effects

Some people using omalizumab have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reactions may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any signs of an allergic reaction to omalizumab:

• hives, itching;
• anxiety or fear, feeling like you might pass out;
• flushing (warmth, redness, or tingly feeling);
• chest tightness, wheezing, cough, feeling short of breath, difficult breathing;
• fast or weak heartbeats; or
• swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• ongoing nausea or vomiting, severe or watery diarrhea;
• trouble breathing;
• numbness or tingling in your arms or legs;
• fever, muscle pain, and rash within a few days after receiving an injection;
• signs of an ear infection – fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder; or
• signs of a blood clot – sudden numbness or weakness, problems with vision or speech, coughing up blood, swelling or redness in an arm or leg.

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

Warnings

Some people using this injection have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reactions may occur even after using this injection regularly for a year or longer.

Get emergency medical help if you have any signs of an allergic reaction to omalizumab: hives, rash; anxiety or fear; flushing (warmth, redness, or tingly feeling); feeling like you might pass out; chest tightness, wheezing, feeling short of breath, difficult breathing; fast or weak heartbeats; swelling of your face, lips, tongue, or throat.

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

If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the injection as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Omalizumab should not be used for the emergency treatment of allergic reactions, including anaphylaxis. It is only used in food allergy to reduce the risk of allergic reactions.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Before taking this medicine

You should not use this medicine if you are allergic to omalizumab, or any of the inactive ingredients.  See the bottom of this document for a full list of ingredients. To make sure omalizumab is safe for you, tell your doctor if you have:

• any signs of infection (fever, swollen glands, general ill feeling)
• any other allergies (foods, pollens, etc.)
• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others)
• past or present cancer
• a history of heart attack or stroke
• if you are receiving allergy shots
• if you have ever had a severe allergic reaction (anaphylaxis)
• if you have a latex allergy, as the needle cap on the prefilled syringe contains a type of natural rubber latex.

Using this injection may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

While you are using this medicine, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.

Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant during treatment.   If you become pregnant while using this injection, call your doctor.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of omalizumab on the baby.

Breastfeeding 

It is not known whether omalizumab could harm a nursing baby. Tell your doctor if you are breastfeeding or planning to breastfeed a baby..

How should I use omalizumab?

Before you start treatment with this medicine, your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

Omalizumabis given as an injection under the skin (subcutaneous injection). When you first start your treatment, the injection will be given to you by your healthcare provider. 

You will be watched closely for a short time after receiving the injection to make sure you do not have an allergic reaction to the medication.

Your healthcare provider may decide that the injections can be administered by you or a caregiver, and you will receive training on the right way to prepare and inject this medicine. Do not try to inject omalizumab until you have been shown the right way to use the prefilled syringe injections.

For children 12 years of age and older, the prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, the prefilled syringe should be injected by a caregiver.

Omalizumab is usually given every 2 or 4 weeks, depending on what condition you are treating.

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

If you also use a steroid medicine, do not stop using it suddenly, or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks.

While using this medicine, you may need frequent medical tests, such as allergy tests and lung function tests. Your stools may also need to be checked for parasites, especially if you travel.

Your condition may not improve right away. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Omalizumab Prefilled Syringe instructions:

• Take the carton containing the prefilled syringe out of the refrigerator. Set aside the carton for at least 15 to 30 minutes so the prefilled syringe can warm up on its own to room temperature. Leave the prefilled syringe in the carton to protect it from light.
• Do not speed up the warming process using any heat sources such as warm water or a microwave.
• Check the contents of the prefilled syringe for particulate matter and discoloration prior to administration. The solution should be clear and colorless to pale brownish yellow. Do not use the prefilled syringe if the medicine is cloudy, discolored, or contains particles.
• Check the number of prefilled syringes needed for the patient’s dosage.
• For patients requiring more than 1 injection to complete a full dose, administer each injection at least 1 inch apart from other injection sites.
• Use the injection within 4 hours after taking it out of the refrigerator
• Administer subcutaneous injection into the thigh or abdomen, avoiding the 2-inch (5 cm) area directly around the navel. The outer area of the upper arms may be used only if the injection is being given by a caregiver or healthcare provider. The injection may take 5-10 seconds to administer.
• Dispose of the used syringe in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Omalizumab dosing information

Usual omalizumab dose for food allergy (IgE-Mediated):

Dose: 75 mg to 600 mg subcutaneously every 2 or 4 weeks.

• Determine the dosage and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and the person’s body weight (kg).
• See the dose determination chart in the prescribing information.

Usual adult and pediatric dose for asthma:

Dose: 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks. Dose and frequency of injection is based on weight and pre-treatment IgE levels. 

Comments: 

• Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
• Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
• Periodically reassess the need for continued therapy based on the patient’s disease severity and level of asthma control.

Use: Management of moderate to severe persistent asthma in patients  (12 Years and Older) who are inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen.

Usual Adult Dose for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Dose: 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks. The dose and frequency of injection are based on weight and pre-treatment IgE levels. Click on the link below “Detailed Xolair dosage information” for dose details.

Comments:

• Periodically reassess the need for continued therapy based upon the patient’s disease severity and level of symptom control.
• Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
• Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.

Use: As an add-on maintenance treatment for Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Usual Adult Dose for Chronic Spontaneous Urticaria (CSU):

Dose: 150mg or 300 mg subcutaneously every 4 weeks.

Comments:

• Dosing is not dependent on IgE levels or body weight.
• Avoid administering more than 150 mg per injection site.
• The appropriate duration of therapy for CSU has not been evaluated. Periodically reassess the need for continued therapy.

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment.. 

Xolair formulations

Xolair Autoinjector (single-dose prefilled): 75 mg/0.5 mL, 150 mg/mL and 300 mg/2 mL

Prefilled syringe (single-dose): 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL

Single-dose vial for reconstitution: 150 mg lyophilized powder

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What other drugs will affect omalizumab?

Other drugs may interact with this medicine including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using.
It is important to tell your doctor or healthcare provider if you have any of the following: allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances) and medications that suppress your immune system. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

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

Storage

• Store in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Keep your unused prefilled syringes in the original carton until use to protect them from light.
• The Xolair prefilled syringe can be removed and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not exceed 2 days. 
• Do not use the prefilled syringe if it is exposed to temperatures above 77°F (25°C) and discard it in a sharps disposal container.
• Do not freeze. Do not use if prefilled syringes have been frozen.
• Keep this medicine out of direct sunlight.
• Do not use this medicine if it is past the expiration date.

Ingredients 

Active ingredient: omalizumab

Inactive ingredients:

Xolair Prefilled syringe or autoinjector: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20.

Xolair Vial: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20 and sucrose.

Manufacturer

Manufactured by:

• Genentech, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. U.S. License No.: 1048.

Jointly marketed by:

• Genentech USA, Inc., A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990.
• Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936-1080.

Omalizumab 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 omalizumab.Xolair (omalizumab) – Genentech, Inc.

What is Orencia?

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

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

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

Orencia was first FDA-approved on 23 December 2005.

Warnings

Hypersensitivity reactions, including anaphylaxis, have occurred.

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

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

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

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

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

Before taking

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

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

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

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

Pregnancy and breastfeeding

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

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

How will I receive Orencia?

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

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

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

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

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

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

For the preventative treatment of aGVHD

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

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while using Orencia?

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

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

What are the side effects of Orencia?

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

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

Orencia may cause serious side effects, including:

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

The most common side effects of Orencia include:

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

In children and adolescents, other side effects may include:

• diarrhea
• fever
• cough
• abdominal pain.

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

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

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

What other drugs will affect Orencia?

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

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

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

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

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

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

Storage

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

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

Ingredients

Active: abatacept.

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

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

Manufacturer

Bristol-Myers Squibb Company.

Orencia Biosimilars

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

Reference products

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

What is ozanimod?

Ozanimod is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Ozanimod is used only if you have a specific genotype. Your doctor will test you for this genotype.

Ozanimod is also used to treat adults with moderately to severely active ulcerative colitis.

It is not known if this medicine is safe and effective in children.

Warnings

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light. Your risk of infection could last for 3 months after you stop taking ozanimod.

You should not use ozanimod if you have a serious heart condition such as “AV block” or sick sinus syndrome and no pacemaker, or if you’ve recently had heart failure, a heart rhythm disorder, chest pain, heart attack, or stroke. You also should not use ozanimod if you have severe untreated sleep apnea.

Do not use ozanimod if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take this medicine.

Ozanimod can slow your heart rate when you start taking it. Tell your doctor if you have slow heartbeats, chest pain, shortness of breath, feeling like your heart is skipping beats.

You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, aches, tiredness, cough, rash, painful and frequent urination, confusion, neck stiffness, or increased sensitivity to light. Your risk of infection could last for 3 months after you stop taking this medicine.

Before taking this medicine

You should not use ozanimod if you are allergic to it, or if you have certain serious heart conditions, especially:

• recent (within the past 6 months) heart failure, heart attack, stroke, “mini-stroke” or TIA, chest pain (unstable angina), or other serious heart problem;
• “AV block” or sick sinus syndrome (unless you have a pacemaker); or
• severe untreated sleep apnea (breathing stops during sleep).

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take ozanimod.

Some heart rhythm medications can cause unwanted or dangerous effects when used with ozanimod. Your doctor may change your treatment plan if you also use amiodarone, disopyramide, dofetilide, dronedarone, ibutilide, procainamide, quinidine, or sotalol.

Before you take ozanimod, tell your doctor if you have never had chickenpox or received a varicella vaccine (Varivax). You may need to receive the vaccine and then wait 1 month before taking this medicine.

Tell your doctor if you have received any vaccine within the past 30 days, or if you are scheduled to receive a vaccine.

Tell your doctor if you have a fever or infection, or if you have ever had:

• a weak immune system (caused by disease or by using certain medicine);
• a very slow heart rate;
• heart rhythm problems, long QT syndrome;
• a heart attack, stroke, or chest pain;
• high blood pressure;
• sleep apnea or other breathing problems;
• diabetes;
• liver disease; or
• an eye condition called uveitis.

ozanimod may harm an unborn baby. Use effective birth control while using ozanimod and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

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

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

How should I take ozanimod?

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

Ozanimod can slow your heart rate when you start taking it. Before your first dose, your heart function will be checked using an electrocardiograph or ECG (sometimes called an EKG).

Ozanimod comes in a 7-day starter pack containing capsules of different colors and strengths. You should follow the dosing schedule as prescribed by your doctor. This may lower the risk of side effects.

You may take ozanimod with or without food. Avoid foods high in tyramine (aged, fermented, cured, smoked and pickled foods). Eating these foods while taking this medicine can raise your blood pressure.

You may get infections more easily, even serious or fatal infections. You will need frequent medical tests, and your risk of infection could last for 3 months after you stop taking this medicine.

If you get an infection, further doses may be delayed until your infection clears up.

If you stop taking ozanimod or miss a dose during the first 2 weeks, ask your doctor before you start taking the medicine again. You may need to use a starter pack again, to gradually increase your dose.

Store at room temperature away from moisture and heat.

Always ask your doctor before you stop taking ozanimod for any reason. Your MS symptoms may return and become worse than before or during treatment with this medicine. Tell your doctor if you have any signs of worsening MS.

Dosing information

Usual Adult Dose for Multiple Sclerosis:

DOSE TITRATION REGIMEN:
-Days 1 through 4: 0.23 mg orally once a day
-Days 5 through 7: 0.46 mg orally once daily
-Day 8 and thereafter: 0.92 mg orally once a day

MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8

Uses:
-For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
-For the treatment of moderately to severely active ulcerative colitis

Usual Adult Dose for Ulcerative Colitis:

DOSE TITRATION REGIMEN:
-Days 1 through 4: 0.23 mg orally once a day
-Days 5 through 7: 0.46 mg orally once daily
-Day 8 and thereafter: 0.92 mg orally once a day

MAINTENANCE DOSE: 0.92 mg orally once daily starting on Day 8

Uses:
-For the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
-For the treatment of moderately to severely active ulcerative colitis

What happens if I miss a dose?

Call your doctor for instructions. If you miss 1 or more doses in the first 2 weeks of treatment, you may need to start a new 7-day starter pack.

If you miss a dose after the first 2 weeks: Skip the missed dose and use your next dose at the regular time.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking ozanimod?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid getting a vaccine without first asking your doctor. While you are taking ozanimod, a “live” vaccine may not fully protect you from disease and you could develop an infection.

Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

You should not receive a live vaccine within 1 month before taking ozanimod, while taking it, and for at least 3 months after you stop taking it.

Ozanimod side effects

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

Call your doctor at once if you have:

• slow heartbeats, chest pain, shortness of breath, or feel like your heart is skipping beats;
• a light-headed feeling, like you might pass out;
• cough, new or worsening shortness of breath;
• sudden confusion, severe headache, vision loss, or a seizure;
• pounding in your neck or ears;
• liver problems – nausea, vomiting, upper stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
• changes in vision – blurred vision, increased sensitivity to light, seeing an unusual color in your vision, or having a blind spot or shadows in the center of your vision; or
• symptoms of infection – fever, flu symptoms, feeling very tired, cough, rash, painful and frequent urination, neck stiffness, increased sensitivity to light.

Common ozanimod side effects may include:

• headache, back pain;
• urination problems;
• high or low blood pressure;
• abnormal liver function tests; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

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 ozanimod?

Ozanimod can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• alemtuzumab, clopidogrel, eltrombopag, gemfibrozil, rifampin;
• an antidepressant;
• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection;
• heart rhythm medicine;
• medicine to treat Parkinson’s disease; or
• opioid pain medicine.

What is Rapamune?

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

Rapamune is a prescription medicine used to prevent rejection (anti-rejection medicine) in people 13 years of age and older who have received a kidney transplant. Rejection is when your body’s immune system recognizes the new organ as a “foreign” threat and attacks it. Rapamune is used with other medicines called cyclosporine (Gengraf, Neoral, Sandimmune), and corticosteroids.

Rapamune is also given without other medicines to treat a rare lung disorder called lymphangioleiomyomatosis (LAM). LAM affects predominantly women of childbearing age. This disorder happens mostly in women and causes lung tumors that are not cancerous but can affect breathing.

Warnings

You should not use Rapamune if you have ever had a lung transplant or liver transplant.

Rapamune may cause your body to overproduce white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

Call your doctor right away if you have: fever, flu symptoms, burning when you urinate, a new skin lesion, any change in your mental state, decreased vision, weakness on one side of your body, problems with speech or walking, or pain around your transplant.

Before taking this medicine

You should not use Rapamune if you are allergic to sirolimus, or if you have ever had a lung transplant or liver transplant.

Talk with your doctor about the risks and benefits of using this medicine. Rapamune can affect your immune system, and may cause overproduction of certain white blood cells. This can lead to cancer, severe brain infection causing disability or death, or a viral infection causing kidney transplant failure.

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

• high cholesterol or triglycerides;
• cytomegalovirus (CMV);
• liver disease; or
• a family history of skin cancer (melanoma).

Do not use Rapamune if you are pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine, and for at least 12 weeks after your last dose.

You should not breast-feed while using this medicine.

Rapamune should not be given to a child younger than 13 years old.

How should I take Rapamune?

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

Rapamune is usually taken once a day. If you also take cyclosporine, take it at least 4 hours before you take this medicine.

You may take Rapamune with or without food, but take it the same way every time.

Do not crush, chew, or break a Rapamune tablet. Tell your doctor if you have trouble swallowing the tablet whole.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Rapamune oral liquid must be mixed only with water or orange juice, no other juices or liquids. Measure the liquid carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Sirolimus can increase your risk of infection by changing the way your immune system works. You will need frequent medical tests. Your dosing schedule may be delayed based on the results of these tests.

You should not stop using Rapamune without your doctor’s advice. Stopping suddenly could make your condition worse.

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

Store the oral liquid in the refrigerator. Do not freeze. You may notice a slight haze to the liquid. This haze should disappear when the liquid reaches room temperature.

If you are using Rapamune oral liquid with a disposable syringe, you may store a loaded syringe in the carrying case provided. Keep the case at room temperature and use the medicine within 24 hours. Use a disposable syringe only once and then throw it away.

Dosing information

Usual Adult Dose of Rapamune for Organ Transplant — Rejection Prophylaxis:

FOR PATIENTS AT LOW TO MODERATE IMMUNOLOGIC RISK:
Dosing by body weight:
-Less than 40 kg:
Loading dose: 3 mg/m2 on day 1
Maintenance: 1 mg/m2 once daily
-Greater than or equal to 40 kg:
Loading dose: 6 mg orally on day 1
Maintenance: 2 mg orally once daily

IN PATIENTS AT HIGH IMMUNOLOGIC RISK (defined as Black transplant recipients and/or repeat renal transplant recipients who lost a previous allograft for immunologic reason and/or patients with high-panel reactive antibodies [PRA; peak PRA level greater than 80%]):
-For patients receiving sirolimus with cyclosporine:
Loading Dose: Up to 15 mg on day one post-transplantation
Maintenance Dose: Beginning on day 2, an initial maintenance dose of 5 mg/day should be given. A trough level should be obtained between days 5 and 7, and the daily dose of sirolimus should be adjusted thereafter.
-Antibody induction therapy may be used.

Comments:
-It is recommended that this sirolimus be used in a regimen with cyclosporine and corticosteroids.
-Sirolimus should be taken consistently with or without food.
-Once the sirolimus maintenance dose is adjusted, patients should continue on the new maintenance dose for at least 7 to 14 days before further dosage adjustment with concentration monitoring.

MAINTENANCE THERAPY AFTER WITHDRAWAL OF CYCLOSPORINE:
-Cyclosporine withdrawal is not recommended in high-immunological risk patients. Following 2 to 4 months of combined therapy, withdrawal of cyclosporine may be considered in low-to-moderate risk patients. Cyclosporine should be discontinued over 4 to 8 weeks, and a necessary increase in the dosage of sirolimus (up to 4-fold) should be anticipated due to removal of metabolic inhibition by cyclosporine and to maintain adequate immunosuppressive effects. -Dose-adjusted trough target concentrations are typically 16 to 24 ng/mL for the first year post-transplant and 12 to 20 ng/mL thereafter (measured by chromatographic methodology).

Usual Adult Dose of Rapamune for Pulmonary Lymphangioleiomyomatosis:

-Initial dose: 2 mg/day
-Sirolimus whole blood trough concentrations should be measured in 10 to 20 days, with dosage adjustment to maintain concentrations between 5 and 15 ng/mL.

Comment:
-This drug should be taken consistently with or without food.

Usual Pediatric Dose of Rapamune for Organ Transplant — Rejection Prophylaxis:

FOR PATIENTS AT LOW TO MODERATE IMMUNOLOGIC RISK:
Greater than or equal to 13 years of age:
Dosing by body weight:
-Less than 40 kg:
Loading dose: 3 mg/m2 on day 1
Maintenance: 1 mg/m2 once daily
-Greater than or equal to 40 kg:
Loading dose: 6 mg orally on day 1
Maintenance: 2 mg orally once daily

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

What should I avoid while taking Rapamune?

Avoid exposure to sunlight or tanning beds. Rapamune may increase your risk of skin cancer. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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

Avoid getting Rapamune oral liquid on your skin. Wash the skin with soap and water if this happens. If the medicine gets into your eyes, rinse them with plain water.

Grapefruit may interact with sirolimus and lead to unwanted side effects. Avoid the use of grapefruit and grapefruit juice while taking Rapamune.

Do not receive a “live” vaccine while using Rapamune. 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), and zoster (shingles).

Rapamune side effects

Rapamune may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly.

Get emergency medical help if you have signs of an allergic reaction to Rapamune: hives, rash, or peeling skin; wheezing, difficulty breathing, chest pain or tightness; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• redness, oozing, or slow healing of a skin wound;
• a new skin lesion, or a mole that has changed in size or color;
• unusual bleeding or bruising;
• sudden chest pain or discomfort, cough, feeling short of breath;
• tenderness around the transplanted kidney;
• signs of infection – fever, chills, painful mouth sores, skin sores, cold or flu symptoms, pain or burning when you urinate; or
• low red blood cells (anemia) – pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Rapamune side effects may include:

• fever, cold symptoms such as stuffy nose, sneezing, sore throat;
• mouth sores;
• nausea, stomach pain, diarrhea;
• headache, muscle aches;
• chest pain;
• dizziness; or
• acne.

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 Rapamune?

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

• bromocriptine (Cycloset, Parlodel);
• cyclosporine;
• danazol;
• St. John’s wort;
• tacrolimus;
• cholesterol-lowering medication;
• an antibiotic or antifungal medicine;
• antiviral medicine to treat HIV or hepatitis C;
• heart or blood pressure medication;
• medicine to reduce stomach acid or treat an ulcer; or
• seizure medicine.

What is ravulizumab-cwvz?

Ravulizumab-cwvz is a prescription medication used to treat myasthenia gravis (gMG), hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and neuromyelitis optica spectrum disorder (NMOSD) in certain patients. Ravulizumab helps regulate the immune system to prevent it from harming cells, which improves symptoms of these conditions.

Ravulizumab is given as an intravenous (IV) infusion by a healthcare provider. After the initial loading doses, ravulizumab is administered as a maintenance dose every 4 to 8 weeks

Ravulizumab brand name is Ultomiris by Alexion Pharmaceuticals, Inc.

Ravulizumab FDA approval was granted on December 21, 2018, for paroxysmal nocturnal hemoglobinuria. Since the Ravulizumab FDA approval for myasthenia gravis (general) was granted and several other conditions.

What is ravulizumab used for?

Ravulizumab FDA-approved indications are:

• generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive
• paroxysmal nocturnal hemoglobinuria (PNH) in adults and children aged one month and older
• atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) in adults and children aged one month and older, with (does not include Shiga toxin E. coli-related hemolytic uremic syndrome [STEC-HUS])
• neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive.

​​How does ravulizumab work?

Ravulizumab mechanism of action is as a monoclonal antibody complement inhibitor (C5).

Ravulizumab is a monoclonal antibody that blocks a part of the immune system called the complement system. It specifically targets and inhibits the C5 protein, which plays a key role in immune responses. Ravulizumab binds to the C5 protein and prevents it from being activated. This stops the immune system from mistakenly attacking healthy cells, which helps reduce symptoms and prevent disease progression.

Monoclonal antibodies are lab-made proteins designed to attach to specific targets, ravulizumab targets C5. The precise way Ultomiris infusion works is unknown, but it is thought to be due to a reduction or inhibition of C5b-9 deposition. 

Ravulizumab Clinical Trial Results

Improvement in Myasthenia Gravis (gMG) Symptoms

Ravulizumab has shown to reduce symptoms of generalized myasthenia gravis, as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. This scale ranges from 0 to 24, with higher scores indicating more severe impairment.

Key Findings from Clinical Trial ALXN1210-MG-306 (NCT03920293)

At 26 weeks, patients treated with ravulizumab showed significant improvement:

• 30% of patients experienced at least a 5-point improvement in MG-ADL (vs. 11.3% in placebo)
• 56.7% of patients had at least a 3-point improvement in MG-ADL (vs. 34.1% in placebo)
• The least squares (LS) mean MG-ADL score improved by -3.1 (vs. -1.4 in placebo).

Additional Clinical Trial Data

Clinical trial results of ravulizumab cwvz in hemolytic uremic syndrome (aHUS), paroxysmal nocturnal hemoglobinuria (PNH), and neuromyelitis optica spectrum disorder (NMOSD) are available in the Ravulizumab Package Insert – Clinical Studies.

Ravulizumab side effects

Common ravulizumab side effects

Common side effects of ravulizumab in gMG may include:

• Diarrhea (15%)
• high blood pressure (14%)
• Stomach pain (6%)
• Upper respiratory tract infection (14%)
• Urinary tract infection (6%)
• Back Pain (8%)
• Dizziness (9%).

These side effects occurred in 5% or more of generalized myasthenia gravis patients treated with ravulizumab in the Clinical Trial ALXN1210-MG-306.

Side effects vary depending on the condition being treated and the dose given.

Serious ravulizumab side effects

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

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed or if you have chest pain, trouble breathing, or swelling in your face.

Call your doctor right away if you have signs of infection such as:

• muscle pain with flu-like symptoms;
• fever and a rash;
• fever and a headache;
• headache and stiffness in your neck or back;
• headache and nausea or vomiting;
• confusion; or
• your eyes may be more sensitive to light.

Call your doctor at once if you have symptoms of gonorrhea, such as:

• pain or burning when you urinate;
• pain or swelling of the genital or rectal area;
• unusual vaginal bleeding; or
• foul discharge from the penis or vagina.

If you stop using this medicine, tell your doctor if you have any new or worsening symptoms, such as tiredness, confusion, stomach pain, chest pain, trouble breathing or swallowing, trouble having an erection (in men), blood in your urine, a seizure, or loss of consciousness.

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

Ravulizumab for Myasthenia Gravis

Understanding Myasthenia Gravis

Myasthenia gravis (MG) is a neuromuscular disorder caused by disrupted nerve-to-muscle communication at the neuromuscular junction. This occurs when the immune system attacks healthy cells or proteins needed for normal function, which prevents proper muscle activation.

If myasthenia gravis is AChR antibody-positive, the condition is specifically caused by antibodies targeting acetylcholine receptors.

How Ravulizumab Works for Myasthenia Gravis

Ravulizumab is a complement inhibitor that blocks complement, part of the immune system, responsible for damaging the neuromuscular junction. By reducing this immune attack, Ravulizumab helps improve muscle function and symptoms in people with myasthenia gravis.

Ravulizumab REMS Program (Ultomiris REMS)

Due to the risk of serious meningococcal infections, Ravulizumab is only available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program known as Ultomiris REMS. This program ensures patient safety by reducing the risk of life-threatening infections.

Steps Required Before Starting Ravulizumab (Ultomiris REMS Program)

Before receiving Ravulizumab, your doctor must:

• Enroll you in the REMS program.
• Explain the risks of meningococcal infections.
• Provide information on early symptoms of infection and the need for immediate medical attention.
• Confirm meningococcal vaccination and, if needed, provide preventive antibiotics if treatment must start before full vaccination.
• Give you a Patient Safety Card outlining the risk of infection.

 Important: Meningococcal vaccines do not prevent all infections. Seek emergency medical care if you experience any of the following symptoms:

Signs of a Serious Meningococcal Infection

• High fever or fever with rapid heart rate
• Severe headache with fever
• Confusion or disorientation
• Muscle aches with flu-like symptoms
• Fever with a rash
• Headache with nausea or vomiting
• Stiff neck or back
• Light sensitivity (photosensitivity)

Warnings

Ravulizumab infusion affects your immune system. You may get infections more easily, even serious or fatal infections such as meningitis. Call your doctor if you have a fever, flu-like symptoms, muscle pain, headache, confusion, neck or back stiffness, vomiting, rash, or if your eyes are more sensitive to light.

You will need to receive certain vaccinations, including vaccinations to protect against meningococcal disease, at least 2 weeks before you start using ravulizumab unless the risks of delaying ravulizumab outweigh the risks of a serious infection.

Ravulizumab comes with a Patient Safety Card listing symptoms of meningococcal infection. Keep this card with you at all times while using ravulizumab and for at least 8 months after your last dose. Your infection risk could last for several months after you stop using this medicine.

Some people may have an increased risk of gonorrhea (a sexually transmitted disease) while using this medicine. Talk with your doctor about safe ways to keep from getting an infection during sex.

This medicine should not be started in patients with unresolved serious Neisseria meningitidis infection.

Before taking this medicine

Before you receive ravulizumab infusion, tell your healthcare provider about all of your medical conditions, including if you:

• are allergic to ravulizumab or Ultomiris
• have a meningococcal infection (such as meningitis or sepsis), or if you are not currently vaccinated against meningitis (unless the risks of delaying treatment outweigh the risks of developing meningitis). You will need to receive a vaccine to protect against meningococcal infections at least 2 weeks before you start using Ultomiris. 
• If your child is treated with this medicine, make sure he or she is vaccinated against pneumonia and influenza type B (Hib). If you need to start receiving this medicine before you are vaccinated, you may be given antibiotic medicine to take during the first 2 weeks of Ultomiris treatment.
• have recently had any symptoms of an infection (fever, chills, or flu-like symptoms) or recently have had meningitis
• are pregnant or intend to become pregnant
• are breastfeeding or intend to breastfeed.

Ravulizumab infusion is only approved for patients 1 month and older for PNH and aHUS. For other indications (gMG and NMOSD) it is only approved for adults. Subcutaneous administration of Ultomiris has not been evaluated and is not approved for use in children.

Pregnancy

It is not known if ravulizumab will harm your unborn baby. Tell your doctor if you are pregnant. It is not known whether ravulizumab will harm an unborn baby. However, having PNH during pregnancy may cause complications in the baby or the mother, including blood clots, infections, bleeding, miscarriage, premature delivery, or death. The benefit of treating PNH may outweigh any risks to the baby or the mother.

Breastfeeding

It is not known if this medicine passes into your breast milk. You should not breastfeed during treatment and for 8 months after your final dose.

How is ravulizumab administered?

Intravenous (IV) infusion by a healthcare provider

Ravulizumab is given as an intravenous (IV) infusion by a healthcare professional.

• The first two infusions are usually 2 weeks apart, followed by maintenance infusions every 4 to 8 weeks.
• The infusion time ranges from 0.4 to 1.4 hours, depending on body weight and dosage.
• After each infusion, patients are monitored for at least 1 hour for any signs of an allergic reaction.

Dosage & weight considerations

• Dosages are weight-based, meaning your dose may change if you gain or lose weight.
• If switching from eculizumab (Soliris), you must wait 2 weeks after your last eculizumab dose before starting Ravulizumab.

Important safety information

Infection risks and monitoring

• Increased risk of infections, you may get infections more easily, including serious or fatal infections. Regular medical tests are required.
• The Patient Safety Card and carry it with you at all times while on Ravulizumab and for at least 8 months after the last dose.
• Infection risk may continue for several months after stopping treatment.

Risk of gonorrhea (sexually transmitted infection)

• Some patients may have a higher risk of gonorrhea.
• Talk to your doctor about safe practices to prevent infection.

Long-lasting effects after stopping treatment

• For Paroxysmal Nocturnal Hemoglobinuria (PNH): Monitoring is needed for at least 16 weeks after stopping treatment.
• For Atypical Hemolytic Uremic Syndrome (aHUS): Patients should be monitored for at least 12 months after stopping ravulizumab.

Ravulizumab dosage

Dosing is based on weight, and whether it’s a loading or maintenance dose:

• Patients 5 kg – 20 kg: Maintenance dose every 4 weeks.
• Patients 20 kg – 100+ kg: Maintenance dose every 8 weeks.

See, below for detailed “Detailed Ultomiris dosage information” including loading dose by weight and condition.

What is ravulizumab J Code?

Ravulizumab J code is J1303 (10 mg, injection)

What happens if I miss a dose?

If you miss a Ravulizumab IV or SC dose or administer a partial SC dose, call your healthcare provider right away.

Ravulizumab Package Insert 

Review the Ravulizumab Package Insert (Ultomiris) for more detailed information about this medicine. The PI contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your doctor or other health care provider. This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Package Insert is sometimes called Ultomiris Prescribing Information (PI) or Ultomiris FDA label.

What other drugs will affect ravulizumab?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Ultomiris and other medicines can affect each other causing side effects.

• A supplemental dose of Ultomiris is required for patients administered intravenous immunoglobulins or undergoing plasma exchange, plasmapheresis
• Monitor patients taking neonatal Fc Receptor Blockers (FcRn), such as efgartigimod or rozanolixizumab, closely for reduced effectiveness of Ultomiris.

Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. See the prescribing information for a full list of interactions.

Storage

Proper Storage Instructions:

• Temperature: Keep refrigerated at 2°C – 8°C (36°F – 46°F).
• Packaging: Store in the original carton to protect from light.
• Do Not: Freeze or Shake the vial.

Storage After Dilution:

• If not used immediately, store the prepared infusion in the refrigerator at 2°C – 8°C (36°F – 46°F).
• Do not exceed 24 hours in storage, including the expected infusion time.

Always follow the product guidelines for proper handling and administration.

Ingredients

Active ingredient: ravulizumab-cwvz. 

Inactive ingredients: 

Ultomiris 100 mg/mL: L-arginine, polysorbate 80 (vegetable origin), sodium phosphate dibasic, sodium phosphate monobasic, sucrose, and Water for Injection. 

Ultomiris 10 mg/mL: polysorbate 80 (vegetable origin), sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, and Water for Injection. 

Manufacturer

Manufactured by Alexion Pharmaceuticals, Inc., 121 Seaport Boulevard, Boulevard Boston, MA 02210 USA.

Ravulizumab 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 ravulizumab.Ultomiris (ravulizumab-cwvz) – Alexion Pharmaceuticals, Inc.

What is rozanolixizumab?

Rozanolixizumab is used to treat generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) or antimuscle-specific tyrosine kinase (MuSK) antibody positive. It is given as a subcutaneous infusion once a week for 6 weeks by a healthcare provider. The brand name is Rystiggo. 

Rozanolixizumab works by blocking a protein called the neonatal Fc receptor (FcRn). This protein helps harmful IgG antibodies survive in people with generalized myasthenia gravis (gMG). By reducing these antibody levels, the drug can improve muscle strength in people with gMG. Rozanolixizumab belongs to the drug class called neonatal Fc receptor blockers.

Rozanolixizumab gained FDA approval on June 27, 2023, under the brand Rystiggo. There is no generic or biosimilar.

Side effects

The most common side effects of rozanolixizumab are:

• headache
• infections, including the cold and the flu
• diarrhea
• fever
• hypersensitivity (allergic) reactions
• nausea
• reactions around the site where the needle pierced your skin
• stomach pain
• joint pain.

Serious side effects and warnings

Rozanolixizumab can cause the following serious side effects.

• Hypersensitivity reactions, including angioedema, swelling, and rash, have occurred in some patients treated with rozanolixizumab. Your doctor will monitor you during your infusion for hypersensitivity reactions. Seek medical attention if you develop an allergic reaction following the infusion.
• An increased risk of infection. In clinical studies, the most common infections were upper respiratory tract infections, COVID-19, urinary tract infections, and herpes simplex infections. Your healthcare provider should check you for infections before starting and during treatment with rozanolixizumab. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment such as a fever, chills, frequent and/or painful urination, cough, runny nose, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. Complete your age-appropriate vaccines according to immunization guidelines before starting a new treatment cycle. Receiving live or live-attenuated vaccines during treatment is not recommended.
• Aseptic meningitis has also been reported. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with rozanolixizumab such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting.

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

Before taking this medicine

You should complete all age-appropriate vaccinations before you start a treatment cycle of rozanolixizumab. Do not receive live or live-attenuated vaccines during treatment.

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

• Currently have an infection or have had any infections recently
• Have received or are scheduled to receive a vaccine (immunization). The use of vaccines during rozanolixizumab treatment has not been studied, and the safety of live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment and you should complete all your age-appropriate vaccines according to vaccination guidelines before starting a new treatment cycle.
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed.

Based on animal data, rozanolixizumab may cause harm to an unborn baby. It is not known if rozanolixizumab passes into breast milk.

How will I receive rozanolixizumab?

Rozanolixizumab is administered as an injection under your skin (subcutaneously) by your healthcare provider.

• It is given using an infusion pump under the skin of the lower right or lower left part of your abdominal area, but not close to your navel
• It is given once a week for 6 weeks (this is one treatment cycle).
• Subsequent treatment cycles may be administered depending on your response.
• The safety of administering a treatment cycle sooner than every 63 days from the start of the previous treatment cycle has not been established.

Infusion rate

Rozanolixizumab is infused at a rate of 20 mL/hour.

• You will be monitored during the infusion and for at least 15 minutes after for hypersensitivity reactions.

Dosing information

Dose of Rozanolixizumab for Generalized Myasthenia Gravis (gMG):

• Less than 50 kg: 420 mg
• 50 kg to less than 100 kg: 560 mg
• 100 kg or more: 840 mg 

Do not flush the line after use because the infusion volume has been adjusted to account for losses in the line.

What happens if I miss a dose?

If a scheduled dose is missed, rozanolixizumab may be administered up to 4 days after the scheduled time.

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

What should I avoid while receiving rozanolixizumab?

Avoid receiving live vaccines while you are being treated with this medicine.

What other drugs will affect rozanolixizumab?

Care should be taken when using rozanolixizumab with other medications that bind to the human neonatal Fc receptor (FcRn) (such as immunoglobulin products, monoclonal antibodies, or antibody derivatives containing the human Fc domain of the IgG subclass) because it may reduce the effectiveness of these medications.

Rozanolixizumab may have interactions with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use, and when you start, stop, or change a dose of any medicine.

Ingredients

Active ingredient: rozanolixizumab-noli 

Inactive ingredients (Rystiggo): histidine, L-histidine hydrochloride monohydrate, polysorbate 80, proline, and water for injection, USP. 

Available in a single-dose vial for subcutaneous infusion in the following strengths:

• 280 mg/2 mL
• 420 mg/3 mL
• 560 mg/4 mL
• 840 mg/6 mL.

The concentration of each vial is 140 mg/mL.

Manufacturer

Rozanolixizumab is manufactured by UCB Inc., a biopharmaceutical company headquartered in Brussels, Belgium. 

Rozanolixizumab 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 rozanolixizumab.Rystiggo (rozanolixizumab-noli) – UCB, Inc.

What is Rystiggo?

Rystiggo is used to treat generalized myasthenia gravis (gMG) that is acetylcholine receptor (anti-AChR) or muscle-specific tyrosine kinase (anti-MuSK) antibody-positive in adults. It is administered subcutaneously once a week for 6 weeks by a healthcare provider.

Rystiggo works by binding to and blocking a protein called neonatal Fc receptor (FcRn), which is crucial for the transport of immunoglobulin G (IgG) antibodies, including AChR and MuSK pathogenic autoantibodies, across cells and membranes. IgGs bound to FcRn are protected from degradation, whereas unbound ones are vulnerable to degradation. By binding to and blocking FcRn, Rystiggo leaves IgG antibodies unbound, increasing their removal and reducing their damage to other proteins involved in signal transmission in gMG. Rystiggo belongs to the drug class called neonatal Fc receptor blockers. 

The MycarinG Study (NCT03971422, n=200), a Phase 3 clinical trial, reported significant improvements in the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale after 6 weeks of Rystiggo treatment.

• Some patients reported improvement in as little as 1 week.
• Up to 72% of trial participants responded to treatment.
• An open-label extension (MG0004, NCT04124965) showed repeated cycles for up to 52 infusions resulted in consistent, clinically meaningful improvements across cycles.

Rystiggo (rozanolixizumab-noli) gained FDA approval on June 27, 2023. There is no generic or biosimilar. 

Side effects

The most common Rystiggo side effects are:

• headache
• infections, including a cold and the flu
• diarrhea
• fever
• hypersensitivity (allergic) reactions
• nausea.

Serious side effects and warnings

Rystiggo may cause the following serious side effects:

• Infection: Rystiggo may increase the risk of infection. In clinical studies, the most common infections were upper respiratory tract infections, COVID-19, urinary tract infections, and herpes simplex infections. Your healthcare provider should check you for infections before starting and during treatment with Rystiggo. Tell your healthcare provider if you have any history of infections. Tell your healthcare provider right away if you have signs or symptoms of an infection during treatment with Rystiggo. Some of the signs and symptoms may include fever, chills, frequent and/or painful urination, cough, runny nose, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain
• Aseptic Meningitis: Rystiggo could cause aseptic meningitis. Tell your healthcare provider right away if you develop any signs or symptoms of meningitis during treatment with Rystiggo, such as severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting
• Hypersensitivity Reactions: Rystiggo can cause swelling and rash. Your healthcare provider should monitor you during and after treatment and discontinue Rystiggo if needed. Tell your healthcare provider immediately about any undesirable reactions you experience after administration.

Safety in children has not been established.

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

Before taking this medicine

To make sure Rystiggo is safe for you, tell your healthcare provider about all your medical conditions, including if you:

• have a history of infection or think you have an active infection
• have received or are scheduled to receive a vaccine (immunization). The use of vaccines during Rystiggo treatment has not been studied, and the safety of live or live-attenuated vaccines is unknown. Administration of live or live-attenuated vaccines is not recommended during treatment with this medicine. Completion of age-appropriate vaccines according to vaccination guidelines before starting a new treatment cycle with Rystiggo is recommended
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Based on animal data, Rystiggo may harm an unborn baby. Talk to your healthcare provider immediately if you become pregnant while receiving Rystiggo.

Breastfeeding

It is unknown if Rystiggo passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you are receiving Rystiggo.

How is Rystiggo administered?

Rystiggo is administered by a healthcare provider as a subcutaneous infusion 1 time a week for 6 weeks (this is one treatment cycle).

• Rystiggo may be administered in an infusion center or healthcare provider’s clinic, or at-home infusions by a nurse may be possible in certain areas. 
• It usually takes 15 minutes to administer the injection subcutaneously using an infusion pump.
• It is usually administered into your lower abdominal area, but not within 2 inches of your navel.
• Subsequent treatment cycles may be administered depending on your response to Rystiggo.

Dosing information

Dose of Rystiggo for AChR or MuSK antibody +ve gMG in adults

• Less than 50 kg: 420 mg (volume to be infused: 3 mL)
• 50 kg to less than 100 kg: 560 mg (volume to be infused: 4 mL)
• 100 kg or more: 840 mg (volume to be infused: 6 mL).

Administer subsequent treatment cycles based on clinical evaluation; the safety of initiating subsequent cycles sooner than 63 days from the start of the previous treatment cycle has not been established.

What happens if I miss a dose?

If a scheduled dose is missed, Rystiggo may be administered up to 4 days after the scheduled time point.

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

What should I avoid while receiving Rystiggo?

You should avoid receiving live vaccines while you are being treated with this medicine.

What other drugs will affect Rystiggo?

Care should be taken when using Rystiggo with other medications that bind to the human neonatal Fc receptor (FcRn) (such as immunoglobulin products, monoclonal antibodies, or antibody derivates containing the human Fc domain of the IgG subclass) because it may reduce the effectiveness of these medications.

Rystiggo may interact with other prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use, and when you start, stop, or change a dose of any medicine.

Ingredients

Active: rozanolixizumab-noli 

Inactive ingredients: each mL contains histidine 1.05 mg, L-histidine hydrochloride monohydrate 4.87 mg, polysorbate 80 (0.30 mg), proline 28.78 mg, and water for injection, USP. 

Rystiggo injection is available in single-dose vials as the following strengths:

• 280 mg/2 mL 
• 420 mg/3 mL
• 560 mg/4 mL
• 840 mg/6 mL.

Each vial has a concentration of 140 mg/mL.

Manufacturer

Rystiggo (rozanolixizumab-noli) is manufactured by UCB (Union Chimique Belge), with global headquarters in Brussels, Belgium.

Rystiggo 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 Rystiggo.Rystiggo (rozanolixizumab-noli) – UCB, Inc.

What is Afinitor?

Afinitor is a cancer medicine that interferes with the growth of cancer cells and slows their spread in the body.

Afinitor is used to treat certain types of kidney cancer, breast cancer, or brain tumor. It is also used to treat certain types of advanced or progressive tumors of the stomach, intestines, or pancreas.

Afinitor is also used to treat certain types of seizures or non-cancerous (benign) tumors of the brain or kidney in people with a genetic condition called tuberous sclerosis complex.

This medication guide provides information about the Afinitor brand of everolimus. Zortress is another brand of everolimus used to prevent organ rejection after a kidney transplant.

Warnings

Afinitor can cause serious and sometimes fatal side effects. Call your doctor right away if you have: signs of infection–fever, chills, skin rash, joint pain, tiredness; lung problems–cough, chest pain, wheezing, shortness of breath; kidney problems–swelling, little or no urination; or liver problems–loss of appetite, dark urine, yellowing of your skin or eyes, or upper stomach pain.

If you have ever had hepatitis B, Afinitor can cause this condition to come back or get worse.

You may be more likely to have an allergic reaction if you take an “ACE inhibitor” heart or blood pressure medication while you are taking Afinitor. Tell your doctor about all your current medicines and any you start or stop using.

Before taking this medicine, tell your doctor if you have a breathing disorder such as asthma or COPD, liver disease (or a history of hepatitis B), an active infection, diabetes or high blood sugar, or high cholesterol.

Do not use everolimus if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 8 weeks after your treatment ends.

Before taking this medicine

You should not use Afinitor if you are allergic to everolimus, sirolimus (Rapamune), or temsirolimus (Torisel).

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

• an active or chronic infection;
• liver disease, especially hepatitis B;
• kidney disease;
• diabetes or high blood sugar;
• high cholesterol;
• if you are scheduled to receive any vaccine; or
• high blood pressure.

Afinitor can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.

• If you are a woman, do not use Afinitor if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 8 weeks after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 4 weeks after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Afinitor.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because Afinitor can harm an unborn baby.

You should not breastfeed while using this medicine and for at least 2 weeks after your last dose.

How should I take Afinitor?

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

Take Afinitor at the same time each day. You may take the medicine with or without food, but take it the same way each time.

Do not take a regular tablet together with a dispersible tablet. Use only one form of this medicine.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

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

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

Surgical incisions or other wounds may take longer to heal while you are taking Afinitor. You may need to stop taking this medicine for 1 week before and 2 weeks after a surgery. Follow your doctor’s instructions.

Store at room temperature in the original container, away from moisture, heat, and light. Keep unused dispersible tablets in the foil blister pack.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if you are more than 6 hours late for the dose. Do not use two doses at one time.

What to avoid

Do not receive a “live” vaccine while using Afinitor, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, and varicella (chickenpox)

Grapefruit may interact with everolimus and lead to unwanted side effects. Avoid the use of grapefruit products.

If you develop mouth sores or ulcers, avoid using mouthwashes or applying medicines that contain alcohol, peroxide, iodine, or thyme. Your doctor may prescribe a steroid mouthwash if your mouth sores are severe.

Afinitor side effects

Get emergency medical help if you have signs of an allergic reaction to Afinitor: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have some of these symptoms if you also take an “ACE inhibitor” heart or blood pressure medication.

Call your doctor at once if you have:

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
• lung problems – new or worsening cough, chest pain, wheezing, feeling short of breath;
• signs of infection – fever, chills, tiredness, joint pain, skin rash;
• kidney problems – little or no urination; swelling in your feet or ankles;
• liver problems – nausea, loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• low blood cell counts – flu-like symptoms, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed;
• any wound that will not heal; or
• a surgical incision that is red, warm, swollen, painful, bleeding, or oozing pus.

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

Common Afinitor side effects may include:

• fever, cough, infections, feeling weak or tired;
• mouth sores;
• nausea, loss of appetite;
• swelling anywhere in your body;
• rash;
• missed menstrual periods;
• headache; or
• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath odor.

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.

What other drugs will affect Afinitor?

Tell your doctor about all your current medicines. Many drugs can affect Afinitor, especially:

• an antibiotic or antifungal medicine;
• heart or blood pressure medication;
• medicine to treat hepatitis C, or HIV/AIDS;
• seizure medicine;
• St. John’s wort;
• tuberculosis medication; or
• drugs that weaken the immune system, such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

What is abatacept?

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

Abatacept is a selective T-cell costimulation modulator.

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

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

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

Who can use abatacept?

Abatacept is FDA-approved to be used for:

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

Abatacept side effects

Common abatacept side effects

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

Serious abatacept side effects

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

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

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

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

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

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

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

Warnings 

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

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

Hypersensitivity and anaphylaxis have occurred. 

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

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

You should be screened for viral hepatitis before starting abatacept.

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

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

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

Before taking this medicine

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

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

Tell your doctor if you have ever had:

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

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

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

Pregnancy

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

Breastfeeding

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

How should I use abatacept?

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

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

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

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

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

For preventative treatment of aGVHD:

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

General administration information

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

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

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

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

If you need surgery, tell the surgeon beforehand you are using abatacept.

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

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

Autoimmune disorders are often treated with a combination of different drugs. Use all medications as directed and read all medication guides you receive. Do not change your dose or dosing schedule without your doctor’s advice.

Dosing Information

Usual Adult Dose for Rheumatoid Arthritis:

IV Dosing Regimen:
Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter.
Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter.
Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter.
Subcutaneous Dosing Regimen:
Optional IV loading dose:

• Weight less than 60 kg: 500 mg IV once.
• Weight 60 to 100 kg: 750 mg IV once.
• Weight more than 100 kg: 1000 mg IV once

Subcutaneous injection: 125 mg subcutaneously once a week
Comments:
This drug may be used as monotherapy or concomitantly with disease-modifying antirheumatic drugs (DMARDs) other than Janus kinase (JAK) inhibitors or biologic disease-modifying antirheumatic drugs (bDMARDS), such as tumor necrosis factor (TNF) antagonists.
The IV infusion should be administered over 30 minutes.
Before the first subcutaneous dose, an optional loading dose may be administered as a single IV infusion; if an IV loading dose is used, the first subcutaneous injection should be administered within 1 day of the infusion.
For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.
Use: For the treatment of patients with moderately to severely active rheumatoid arthritis

Usual Adult Dose for Psoriatic Arthritis:

IV Dosing Regimen:
Weight less than 60 kg: 500 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight 60 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Subcutaneous Dosing Regimen: 125 mg subcutaneously once a week
Comments:
This drug may be used with or without nonbiologic DMARDs.
The IV infusion should be administered over 30 minutes.
For patients switching from IV therapy to subcutaneous administration, the first subcutaneous dose should be administered instead of the next scheduled IV dose.
Use: For the treatment of patients with active psoriatic arthritis

Usual Adult Dose for Graft Versus Host Disease – Prophylaxis:

10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose
Comments:
Before administering this drug, recommended antiviral prophylaxis for Epstein-Barr virus (EBV) reactivation should be administered and continued for 6 months after hematopoietic stem cell transplantation (HSCT); additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
The IV infusion should be administered over 60 minutes.
Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of acute graft versus host disease (aGVHD) in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor

Usual Pediatric Dose for Juvenile Idiopathic Arthritis:

IV Dosing Regimen:
6 years or older:
Weight less than 75 kg: 10 mg/kg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight 75 to 100 kg: 750 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Weight more than 100 kg: 1000 mg IV initially, at 2 and 4 weeks, and every 4 weeks thereafter
Maximum dose: 1000 mg/dose
Subcutaneous Dosing Regimen:
2 years or older:
Weight 10 to less than 25 kg: 50 mg subcutaneously once a week
Weight 25 to less than 50 kg: 87.5 mg subcutaneously once a week
Weight at least 50 kg: 125 mg subcutaneously once a week
Comments:
This drug may be used as monotherapy or concomitantly with methotrexate.
The IV infusion should be administered over 30 minutes.
Subcutaneous administration: Patients may self-inject or the patient’s caregiver may administer this drug if both the health care provider and parent/legal guardian decides it is appropriate; the ability of pediatric patients to self-inject with the autoinjector has not been tested.
Use: For the treatment of patients with moderately to severely active polyarticular juvenile idiopathic arthritis

Usual Pediatric Dose for Graft Versus Host Disease – Prophylaxis:

2 to less than 6 years: 15 mg/kg IV on the day before transplantation (Day -1), then 12 mg/kg IV on Days 5, 14, and 28 after transplantation
6 years or older: 10 mg/kg IV on the day before transplantation (Day -1), then 10 mg/kg IV on Days 5, 14, and 28 after transplantation
Maximum dose: 1000 mg/dose
Comments:
Before administering this drug, recommended antiviral prophylaxis for EBV reactivation should be administered and continued for 6 months after HSCT; additionally, prophylactic antivirals for CMV infection/reactivation should be considered during therapy and for 6 months after HSCT.
The IV infusion should be administered over 60 minutes.
Use: In combination with a calcineurin inhibitor and methotrexate, for the prophylaxis of aGVHD in patients undergoing HSCT from a matched or 1 allele-mismatched unrelated-donor.

What happens if I miss a dose?

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

What should I avoid while using abatacept?

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

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

What other drugs will affect abatacept?

Tell your doctor about all your other medicines, especially:

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

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

Does abatacept interact with my other drugs?

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

Ingredients

Active ingredient: abatacept.

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

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

Storage

Store in the original carton in a refrigerator. Protect from light and do not freeze. Do not use it after the expiration date on the medicine label has passed.

If you need to travel with your medicine, place the syringes in a cooler with ice packs.

Abatacept mixed with a diluent may be stored in a refrigerator or at room temperature and must be used within 24 hours.

Company

Bristol-Myers Squibb Company, Princeton, NJ 08543 USA, U.S. License Number 1713.

Abatacept Biosimilars

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

Reference products

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