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ZINBRYTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, ZINBRYTA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if ZINBRYTA is safe and effective for use in children under 18 years of age. See ZINBRYTA Risk Information

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Make an informed decision

There are potential benefits of treating relapsing MS with ZINBRYTA. There are also serious risks involved with ZINBRYTA that you need to know and consider before starting therapy.

Because of the risk of serious liver problems (including autoimmune-related liver problems) and other immune system problems, ZINBRYTA is only available through a restricted program called the ZINBRYTA REMS Program. In order to receive ZINBRYTA, doctors, patients, and pharmacies must agree to comply with the requirements of the ZINBRYTA REMS Program. A Risk Evaluation and Mitigation Strategy (REMS) Program is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure the benefits of a drug continue to outweigh its risks.

The ZINBRYTA REMS Program is designed with your safety in mind and for your doctor to help guide you through your treatment journey. To learn more about the ZINBRYTA REMS Program, call 1-800-456-2255 or click here.

Before, during, and after ZINBRYTA

If you and your doctor decide that ZINBRYTA is the right treatment for your relapsing MS, there are certain things that you will need to do:

Complete the ZINBRYTA REMS Program Patient Enrollment Form with your doctor.

Complete liver testing before your first dose of ZINBRYTA.

Complete liver testing every month during ZINBRYTA treatment and monthly for 6 months after discontinuation.

  • It is very important that you have these monthly blood tests, even if you are feeling well
  • Testing at home may be an option for you. Talk to your doctor about which option works best for you

Inform your doctor if you have any side effects, reactions, or symptoms after receiving ZINBRYTA.

  • Be sure to carry your ZINBRYTA REMS Program Patient Wallet Card with you at all times and show it to any doctor involved in your healthcare

Before using ZINBRYTA, tell your healthcare provider if you:

  • Have or have had liver problems
  • Have or have had skin problems including eczema or psoriasis
  • Have tuberculosis
  • Have an active infection
  • Are planning to receive a vaccine
  • Have or have had depression
  • Are pregnant or plan to become pregnant. It is not known if ZINBRYTA will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if ZINBRYTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZINBRYTA

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using ZINBRYTA with other medicines can cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Being open and honest with your doctor is key for a successful partnership on your journey with relapsing MS.

Inject ZINBRYTA under the skin, once a month

  • See the Instructions for Use for detailed instructions on using ZINBRYTA the right way
  • Use ZINBRYTA exactly as your healthcare provider tells you. A healthcare provider should show you how to inject ZINBRYTA before you use it for the first time
  • Inject ZINBRYTA 1 time every month
  • ZINBRYTA is for use under the skin (subcutaneous injection) of your thigh, stomach (abdomen), or back of the upper arm
  • If you miss a dose of ZINBRYTA, inject your dose of ZINBRYTA as soon as possible within 2 weeks of the missed dose. If it is more than 2 weeks after your missed dose, skip the missed dose. Inject your next dose at your regular time the next month. Do not inject more than 1 dose of ZINBRYTA at a time
  • Your healthcare provider should do blood tests before you start ZINBRYTA, every month during your treatment with ZINBRYTA, and monthly for 6 months after you have stopped using ZINBRYTA to check for side effects. Your healthcare provider should check your test results before your next dose

Get comfortable injecting ZINBRYTA

Knowledge is power when learning how to properly inject using the fully assembled ZINBRYTA prefilled syringe. Nurse Educators  serve as a resource for you and your care partners and can help you with your injection technique. This is important because how you give a ZINBRYTA injection may be different from any previous injectable therapy you may have had.

We encourage you to seek treatment assistance with a Nurse Educator, who can help you if you have any questions or concerns. Remember, you can always request to have a Nurse Educator meet with you after your treatment begins.

Important Safety Information


ZINBRYTA can cause serious side effects, including:

  • Liver problems. ZINBRYTA may cause serious liver problems (including autoimmune-related liver problems) that may lead to death. Your healthcare provider should do blood tests to check your liver before you start using ZINBRYTA, every month while you are using ZINBRYTA, and monthly for 6 months after you stop using ZINBRYTA. Your healthcare provider should check your test results before your next dose.

    Call your healthcare provider right away if you have any of the following symptoms of liver problems:
    • Nausea or vomiting
    • Stomach pain
    • Unusual tiredness
    • Not wanting to eat
    • Yellowing of the skin or whites of your eyes
    • Dark urine
  • Immune system problems. Some people using ZINBRYTA develop immune-mediated disorders (a condition where the body’s immune system attacks healthy cells in their body) and other immune system problems.

    Call your healthcare provider right away if you have any of the following symptoms:

    • Skin reactions such as rash or skin irritation
    • Tender, painful, or swollen lymph nodes
    • Intestinal problems (colitis)
      • Symptoms can include fever, stomach pain, blood in your stools, or diarrhea that does not go away
    • Any new and unexplained symptoms affecting any part of your body

Because of the risk of serious liver problems (including autoimmune-related liver problems) and other immune system problems, ZINBRYTA is only available through a restricted program called the ZINBRYTA Risk Evaluation and Mitigation Strategy (REMS) Program.

 

Do not use ZINBRYTA if you:

  • Have liver problems
  • Have or have had autoimmune-related liver problems including autoimmune hepatitis
  • Are allergic to daclizumab or any of the other ingredients in ZINBRYTA

Before using ZINBRYTA, tell your healthcare provider if you:

  • Have or have had liver problems
  • Have or have had skin problems including eczema or psoriasis
  • Have tuberculosis
  • Have an active infection
  • Are planning to receive a vaccine
  • Have or have had depression
  • Are pregnant or plan to become pregnant. It is not known if ZINBRYTA will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if ZINBRYTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZINBRYTA

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using ZINBRYTA with other medicines can cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.


ZINBRYTA can cause serious side effects, including:

  • Allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart or blood. These can be very serious and can cause death. Call your healthcare provider right away if you have any of the following symptoms while using ZINBRYTA: fever, rash, swelling of the face, tongue or throat or trouble breathing.
  • Infections. Some people who use ZINBRYTA may get an infection, such as an upper respiratory tract infection or a urinary tract infection. Some infections may be serious. Call your healthcare provider if you have symptoms of an infection. Talk to your healthcare provider before you get vaccinations while using ZINBRYTA.
  • Depression and suicide. Some people who use ZINBRYTA may develop depression, depressed mood, or suicidal thoughts. Call your healthcare provider right away if you have ever been treated for depression or have any of the following symptoms while using ZINBRYTA:
    • Feel sad or have crying spells
    • Are sleeping a lot more or a lot less than usual
    • Feel hopeless or helpless
    • Are more irritable, angry or aggressive than usual
    • Have trouble paying attention
    • Feel tired or sleepy all the time
    • Have thoughts about hurting yourself or ending your life
  • The most common side effects of ZINBRYTA include: upper respiratory tract infection, flu, pain or swelling in your nose, throat, or mouth, bronchitis, abnormal liver function tests, dry, itchy, scaly, or inflamed skin (eczema), rash, depression and depressed mood, swollen lymph glands

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZINBRYTA.

To report side effects to FDA, please call 1-800-FDA-1088. Please see full Prescribing Information including Boxed Warning and Patient Medication Guide. This information is not intended to replace discussions with your healthcare provider.

If you cannot afford your medications, Biogen and AbbVie may be able to help. Contact 1-800-456-2255 for more information.

 

Indication

ZINBRYTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, ZINBRYTA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if ZINBRYTA is safe and effective for use in children under 18 years of age.

ZINBRYTA Important Safety Information and Indication

ZINBRYTA can cause serious side effects, including:

  • Liver problems. ZINBRYTA may cause serious liver problems (including autoimmune-related liver problems) that may lead to death. Your healthcare provider should do blood tests to check your liver before you start using ZINBRYTA, every month while you are using ZINBRYTA, and monthly for 6 months after you stop using ZINBRYTA. Your healthcare provider should check your test results before your next dose.

    Call your healthcare provider right away if you have any of the following symptoms of liver problems:
    • Nausea or vomiting
    • Stomach pain
    • Unusual tiredness
    • Not wanting to eat
    • Yellowing of the skin or whites of your eyes
    • Dark urine
  • Immune system problems. Some people using ZINBRYTA develop immune-mediated disorders (a condition where the body’s immune system attacks healthy cells in their body) and other immune system problems.

    Call your healthcare provider right away if you have any of the following symptoms:

    • Skin reactions such as rash or skin irritation
    • Tender, painful, or swollen lymph nodes
    • Intestinal problems (colitis)
      • Symptoms can include fever, stomach pain, blood in your stools, or diarrhea that does not go away
    • Any new and unexplained symptoms affecting any part of your body

Because of the risk of serious liver problems (including autoimmune-related liver problems) and other immune system problems, ZINBRYTA is only available through a restricted program called the ZINBRYTA Risk Evaluation and Mitigation Strategy (REMS) Program.

 

Do not use ZINBRYTA if you:

  • Have liver problems
  • Have or have had autoimmune-related liver problems including autoimmune hepatitis
  • Are allergic to daclizumab or any of the other ingredients in ZINBRYTA

Before using ZINBRYTA, tell your healthcare provider if you:

  • Have or have had liver problems
  • Have or have had skin problems including eczema or psoriasis
  • Have tuberculosis
  • Have an active infection
  • Are planning to receive a vaccine
  • Have or have had depression
  • Are pregnant or plan to become pregnant. It is not known if ZINBRYTA will harm your unborn baby
  • Are breastfeeding or plan to breastfeed. It is not known if ZINBRYTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use ZINBRYTA

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Using ZINBRYTA with other medicines can cause serious side effects. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.


ZINBRYTA can cause serious side effects, including:

  • Allergic reactions or serious problems that may affect different parts of the body such as your liver, kidneys, heart or blood. These can be very serious and can cause death. Call your healthcare provider right away if you have any of the following symptoms while using ZINBRYTA: fever, rash, swelling of the face, tongue or throat or trouble breathing.
  • Infections. Some people who use ZINBRYTA may get an infection, such as an upper respiratory tract infection or a urinary tract infection. Some infections may be serious. Call your healthcare provider if you have symptoms of an infection. Talk to your healthcare provider before you get vaccinations while using ZINBRYTA.
  • Depression and suicide. Some people who use ZINBRYTA may develop depression, depressed mood, or suicidal thoughts. Call your healthcare provider right away if you have ever been treated for depression or have any of the following symptoms while using ZINBRYTA:
    • Feel sad or have crying spells
    • Are sleeping a lot more or a lot less than usual
    • Feel hopeless or helpless
    • Are more irritable, angry or aggressive than usual
    • Have trouble paying attention
    • Feel tired or sleepy all the time
    • Have thoughts about hurting yourself or ending your life
  • The most common side effects of ZINBRYTA include: upper respiratory tract infection, flu, pain or swelling in your nose, throat, or mouth, bronchitis, abnormal liver function tests, dry, itchy, scaly, or inflamed skin (eczema), rash, depression and depressed mood, swollen lymph glands

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZINBRYTA.

To report side effects to FDA, please call 1-800-FDA-1088. Please see full Prescribing Information including Boxed Warning and Patient Medication Guide. This information is not intended to replace discussions with your healthcare provider.

If you cannot afford your medications, Biogen and AbbVie may be able to help. Contact 1-800-456-2255 for more information.

Indication

ZINBRYTA is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS). Because of its risks, ZINBRYTA is generally used in people who have tried 2 or more MS medicines that have not worked well enough. It is not known if ZINBRYTA is safe and effective for use in children under 18 years of age.

AVONEX® (interferon beta-1a) Important Safety Information and Indication

Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with AVONEX.

AVONEX can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking AVONEX.

  • Behavioral health problems including depression, suicidal thoughts or hallucinations. Some people taking AVONEX may develop mood or behavior problems including irritability (getting upset easily), depression (feeling hopeless or feeling bad about yourself), nervousness, anxiety, aggressive behavior, thoughts of hurting yourself or suicide, and hearing or seeing things that others do not hear or see (hallucinations).
  • Liver problems, or worsening of liver problems including liver failure and death. Symptoms may include nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, and sleepiness. During your treatment with AVONEX you will need to see your healthcare provider regularly and have regular blood tests to check for side effects.
  • Serious allergic reactions and skin reactions. Symptoms may include itching, swelling of the face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, and skin rash, hives, sores in your mouth, or your skin blisters and peels.

AVONEX will not cure your MS but may decrease the number of flare-ups of the disease and slow the occurrence of some of the physical disability that is common in people with MS. MS is a life-long disease that affects your nervous system by destroying the protective covering (myelin) that surrounds your nerve fibers.

The way AVONEX works in MS is not known. It is not known if AVONEX is safe and effective in children.

Do not take AVONEX if you are allergic to interferon beta, albumin (human), or any of the ingredients in AVONEX.

Before taking AVONEX, tell your healthcare provider if you:

  • are being treated for a mental illness, or had treatment in the past for any mental illness, including depression and suicidal behavior.
  • have or had bleeding problems or blood clots, have or had low blood cell counts, have or had liver problems, have or had seizures (epilepsy), have or had heart problems, have or had thyroid problems, have or had any kind of autoimmune disease (where the body’s immune system attacks the body’s own cells), such as psoriasis, systemic lupus erythematosus, or rheumatoid arthritis.
  • drink alcohol.
  • are pregnant or plan to become pregnant. It is not known if AVONEX will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with AVONEX.
  • are breastfeeding or plan to breastfeed. It is not known if AVONEX passes into your breast milk. You and your healthcare provider should decide if you will use AVONEX or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

AVONEX can cause serious side effects including:

  • Heart problems, including heart failure. While AVONEX is not known to have any direct effects on the heart, a few patients who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking AVONEX. If you already have heart failure, AVONEX may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using AVONEX.
      • Some people using AVONEX may have other heart problems including low blood pressure, fast or abnormal heart beat, chest pain, and heart attack or heart muscle problem (cardiomyopathy).
  • Blood problems. AVONEX can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising.
  • Seizures. Some patients have had seizures while taking AVONEX, including patients who have never had seizures before.
  • Infections. Some people who take AVONEX may get an infection. Symptoms of an infection may include fever, chills, pain or burning with urination, urinating often, bloody diarrhea, and coughing up mucus.
  • Thyroid problems. Some people taking AVONEX develop changes in their thyroid function. Symptoms of thyroid changes include problems concentrating, feeling cold or hot all the time, weight changes, and skin changes.

Tell your healthcare provider right away if you have any of the symptoms listed above.

The most common side effects of AVONEX include:

  • Flu-like symptoms. Most people who take AVONEX have flu-like symptoms early during the course of therapy. Usually, these symptoms last for a day after the injection. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include muscle aches, fever, tiredness, and chills.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide for additional important safety information. This information is not intended to replace discussions with your healthcare provider.

Indication

AVONEX (interferon beta-1a) is approved by FDA to treat relapsing forms of multiple sclerosis (MS) to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. AVONEX is approved for use in people who have experienced a first attack and have lesions consistent with MS on their MRI.

PLEGRIDY® (peginterferon beta-1a) Important Safety Information and Indication

Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with PLEGRIDY.

PLEGRIDY can cause serious side effects. Call your healthcare provider right away if you have any of the symptoms listed below.

  • Liver problems, or worsening of liver problems including liver failure and death. Symptoms may include yellowing of your skin or the white part of your eye, nausea, loss of appetite, tiredness, bleeding more easily than normal, confusion, sleepiness, dark colored urine, and pale stools. During your treatment with PLEGRIDY you will need to see your healthcare provider regularly. You will have regular blood tests to check for these possible side effects
  • Depression or suicidal thoughts. Symptoms may include new or worsening depression (feeling hopeless or bad about yourself), thoughts of hurting yourself or suicide, irritability (getting upset easily), nervousness, or new or worsening anxiety

Do not take PLEGRIDY if you are allergic to interferon beta or peginterferon beta-1a, or any of the other ingredients in PLEGRIDY.

Before taking PLEGRIDY, tell your healthcare provider if you:

  • Are being treated for a mental illness or had treatment in the past for any mental illness, including depression and suicidal behavior
  • Have or had liver problems, low blood cell counts, bleeding problems, heart problems, seizures (epilepsy), thyroid problems, or any kind of autoimmune disease
  • Take prescription and over-the-counter medicines, vitamins, and herbal supplements
  • Are pregnant or plan to become pregnant. It is not known if PLEGRIDY will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with PLEGRIDY
  • Are breastfeeding or plan to breastfeed. It is not known if PLEGRIDY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use PLEGRIDY

PLEGRIDY can cause additional serious side effects including: 

  • Serious allergic reactions. Serious allergic reactions can happen quickly. Symptoms may include itching, swelling of the face, eyes, lips, tongue, or throat, trouble breathing, feeling faint, anxiousness, skin rash, hives, or skin bumps
  • Injection site reactions. PLEGRIDY may commonly cause redness, pain or swelling at the place where the injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected and it does not heal within a few days. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider
  • Heart problems, including congestive heart failure. While PLEGRIDY is not known to have any direct effects on the heart, some people who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking interferon beta. If you already have heart failure, PLEGRIDY may cause your heart failure to get worse. Call your healthcare provider right away if you have worsening symptoms of heart failure such as shortness of breath or swelling of your lower legs or feet while using PLEGRIDY
      • Some people using PLEGRIDY may have other heart problems, including low blood pressure, fast or abnormal heart beat, chest pain, heart attack, or a heart muscle problem (cardiomyopathy)
  • Autoimmune diseases. Problems with easy bleeding or bruising (idiopathic thrombocytopenia), thyroid gland problems (hyperthyroidism and hypothyroidism), and autoimmune hepatitis have happened in some people who use interferon beta
  • Blood problems and changes in your blood tests. PLEGRIDY can decrease your white blood cells or platelets, which can cause an increased risk of infection, bleeding or anemia, and can cause changes in your liver function tests. Your healthcare provider should do blood tests while you use PLEGRIDY to check for side effects
  • Seizures. Some people have had seizures while taking PLEGRIDY, including people who have never had seizures before

The most common side effects of PLEGRIDY include: 

  • Flu-like symptoms. Many people who take PLEGRIDY have flu-like symptoms early in the course of therapy. These symptoms are not really the flu. You cannot pass it on to anyone else. Symptoms may include headache, muscle and joint aches, fever, chills or tiredness
      • You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers and drinking plenty of water. For many people, these symptoms lessen or go away over time

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide for additional important safety information. This information is not intended to replace discussions with your healthcare provider.

Indication

PLEGRIDY® (peginterferon beta-1a) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS).

TECFIDERA® (dimethyl fumarate) Important Safety Information and Indication

Do not use TECFIDERA if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to TECFIDERA or any of its ingredients.

Before taking and while you take TECFIDERA, tell your doctor about any low white blood cell counts or infections or any other medical conditions. 

What are the possible side effects of TECFIDERA?

TECFIDERA may cause serious side effects including:

  • Allergic reactions
  • PML, which is a rare brain infection that usually leads to death or severe disability.
  • Decreases in your white blood cell count. Your doctor should check your white blood cell count before you take TECFIDERA and from time to time during treatment
  • Liver problems. Your doctor should do blood tests to check your liver function before you start taking TECFIDERA and during treatment if needed. Tell your doctor right away if you get any symptoms of a liver problem during treatment, including:
      • severe tiredness
      • loss of appetite
      • pain on the right side of your stomach
      • dark or brown (tea color) urine
      • yellowing of your skin or the white part of your eyes

The most common side effects of TECFIDERA include flushing and stomach problems. These can happen especially at the start of treatment and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your doctor if these symptoms bother you or do not go away. Ask your doctor if taking aspirin before taking TECFIDERA may reduce flushing.

These are not all the possible side effects of TECFIDERA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also tell your doctor if you are taking prescription or over-the-counter medicines, vitamins, or herbal supplements. If you take too much TECFIDERA, call your doctor or go to the nearest hospital emergency room right away.

For additional important safety information, please see full Prescribing Information and Patient Information. This is not intended to replace discussions with your doctor.

Indication

Tecfidera® (dimethyl fumarate) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.

TYSABRI® (natalizumab) Important Safety Information and Indication

TYSABRI increases your risk of getting a rare brain infection—called progressive multifocal leukoencephalopathy (PML)—that usually leads to death or severe disability.

  • There is no known treatment, prevention, or cure for PML.
  • You should not take certain medicines that weaken your immune system at the same time you are taking TYSABRI. Even if you use TYSABRI alone to treat your MS, you can still get PML.
  • Your risk of getting PML is higher if you:
      • have received TYSABRI for a long time, especially for longer than 2 years
      • have received certain medicines that can weaken your immune system before you start receiving TYSABRI
      • have been infected by the John Cunningham Virus (JCV). Before or while you receive TYSABRI, your doctor may do a blood test to check if you have been infected by JCV. JCV is a common virus that can cause PML in people who have weakened immune systems, such as people taking TYSABRI.
  • Your risk of getting PML is greatest if you have all 3 risk factors listed above. There may be other risk factors that have not yet been identified.
  • Patients who are anti-JCV antibody negative are still at the risk for the development of PML due to the potential for a new JCV infection or a false negative test result. Therefore, patients with a negative test result should be retested periodically.
  • While you receive TYSABRI, and for 6 months after you stop receiving TYSABRI, it is important that you call your doctor right away if you have any new or worsening medical problems (such as problems with your thinking, eyesight, balance, or strength; weakness on 1 side of your body; and using your arms and legs) that have lasted several days. Tell all of your doctors that you are getting treatment with TYSABRI.
  • Because of your risk of getting PML while you receive TYSABRI, TYSABRI is available only through a restricted distribution program called the TOUCH® Prescribing Program.
  • If you have PML or are allergic to TYSABRI or any of its ingredients, you should not receive TYSABRI.

Before receiving TYSABRI, it is important to tell your doctor:

  • If you have a medical condition that can weaken your immune system, such as HIV infection or AIDS, leukemia or lymphoma, organ transplant, or others, or if you have any new or worsening medical problems that have lasted several days.
  • If you are pregnant or plan to become pregnant or if you are breastfeeding or plan to breastfeed. It is not known if TYSABRI can harm your unborn baby or if the TYSABRI that passes into your breast milk can harm your baby.
  • About all of the medicines and supplements you take, especially medicines that can weaken your immune system. If you are not sure, ask your doctor.

TYSABRI can cause serious side effects. If you have any of the symptoms listed below, call your doctor right away:

  • Infection of the brain or the covering of your brain and spinal cord (encephalitis or meningitis) caused by herpes viruses that may lead to death. Symptoms include sudden fever, severe headache, or confusion.
  • Liver damage. Symptoms of liver damage include yellowing of the skin and eyes (jaundice), unusual darkening of the urine, nausea, feeling tired or weak, or vomiting.
  • Allergic reactions (eg., hives, itching, trouble breathing, chest pain, dizziness, wheezing, chills, rash, nausea, flushing of skin, low blood pressure), including serious allergic reactions (eg, anaphylaxis). Serious allergic reactions usually happen within 2 hours of the start of the infusion, but they can happen any time after receiving TYSABRI.
  • Weakened immune system. TYSABRI may increase your risk of getting an unusual or serious infection.

The most common side effects of TYSABRI are:

  • Headache, urinary tract infection, lung infection, pain in your arms and legs, vaginitis, stomach-area pain, feeling tired, joint pain, depression, diarrhea, rash, and nausea. If you experience any side effect that bothers you or does not go away, tell your doctor.

These are not all of the possible side effects of TYSABRI. For more information, ask your doctor. To report side effects to FDA, please call 1-800-FDA-1088.

Please see full Prescribing Information including Boxed Warning and Patient Medication Guide.

This information is not intended to replace discussions with your healthcare provider.

Indication

TYSABRI® (natalizumab) is a prescription medicine used to treat adults with relapsing forms of multiple sclerosis (MS) to slow the worsening of symptoms common in people with MS and to decrease the number of flare-ups (relapses). TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML). When starting and continuing treatment with TYSABRI, it is important to discuss with your doctor whether the expected benefit of TYSABRI is enough to outweigh this risk.