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

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

Important Safety Information

AVONEX® (interferon beta 1a) can cause serious side effects. Before beginning treatment, you should discuss with your healthcare provider the potential benefits and risks associated with AVONEX (interferon beta-1a).

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 doctor 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 on AVONEX.com for additional important safety information. This information is not intended to replace discussions with your healthcare provider.

 

Indication

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

Important Safety Information

Before taking and while you take Tecfidera (dimethyl fumarate), 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 decreases in your white blood cell count. Your doctor may check your white blood cell count before you take Tecfidera and from time to time during treatment.

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. Call your doctor if these symptoms bother you or do not go away.

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.

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

 

Indication

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

Important Safety Information

  • TYSABRI increases your risk of getting a rare brain infection—called progressive multifocal leukoencephalopathy (PML)—that usually leads to death or severe disability. If PML occurs, it usually occurs in people with weakened immune systems. There is no known treatment, prevention, or cure for PML.
  • Your risk of getting PML may be higher if you are also being treated with other medicines that can weaken your immune system, including other treatments for MS. 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 MS, you can still get PML.
  • Your risk of getting PML is higher if you:
    • have received TYSABRI for a long time, especially longer than 2 years
    • have received certain medicines that can weaken your immune system before you start receiving TYSABRI
    • have been exposed to John Cunningham Virus (JCV). JCV is a commmon virus that is harmless in most people but can cause PML in people who have weakened immune systems, such as people taking TYSABRI. Most people who are exposed to JCV, do not know it or do not have any symptoms. This exposure usually happens in childhood. Before you start receiving TYSABRI or during your treatment, your doctor may do a blood test to check if you have been exposed to JCV.
    • Your risk of getting PML is greatest if you have all three risk factors listed above. There may be other risk factors for getting PML during TYSABRI treatment that we do not know about yet. Before you decide to receive TYSABRI, your doctor should discuss the risks and benefits of TYSABRI treatment with you.
  • 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 one 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. To receive TYSBARI, you must talk to your doctor, understand the risks and benefits of TYSABRI, and agree to follow all of the instructions in the TOUCH® Prescribing Program. Only prescribers, infusion centers, and patients enrolled in TOUCH can, respectively, prescribe, infuse, and receive TYSABRI.
  • If you have PML or are allergic to TYSABRI or any of its ingredients, you should not receive TYSABRI.
  • Before you receive TYSABRI, 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, tell your doctor. 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. To learn about the best way to feed your baby while you receive TYSABRI, talk with your doctor.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your doctor if you take medicines that can weaken your immune system. If you are not sure, ask your doctor.
  • TYSABRI may increase your risk of getting an 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. If you have sudden fever, if you have severe headache, or if you feel confused after receiving TYSABRI, call your doctor right away.
  • TYSABRI may cause 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. Blood tests can be done to check for liver damage. If you experience any symptoms of liver damage call your doctor right away.
  • Other serious side effects with TYSABRI include allergic reactions (e.g., hives, itching, trouble breathing, chest pain, dizziness, wheezing, chills, rash, nausea, flushing of skin, low blood pressure), including serious allergic reactions (e.g., anaphylaxis) and infections. Serious allergic reactions usually happen within 2 hours of the start of the infusion, but they can happen any time after receiving TYSABRI. If you have any symptom of an allergic reaction, tell your doctor or nurse right away. If you are having an allergic reaction, you may need treatment.
  • Because TYSABRI can weaken your immune system, TYSABRI may increase your risk of getting an unusual or serious infection. If you also take other medicines that can weaken your immune system, you have a higher risk of getting infections.
  • Common side effects include 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 the possible side effects of TYSABRI. For more information, ask your doctor.
  • For medical advice about side effects, call your doctor. To report side effects, call FDA at 1-800-FDA-1088.
Please see full Prescribing Information (PDF) including Boxed Warning and Patient Medication Guide (PDF).