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TYSABRI 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 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:

• Herpes infections. Increased risk of 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. Infection of the eye caused by herpes viruses leading to blindness in some patients has occurred. Call your doctor if you have changes in vision, redness, or eye pain.
• 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 (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). 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, nose and throat infections, 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 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.

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.