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Indication and Important Safety Information

What is VUMERITY® (diroximel fumarate)?

  • VUMERITY is a prescription medicine used to treat people with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults

  • It is not known if VUMERITY is safe and effective in children

Important Safety Information

Do not take VUMERITY if you:

  • have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to diroximel fumarate, dimethyl fumarate, or any of the ingredients in VUMERITY

  • are taking dimethyl fumarate

Before taking and while you take VUMERITY, tell your healthcare provider about all of your medical conditions, including if you:

  • have liver problems

  • have kidney problems

  • have or have had low white blood cell counts or an infection

  • are pregnant or plan to become pregnant. It is not known if VUMERITY will harm your unborn baby

  • are breastfeeding or plan to breastfeed. It is not known if VUMERITY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using VUMERITY

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

What should I avoid while taking VUMERITY?

  • Do not drink alcohol at the time you take a VUMERITY dose

What are the possible side effects of VUMERITY?

VUMERITY may cause serious side effects including:

  • allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing). Stop taking VUMERITY and get emergency medical help right away if you get any of these symptoms

  • PML (progressive multifocal leukoencephalopathy) a rare brain infection that usually leads to death or severe disability over a period of weeks or months. Tell your healthcare provider right away if you get any of these symptoms of PML:

    • weakness on one side of the body that gets worse

    • clumsiness in your arms or legs

    • vision problems

    • changes in thinking and memory

    • confusion

    • personality changes

  • decreases in your white blood cell count. Your healthcare provider should do a blood test to check your white blood cell count before you start treatment with VUMERITY and while you are on therapy. You should have blood tests after 6 months of treatment and every 6 to 12 months after that

  • liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking VUMERITY and during treatment if needed. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment.

    • severe tiredness

    • loss of appetite

    • pain on the right side of your stomach

    • have dark or brown (tea color) urine

    • yellowing of your skin or the white part of your eyes

The most common side effects of VUMERITY include:

  • flushing, redness, itching, or rash

  • nausea, vomiting, diarrhea, stomach pain, or indigestion

  • Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking VUMERITY with food (avoid high-fat, high-calorie meal or snack) may help reduce flushing. Call your healthcare provider if you have any of these symptoms and they bother you or do not go away. Ask your healthcare provider if taking aspirin before taking VUMERITY may reduce flushing

These are not all the possible side effects of VUMERITY. Call your healthcare provider 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

Please see full Prescribing Information, including Patient Information.

 

TECFIDERA® (dimethyl fumarate) Indication and Important Safety Information

What is TECFIDERA?

  • TECFIDERA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

  • It is not known if TECFIDERA is safe and effective in children under 18 years of age

Important Safety Information

Who should not take TECFIDERA® (dimethyl fumarate)?

  • 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 healthcare provider if you have or have had:

  • low white blood cell counts or an infection

  • any other medical conditions

Tell your healthcare provider if you are:

  • pregnant or plan to become pregnant. It is not known if TECFIDERA will harm your unborn baby

    • If you become pregnant while taking TECFIDERA, talk to your healthcare provider about enrolling in the TECFIDERA Pregnancy Registry. You can enroll in this registry by calling 1-866-810-1462 or visiting www.tecfiderapregnancyregistry.com. The purpose of this registry is to monitor the health of you and your baby

  • breastfeeding or plan to breastfeed. It is not known if TECFIDERA passes into your breast milk. You and your healthcare provider should decide if you will take TECFIDERA or breastfeed

  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements

What are the possible side effects of TECFIDERA?

TECFIDERA may cause serious side effects, including:

  • allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)

  • PML a rare brain infection that usually leads to death or severe disability

  • decreases in your white blood cell count Your healthcare provider should do a blood test before you start treatment with TECFIDERA and while on therapy

  • liver problems. Your healthcare provider should do blood tests to check your liver function before you start taking TECFIDERA and during treatment if needed. Tell your healthcare provider right away if you get any of these symptoms of a liver problem during treatment

    • severe tiredness

    • loss of appetite

    • pain on the right side of your stomach

    • have dark or brown (tea color) urine

    • yellowing of your skin or the white part of your eyes

  • herpes zoster infections (shingles), including central nervous system infections

  • other serious infections

The most common side effects of TECFIDERA include:

  • flushing, redness, itching, or rash

  • nausea, vomiting, diarrhea, stomach pain, or indigestion

  • Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your healthcare provider if you have any of these symptoms and they bother you or do not go away. Ask your healthcare provider if taking aspirin before taking TECFIDERA may reduce flushing

These are not all the possible side effects of TECFIDERA. Call your healthcare provider 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.

Please see full Prescribing Information, including Patient Information.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

TYSABRI® (natalizumab) Indication and Important Safety Information

What is TYSABRI?

TYSABRI is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. 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.

It is not known if TYSABRI is safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TYSABRI® (natalizumab)?

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

Who should not receive TYSABRI?

Do not receive TYSABRI if you have PML or are allergic to natalizumab or any of the ingredients in TYSABRI.

What should I tell my doctor before receiving each dose of 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

What are the possible side effects of TYSABRI?

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 does not take the place of talking with your doctor about your medical condition or your treatment.

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

What is AVONEX?

AVONEX is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if AVONEX is safe and effective in children.

Important Safety Information

Who should not use AVONEX® (interferon beta-1a)?

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

What is the most important information I should know about 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

What should I tell my healthcare provider before using 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.

What are the possible side effects of AVONEX?

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 heartbeat, 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 full Prescribing Information and Medication Guide.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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

What is PLEGRIDY?

PLEGRIDY is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

It is not known if PLEGRIDY is safe and effective in people under 18 or over 65 years of age.

Important Safety Information

Who should not take PLEGRIDY® (peginterferon beta-1a)?

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

What is the most important information I should know about PLEGRIDY?

PLEGRIDY can cause serious side effects, including:

  • 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

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

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

What are the possible side effects of PLEGRIDY?

PLEGRIDY may 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 heartbeat, 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.

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

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