SAFETY & SIDE EFFECTS

Rebif® has a well-established 20+ year safety profile

The well-established safety profile of Rebif® is supported by more than 20 years of combined clinical trial data and real-world patient experience. Safety is an important topic to discuss with your healthcare provider when choosing a relapsing multiple sclerosis (RMS) treatment.

Rebif® has not been associated with progressive multifocal leukoencephalopathy (PML), a rare brain disease.

Rebif® did not result in increases in the incidence of viral, bacterial, or fungal infections.

 

Patients treated with Rebif® showed a similar incidence of infections compared to placebo

Some people develop lower white blood cell counts, which could increase the risk of infection. Your healthcare provider should monitor your white blood cell counts during the course of your therapy with Rebif®

The Rebif® Prescribing Information (PI) does not include any restrictions on vaccinations.

 

Getting vaccinated is a key part of medical care, and that is no different for people with MS. Some inactivated vaccines may provide protection and may be administered while treating your MS with an interferon, like Rebif®. Ask your healthcare provider about your ability to be vaccinated while taking Rebif®. They will use their clinical judgement and refer to the latest medical information to decide what is right for you.

Rebif® does not continuously suppress the immune system

Rebif® is an immunomodulator, a medication used to help regulate the immune system. It doesn’t continuously suppress your immune system.

POSSIBLE SERIOUS SIDE EFFECTS OF REBIF®

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

  • Behavioral health problems, including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide.

  • Liver problems or worsening of liver problems, including liver failure. 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 Rebif® you will need to see your healthcare provider regularly and have regular blood tests to check for side effects.

  • Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels.

  • Injection site problems. Rebif may cause redness, pain, itching or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.

  • Blood problems. Rebif® 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. Your healthcare provider may ask you to have regular blood tests to check for blood problems.
  • Pulmonary arterial hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including Rebif. Symptoms may include new fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.

  • Seizures. Some people have had seizures while taking Rebif.®

 

MOST COMMON SIDE EFFECTS OF REBIF®

  • Flu-like symptoms (see below for more details)

  • Stomach pain

  • Change in liver blood tests

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

For more information, please see the additional Important Safety Information, full Rebif Prescribing Information, and Medication Guide.

n

Managing flu-like symptoms

Flu-like symptoms are one of the most common side effects of Rebif®. These can range from fever, chills, and sweating to muscle aches and tiredness. These symptoms are not actually flu, and they are not caused by a viral infection—nor do they include vomiting and diarrhea. For many people, these symptoms lessen or go away over time.

If you have questions or your symptoms are concerning, talk to your healthcare provider. Here are some steps you can take that may help you manage flu-like symptoms:

  • Consider taking an over-the-counter pain reliever/fever reducer as directed by your healthcare provider. These are medicines that you can buy at your local pharmacy without a prescription. They may also have their own side effects, so read the instructions carefully. Talk to your healthcare provider or an MS LifeLines® Nurse for more information

  • Find a time of day that works for you to take your Rebif®. Some people inject Rebif® around bedtime to help them sleep through some flu-like symptoms they may have. Others find that injecting earlier in the day works best for them. Remember, Rebif® should be taken on the same 3 days a week—for example, Monday, Wednesday, and Friday. Your injections should be at least 48 hours apart. Take injections at the same time each day

Be sure to talk to your healthcare provider about titration when first starting on Rebif®. Titration means starting at a lower dose and then gradually building up to the full dose. This may help reduce flu-like symptoms when you're first starting on Rebif®.

Please see Important Safety Information below and the Rebif® Medication Guide and Prescribing Information at the top of this page. Speak with your healthcare provider for more information or about any side effects that you may have.

n
n
Supporting Safety Profile

Managing injection site reactions

Rebif® may cause redness, pain, or swelling at the place where an injection was given. Some patients have developed skin infections or areas of severe skin damage (necrosis), requiring treatment by a doctor. If one of your injection sites becomes swollen and painful or the area looks infected, you should call your healthcare provider right away.

Here is some information that may help you with injection site discomfort:

  • Bring the syringe to room temperature. Removing the syringe from your refrigerator 1 to 4 hours before injecting may help to reduce irritation. Keep in mind that Rebif® syringes should never be warmed in a microwave or placed in boiling water

  • Clean your injection site beforehand with alcohol swabs. Allow the area to dry before injecting to reduce irritation

  • Rotate your injection sites! Be sure to rotate your site each time, and don't reuse the same injection spot for at least 7 days. Your treatment tracker can help you to keep track of your injections. Download your own treatment tracker

  • Apply a cold compress or ice pack to the injection site after injection; this may help reduce local skin reactions

  • Monitor your injection site over several days for redness, swelling, or tenderness

n
n
n
n
Image of a happy couple look at a laptop screen

Family planning when you have relapsing multiple sclerosis

Talk with your healthcare provider about planning for pregnancy and treating RMS.

LEARN WHAT TO ASK
Image of a woman sitting at a desk working on a laptop

Rebif® gives you options

With Rebif®, there’s flexibility with dosing schedules and injection types.

KNOW YOUR OPTIONS

 

The people in these photos are not actual Rebif® patients.

 

IMPORTANT SAFETY INFORMATION AND INDICATION

+

Important Safety Information

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

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

  • Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide.
  • Liver problems or worsening of liver problems including liver failure. 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 Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects.
  • Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels.
  • Injection site problems. Rebif may cause redness, pain, itching or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.
  • Blood problems. Rebif 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. Your healthcare provider may ask you to have regular blood tests to check for blood problems.
  • Pulmonary arterial hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including Rebif. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.
  • Seizures. Some people have had seizures while taking Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

  • mental illness, including depression and suicidal behavior
  • liver problems
  • bleeding problems or blood clots
  • low blood cell counts
  • seizures (epilepsy)
  • thyroid problems
  • drink alcohol
  • are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Rebif
  • are breastfeeding or plan to breastfeed. Rebif may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif

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

The most common side effects of Rebif include:

  • flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. 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
  • stomach pain
  • change in liver blood tests

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 Rebif. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit  www.fda.gov/medwatch.

Indication

Rebif® (interferon beta-1a) is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if Rebif is safe and effective in children.

Please see Rebif® Prescribing Information and Medication Guide.

IMPORTANT SAFETY INFORMATION AND INDICATION

+

Important Safety Information

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

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

  • Behavioral health problems including depression and suicidal thoughts. You may have mood problems including depression (feeling hopeless or feeling bad about yourself), and thoughts of hurting yourself or suicide.
  • Liver problems or worsening of liver problems including liver failure. 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 Rebif you will need to see your healthcare provider regularly and have regular blood tests to check for side effects.
  • Serious allergic and skin reactions. Symptoms may include itching, swelling of your face, eyes, lips, tongue or throat, trouble breathing, anxiousness, feeling faint, skin rash, hives, sores in your mouth, or skin blisters and peels.
  • Injection site problems. Rebif may cause redness, pain, itching or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.
  • Blood problems. Rebif 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. Your healthcare provider may ask you to have regular blood tests to check for blood problems.
  • Pulmonary arterial hypertension. Pulmonary arterial hypertension can occur with interferon beta products, including Rebif. Symptoms may include new or increasing fatigue or shortness of breath. Contact your healthcare provider right away if you develop these symptoms.
  • Seizures. Some people have had seizures while taking Rebif.

Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:

  • mental illness, including depression and suicidal behavior
  • liver problems
  • bleeding problems or blood clots
  • low blood cell counts
  • seizures (epilepsy)
  • thyroid problems
  • drink alcohol
  • are pregnant or plan to become pregnant. It is not known if Rebif will harm your unborn baby. Tell your healthcare provider if you become pregnant during your treatment with Rebif
  • are breastfeeding or plan to breastfeed. Rebif may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif

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

The most common side effects of Rebif include:

  • flu-like symptoms. You may have flu-like symptoms when you first start taking Rebif. 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
  • stomach pain
  • change in liver blood tests

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 Rebif. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit  www.fda.gov/medwatch.

Indication

Rebif® (interferon beta-1a) is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if Rebif is safe and effective in children.

Please see Rebif® Prescribing Information and Medication Guide.

US-REB-00529
Last update 12/2023


This website is intended only for residents of the United States.

Use and access of this site are subject to the terms and conditions set out in our Legal Statement and Privacy Policy. 

EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada. Rebif, MS LifeLines, Rebiject II, Rebidose, and the Rebif logo are registered trademarks of Merck KGaA, Darmstadt, Germany, or its affiliates.

©2023 Merck KGaA, Darmstadt, Germany or its affiliates.  All rights reserved. EMD Serono Inc.

US-REB-00529
Last update 12/2023