Safety profile

MS LifeLines Nurse
Rebif has a well-established safety profile

Why does 20+ years matter?

The Rebif® (interferon beta-1a) story begins long before it was approved by the Food and Drug Administration (FDA) in 2002 as a relapsing multiple sclerosis (RMS) treatment. In fact, Rebif’s well-established safety profile is supported by more than 20 years of combined clinical trial data and real-world patient experience. You should discuss safety with your healthcare provider when choosing an RMS treatment. For example, it’s important to note that progressive multifocal leukoencephalopathy (PML), a rare brain disease, has never been mentioned on the Rebif label.

However, Rebif can cause serious side effects. Tell your healthcare provider right away if you experience behavioral health problems, including depression and suicidal thoughts, serious allergic and skin reactions, injection site skin damage, liver problems or worsening of liver problems, including liver failure. Symptoms may include changes in urine, stool, and skin color, tiredness, confusion, and bleeding. Rebif can also cause low red and white blood cell and platelet counts. Symptoms may include infections, problems with bleeding, and bruising. Some people have had seizures while taking Rebif.

Be sure to talk with your doctor about the safety information on this page.

* The safety and efficacy of treatment with Rebif beyond 2 years have not been established.
Common adverse events have been consistent across PRISMS and EVIDENCE clinical trials.

support to help you
start and stay on therapy

When you take Rebif, you can also count on the full support of MS LifeLines Nurses to help make sure you’re injecting safely and correctly. And if you ever have questions about Rebif, Rebif side effects, or RMS, remember that MS LifeLines® may be able to help.

Safety and Tolerability

When you take a medication, safety and tolerability are 2 important terms to understand.

Safety refers to things that can happen, related to treatment with a drug, that may require medical attention or constitute a medical risk.

Tolerability is related to how a drug makes you feel when you are taking it, like when you’re experiencing side effects from a treatment. Sometimes, people can tolerate certain side effects in order to meet their treatment goals. Other times, side effects can be unbearable, so a change of treatment may be recommended.

It’s important to discuss with your healthcare provider whatever you’re experiencing. He or she can assess if you require medical attention or adjustment to your treatment.

Learn more about possible Rebif side effects

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Learning from real-world experience

The FDA approves drugs based on clinical trials that establish their effectiveness and safety profile. Even though clinical trials provide important information on a drug’s efficacy and safety, it is impossible to have complete information about the safety of a drug at the time of approval. Sometimes, adverse reactions not seen in clinical trials are reported after approval.

When considering a medication’s safety profile, it’s important to look at what’s been reported after a drug has been in the market (“postmarketing data”). The FDA has several programs that allow manufacturers, healthcare professionals, and consumers to report problems associated with approved drugs. Pharmaceutical companies also have drug safety divisions specifically dedicated to patient safety. They are responsible for identifying, reporting, and following up on any adverse events. They continuously monitor a drug’s safety profile over the life of the product.

Should important new information be reported, in some cases, the Prescribing Information (PI) is updated to ensure that the correct and current safety information is available for patients and healthcare providers. It’s important that you discuss all health issues and questions with your healthcare provider before deciding which therapy is right for you.

Rebif and pregnancy

Before you take Rebif, tell your healthcare provider if you 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.

Rebif Ambassador on computer

The well-established safety profile of Rebif was a factor when making my decision on a therapy.

Ric S.
Rebif Ambassador, living with relapsing MS Rebif Ambassadors are sponsored by EMD Serono, Inc.


MS LifeLines and Rebif Ambassadors are sponsored by EMD Serono, Inc.

Important Safety Information

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

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. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid
  • 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
  • Seizures. Some people have had seizures while taking Rebif

Rebif 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.

Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in 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), or thyroid problems
  • you drink alcohol
  • you 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
  • you are breastfeeding or plan to breastfeed. It is not known if Rebif passes into your breast milk. You and your healthcare provider should decide if you will use Rebif or breastfeed. You should not do both

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.

Refer to the Instructions for Use that comes with Rebif® Rebidose® (interferon beta-1a) Autoinjector.

Indication

Rebif® (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.


This information is not intended to replace discussions with your doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide and talk to your doctor. You can also visit rebif.com or call, toll-free, 1-877-447-3243. Rebif is available by prescription only.

Rebif, Rebif Rebidose, Rebiject II, MS LifeLines, and the Rebif logo are registered trademarks of EMD Serono, Inc. or its affiliates.

Brought to you by EMD Serono, Inc., the marketer of Rebif in the US.

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

Copyright © 2019 EMD Serono, Inc. All rights reserved. EMD Serono, Inc., One Technology Place, Rockland, MA 02370

US-INF-1015-0011e(2)

Important Safety Information and Indication

Important Safety Information

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

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. Symptoms at the injection site may include redness, pain, swelling, color changes (blue or black), and drainage of fluid
  • 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
  • Seizures. Some people have had seizures while taking Rebif

Rebif 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.

Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in 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), or thyroid problems
  • you drink alcohol
  • you 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
  • you are breastfeeding or plan to breastfeed. It is not known if Rebif passes into your breast milk. You and your healthcare provider should decide if you will use Rebif or breastfeed. You should not do both

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.

Refer to the Instructions for Use that comes with Rebif® Rebidose® (interferon beta-1a) Autoinjector.

Indication

Rebif® (interferon beta-1a) is used to treat relapsing forms of MS to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.


This information is not intended to replace discussions with your doctor. For additional information about Rebif, please consult the Prescribing Information and Medication Guide and talk to your doctor. You can also visit rebif.com or call, toll-free, 1-877-447-3243. Rebif is available by prescription only.

Rebif, Rebif Rebidose, Rebiject II, MS LifeLines, and the Rebif logo are registered trademarks of EMD Serono, Inc. or its affiliates.

Brought to you by EMD Serono, Inc., the marketer of Rebif in the US.

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

Copyright © 2019 EMD Serono, Inc. All rights reserved. EMD Serono, Inc., One Technology Place, Rockland, MA 02370

US-INF-1015-0011e(2)

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