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 in the Rebif Prescribing Information.
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.
SUPPORTING THE SAFETY PROFILE
When you take Rebif, you can also count on the full support of MS LifeLines Nurses to help you inject correctly. And if you ever have questions about Rebif, Rebif side effects, or RMS, ask your healthcare provider. MS LifeLines® may also be able to help.
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.
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 receives information from manufacturers, healthcare professionals, and consumers about 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 healthcare providers and patients. It’s important that you discuss all health issues and questions with your healthcare provider before deciding which therapy is right for you.
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.
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.
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:
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:
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 are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
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.
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:
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:
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 are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
