A well-established safety profile
The Rebif® (interferon beta-1a) story begins long before it was approved by the FDA in 2002 as a relapsing multiple sclerosis 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 may want to talk about that with your healthcare provider when choosing a relapsing MS treatment. Be sure to talk with your doctor about it, as well as the other Important Safety Information on this page.
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 relapsing multiple sclerosis, remember that the help of MS LifeLines® is only a phone call away.
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.
*Common adverse events have been consistent across PRISMS AND EVIDENCE clinical trials.
The safety and efficacy of treatment with Rebif beyond 2 years has not been established.
Pregnancy and 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.
Safety vs tolerability
When you take a medication, safety and tolerability are two important terms to understand—but sometimes it’s tough to know the difference. The first, safety, refers to things that can happen that may require medical attention—investigation, monitoring, or treatment—or constitute a medical risk. You may not feel a safety issue at all, so your healthcare provider will test you periodically with laboratory and other safety tests to monitor for safety concerns.
Tolerability is more related to how a drug makes you feel—like if there are uncomfortable side effects. Sometimes people can put up with effects like these in order to meet their treatment goals. Other times, these effects are unbearable, so a change of treatment may be recommended. Keep in mind, a side effect can be a safety issue too.
All MS treatments have different safety and tolerability issues to consider, so it’s important to discuss whatever you’re experiencing with your healthcare provider. He or she can assess if what you’re experiencing is a safety concern and discuss if there are ways to make your experience better.
Learning from real-world experience
The FDA approves drugs based on clinical trials that establish their effectiveness and safety. Once drugs are widely prescribed, we see how they work across a broader range of patients. Sometimes, adverse reactions not seen in clinical trials are reported after approval.
When considering a medication’s risks versus benefits, it’s important to look at what’s been reported after a drug has been in the market (“postmarketing data”). Pharmaceutical companies have drug safety divisions specifically dedicated to patient safety. They are responsible for identifying, reporting, and following up on any adverse events. Along with the FDA, 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 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.
Some things to remember
Rebif will not cure multiple sclerosis (MS) but it has been shown to decrease the number of flare-ups and slow the occurrence of some of the physical disability that is common in people with MS. Rebif can cause serious side effects, so before you start taking Rebif, you should talk with your healthcare provider about the possible benefits of Rebif and its possible side effects to decide if Rebif is the right relapsing MS treatment for you.