Multiple Sclerosis - MS LifeLines

An educational and supportive community for people living with multiple sclerosis.

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Brought to you by EMD Serono, Inc. and Pfizer Inc, the co-marketers of Rebif® (interferon beta-1a) in the US EMD SeronoPfizer

Prescribing Information - Medication Guide

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

Indication

Rebif 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. Rebif is not approved for treatment of chronic progressive MS. Rebif is available in 22 mcg and 44 mcg prefilled, preassembled syringes and a titration pack by prescription only.

Important Safety Information

Before beginning treatment, patients should discuss with their doctor the potential benefits and risks associated with Rebif. Let your doctor know if you have a history of depression, seizures, liver disease, thyroid problems, or blood cell count or bleeding problems, or if you have had previous allergic reactions to medications. Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Rebif and other medicines may affect each other causing serious side effects. Talk to your doctor before you take any new medicines. Rebif is not recommended for women who are or plan to become pregnant.

Potential serious side effects of Rebif include depression and risk of suicide, liver problems, risk to pregnancy, injection-site problems, and severe allergic reactions. Allergic reactions are rare and may be associated with difficulty in breathing and loss of consciousness, which require immediate medical attention.

The most common side effects with Rebif are injection-site reactions, flu-like symptoms (fever, chills, muscle aches, tiredness), depression, abdominal pain, increased liver enzymes, and blood cell count decreases. Let your doctor know if you have any of these symptoms or feel sad, tired, hot or cold, or experience hives, rashes, bruising, yellowing of the skin, or a change in body weight (gain or loss).

Compared with Avonex, side effects were generally similar despite the higher, more frequent dosing of Rebif. Differences included people taking Avonex had more flulike symptoms than those taking Rebif. People taking Rebif had a greater number of injection-site reactions, elevated liver enzymes, and decreased white blood cell counts; these events also occurred more frequently with Rebif posttransition versus prior use of Avonex.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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 www.mslifelines.com or call toll-free 1-877-44-REBIF (1-877-447-3243). Rebif is available by prescription only.

MS LifeLines is an educational support service for people living with MS and their families. MS LifeLines and MS LifeLines Ambassadors are sponsored by EMD Serono, Inc. and Pfizer Inc.

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

MS in Balance Your Life in Full is a service mark of EMD Serono, Inc. or its affiliates.

Copyright 2010 EMD Serono, Inc. All rights reserved.

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