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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.