Product features

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.

Important safety information

What is the most important information I should know about Rebif?

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 doctor about the possible benefits of Rebif and its possible side effects to decide if Rebif is right for you. Potential serious side effects include:

• Depression. Some patients treated with interferons, including Rebif, have become seriously depressed (feeling sad). Some patients have thought about killing themselves and a few have committed suicide. Depression (a sinking of spirits or sadness) is not uncommon in people with multiple sclerosis. However, if you are feeling noticeably sadder or helpless, or feel like hurting yourself or others you should tell a family member or friend right away and call your doctor as soon as possible. Your doctor may ask that you stop using Rebif. You should also tell your doctor if you have ever had any mental illness, including depression, and if you take any medications for depression
• Liver problems. Your liver may be affected by taking Rebif and a few patients have developed severe liver injury. Your health care provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily you should call your doctor right away
• Risk to pregnancy. If you become pregnant while taking Rebif you should call your doctor right away. Rebif may cause you to lose your baby (miscarry) or may cause harm to your unborn child. You and your doctor will need to decide whether the potential benefit of taking Rebif is greater than the risks are to your unborn child
• Allergic reactions. Some patients taking Rebif have had severe allergic reactions leading to difficulty breathing, and loss of consciousness. Allergic reactions can happen after your first dose or may not happen until after you have taken Rebif many times. Less severe allergic reactions such as itching, flushing or skin bumps can also happen at any time. If you think you are having an allergic reaction, stop using Rebif immediately and call your doctor
• Injection-site problems. Rebif may cause redness, pain or swelling at the place where an injection was given. Some patients have developed skin infections or areas of severe skin damage (necrosis) requiring treatment by a doctor. If one of your injection sites becomes swollen and painful or the area looks infected and it doesn't heal within a few days, you should call your doctor. For more information, please see medication guide

Who should not take Rebif?

Do not take Rebif if you:

• Have had an allergic reaction such as difficulty breathing, flushing or hives to another interferon beta or to human albumin

If you have any of the following conditions or serious medical problems, you should tell your doctor before taking Rebif:

• Depression (a sinking feeling or sadness), anxiety (feeling uneasy or fearful for no reason), or trouble sleeping
• Liver diseases
• Problems with your thyroid gland
• Blood problems such as bleeding or bruising easily and anemia (low red blood cells) or low white blood cells
• Epilepsy
• Are planning to become pregnant

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.

What are the possible side effects of Rebif?

• Flu-like symptoms (fever, chills, sweating, muscle aches and tiredness)
• Skin reactions. Soreness, redness, pain, bruising or swelling may occur at the place of injection
• Depression and anxiety. Some patients taking interferons have become very depressed and or anxious
• Liver problems
• Abdominal pain
• Blood problems. You may have a drop in the levels of infection-fighting blood cells, red blood cells or cells that help to form blood clots. If the drop in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily
• Thyroid problems. Your thyroid function may change. Symptoms of changes in the function of your thyroid include feeling cold or hot all the time, change in your weight (gain or loss) without a change in your diet or amount of exercise you are getting
• Severe allergic reactions. Allergic reactions are rare and may be associated with difficulty in breathing and loss of consciousness, which require immediate medical attention

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).

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

Compared with Avonex, side effects were generally similar despite the higher, more frequent dosing of Rebif. Differences included people taking Avonex had more flu-like 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.rebif.com or call toll-free 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. Speakers and MS LifeLines Ambassadors who participate in Talk MS or in live events are sponsored by EMD Serono, Inc. and Pfizer Inc. UNIQUELY [you] is a service mark of EMD Serono, Inc. or its affiliates. Rebif, Rebif Rebidose, Rebiject II and MS LifeLines are registered trademarks and the Rebif logo is a trademark of EMD Serono, Inc. or its affiliates.

Avonex is a registered trademark of Biogen Idec.
Betaseron is a registered trademark of Bayer HealthCare Pharmaceuticals Inc.
Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
Extavia is a registered trademark of Novartis AG.
Tysabri is a registered trademark of Elan Pharmaceuticals, Inc.

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

Prescribing Information (PDF) - Medication Guide (PDF)

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