Injection for subcutaneous use
Read this Medication Guide before you start using REBIF and each time you get a refill. There may be new information. The information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about REBIF?
REBIF can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking REBIF.
Behavioral health problems including depression and suicidal thoughts. You may have mood problems including:
- depression (feeling hopeless or feeling bad about yourself)
- thoughts of hurting yourself or suicide
Liver problems or worsening of liver problems including liver failure. Symptoms may include:
- loss of appetite
- dark colored urine and pale stools
- yellowing of your skin or the white part of your eye
- bleeding more easily than normal
|During your treatment with REBIF you will need to see your healthcare provider regularly and have regular blood tests to check for side effects.
Serious allergic and skin reactions. Symptoms may include:
- swelling of your face, eyes, lips, tongue or throat
- trouble breathing
- feeling faint
- skin rash, hives, sores in your mouth, or skin blisters and peels
Injection site problems. REBIF may cause redness, pain, itching or swelling at the place where your injection was given. Call your healthcare provider right away if an injection site becomes swollen and painful or the area looks infected. You may have a skin infection or an area of severe skin damage (necrosis) requiring treatment by a healthcare provider.
What is REBIF?
REBIF is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is a form of protein called beta interferon that is produced in the body.
It is not known if REBIF is safe and effective in children.
Who should not take REBIF?
Do not take REBIF if you:
- are allergic to interferon beta, human albumin, or any of the ingredients in REBIF. See the end of this Medication Guide for a complete list of ingredients in REBIF.
What should I tell my healthcare provider before taking REBIF?
Before you take REBIF, tell your healthcare provider if have or have had any of the following conditions:
- mental illness, including depression and suicidal behavior
- liver problems
- bleeding problems or blood clots
- low blood cell counts
- seizures (epilepsy)
- thyroid problems
- drink alcohol
- you are pregnant or plan to become pregnant. It is not known if REBIF can harm your unborn baby.
- you are breastfeeding or plan to breastfeed. REBIF may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take REBIF.
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
REBIF and other medicines may affect each other causing side effects.
Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use REBIF?
See the Instructions for Use at the end of this Medication Guide on how to prepare and give an injection of REBIF using a prefilled syringe. For the REBIF Rebidose autoinjector, read the Instructions for Use that comes with the REBIF Rebidose autoinjector.
- Your healthcare provider should show you how to prepare and measure your dose of REBIF and how to inject your REBIF before you use it for the first time.
- REBIF is given by injection under the skin (subcutaneous injection) on the same 3 days a week, for example, Monday, Wednesday and Friday.
- Your injections should be at least 48 hours apart. Take them the same time each day.
- Inject REBIF exactly as your healthcare provider tells you.
- Your healthcare provider will tell you how much REBIF to inject, and may change the dose based on how your body responds. Do not inject more than your healthcare provider tells you to.
- Do not change your dose unless your healthcare provider tells you to.
- Change (rotate) your injection site you choose with each injection. This will help decrease the chance that you will have an injection site reaction.
Do not inject REBIF into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way.
- REBIF comes as a:
Your healthcare provider will decide which is best for you. Always use a new, unopened, prefilled syringe of REBIF or REBIF Rebidose autoinjector for each injection. Do not reuse prefilled syringes or REBIF Rebidose autoinjectors.
- prefilled syringe (REBIF)
- single-use prefilled autoinjector (REBIF Rebidose autoinjector)
What are the possible side effects of REBIF?
REBIF may cause serious side effects, including:
See "What is the most important information I should know about REBIF?"
Blood problems. REBIF can affect your bone marrow and cause low red and white blood cell, and platelet counts. In some people, these blood cell counts may fall to dangerously low levels. If your blood cell counts become very low, you can get infections and problems with bleeding and bruising. Your healthcare provider may ask you to have regular blood tests to check for blood problems.
Seizures. Some people have had seizures while taking REBIF.
The most common side effects of REBIF include:
- flu-like symptoms. You may have flu-like symptoms when you first start taking REBIF. You may be able to manage these flu-like symptoms by taking over-the-counter pain and fever reducers. For many people, these symptoms lessen or go away over time. Symptoms may include:
- muscle aches
- stomach pain
- change in liver blood tests
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 may report side effects to the FDA at 1-800-FDA-1088.
How should I store REBIF?
- Store REBIF in the refrigerator between 36°F to 46°F (2°C to 8°C).
Do not freeze REBIF.
- If you cannot refrigerate your REBIF, you can store your REBIF at temperatures above 36°F and below 77°F (2°C to 25°C) for up to 30 days.
- Keep REBIF away from heat and light.
Keep REBIF and all medicines out of the reach of children.
General information about the safe and effective use of REBIF
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REBIF for a condition for which it was not prescribed. Do not give REBIF to other people, even if they have they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about REBIF. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about REBIF that is written for healthcare professionals.
For more information, go to www.REBIF.com or call toll-free 1-877-447- 3243.
What are the ingredients in REBIF?
Active ingredient: interferon beta-1a
Inactive ingredients: albumin (human), mannitol, sodium acetate, water for injection
This Medication Guide has been approved by the U.S. Food and Drug Administration.
EMD Serono, Inc.