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Rebif

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Rebif

Rebif®
(interferon beta-1a) Injection

Rebif

DRUG DESCRIPTION

Rebif® (interferon beta-1a) is a purified 166 amino acid glycoprotein with a molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of Rebif® is identical to that of natural fibroblast derived human interferon beta. Natural interferon beta and interferon beta-1a (Rebif®) are glycosylated with each containing a single N-linked complex carbohydrate moiety.

Using a reference standard calibrated against the World Health Organization natural interferon beta standard (Second International Standard for Interferon, Human Fibroblast GB 23 902 531), Rebif® has a specific activity of approximately 270 million international units (MIU) of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using WISH cells and Vesicular Stomatitis virus. Rebif® 8.8 mcg, 22 mcg and 44 mcg contains approximately 2.4 million international units , 6 million international units or 12 million international units, respectively, of antiviral activity using this method.

Rebif® (interferon beta-1a) is formulated as a sterile solution in a pre-filled syringe or Rebif® Rebidose® autoinjector intended for subcutaneous (sc) injection. Each 0.5 ml (0.5 cc) of Rebif® contain either 22 mcg or 44 mcg of interferon beta-1a, 2 mg or 4 mg albumin (human) USP, 27.3 mg mannitol USP, 0.4 mg sodium acetate, Water for Injection USP. Each 0.2 ml (0.2 cc) of Rebif® contains 8.8 mcg of interferon beta-1a, 0.8 mg albumin (human) USP, 10.9 mg mannitol USP, 0.16 mg sodium acetate, and Water for Injection USP.

What are the possible side effects of interferon beta-1a (Avonex, Avonex Prefilled Syringe, Rebif)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
  • easy bruising or bleeding, weakness;
  • seizure (convulsions);
  • numbness or tingling in your hands or feet;
  • pain or burning when you urinate;
  • pain, swelling, or skin...

Read All Potential Side Effects and See Pictures of Rebif »

What are the precautions when taking interferon beta-1a (Rebif)?

Before using interferon, tell your doctor or pharmacist if you are allergic to it; or to products containing human albumin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Some brands of this medication contain albumin made from human blood. Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections from the medication (for example viruses such as hepatitis). Consult your doctor or pharmacist for more information.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g.,...

Read All Potential Precautions of Rebif »

Last reviewed on RxList: 5/3/2013
This monograph has been modified to include the generic and brand name in many instances.

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Rebif - User Reviews

Rebif User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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