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Avonex

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Avonex

AVONEX®
(interferon beta-1a) Intramuscular Injection

Avonex

DRUG DESCRIPTION

AVONEX is a 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 AVONEX is identical to that of natural human interferon beta.

Using the World Health Organization (WHO) International Standard for Interferon, AVONEX has a specific activity of approximately 200 million international units of antiviral activity per mg of interferon beta-1a determined specifically by an in vitro cytopathic effect bioassay using lung carcinoma cells (A549) and Encephalomyocarditis virus (ECM). AVONEX 30 micrograms contains approximately 6 million international units of antiviral activity using this method. The activity against other standards is not known. Comparison of the activity of AVONEX with other interferon betas is not appropriate, because of differences in the reference standards and assays used to measure activity.

AVONEX Lyophilized Powder Vial

A vial of AVONEX is a sterile, white to off-white lyophilized powder for intramuscular injection after reconstitution with supplied diluent (Sterile Water for Injection, USP). Each vial of reconstituted AVONEX contains 30 micrograms of interferon beta-1a; 15 mg Albumin (Human), USP; 5.8 mg Sodium Chloride, USP; 5.7 mg Dibasic Sodium Phosphate, USP; and 1.2 mg Monobasic Sodium Phosphate, USP, in 1.0 mL at a pH of approximately 7.3.

AVONEX Single-Use Prefilled Syringe

A prefilled syringe of AVONEX is a sterile liquid for intramuscular injection. Each 0.5 Ml (30 microgram dose) of AVONEX in a prefilled glass syringe contains 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP at a pH of approximately 4.8.

AVONEX PEN Single-Use Prefilled Autoinjector

AVONEX PEN is a sterile liquid for intramuscular injection in a prefilled glass syringe surrounded by an autoinjector. Each 0.5 mL (30 microgram dose) in the AVONEX PEN contains 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP at a pH of approximately 4.8.

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 Avonex »

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

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.

There is a risk of contracting a virus from using this medication because it contains albumin from human blood. Careful screening of blood donors, special manufacturing methods, and FDA-approved tests are all used to reduce such a risk. For more details, talk to your doctor.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), heart disease (e.g., angina,...

Read All Potential Precautions of Avonex »

Last reviewed on RxList: 3/27/2013
This monograph has been modified to include the generic and brand name in many instances.

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Avonex - User Reviews

Avonex 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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