Betaseron (Interferon beta-1b) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Betaseron

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HCV is one of several viruses that cause hepatitis (inflammation of the liver).
Up to 85% of individuals who are initially (acutely) infected with HCV will fail to eliminate the virus and will become chronically infected.
HCV is spread most commonly through inadvertent exposure to infected blood. Intravenous drug abuse is the most common mode of transmission. The risk of acquiring HCV through sexual contact is low.
Generally, patients do not develop symptoms of chronic infection with HCV until they have extensive scarring of the liver (cirrhosis). Some individuals, however, may have fatigue and other non-specific symptoms in the absence of cirrhosis. A minority of patients with HCV have symptoms from organs outside of the liver.
In the U.S., Infection with HCV is the most common cause of chronic hepatitis and the most common reason for liver transplantation.
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Betaseron

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Betaseron®
(Interferon beta-lb)

DRUG DESCRIPTION

Betaseron® (Interferon beta-lb) is a purified, sterile, lyophilized protein product produced by recombinant DNA techniques. Interferon beta-1b is manufactured by bacterial fermentation of a strain of Escherichia coli that bears a genetically engineered plasmid containing the gene for human interferon beta_ser17. The native gene was obtained from human fibroblasts and altered in a way that substitutes serine for the cysteine residue found at position 17. Interferon beta-1b has 165 amino acids and an approximate molecular weight of 18,500 daltons. It does not include the carbohydrate side chains found in the natural material.

The specific activity of Betaseron (interferon beta-1b) is approximately 32 million international units (IU)/mg Interferon beta-lb. Each vial contains 0.3 mg of Interferon beta-lb. The unit measurement is derived by comparing the antiviral activity of the product to the World Health Organization (WHO) reference standard of recombinant human interferon beta. Mannitol, USP and Albumin (Human), USP (15 mg each/vial) are added as stabilizers.

Lyophilized Betaseron (interferon beta-1b) is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution).

What are the possible side effects of interferon beta-1b (Betaseron, Extavia)?

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.

Stop using interferon beta-1b and call your doctor at once if you have any of these serious side effects:

depressed mood, anxiety, trouble sleeping, restlessness, or thoughts of suicide or hurting yourself;
bruising, swelling, oozing, or skin changes where the injection was given;
weight changes, pounding heartbeats, feeling too...

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What are the precautions when taking interferon beta-1b (Betaseron)?

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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood cell disorders (e.g., anemia, neutropenia, thrombocytopenia), heart disease (e.g., angina, irregular heartbeat, congestive heart failure), liver disease, mental/mood disorders (e.g., depression, psychosis, suicidal thoughts), seizure disorder, thyroid disease, use/abuse of alcohol.

This medication is not recommended for use during pregnancy. Consult your doctor for more...

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Last reviewed on RxList: 6/26/2008
This monograph has been modified to include the generic and brand name in many instances.