"The US Food and Drug Administration (FDA) is warning that a case of definite multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking fingolimod (Gilenya, Novartis) for relapsing forms of mult"...
(interferon beta-1b) for Injection
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 betaser17 . 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 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 is a sterile, white to off-white powder, for subcutaneous injection after reconstitution with the diluent supplied (Sodium Chloride, 0.54% Solution). Albumin (Human) USP and Mannitol, USP (15 mg each/vial) are added as stabilizers.
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 hot or cold;
- fever, chills, body aches,...
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.
Interferon can make you more likely to get infections or may worsen any current infections....
Last reviewed on RxList: 8/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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