"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) Kit for Subcutaneous Use
EXTAVIA® (interferon beta-1b) 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. EXTAVIA contains the same active ingredients as other interferon beta-1b products. For this reason, these products should not be given concomitantly.
The specific activity of EXTAVIA (interferon beta-1b kit) is approximately 32 million international units (IU)/mg Interferon beta-1b. Each vial contains 0.3 mg of interferon beta-1b. 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 EXTAVIA (interferon beta-1b kit) 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 hot or cold;
- fever, chills, body aches,...
Last reviewed on RxList: 9/16/2009
This monograph has been modified to include the generic and brand name in many instances.
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