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Interferon Beta 1b

    Brands

    DEA Class;  Rx

    Common Brand Names; Betaseron, Extavia

    • Immunomodulators; 
    • Multiple Sclerosis Treatments

    Recombinant interferon beta; not glycosylated
    Indicated for relapsing forms of multiple sclerosis, such as clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
    May increase the risk for depression, suicidal ideation, and suicide attempts

    Indicated for treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    Hypersensitivity to beta interferons, human albumin or other ingredients

    • Injection site reaction (85%)
    • Flu-like syndrome (60%)
    • Headache (57%)
    • Myasthenia (46%)
    • Fever (36%)
    • Nausea (27%)
    • Chills (25%)
    • Constipation (20%)
    • Abd pain (19%)
    • Leukopenia (18%)
    • Chest pain (11%)
    • Malaise (8%)
    • Inj site necrosis (5%)
    • Hypersensitivity (3%)
    • Lymphopenia (>5%)
    • Myalgia (>5%)
    • Neutropenia (>5%)
    • Increased liver enzymes (>5%)
    • Hypertonia (>5%)
    • Pain (>5%)
    • Rash (>5%)
    • Insomnia (>5%)
    • Abdominal pain (>5%)
    • Asthenia (>5%)

    Do not administer into affected area until fully healed; if multiple lesions occur, discontinue therapy until skin lesions heal

    Abortifacient potential

    Increased risk of infection

    Betaseron & Extavia, although dosed similarly, not considered therapeutically equivalent

    Leukopenia may occur; monitor complete blood count

    Anaphylaxis reported as a rare complication of interferon beta-1b use; other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash, and urticaria; discontinue therapy if anaphylaxis occurs; the removable rubber cap of the diluent (0.54% sodium chloride solution, USP) pre-filled syringe contains natural rubber latex, which may cause allergic reactions and should not be handled by latex-sensitive individuals; the safe use of pre-filled syringe in latex-sensitive individuals has not been studied

    Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects during pregnancy

    There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production

    Adults

    250 mcg every other day subcutaneously.

    Geriatric

    250 mcg every other day subcutaneously.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    Interferon beta-1b

    lyophilized powder for injection

    • 0.3mg/vial supplied with diluent for reconstitution