Classes
DEA Class; Rx
Common Brand Names; Betaseron, Extavia
- Immunomodulators;
- Multiple Sclerosis Treatments
Description
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
Indications
Indicated for treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Contraindications
Hypersensitivity to beta interferons, human albumin or other ingredients
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
250 mcg every other day subcutaneously.
250 mcg every other day subcutaneously.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Interferon beta-1b
lyophilized powder for injection
- 0.3mg/vial supplied with diluent for reconstitution