Interferon Beta-1B (1 brand name, 1 dosage form, 1 route)
Available dosage forms: VIAL.
Routes of administration: SUBCUTANEOUS.
Brand Names
- BETASERON
Indications and Usage
BETASERON is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Contraindications
BETASERON is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), or any other component of the formulation.
Adverse Reactions
The following serious adverse reactions are discussed in more details in other sections of labeling: •Hepatic Injury [see Warnings and Precautions (5.1)] •Anaphylaxis and Other Allergic Reactions [see Warnings and Precautions (5.2)] •Depression and Suicide [see Warnings and Precautions (5.3)] •Congestive Heart Failure [see Warnings and Precautions (5.4)] •Injection Site Reactions Including Necrosis [see Warnings and Precautions (5.5)] •Leukopenia [see Warnings and Precautions (5.6)] •Thrombotic Microangiopathy [see Warnings and Precautions (5.7)] •Pulmonary Arterial Hypertension [see Warnings and Precautions (5.8)] •Flu-like Symptom Complex [see Warnings and Precautions ( 5.9 )] •Seizures [see Warnings and Precautions ( 5.10 )] •Drug Induced Lupus Erythematosus [see Warnings and Precautions ( 5.11 )]
Mechanism of Action
The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown.