Label: BETASERON- interferon beta-1b kit

  • NDC Code(s): 50419-524-01, 50419-524-05, 50419-524-09, 50419-524-35, view more
  • Packager: Bayer HealthCare Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated July 28, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use BETASERON safely and effectively. See full prescribing information for BETASERON. BETASERON (interferon beta-1b) for injection ...
  • Table of Contents
    Table of Contents
  • 1 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 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosing Information - The recommended starting dose is 0.0625 mg (0.25 mL) subcutaneously every other day, with dose increases over a six-week period to the recommended dose of 0.25 mg (1 mL ...
  • 3 DOSAGE FORMS AND STRENGTHS
    For injection: 0.3 mg lyophilized powder in a single-dose vial for reconstitution.
  • 4 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.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hepatic Injury - Severe hepatic injury including cases of hepatic failure, some of which have been due to autoimmune hepatitis, has been rarely reported in patients taking BETASERON. In some ...
  • 6 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally ...
  • 11 DESCRIPTION
    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 ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of BETASERON (interferon beta-1b) in patients with multiple sclerosis is unknown. 12.2 Pharmacodynamics - Interferons (IFNs) are a family of ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis - BETASERON has not been tested for its carcinogenic potential in animals. Mutagenesis - BETASERON was not genotoxic in ...
  • 14 CLINICAL STUDIES
    The clinical effects of BETASERON were studied in four randomized, multicenter, double-blind, placebo-controlled studies in patients with multiple sclerosis (Studies 1, 2, 3, and 4). Patients ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    16.1 How Supplied - BETASERON is supplied as a lyophilized powder in a clear glass, single-dose vial (3 mL capacity). Each carton contains 5 single-dose cartons (NDC 50419-524-05) or 14 ...
  • 17 PATIENT COUNSELING INFORMATION
    See FDA-approved patient labeling (Medication Guide and Instructions for Use). Instruct patients to carefully read the supplied BETASERON Medication Guide and caution patients not to change the ...
  • Medication Guide
    Medication Guide - BETASERON - (bay-ta-seer-on) interferon beta-1b - (in-ter-feer-on beta-one-be) What is the most important information I should know about ...
  • Instructions for Use
    BETASERON - (bay-ta-seer-on) interferon beta-1b - (in-ter-feer-on beta-one-be) Read the Instructions for Use that come with your BETASERON before you start using it and each time you get a ...
  • PRINCIPAL DISPLAY PANEL
    The principal display panel is a representative example and may not reflect the most current label.   NDC 50419-524-01 Rx only - BETASERON - (interferon beta-1b) For injection - 0.3 mg per vial - For ...
  • INGREDIENTS AND APPEARANCE
    Product Information