Label: TEMOZOLOMIDE- temozolomide capsule

  • NDC Code(s): 31722-411-14, 31722-411-31, 31722-412-14, 31722-412-31, view more
  • Packager: Camber Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 19, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    HIGHLIGHTS OF PRESCRIBING INFORMATION - These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Newly Diagnosed Glioblastoma - Temozolomide capsules are indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Monitoring to Inform Dosage and Administration - Prior to dosing, withhold temozolomide capsules until patients have an absolute neutrophil count (ANC) of 1.5 x 10 - 9/L or greater and a ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Temozolomide capsules, USP are available in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, and 250 mg strengths. The capsules contain a white capsule body with a color cap, and the colors vary based on ...
  • 4 CONTRAINDICATIONS
    Temozolomideis contraindicated in patients with a history of serious hypersensitivity reactions to:     •temozolomideor any other ingredients in temozolomide capsules; and ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myelosuppression - Myelosuppression, including pancytopenia, leukopenia, and anemia, some with fatal outcomes, have occurred with temozolomide - [see - Adverse Reactions (6.1 ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are described elsewhere in the labeling:  • Myelosuppression - [see Warnings and Precautions (5.1)]  • Hepatotoxicity - [see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary  - Based on findings from animal studies and its mechanism of action - [see - Clinical Pharmacology (12.1)] , temozolomide can cause fetal harm when ...
  • 10 OVERDOSAGE
    Dose-limiting toxicity was myelosuppression and was reported with any dose but is expected to be more severe at higher doses. An overdose of 2000 mg per day for 5 days was taken by one patient ...
  • 11 DESCRIPTION
    Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Temozolomide is carcinogenic in rats at doses less than the maximum recommended human dose. Temozolomide induced mammary carcinomas ...
  • 14 CLINICAL STUDIES
    14.1 Newly Diagnosed Glioblastoma - The efficacy of temozolomide was evaluated in MK-7365-051 (NCT00006353), a randomized (1:1), multicenter, open-label trial. Eligible patients were required ...
  • 15 REFERENCES
    1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/hazardous-drugs
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Temozolomide is a hazardous drug. Follow applicable special handling and disposal procedures. 1 - Temozolomide Capsules, USP - 5 mg: Opaque green cap and opaque white body, hard gelatin ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information).  Myelosuppression  - Inform patients that temozolomide can cause low blood cell counts and the need for ...
  • Patient Information
    Temozolomide Capsules, USP - (tem″ oh zol′ oh mide)  What are temozolomide capsules?  Temozolomide capsules are a prescription medicine used to treat adults with ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    Temozolamide capsules 5 mg 5s count container label - Temozolamide capsules 5 mg 5s count carton label - Temozolamide capsules 20 mg 5s count container label - Temozolamide capsules ...
  • INGREDIENTS AND APPEARANCE
    Product Information