Label: IMATINIB tablet

  • NDC Code(s): 43598-344-10, 43598-344-30, 43598-344-31, 43598-344-90, view more
  • Packager: Dr.Reddy's Laboratories Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 20, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use IMATINIB MESYLATE TABLETS safely and effectively. See full prescribing information for IMATINIB MESYLATE TABLETS. IMATINIB ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    1.1 Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML) Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Drug Administration - The prescribed dose should be administered orally, with a meal and a large glass of water. Doses of 400 mg or 600 mg should be administered once daily, whereas a ...
  • 3 DOSAGE FORMS AND STRENGTHS
    100 mg film-coated tablets - Yellow to brownish orange, round film coated tablets debossed with “1” on one side and score line on the other side.  400 mg film-coated tablets - Yellow to brownish ...
  • 4 CONTRAINDICATIONS
    None .
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Fluid Retention and Edema Imatinib mesylate is often associated with edema and occasionally serious fluid retention [see Adverse Reactions (6.1)]. Weigh and monitor patients regularly ...
  • 6 ADVERSE REACTIONS
    The following serious adverse reactions are described elsewhere in the labeling: • Fluid Retention and Edema [see Warnings and Precautions (5.1)] • Hematologic Toxicity [see Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Agents Inducing CYP3A Metabolism Concomitant administration of imatinib mesylate and strong CYP3A4 inducers may reduce total exposure of imatinib; consider alternative agents [see ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Imatinib mesylate can cause fetal harm when administered to a pregnant woman based on human and animal data. There are no clinical studies regarding use of ...
  • 10 OVERDOSAGE
    Experience with doses greater than 800 mg is limited. Isolated cases of imatinib mesylate overdose have been reported. In the event of overdosage, observe the patient and give appropriate ...
  • 11 DESCRIPTION
    Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg and 400 mg tablets for oral administration. Each 100 mg tablet contains 119.47 mg of ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Imatinib mesylate is a protein-tyrosine kinase inhibitor that inhibits the BCR-ABL tyrosine kinase, the constitutive abnormal tyrosine kinase created by the ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In the 2-year rat carcinogenicity study administration of imatinib at 15, 30, and 60 mg/kg/day resulted in a statistically significant ...
  • 14 CLINICAL STUDIES
    14.1 Chronic Myeloid Leukemia - Chronic Phase, Newly Diagnosed: An open-label, multicenter, international randomized Phase 3 study (Imatinib mesylate versus IFN+Ara-C) has been conducted ...
  • 15 REFERENCES
    1. OSHA Hazardous Drugs. OSHA. [Accessed on 20-September-2013, from http://www.osha.gov/SLTC/hazardousdrugs/index.html]
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Each film-coated tablet contains 100 mg or 400 mg of imatinib free base.  100 mg Tablets - Yellow to brownish orange, round film coated tablets debossed with “1” on one side and score line on the ...
  • 17 PATIENT COUNSELING INFORMATION
    Dosing and Administration - Advise patients to take imatinib mesylate tablets exactly as prescribed, not to change their dose or to stop taking imatinib mesylate tablets unless they are told to ...
  • PACKAGE LABEL PRINCIPAL DISPLAY PANEL SECTION
    100 mg -90's count
  • PRINCIPAL DISPLAY PANEL
    400 mg-30's count
  • PRINCIPAL DISPLAY PANEL
    100 mg - Carton
  • PRINCIPAL DISPLAY PANEL
    400 mg - Carton
  • INGREDIENTS AND APPEARANCE
    Product Information