Label: DASATINIB- dasatinib tablet, film coated
DASATINIB- dasatinib tablet, film coated

  • NDC Code(s): 70377-083-11, 70377-084-11, 70377-085-11, 70377-086-11, view more
  • Packager: Biocon Pharma Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 25, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use DASATINIB TABLETS safely and effectively. See full prescribing information for DASATINIB TABLETS. DASATINIB tablets, for oral ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    Dasatinib tablets are indicated for the treatment of adult patients with - newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Dosage of Dasatinib Tablets in Adult Patients - The recommended starting dosage of dasatinib tablets for chronic phase CML in adults is 100 mg administered orally once daily. The ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Dasatinib tablets are available as 20-mg, 50-mg, 70-mg, 80-mg, 100-mg, and 140-mg white to off-white, biconvex, film-coated tablets.
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Myelosuppression - Treatment with dasatinib is associated with severe (NCI CTCAE Grade 3 or 4) thrombocytopenia, neutropenia, and anemia, which occur earlier and more frequently in patients ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Dosage and Administration (2.5) and Warnings and ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs on Dasatinib - Strong CYP3A4 Inhibitors - The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations [see Clinical Pharmacology (12.3)] ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on limited human data, dasatinib can cause fetal harm when administered to a pregnant woman. Adverse pharmacologic effects including hydrops fetalis, fetal ...
  • 10 OVERDOSAGE
    Experience with overdose of dasatinib in clinical studies is limited to isolated cases. The highest overdosage of 280 mg per day for 1 week was reported in two patients and both developed severe ...
  • 11 DESCRIPTION
    Dasatinib tablets are a kinase inhibitor. The chemical name for dasatinib is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - In a 2-year carcinogenicity study, rats were administered oral doses of dasatinib at 0.3, 1, and 3 mg/kg/day. The highest dose resulted ...
  • 14 CLINICAL STUDIES
    14.1 Newly Diagnosed Chronic Phase CML in Adults - DASISION (Dasatinib vs Imatinib Study in Treatment-Naive Chronic Myeloid Leukemia Patients) (NCT00481247) was an open-label, multicenter ...
  • 15 REFERENCES
    1. http://www.osha.gov/SLTC/hazardousdrugs/index.html
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    How Supplied - Dasatinib tablets are available as described in Table 21. Table 21:        Dasatinib Tablets Trade Presentations - NDC NumberStrengthDescriptionTablets per ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Myelosuppression - Inform patients of the possibility of developing low blood cell counts. Advise patients ...
  • PATIENT INFORMATION
    Dasatinib ("da sa' ti nib) Tablets - What are Dasatinib Tablets? Dasatinib Tablets are a prescription medicine used to treat: adults with newly diagnosed Philadelphia ...
  • PRINCIPAL DISPLAY PANEL
  • Dasatinib Tablets 20 mg
    Dasatinib tablets 20 mg - NDC: 70377-083-11
  • Dasatinib tablets 50 mg
    Dasatinib tablets 50 mg - NDC: 70377-084-11
  • Dasatinib tablets 70 mg
    Dasatinib tablets 70 mg - NDC: 70377-085-11
  • Dasatinib tablets 80 mg
    Dasatinib tablets 80 mg - NDC: 70377-086-11
  • DASATINIB Tablets 100 mg
    Dasatinib Tablets 100 mg - NDC: 70377-087-11
  • DASATINIB Tablets 140 mg
    Dasatinib Tablets 140 mg - NDC: 70377-088-11
  • INGREDIENTS AND APPEARANCE
    Product Information