This site is intended for US-based Healthcare Professionals only.
  • SPRYCEL Patient Site
  • BMS Resources
  • Full Prescribing Information
  • Indications

    INDICATIONS

    SPRYCEL® (dasatinib) is indicated for the treatment of adult patients with:

    • Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
    • Chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib
    • Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy

    SPRYCEL® is indicated for the treatment of pediatric patients 1 year of age and older with:

    • Newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) in combination with chemotherapy
    • Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

SPRYCEL dosing for children* with Ph+ CML in chronic phase

Tablet dosing for pediatric patients1

Chart shows daily dosage recommendations for pediatric patients from 10 to ≥45 kg. Chart shows daily dosage recommendations for pediatric patients from 10 to ≥45 kg.

Tablet dosing is not recommended for patients weighing less than 10 kg.

  • SPRYCEL® (dasatinib) tablets are administered once daily with or without food
  • Recalculate the dose every 3 months based on changes in body weight, or more often if necesssary
  • Do not crush, cut, or chew tablets. Swallow tablets whole

*Aged 1 year or older.

IMPORTANT SAFETY INFORMATION ABOUT DRUG INTERACTIONS

Effect of Other Drugs on Dasatinib

  • Strong CYP3A4 inhibitors: The coadministration with strong CYP3A inhibitors may increase dasatinib concentrations. Increased dasatinib concentrations may increase the risk of toxicity. Avoid concomitant use of strong CYP3A4 inhibitors. If concomitant administration of a strong CYP3A4 inhibitor cannot be avoided, consider a SPRYCEL dose reduction
    • Grapefruit juice may increase plasma concentrations of SPRYCEL and should be avoided
  • Strong CYP3A4 inducers: The coadministration of SPRYCEL with strong CYP3A inducers may decrease dasatinib concentrations. Decreased dasatinib concentrations may reduce efficacy. Consider alternative drugs with less enzyme induction potential. If concomitant administration of a strong CYP3A4 inducer cannot be avoided, consider a SPRYCEL dose increase
    • St. John’s wort may decrease plasma concentrations of SPRYCEL and should be avoided
  • Gastric Acid Reducing Agents: The coadministration of SPRYCEL with a gastric acid reducing agent may decrease the concentrations of dasatinib. Decreased dasatinib concentrations may reduce efficacy
    Do not administer H2 antagonists or proton pump inhibitors with SPRYCEL. Consider the use of antacids in place of H2 antagonists or proton pump inhibitors. Administer the antacid at least 2 hours prior to or 2 hours after the dose of SPRYCEL. Avoid simultaneous administration of SPRYCEL with antacids.
See resources available for your patients
and practice

Reference:

  1. SPRYCEL full Prescribing Information. Bristol-Myers Squibb Company.