Sprycel (Dasatinib) – Leukemias | HongKong DengYue Medicine

Sprycel Application Scope

​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 also indicated for the treatment of pediatric patients 1 year of age and older with:

• Ph+ CML in chronic phase.

• Newly diagnosed Ph+ ALL in combination with chemotherapy.

  

Sprycel Characteristics

• Ingredients: Dasatinib

• Properties:​ A white to off-white, biconvex, film-coated tablet

• Packaging Specification:​ In strengths of 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg; each blister pack contains 30 tablets

• Storage:​ Store at room temperature (15–30°C), away from moisture and light

• Expiry Date: As indicated on the package

• Executive Standard: In accordance with FDA and EMA pharmaceutical standards

• Approval Number: FDA NDA #021986

• Date of Revision: Latest revision: February 2023

• Manufacturer: Bristol-Myers Squibb Company, Princeton, NJ 08543 USA

Guidelines for the Use of Sprycel

• Dosage and Administration:

  • Recommended Dose:

    • Chronic Phase CML: 100 mg once daily.

    • Accelerated or Blast Phase CML/Ph+ ALL: 140 mg once daily.

    • Tablets should not be crushed or cut; they should be swallowed whole. Sprycel can be taken with or without a meal, either in the morning or in the evening.

  • Administration: Can be taken in the morning or evening, with or without food.

  • Missed Dose:​ If a dose is missed, take it as soon as possible on the same day. Do not take two doses at once.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Myelosuppression (anemia, neutropenia, thrombocytopenia)

    • Fluid retention (pleural effusion, peripheral edema)

    • Diarrhea, nausea, rash, headache, fatigue

  • Serious Adverse Reactions:

    • Severe bleeding events

    • Pulmonary arterial hypertension (PAH)

    • QT prolongation

    • Hepatotoxicity

    ​

• Contraindications:

  • Hypersensitivity to dasatinib or any component of the formulation.

  • Breastfeeding is contraindicated during treatment.

• Precautions:

  • Use with caution in patients with a history of heart disease.

  • Monitor blood counts regularly during treatment.

  • Avoid concomitant use with strong CYP3A4 inhibitors or inducers.

Sprycel Interactions

• Strong CYP3A4 Inhibitors: May increase dasatinib plasma concentrations; avoid concomitant use.

• Strong CYP3A4 Inducers: May decrease dasatinib plasma concentrations; avoid concomitant use.

• Antacids and H2 Antagonists: May reduce dasatinib absorption; separate administration by several hours.

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.