Dasatinib (Dasakast) 50 mg 60 tab.

Dasakast (Dasatinib) 50 mg, 60 Tablets

International Nonproprietary Name (INN): Dasatinib
Brand name: Dasakast
Manufacturer: Aprazer Healthcare
Country of origin: India
Dosage form: Film-coated tablets
Strength: 50 mg
Pack size: 60 tablets

Pharmacotherapeutic group

Antineoplastic agent, tyrosine kinase inhibitor (ATC code: L01EA02).

Pharmacology

Dasatinib is a second-generation, multi-targeted tyrosine kinase inhibitor. It potently inhibits the BCR-ABL kinase as well as SRC-family kinases, c-KIT, PDGFRβ, and ephrin receptor kinases.
This inhibition blocks malignant cell proliferation and induces apoptosis.
Dasatinib is effective against many imatinib-resistant BCR-ABL mutations.

Indications

• Treatment of adult and pediatric patients with Chronic Myeloid Leukemia (CML) in chronic, accelerated, or blast phase who are resistant or intolerant to prior therapy.
• Treatment of adult and pediatric patients with Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).
• Treatment of lymphoid blast phase CML.

Composition

Each tablet contains:

• Active ingredient: Dasatinib 50 mg.
• Excipients: Lactose monohydrate, microcrystalline cellulose, crospovidone, magnesium stearate, titanium dioxide, hypromellose, polyethylene glycol, ferric oxide yellow.

Dosage and administration

• Administer orally, once daily, with or without food.
• Tablets should be swallowed whole, not crushed or split.
• Recommended adult dose:
  • Chronic phase CML — 100 mg once daily.
  • Accelerated or blast phase CML, or Ph+ ALL — 140 mg once daily.
• Dose adjustments may be required based on tolerance and response.
• Pediatric doses are weight-based.

Contraindications

• Hypersensitivity to dasatinib or any component of the formulation.
• Severe hepatic impairment without medical monitoring.
• Pregnancy and lactation (use only if potential benefit justifies potential risk).
• Children under 1 year of age.

Adverse effects

Common:
Headache, fatigue, nausea, diarrhea, abdominal pain, peripheral edema, rash, pyrexia, elevated liver enzymes, musculoskeletal pain.

Serious:
Pleural effusion, pulmonary hypertension, anemia, neutropenia, thrombocytopenia, bleeding, arrhythmia, thromboembolic events.

Seek immediate medical advice if serious reactions occur.

Precautions

• Therapy should be initiated and monitored by an experienced hematologist or oncologist.
• Regular monitoring of complete blood count and liver function tests is required.
• Avoid co-administration with strong CYP3A4 inhibitors (e.g. ketoconazole) or inducers (e.g. rifampicin).
• Avoid grapefruit juice.
• Use effective contraception during treatment and for at least 1 month after discontinuation.

Drug interactions

• CYP3A4 inhibitors increase dasatinib plasma levels.
• CYP3A4 inducers decrease its efficacy.
• Antacids may reduce absorption — separate administration by ≥2 hours.

Storage

Store below 30 °C, in the original container, away from moisture and direct light.

Keep out of reach of children.

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