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Tyrosine Kinase Inhibitor — CML / Ph+ ALL Pregnancy: Suspected to cause congenital malformations (including neural tube defects) and harmful pharmacological effects on the foetus; should not be used during pregnancy unless the clinical condition requires it. Both sexually active men and women of childbearing potential should use effective contraception during treatment. Breast-feeding should be stopped during treatment.

Dasatinib

Brand names: Sprycel

Dasatinib is an oral BCR-ABL tyrosine kinase inhibitor used in chronic myeloid leukaemia and Philadelphia chromosome-positive acute lymphoblastic leukaemia.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 100 mg (chronic phase CML); 140 mg (advanced phase CML or Ph+ ALL)
Route: Oral
Frequency: Once daily
Therapy should be initiated by a physician experienced in the diagnosis and treatment of leukaemia. Adults: chronic phase CML recommended starting dose 100 mg once daily; accelerated, myeloid or lymphoid blast (advanced) phase CML or Ph+ ALL 140 mg once daily. Dose escalation (in patients not achieving a haematologic/cytogenetic response) to 140 mg once daily (chronic phase CML) or 180 mg once daily (advanced phase CML or Ph+ ALL) was allowed in clinical studies. Dose reductions for myelosuppression (e.g. to 80 mg, 50 mg once daily) per SPC tables. May be taken with or without food; tablets swallowed whole (do not crush, cut or chew). Patients with hepatic impairment may receive the recommended starting dose (caution advised). Paediatric (Ph+ CML-CP and Ph+ ALL): dose by body weight, once daily — 10 to less than 20 kg: 40 mg; 20 to less than 30 kg: 60 mg; 30 to less than 45 kg: 70 mg; at least 45 kg: 100 mg. Tablet not recommended below 10 kg (use powder for oral suspension); recalculate dose every 3 months by body weight. No experience under 1 year of age.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients

Side effects

  • Myelosuppression (anaemia, neutropenia, thrombocytopenia)
  • Fluid retention events (including pleural effusion)
  • Diarrhoea, nausea
  • Headache, fatigue, musculoskeletal pain
  • Skin rash; haemorrhage; dyspnoea; infection

Interactions

  • Potent CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, erythromycin, clarithromycin, ritonavir, telithromycin, grapefruit juice): increase dasatinib exposure — coadministration not recommended
  • CYP3A4 inducers (e.g. dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, St John's Wort): substantially reduce dasatinib exposure
  • Narrow-therapeutic-index CYP3A4 substrates (e.g. astemizole, terfenadine, cisapride, pimozide, quinidine, bepridil, ergot alkaloids): caution — dasatinib may increase their exposure
  • H2 antagonists (e.g. famotidine), proton pump inhibitors (e.g. omeprazole) and aluminium/magnesium hydroxide antacids: reduce dasatinib exposure (antacids to be separated by 2 hours)

Clinical monograph

How it works

It potently inhibits BCR-ABL and several SRC-family kinases, blocking the constitutive tyrosine kinase signalling that drives proliferation of Philadelphia chromosome-positive leukaemic cells, and is active against many imatinib-resistant mutations.

Prescribing in practice

  • Pleural effusion is a characteristic adverse effect; investigate breathlessness, cough or chest pain promptly, alongside the risks of myelosuppression and bleeding.
  • Pulmonary arterial hypertension is a recognised risk, and cardiac and fluid-retention effects should be considered.
  • It is a substrate for CYP3A4 and absorption is pH-dependent, so review interacting drugs and acid-suppressing therapy.

Monitoring

Monitor full blood count and for fluid retention or respiratory symptoms, with molecular response (BCR-ABL transcripts) assessed over time.

Counselling the patient

  • Report new breathlessness, cough, chest pain or swelling, as these may indicate fluid around the lungs.
  • Tell your team about all other medicines, including indigestion remedies, as they can affect this drug.
  • Take the medicine consistently and do not stop without advice.

Evidence & guidelines

The DASISION trial established dasatinib as first-line therapy in chronic myeloid leukaemia, and it is recommended by NICE in defined settings.

Reference: DASISION Trial (Kantarjian et al. NEJM 2010); NICE TA425; SPC Sprycel; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.