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BCR-ABL TKI (specialist) Pregnancy: Suspected to cause congenital malformations (including neural tube defects) and harmful foetal effects; should not be used during pregnancy unless the woman's condition requires it. Both sexually active men and women of childbearing potential should use effective contraception. Breast-feeding should be stopped during treatment.

Dasatinib

Brand names: Sprycel

Dasatinib is an oral tyrosine kinase inhibitor used by specialists in the treatment of chronic myeloid leukaemia and Philadelphia-chromosome-positive acute lymphoblastic leukaemia; it is a haemato-oncology drug rather than a rheumatology agent.

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 (accelerated/blast phase CML or Ph+ ALL)
Route: Oral
Frequency: Once daily
Max: Adults: up to 180 mg once daily on dose escalation (advanced phase CML or Ph+ ALL)
Therapy should be initiated by a physician experienced in the diagnosis and treatment of leukaemia. Recommended starting dose: chronic phase CML 100 mg once daily; accelerated, myeloid or lymphoid blast (advanced) phase CML or Ph+ ALL 140 mg once daily. Dose escalation in adults to 140 mg once daily (chronic phase) or 180 mg once daily (advanced phase / Ph+ ALL) was allowed for patients not achieving response. Dose reduction for myelosuppression: chronic phase CML reduce to 80 mg, then 50 mg once daily; advanced phase/Ph+ ALL reduce to 100 mg, then 80 mg once daily. Hepatic impairment (mild/moderate/severe): recommended starting dose may be used, with caution. Paediatric (Ph+ CML-CP and Ph+ ALL) dosed once daily by body-weight bands (10 to <20 kg = 40 mg; 20 to <30 kg = 60 mg; 30 to <45 kg = 70 mg; at least 45 kg = 100 mg); tablet not recommended below 10 kg (use powder for oral suspension); no experience under 1 year. Treatment continued until disease progression or intolerance.

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

  • Infection (including bacterial, viral, fungal) - very common
  • Myelosuppression (anaemia, neutropenia, thrombocytopenia) - very common
  • Pneumonia, upper respiratory tract infection/inflammation, herpes virus infection, enterocolitis infection, sepsis - common
  • Hepatitis B reactivation - frequency not known
  • Fluid retention including pleural effusion (see section 4.4)

Interactions

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

Clinical monograph

How it works

It potently inhibits BCR-ABL and SRC-family kinases, blocking the constitutive signalling that drives proliferation of leukaemic cells.

Prescribing in practice

  • Can cause fluid retention including pleural effusion and is associated with QT prolongation and myelosuppression — monitor closely and interrupt or reduce dose as needed.
  • Metabolised by CYP3A4, so avoid strong inducers and inhibitors and minimise drugs that prolong the QT interval.
  • A specialist haemato-oncology medicine; prescribe according to the SPC and treatment protocols.

Monitoring

Monitor full blood count, for signs of fluid retention, and ECG/electrolytes where QT-prolongation risk exists.

Counselling the patient

  • Report breathlessness, swelling or unexpected bruising and bleeding.
  • Take consistently with respect to food as directed and avoid grapefruit.
  • Seek urgent advice for fever or signs of infection.

Evidence & guidelines

Efficacy in chronic myeloid leukaemia is established by major randomised trials and NICE appraisals.

Reference: NICE TA425; BSH CML guidelines; ESMO; SmPC; 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.

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