dasatinib monohydrate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
dasatinib monohydrate: clinical details
Prescribing considerations
- Treatment should be initiated and supervised by a clinician experienced in diagnosing and treating leukaemia.
- Review CYP3A4 modulators, acid-suppressing treatment, bleeding-risk medicines and QT-prolonging medicines before initiation and whenever treatment changes.
- Test for hepatitis B before treatment; seek hepatology input for positive serology and monitor carriers during and after therapy.
- Assess cardiopulmonary history and investigate baseline cardiac symptoms or relevant risk factors.
- Tablets and oral suspension are not bioequivalent; switching requires formulation-specific reassessment.
- Consider oral-suspension sucrose, benzyl alcohol, benzoates and sulphur dioxide in susceptible patients.
Contraindications and cautions
- Hypersensitivity to dasatinib or any product excipient.
- The oral suspension should not be used in people with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
Monitoring
- Full blood count for myelosuppression.
- Disease response using appropriate haematological, cytogenetic and molecular assessments.
- Respiratory symptoms and signs of pleural effusion, pulmonary hypertension or interstitial lung disease.
- Bleeding, fluid retention and cardiac dysfunction.
- Electrolytes and cardiac rhythm where QT risk is present.
- Liver function and hepatitis B reactivation in at-risk patients.
- Bone growth and development in children.
Clinical pharmacology
Dasatinib inhibits BCR-ABL, SRC-family and several other oncogenic kinases. It is extensively metabolised, mainly through CYP3A4, is highly protein bound and is eliminated predominantly in faeces as metabolites.
Formulation and product differences
- Film-coated tablets must be swallowed whole and contain lactose.
- The powder is prepared as an oral suspension by a pharmacist or qualified healthcare professional and contains sucrose, benzoates, benzyl alcohol and sulphur dioxide.
- The suspension requires refrigeration after preparation, thorough shaking and measurement with the supplied oral syringe.
- Tablet and suspension exposure differs, so they must not be exchanged directly.
dasatinib monohydrate preparations and strengths
Oral suspension
Route: Oral
Strengths: 10 mg/mL
Tablet
Route: Oral
Strengths: 20 mg, 50 mg, 80 mg, 100 mg, 140 mg
dasatinib monohydrate interactions
A specialist or pharmacist should review all prescribed, over-the-counter and herbal products before treatment and whenever medicines change.
Strong CYP3A4 inhibitors, including itraconazole, clarithromycin and ritonavir
May increase dasatinib exposure and toxicity; co-administration is generally avoided or requires specialist management.
Strong CYP3A4 inducers, including rifampicin, carbamazepine, phenytoin and phenobarbital
May substantially reduce dasatinib exposure and treatment effect; alternatives are preferred.
St John's wort
May lower dasatinib exposure and should not be used without specialist approval.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.