ponatinib hydrochloride: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
ponatinib hydrochloride: clinical details
Prescribing considerations
- Treatment should be initiated by a clinician experienced in diagnosing and treating leukaemia.
- Assess cardiovascular status and actively manage modifiable cardiovascular risk factors before treatment and throughout therapy.
- Consider alternatives carefully in patients with previous myocardial infarction, revascularisation or stroke.
- Use caution with hepatic impairment, severe renal impairment, pancreatitis or alcohol misuse, bleeding risk and older age.
- Test for hepatitis B before treatment and involve a liver specialist when serology is positive.
Contraindications and cautions
- Hypersensitivity to ponatinib or any formulation excipient.
- The tablets contain lactose and are unsuitable for specified rare hereditary disorders of galactose metabolism.
Monitoring
- Full blood count at baseline and regularly during treatment.
- Blood pressure and clinical evidence of cardiovascular, cerebrovascular, peripheral arterial or venous events.
- Serum lipase and symptoms of pancreatitis.
- Liver function before treatment and periodically thereafter.
- Disease response using appropriate haematological, cytogenetic or molecular assessments.
- Cardiac function where clinically indicated; arrange ophthalmic assessment for new blurred or reduced vision.
- Signs of hepatitis B reactivation in carriers during treatment and for several months afterwards.
Clinical pharmacology
Ponatinib is an oral pan-BCR-ABL inhibitor active against native and mutant ABL, including T315I. It is metabolised partly through CYP3A4, inhibits P-glycoprotein and BCRP in vitro, is highly protein-bound and is eliminated mainly in faeces.
Formulation and product differences
- The selected product is a white, round film-coated oral tablet containing lactose monohydrate.
- The tablet must be swallowed whole and should not be crushed or dissolved.
- Store it in the original light-protective bottle and leave the desiccant canister inside; the canister must not be swallowed.
ponatinib hydrochloride preparations and strengths
ponatinib hydrochloride interactions
The specialist team and pharmacist should review prescribed, non-prescribed and herbal products before and during treatment.
Strong CYP3A inhibitors, including clarithromycin, itraconazole, voriconazole and ritonavir
May increase ponatinib exposure and adverse effects, requiring specialist review.
Grapefruit products
May increase ponatinib exposure and should be avoided.
Strong CYP3A inducers, including rifampicin, carbamazepine, phenytoin and St John's wort
May reduce ponatinib exposure and effectiveness; alternatives should usually be sought.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.