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Ponatinib Hydrochloride

Tyrosine Kinase Inhibitor Prescription
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Indications

Chronic Myeloid Leukemia (CML): Ponatinib Hydrochloride is used in adults with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML). It is meant for people who are resistant to dasatinib or nilotinib, or who can't tolerate dasatinib or nilotinib and for whom treatment with imatinib afterwards is not clinically appropriate. It is also used in people who have the T315I mutation. Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL): Ponatinib Hydrochloride is also used in adults with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL). Here it is meant for people who are resistant to dasatinib, or who can't tolerate dasatinib and for whom treatment with imatinib afterwards is not clinically appropriate. It is also used in people who have the T315I mutation.

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

Ponatinib is a kinase inhibitor. In laboratory tests, it blocked the tyrosine kinase activity of ABL and of T315I mutant ABL, with IC 50 concentrations of 0.4 nM and 2.0 nM, respectively. It also blocked the in vitro activity of other kinases, with IC 50 concentrations between 0.1 nM and 20 nM. These include members of the VEGFR, PDGFR, FGFR, EPH receptors and SRC families of kinases, and KIT, RET, TIE2 and FLT3.

Ponatinib reduced the in vitro viability of cells expressing native or mutant BCR-ABL, including T315I. In mice, treatment with ponatinib made tumors expressing native or T315I mutant BCR-ABL smaller than those in the control animals.

Pregnancy & Breastfeeding

Pregnancy: There aren't enough data on the use of ponatinib in pregnant women. Animal studies have shown reproductive toxicity, but the possible risk for humans isn't known. Ponatinib should be used during pregnancy only when clearly necessary. If a patient does take it while pregnant, she must be told about the possible risk to the foetus.

Breast-feeding: Nobody knows whether ponatinib passes into human milk. The pharmacodynamic and toxicological data available can't rule out that it does. Breast-feeding should be stopped during treatment with ponatinib.

Fertility: There are no human data on how ponatinib affects fertility. In rats, treatment with ponatinib affected female fertility, while male fertility was not affected. Whether these findings matter for human fertility is unknown.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: Ponatinib treatment should be started by a physician experienced in diagnosing and treating patients with leukemia. Haematologic support, such as platelet transfusion and haematopoietic growth factors, can be used during treatment if clinically indicated. Before starting ponatinib, the patient's cardiovascular status should be assessed, including history and physical examination, and cardiovascular risk factors should be actively managed. Cardiovascular status should keep being monitored during treatment, and medical and supportive therapy for conditions that add to cardiovascular risk should be optimised. Recommended dosage: The recommended starting dose is 45 mg of ponatinib once daily. Treatment should continue as long as the patient shows no evidence of disease progression or unacceptable toxicity. Stopping ponatinib should be considered if a complete haematologic response has not occurred by 3 months (90 days). The risk of arterial occlusive events is likely to be dose-related. For CP-CML patients who have achieved a major cytogenetic response, reducing the dose of ponatinib to 15 mg should be considered. The individual assessment should take these factors into account: cardiovascular risk, side effects of ponatinib therapy, time to cytogenetic response, and BCR-ABL transcript levels. If the dose is reduced, close monitoring of response is recommended. Elderly patients: Of the 449 patients in the clinical study of ponatinib, 155 (35%) were >65 years of age. Older patients are more likely than patients < 65 years to experience adverse reactions. Hepatic impairment: Patients with hepatic impairment may receive the recommended starting dose. Caution is recommended when giving Ponatinib to patients with hepatic impairment. Renal impairment: Renal excretion is not a major route of ponatinib elimination, and ponatinib has not been studied in patients with renal impairment. Patients with estimated creatinine clearance of > 50 mL/min should be able to receive ponatinib safely with no dosage adjustment. Caution is recommended when giving ponatinib to patients with estimated creatinine clearance of < 50 mL/min, or end-stage renal disease. Paediatric population: The safety and efficacy of ponatinib in patients less than 18 years of age have not been established. No data are available.

Side Effects & Interactions

Side Effects

No side-effect data recorded yet.