৳ 1,937.60/unit
Pack: ৳ 58,128
৳ 1,937.60/unit
Pack: ৳ 58,128
At a glance
Ponatinib Hydrochloride is a kinase inhibitor used for the treatment of chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), particularly in patients resistant or intolerant to dasatinib or nilotinib, and those with the T315I mutation.
Indications
- Chronic Myeloid Leukemia (CML) - chronic, accelerated, or blast phase (dasatinib/nilotinib-resistant or intolerant, or T315I mutation)
- Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) - dasatinib-resistant or intolerant, or T315I mutation
Pharmacology
Ponatinib inhibits the tyrosine kinase activity of ABL and T315I mutant ABL. It also inhibits additional kinases including VEGFR, PDGFR, FGFR, EPH receptors, SRC family, KIT, RET, TIE2, and FLT3. It inhibits in vitro viability of cells expressing native or mutant BCR-ABL and reduces tumor size in animal models.
Dosage
Adult Dose (Oral):
- Recommended starting dose: 45 mg once daily
- CP-CML patients with major cytogenetic response: Consider dose reduction to 15 mg
- With strong CYP3A inhibitors: Consider starting dose 30 mg
- Renal impairment (CrCl >50 mL/min): No dose adjustment; CrCl <50 mL/min or ESRD: Caution
- Hepatic impairment: Caution
Side effects
Serious Adverse Reactions (>2%):
- Pneumonia
- Pancreatitis
- Abdominal pain
- Atrial fibrillation
- Pyrexia
- Myocardial infarction
- Peripheral arterial occlusive disease
- Anemia
- Angina pectoris
- Decreased platelets
- Febrile neutropenia
- Hypertension
- Coronary artery disease
- Congestive heart failure
- Cerebrovascular accident
- Sepsis
- Cellulitis
- Acute kidney injury
- Urinary tract infection
- Increased lipase
Use in pregnancy
Use in Pregnancy: No adequate data in pregnant women; use only when clearly necessary; inform of potential risk to the fetus.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Precautions & warnings
- Myelosuppression: Thrombocytopenia, neutropenia, anemia; CBC every 2 weeks for first 3 months, then monthly
- Arterial occlusion (myocardial infarction, stroke, retinal arterial occlusion): Manage cardiovascular risk; interrupt if occurs
- Venous thromboembolism: Monitor; interrupt if thromboembolism occurs
- Hypertension: Monitor and manage blood pressure at each clinic visit
- Congestive heart failure: Monitor for symptoms; consider discontinuation if serious
- Hepatotoxicity: Monitor liver function tests
- Severe hemorrhage: Interrupt and evaluate
- Hepatitis B reactivation: Test before initiating treatment
Overdose effects
Overdose (up to 540 mg reported): QT prolongation, fatigue, pneumonia, sepsis; treatment: stop ponatinib, observe, supportive care.
Storage conditions
Store in a cool and dry place below 30°C; do not use if exposed to temperatures >40°C; keep out of reach of children.