Adult: In patients with T315I mutation; who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate: Initially, 45 mg once daily. Continue treatment until disease progression or unacceptable toxicity occurs. May reduce dose in patients with chronic or accelerated phase who have achieved a major cytogenetic response. Discontinue treatment if a complete haematologic response has not occurred by 3 months. Dose reduction, interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).
Oral Philadelphia chromosome-positive acute lymphoblastic leukaemia
Adult: In patients with T315I mutation; who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate: Initially, 45 mg once daily. Continue treatment until disease progression or unacceptable toxicity occurs. Discontinue treatment if a complete haematologic response has not occurred by 3 months. Dose reduction, interruption, or discontinuation may be required according to individual safety or tolerability (refer to detailed product guidelines).
What are the brands available for Ponatinib in Malaysia?
Iclusig
Special Patient Group
Patients taking strong CYP3A inhibitors (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone): Reduce initial dose to 30 mg once daily.
Administration
Ponatinib May be taken with or without food. Swallow whole. Do not crush/dissolve tab.
Special Precautions
Patient with hypertension, CV risk factors; history of ischaemia, diabetes, hyperlipidaemia, aneurysm, pancreatitis or alcohol abuse; severe or very severe hypertriglyceridaemia, positive hepatitis B serology (including those with active disease). Avoid in patients with a history of MI, prior revascularisation or stroke. Patient undergoing surgery. Renal (CrCl <50 mL/min or ESRD) and hepatic impairment. Elderly. Pregnancy. Discontinue breastfeeding during therapy. Concomitant use with strong CYP3A inhibitors.
Adverse Reactions
Significant: Cardiac arrhythmias (e.g. atrial fibrillation, atrial flutter, AV block, bradyarrhythmia, bradycardia, QT interval prolongation); bone marrow suppression (e.g. neutropenia, thrombocytopenia, anaemia); gastrointestinal perforation or fistula; peripheral neuropathy (e.g. hypoaesthesia, muscular weakness, paraesthesia, peripheral sensory neuropathy); serious or severe ocular events leading to blindness and blurred vision; eye pain, dry eye; severe pancreatitis; serious or severe hypertension (e.g. hypertensive crisis); posterior reversible encephalopathy syndrome; venous thromboembolism (e.g. DVT, pulmonary embolism, retinal venous occlusions); wound healing impairment; risk for formation of aneurysms and/or artery dissection. Rarely, serious tumour lysis syndrome, hyperuricaemia. Blood and lymphatic system disorders: Pancytopenia. Cardiac disorders: Angina pectoris. Endocrine disorders: Hypothyroidism. Eye disorders: Periorbital oedema, eyelid oedema, conjunctivitis. Gastrointestinal disorders: Abdominal pain, diarrhoea, vomiting, constipation, nausea, GERD, stomatitis, abdominal distention or discomfort, dyspepsia, dry mouth. General disorders and administration site conditions: Fatigue, asthenia, pyrexia, pain, chills, influenza-like illness. Infections and infestations: Sepsis. Investigations: Increased lipase or amylase; decreased weight. Metabolism and nutrition disorders: Decreased appetite, dehydration, hypocalcaemia, hyperglycaemia, hypophosphataemia, hypokalaemia, hyponatraemia. Musculoskeletal and connective tissue disorders: Bone pain, myalgia, arthralgia, back pain, pain in extremity, muscle spasms, musculoskeletal pain, musculoskeletal chest pain, neck pain. Nervous system disorders: Headache, dizziness, lethargy, migraine. Psychiatric disorders: Insomnia. Reproductive system and breast disorders: Erectile dysfunction. Respiratory, thoracic and mediastinal disorders: URTI, pneumonia, dyspnoea, cough, epistaxis, dysphonia, pulmonary hypertension. Skin and subcutaneous tissue disorders: Folliculitis, cellulitis, rash, dry skin, pruritus, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, exfoliative dermatitis, pain of skin, skin hyperpigmentation, hyperkeratosis. Vascular disorders: Intermittent claudication, hot flush, flushing. Potentially Fatal: Arterial occlusive events (e.g. MI, stroke, retinal arterial occlusions, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis, need for urgent revascularisation procedures), including CV, cerebrovascular and peripheral arterial occlusive events; serious fluid retention (e.g. peripheral oedema, pleural effusion, pericardial effusions, angioedema, brain oedema); serious heart failure or left ventricular dysfunction, serious haemorrhagic events (e.g. intracranial haemorrhage, subdural haematoma, gastrointestinal haemorrhages); hepatotoxicity (e.g. increased ALT, AST, bilirubin or GGT), liver failure; hepatitis B reactivation.
Patient Counseling Information
This drug may cause dizziness, lethargy or blurred vision, if affected, do not drive or operate machinery. Women of childbearing potential and men with partners who could become pregnant must use proven birth control methods during therapy. Discontinue breastfeeding during therapy.
Monitoring Parameters
Evaluate pregnancy status before treatment. Assess CV status (including history and physical examination, screening for CV disease risk factors) before and regularly during treatment. Perform hepatitis B virus screening before treatment initiation. Monitor CBC with differential and platelets (during therapy); LFTs (at baseline and monthly thereafter or as clinically indicated); serum lipase, serum electrolytes and uric acid. Obtain ECG and blood pressure at baseline and as clinically indicated. Assess for signs and symptoms of arterial occlusive events, venous thromboembolic events, haemorrhage, arrhythmias, heart failure, fluid retention, pancreatitis, gastrointestinal perforation or fistula, hepatotoxicity, peripheral and cranial neuropathy, posterior reversible encephalopathy syndrome and tumour lysis syndrome. Perform ocular exam before and periodically during treatment.
Increased serum concentrations with strong CYP3A inhibitors (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone). Decreased serum concentrations with strong CYP3A inducers (e.g. carbamazepine, rifampicin, phenobarbital). May increase serum concentration of P-gp substrates (e.g. digoxin, dabigatran, colchicine, pravastatin) and BCRP substrates (e.g. methotrexate, rosuvastatin, sulfasalazine).
Food Interaction
Increased serum concentrations with grapefruit juice. Decreased serum concentrations with St. John's wort.
Action
Description: Overview: Ponatinib, an antineoplastic agent, is a potent pan-breakpoint cluster region-abelson (BCR-ABL) tyrosine kinase inhibitor. Mechanism of Action: Ponatinib blocks cells expressing native or mutant BCR-ABL, including T315I. Additionally, ponatinib inhibits multiple tyrosine kinases, including vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptor (PDGFR), Eph receptors, Src family of tyrosine kinases, stem cell factor receptor (c-KIT), ret proto-oncogene (RET), tyrosine kinase with immunoglobulin and epidermal growth factor homology (TIE2), and fms-like tyrosine kinase (FLT3). Pharmacodynamics: Ponatinib has shown that increased age and history of ischaemia, hypertension, diabetes or hypercholesterolaemia are factors that contribute to a higher incidence of arterial occlusive events (AOEs). Additionally, a relationship between higher ponatinib exposures and higher incidence of adverse reactions (including AOEs) is observed. Pharmacokinetics: Absorption: Time to peak plasma concentration: Within 6 hours. Distribution: Volume of distribution: 1,233 L. Plasma protein binding: >99%. Metabolism: Metabolised in the liver by CYP3A4 and to a lesser extent by CYP3A5, CYP2C8 and CYP2D6. Additionally, it is metabolised by esterases and/or amidases. Excretion: Mainly via faeces (approx 87%); urine (approx 5%). Elimination half-life: Approx 24 hours.
Chemical Structure
Ponatinib Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 24826799, Ponatinib. https://pubchem.ncbi.nlm.nih.gov/compound/Ponatinib. Accessed Oct. 28, 2025.
L01EA05 - ponatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
References
Brayfield A, Cadart C (eds). Ponatinib. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/10/2025.Iclusig 15 mg and 45 mg Film-coated Tablets (Steward Cross Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 08/10/2025.Iclusig Tablet, Film Coated (Takeda Pharmaceuticals America, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 08/10/2025.Joint Formulary Committee. Ponatinib. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 08/10/2025.Ponatinib Hydrochloride. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/10/2025.Ponatinib Incyte 45 mg Film-coated Tablets (Incyte Biosciences UK Ltd). MHRA. https://products.mhra.gov.uk. Accessed 08/10/2025.Ponatinib. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 23/10/2025.Ponatinib. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 08/10/2025.
Sign Out
Continue with Google