Concise Prescribing Info
Adult patients suffering from Philadelphia-positive (Ph+) chronic myeloid leukaemia (CP, AP or BP) or Ph+ acute lymphoblastic leukaemia for whom treatment w/ other c-abl tyrosine kinase inhibitors is inappropriate; T315I-positive Ph+ chronic myeloid leukaemia (CP, AP or BP) or T315I-positive Ph+ acute lymphoblastic leukaemia.
Dosage/Direction for Use
Initially 45 mg once daily. Dose modifications may be required during treatment.
May be taken with or without food: Swallow whole, do not crush/dissolve.
Special Precautions
Assess CV status prior to treatment & manage CV risk factors. Not to be used in patients w/ history of MI, prior revascularization or stroke. Interrupt use if myelosuppression, arterial occlusion, venous thromboembolism, serious heart failure, medically uncontrolled HTN, severe haemorrhage, lipase elevations w/ abdominal symptoms or posterior reversible encephalopathy syndrome develops. Monitor for arterial occlusion & thromboembolism evidence; signs or symptoms consistent w/ heart failure. Perform ophth exam including fundoscopy if decreased or blurred vision occurs. Perform complete blood count every 2 wk for 1st 3 mth & then mthly or as clinically indicated. Monitor BP during treatment. Interrupt treatment & evaluate for renal artery stenosis in case of significant worsening, labile or treatment-resistant HTN. Urgent clinical intervention may be required for HTN associated w/ confusion, headache, chest pain or SOB. Check serum lipase every 2 wk for 1st 2 mth & then periodically thereafter. Patients w/ history of pancreatitis or alcohol abuse; severe or very severe hypertriglyceridemia. Perform liver function tests prior to initiation & monitor periodically. HBV reactivation. Test for HBV infection prior to initiation. Closely monitor HBV carriers for signs & symptoms of active HBV infection throughout therapy & several mth following termination. QT interval prolongation. Concomitant use w/ moderate & strong CYP3A inhibitors & inducers; anti-clotting agents. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive & use machines. Hepatic & renal impairment. Fertility, pregnancy. Discontinue use during lactation. Elderly.
Adverse Reactions
Upper resp tract infection; anaemia, decreased platelet & neutrophil count; decreased appetite; insomnia; headache, dizziness; HTN; dyspnoea, cough; abdominal pain, diarrhoea, vomiting, constipation, nausea, increased lipase; increased ALT & AST; rash, dry skin, pruritus; bone & back pain, arthralgia, myalgia, pain in extremity, muscle spasms; fatigue, asthenia, peripheral oedema, pyrexia, pain.
Drug Interactions
Increased serum conc w/ strong CYP3A inhibitors eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit juice. Decreased serum conc w/ strong CYP3A4 inducers eg, carbamazepine, phenobarb, phenytoin, rifabutin, rifampicin, St. John's wort. Altered serum conc of P-gp substrates eg, digoxin, dabigatran, colchicine, pravastatin or BCRP substrates eg, methotrexate, rosuvastatin, sulfasalazine. Caution w/ anti-clotting agents in patients at risk of bleeding events.
ATC Classification
L01XE24 - ponatinib ; Belongs to the class of protein kinase inhibitors, other antineoplastic agents. Used in the treatment of cancer.
Iclusig FC tab 15 mg
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