Concise Prescribing Info
Adult patients suffering from Philadelphia +ve (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 +ve Ph+ chronic myeloid leukaemia (CP, AP or BP) or T315I +ve 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, VTE, 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 CBC 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. Consider risk of formation of aneurysms &/or artery dissections before initiating Iclusig in patients w/ risk factors eg, HTN or history of aneurysms. Check serum lipase every 2 wk for 1st 2 mth & then periodically thereafter. Patients w/ history of pancreatitis or alcohol abuse; manage severe or very severe hypertriglyceridemia. Perform LFTs 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 (CrCl <50 mL/min), ESRD. Women & men of childbearing potential should use effective contraception. Pregnancy. Discontinue use during lactation. Elderly.
Adverse Reactions
URTI; anaemia, decreased platelet & neutrophil counts; 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. Pneumonia, sepsis, folliculitis, cellulitis; pancytopenia, febrile neutropenia, decreased WBC & lymphocyte count; hypothyroidism; dehydration, fluid retention, hypocalcaemia, hyperglycaemia, hyperuricaemia, hypophosphataemia, hypertriglyceridaemia, hypokalaemia, decreased wt, hyponatraemia; CVA, cerebral infarction, peripheral neuropathy, lethargy, migraine, hyper- & hypoaesthesia, paraesthesia, transient ischaemic attack; blurred vision, dry eye, periorbital & eyelid oedema, conjunctivitis, visual impairment; cardiac & congestive cardiac failure, MI, CAD, angina pectoris, pericardial effusion, atrial fibrillation, decreased ejection fraction, acute coronary syndrome, atrial flutter; peripheral arterial occlusive disease, ischaemia & artery stenosis, intermittent claudication, DVT, hot flush, flushing; pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary HTN; pancreatitis, increased blood amylase, GERD, stomatitis, dyspepsia, abdominal distension & discomfort, dry mouth, gastric haemorrhage; increased blood bilirubin & alkaline phosphatase, γ-glutamyltransferase; pruritic & exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, skin pain & hyperpigmentation, exfoliative dermatitis, hyperkeratosis; musculoskeletal, neck & musculoskeletal chest pain; erectile dysfunction; chills, flu-like illness, non-cardiac chest pain, mass, face oedema.
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, MTX, rosuvastatin, sulfasalazine. Caution w/ anti-clotting agents in patients at risk of bleeding events.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EA05 - ponatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Iclusig FC tab 15 mg
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