Iclusig

Iclusig

ponatinib

Manufacturer:

Otsuka

Distributor:

Steward Cross
Concise Prescribing Info
Contents
Ponatinib
Indications/Uses
Adults w/ chronic, accelerated, or blast phase chronic myeloid leukaemia who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib & for whom subsequent treatment w/ imatinib is not clinically appropriate; or who have the T315I mutation. Adults w/ Philadelphia chromosome positive acute lymphoblastic leukaemia who are resistant to dasatinib; who are intolerant to dasatinib & for whom subsequent treatment w/ imatinib is not clinically appropriate; or who have the T315I mutation.
Dosage/Direction for Use
Adult Recommended starting dose: 45 mg once daily. Dose modifications may be required during treatment.
Administration
May be taken with or without food: Swallow whole, do not crush/dissolve.
Contraindications
Special Precautions
Risk of myelosuppression; perform complete blood count every 2 wk for the 1st 3 mth & then mthly or as clinically indicated. Dose-related risk of arterial occlusions; not to be used in patients w/ history of MI, prior revascularization or stroke; assess CV status prior to treatment & manage CV risk factors. Monitor for evidence of arterial occlusion & thromboembolism; perform ophth exam (ie, fundoscopy) if decreased or blurred vision occurs; interrupt treatment immediately in case of arterial occlusion or thromboembolism. Monitor BP during treatment; interrupt treatment in the event of significant, worsening, labile or treatment-resistant HTN, & evaluate for renal artery stenosis. May promote formation of aneurysms &/or artery dissections; carefully consider risk factors (eg, HTN or aneurysm history) before initiation. Fatal & serious heart failure or left ventricular dysfunction; patients should be monitored for signs or symptoms of heart failure. Discontinue treatment if serious heart failure develops. Risk of pancreatitis; check serum lipase every 2 wk for the 1st 2 mth & then periodically thereafter. Patients w/ history of pancreatitis or alcohol abuse; manage severe or very severe hypertriglyceridemia. Risk of hepatotoxicity; perform liver function tests prior to treatment initiation & monitor periodically. Interrupt treatment & evaluate patients for serious or severe haemorrhage. Reactivation of hepatitis B; test for HBV infection before initiating treatment. Closely monitor HBV carriers for signs & symptoms of active HBV infection throughout therapy & several mth following termination. Potential posterior reversible encephalopathy syndrome (PRES); interrupt treatment & resume treatment only once the event is resolved, or if the benefit of continued treatment outweighs the risk of PRES. QT interval prolongation. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ moderate & strong CYP3A inhibitors or inducers; anti-clotting agents. Minor influence on the ability to drive & use machines. Hepatic impairment. Renal impairment (CrCl <50 mL/min or end-stage renal disease). Use effective contraception during treatment. Pregnancy & 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 pain, arthralgia, myalgia, pain in extremity, back pain, 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; cerebrovascular accident, cerebral infarction, peripheral neuropathy, lethargy, migraine, hyperaesthesia, hypoaesthesia, paraesthesia, transient ischaemic attack; blurred vision, dry eye, periorbital oedema, eyelid oedema, conjunctivitis, visual impairment; cardiac failure, MI, congestive cardiac failure, CAD, angina pectoris, pericardial effusion, atrial fibrillation, decreased ejection fraction, acute coronary syndrome, atrial flutter; peripheral arterial occlusive disease, peripheral ischaemia, peripheral 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, blood alkaline phosphatase & γ-glutamyltransferase; pruritic rash, exfoliative rash, erythema, alopecia, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, skin pain, exfoliative dermatitis, hyperkeratosis, skin hyperpigmentation; musculoskeletal pain, neck pain, musculoskeletal chest pain; erectile dysfunction; chills, influenza like illness, non-cardiac chest pain, mass, face oedema.
Drug Interactions
May increase serum conc w/ strong CYP3A inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, grapefruit juice). May decrease serum conc w/ strong CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin, rifabutin, rifampicin, St. John's Wort). Potential to increase plasma 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
L01EA05 - ponatinib ; Belongs to the class of BCR-ABL tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Iclusig FC tab 15 mg
Packing/Price
30's
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