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Iclusig

Iclusig

ponatinib

Manufacturer:

Otsuka
Concise Prescribing Info
Contents
Ponatinib
Indications/Uses
Adults w/ chronic, accelerated phase chronic myeloid leukaemia (CML) who are resistant or intolerant to dasatinib or nilotinib; or who have T315I positive CML.
Dosage/Direction for Use
Initially 45 mg once daily. Reduction of dose to 30 or 15 mg once daily may be required during treatment. Patient w/ hepatic impairment (Child-Pugh A, B, or C); concomitantly used w/ strong CYP3A inhibitors 30 mg once daily.
Administration
May be taken with or without food: Swallow whole, do not crush/dissolve.
Contraindications
Special Precautions
Not indicated & not recommended for the treatment of patients w/ newly diagnosed chronic phase CML. Risk of myelosuppression; venous thromboembolism; treatment-emergent HTN; fatal & serious heart failure or left ventricular dysfunction; pancreatitis; hepatotoxicity; severe haemorrhage; reactivation of hepatitis B. 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 & manage BP during treatment. Interrupt treatment in the event of significant worsening, labile or treatment-resistant HTN, & consider evaluation for renal artery stenosis. Monitor patients for signs or symptoms of heart failure. Discontinue treatment if serious heart failure develops. 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. Elevation in ALT, AST, bilirubin & alkaline phosphatase. Perform liver function tests prior to treatment initiation & monitor periodically. Interrupt treatment & evaluate patients for serious or severe haemorrhage. Test for HBV infection before initiating treatment. Closely monitor HBV carriers for signs & symptoms of active HBV infection throughout therapy & several mth following termination. Concurrent use w/ moderate & strong CYP3A inhibitors & inducers. Concomitant use w/ anti-clotting agents in patients who may be at risk of bleeding events. QT interval prolongation. Patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Patients w/ hepatic & renal impairment (CrCl <50 mL/min or end-stage renal disease). Use effective method of contraception during treatment. Pregnancy. Discontinue breast-feeding during treatment. Childn <18 yr.
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; 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; metabolism & nutrition disorders; nervous system disorders; blurred vision, dry eye, periorbital oedema, eyelid oedema, conjunctivitis; cardiac disorders; vascular disorders; pulmonary embolism, pleural effusion, epistaxis, dysphonia, pulmonary HTN; GI disorders; increased blood bilirubin, blood alkaline phosphatase & γ-glutamyltransferase; skin & subcutaneous tissue disorders; 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).
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
1 × 30's
Form
Iclusig FC tab 45 mg
Packing/Price
1 × 30's
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