Otsuka (Philippines)
Concise Prescribing Info
Ponatinib HCl
Adult w/ chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) resistant to dasatinib or nilotinib; patients intolerant to dasatinib or nilotinib & for subsequent treatment w/ imatinib that is not clinically appropriate; or patients w/ T315I mutation; Philadelphia chromosome +ve acute lymphoblastic leukaemia (Ph+ ALL) that is resistant to dasatinib; patients intolerant to dasatinib & for subsequent treatment w/ imatinib that is not clinically appropriate; or patients w/ T315I mutation.
Dosage/Direction for Use
Recommended starting dose: 45 mg once daily.
May be taken with or without food: Swallow whole, do not crush/dissolve. Avoid grapefruit juice.
Special Precautions
Myelosuppression; arterial occlusions, including fatal MI, stroke, retinal arterial occlusions associated w/ permanent visual impairment or vision loss, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, renal artery stenosis (associated w/ worsening, labile or treatment-resistant HTN) & the need for urgent revascularization procedures; venous thromboembolism; HTN; aneurysm & artery dissections; CHF; pancreatitis; hepatoxicity; haemorrhage; hepatitis B reactivation; posterior reversible encephalopathy syndrome; risk of bleeding w/ anti-clotting agents; QT prolongation; galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Hepatic or renal impairment. May affect ability to drive or operate machines. Women of child breading potential/contraception in male/female. Pregnancy & lactation. Childn.
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.
Drug Interactions
Increased serum conc w/ strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole, & grapefruit juice). Decrease serum conc w/ strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenobarb, phenytoin, rifabutin, rifampicin, & St. John's Wort). May increase plasma conc of co-administered substrates of P-gp (eg, digoxin, dabigatran, colchicine, pravastatin) or BCRP (eg, methotrexate, rosuvastatin, sulfasalazine).
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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