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Iclusig
ponatinib
Black Box Warnings .
Arterial Occlusive Events
including fatal MI, stroke, intracranial large arterial vessel stenosis, severe PVD, and need for urgent revascularization procedures have occurred; seen in patients with and without cardiovascular risk factors, including patients <50 yo; monitor for signs/symptoms of arterial occlusion; interrupt or D/C tx based on severity; weigh risk/benefit prior to restarting tx
Venous Thromboembolic Events
have occurred; monitor for signs/symptoms of venous thromboembolism; interrupt or D/C tx based on severity
Heart Failure
including fatal cases have occurred; monitor for signs/symptoms of heart failure and manage as clinically indicated; interrupt or D/C tx for new or worsening heart failure
Hepatotoxicity
including liver failure and death have occurred; monitor LFTs; interrupt or D/C tx based on severity
Adult Dosing .
Dosage forms: TAB: 10 mg, 15 mg, 30 mg, 45 mg
Special Note
- [uses, dosing may vary]
- Info: refer to institution protocols and pkg insert prior to prescribing for uses and dosing including toxicity-related dose adjustments; D/C >1wk before elective surgery, restart >2wk after major surgery when wound fully healed
CML
- [chronic phase]
- Dose: 45 mg PO qd; Info: for patients with T315I-positive disease or for patients with disease resistant or intolerant to at least 2 kinase inhibitors; decr. dose to 15 mg PO qd if 1% or less BCR-ABL1 achieved; consider D/C tx if hematologic response not achieved by 3mo; do not cut/crush/chew tab
- [accelerated phase]
- Dose: 45 mg PO qd; Info: for patients with T315I-positive disease or for whom no other kinase inhibitors are indicated; consider decr. dose if major cytogenetic response achieved; consider D/C tx if response not achieved by 3mo; do not cut/crush/chew tab
- [blast phase]
- Dose: 45 mg PO qd; Info: for patients with T315I-positive disease or for whom no other kinase inhibitors are indicated; consider D/C tx if response not achieved by 3mo; do not cut/crush/chew tab
Ph-positive ALL
- [combo tx, newly diagnosed disease]
- Dose: 30 mg PO qd; Info: decr. dose to 15 mg PO qd if minimal residual disease-negative complete remission achieved at end of induction; give for up to 20 cycles with combo chemo; do not cut/crush/chew tab
- [monotherapy]
- Dose: 45 mg PO qd; Info: for patients with T315I-positive disease or for whom no other kinase inhibitors are indicated; consider D/C tx if response not achieved by 3mo; do not cut/crush/chew tab
renal dosing
- [not defined]
- CrCl >30: no adjustment; CrCl <30: not defined
- HD/PD: not defined
hepatic dosing
- [CML]
- Child-Pugh Class A, B or C: start 30 mg qd
- [Ph-positive ALL, combo tx]
- Child-Pugh Class A: no adjustment; Child-Pugh Class B or C: not defined, caution advised
- [Ph-positive ALL, monotherapy]
- Child-Pugh Class A, B or C: start 30 mg qd
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.