Ponatinib Dosage

Usual Adult Dose for Chronic Myelogenous Leukemia

45 mg orally once daily

Comments:
-Ponatinib may be taken with or without food and tablets should be swallowed whole.
-59% of patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy.
-Consider reducing the dose for CP CML and AP CML patients who have achieved a major cytogenetic response.
-Consider discontinuing therapy if response has not occurred by 3 months (90 days).

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

DOSE MODIFICATIONS FOR HEPATIC TOXICITY:
Elevation of liver transaminase greater than 3 times ULN (Grade 2 or higher):
-Interrupt ponatinib and monitor hepatic function. After recovery to less than or equal to Grade 1 (less than or equal to 3 times ULN), resume at a dose 15 mg below previous dose (if previous dose was 15 mg, then discontinue).

Elevation of AST or ALT of greater than or equal to 3 times ULN concurrent with an elevation of bilirubin greater than 2 times ULN and alkaline phosphatase less than 2 time ULN:
-Discontinue ponatinib

DOSE MODIFICATIONS FOR PANCREATITIS AND ELEVATION OF LIPASE:
Asymptomatic Grade 1 or 2 elevation of serum lipase:
-Consider interruption or dose reduction.

Asymptomatic Grade 3 or 4 elevation of lipase (greater than 2 times ULN) or asymptomatic radiologic pancreatitis (Grade 2 pancreatitis):
-Interrupt ponatinib. After recovery to less than or equal to Grade 1 (less than 1.5 times ULN), resume at a dose 15 mg below previous dose (if previous dose was 15 mg, then discontinue).

Symptomatic Grade 3 pancreatitis:
-Interrupt ponatinib. After complete resolution of symptoms and recovery of lipase elevation to less than or equal to Grade 1, resume ponatinib at a dose 15 mg below previous dose (if previous dose was 15 mg, then discontinue).

Grade 4 pancreatitis:
-Discontinue ponatinib.

DOSE MODIFICATION FOR USE WITH STRONG CYP450 3A INHIBITORS:
-Reduce dose to 30 mg once daily.

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available