Iclusig Dosage
Generic name: ponatinib hydrochloride 15mg
Dosage form: tablet, film coated
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Recommended Dosing
The optimal dose of Iclusig has not been identified. In clinical trials, the starting dose of Iclusig was 45 mg administered orally once daily. However, 59% of the patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy.
Start dosing with 45 mg once daily. Consider reducing the dose of Iclusig for chronic phase (CP) CML and accelerated phase (AP) CML patients who have achieved a major cytogenetic response.
Consider discontinuing Iclusig if response has not occurred by 3 months (90 days).
Iclusig may be taken with or without food. Tablets should be swallowed whole.
Dose Modifications for Myelosuppression
Suggested dose modifications for neutropenia (ANC* less than 1.0 × 109/L) and thrombocytopenia (platelet less than 50 × 109/L) that are unrelated to leukemia are summarized in Table 1.
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| ANC* < 1 × 109/L or platelet < 50 × 109/L |
First occurrence:
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Second occurrence:
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Third occurrence:
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Dose Modifications for Non-Hematologic Adverse Reactions
If a serious non-hematologic adverse reaction occurs, modify the dose or interrupt treatment. Do not restart Iclusig in patients with arterial or venous occlusive reactions unless the potential benefit outweighs the risk of recurrent arterial or venous occlusions and the patient has no other treatment options. For serious reactions other than arterial or venous occlusion, do not restart Iclusig until the serious event has resolved or the potential benefit of resuming therapy is judged to outweigh the risk.
Hepatic Toxicity
Recommended modifications for hepatic toxicity are summarized in Table 2.
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| Elevation of liver transaminase > 3 × ULN* (Grade 2 or higher) | Occurrence at 45 mg:
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Occurrence at 30 mg:
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Occurrence at 15 mg:
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| Elevation of AST or ALT ≥ 3 × ULN concurrent with an elevation of bilirubin > 2 × ULN and alkaline phosphatase < 2 × ULN | Discontinue Iclusig |
Pancreatitis and Elevation of Lipase
Recommended modifications for pancreatic adverse reactions are summarized in Table 3.
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| Asymptomatic Grade 1 or 2 elevation of serum lipase | Consider interruption or dose reduction of Iclusig |
| Asymptomatic Grade 3 or 4 elevation of lipase (> 2 × ULN*) or asymptomatic radiologic pancreatitis (Grade 2 pancreatitis) | Occurrence at 45 mg:
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Occurrence at 30 mg:
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Occurrence at 15 mg:
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| Symptomatic Grade 3 pancreatitis | Occurrence at 45 mg:
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Occurrence at 30 mg:
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Occurrence at 15 mg:
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| Grade 4 pancreatitis | Discontinue Iclusig |
Dose Modification for Use With Strong CYP3A Inhibitors
The recommended dose should be reduced to 30 mg once daily when administering Iclusig with strong CYP3A inhibitors [see Drug Interactions (7.1)].
Dose Modification for Use in Patients with Hepatic Impairment
The recommended starting dose is 30 mg once daily in patients with hepatic impairment (Child-Pugh A, B, or C) [see Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)].
