Iclusig Dosage/Direction for Use

Recommended Dosage: 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, in the phase 2 trial, 68% 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 patients with chronic phase (CP) CML and accelerated phase (AP) CML who have achieved a major cytogenetic response.
Consider discontinuing Iclusig if response has not occurred by 3 months (90 days).
Dose Modifications for Myelosuppression: Suggested dose modifications for neutropenia (ANC* less than 1.0 x 10⁹/L) and thrombocytopenia (platelet less than 50 x 10⁹/L) that are unrelated to leukemia are summarized in Table 7. (See Table 7.)


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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.
Hepatotoxicity: Recommended modifications for hepatotoxicity are summarized in Table 8. (See Table 8.)


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Pancreatitis and Elevation of Lipase: Recommended modifications for pancreatic adverse reactions are summarized in Table 9. (See Table 9.)


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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 Interactions].
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 Special Populations under Precautions, and Pharmacology: Pharmacokinetic properties under Actions].
Paediatric population: The safety and efficacy of Iclusig in patients less than 18 years of age have not been established. No data are available.
Method of administration: Iclusig is for oral use. The tablets should be swallowed whole. Patients should not crush or dissolve the tablets. Iclusig may be taken with or without food.
Patients should be advised not to swallow the desiccant canister found in the bottle.