Ongoing benefit-risk assessment:

Managing your patients at an appropriate dose.

INDUCE	REDUCE	MAINTAIN
Initiate treatment with the recommended starting dose of 45 mg* 45 mg	Consider dose reduction for CP-CML and AP-CML patients who achieve MCyR and for the management of adverse reactions 30 mg 15 mg	Continue to actively monitor patients for response, and signs of adverse reactions, and continue to treat at an appropriate dose

INDUCE

REDUCE

MAINTAIN

Initiate treatment with the recommended starting dose of 45 mg*

Consider dose reduction for CP-CML and AP-CML patients who achieve MCyR and for the management of adverse reactions

Continue to actively monitor patients for response, and signs of adverse reactions, and continue to treat at an appropriate dose

Start at 30 mg once daily when administering ICLUSIG with strong CYP3A inhibitors and in patients with hepatic impairment (Child-Pugh A, B, or C).
Consider discontinuing ICLUSIG if response has not occurred within 90 days.
There are specific dosing modifications for myelosuppression, non-hematologic adverse reactions (hepatic toxicity, pancreatitis, and elevation of lipase), for use of ICLUSIG with strong CYP3A inhibitors, and for use in patients with hepatic impairment.
Consider the dose intensity-safety relationship when assessing the benefit-risk profile of ICLUSIG patients.

In the PACE trial, significant increases in grade ≥ 3 adverse reactions (hypertension, thrombocytopenia, pancreatitis, neutropenia, rash, ALT increase, AST increase, lipase increase, myelosuppression) corresponded with increases in the dose range of 15 to 45 mg once daily.