ICLUSIG (ponatinib) offers convenient dosing in a single oral tablet1

Available in 45 mg, 30 mg, 15 mg, and 10 mg dosage strengths1

ICLUSIG is a single tablet taken orally once daily1

  • Can be taken with or without food
  • Tablets should be swallowed whole. Do not crush, break, cut, or chew tablets
  • If a dose is missed, take the next dose at the regularly scheduled time the next day
ICLUSIG (ponatinib) is available in 45mg, 30mg, 15mg, and 10mg tablets.

ICLUSIG is available in multiple dosage strengths. Each dosage strength is available as a single oral tablet.1

Dosing strategy as monotherapy in AP-CML, BP-CML, and Ph+ ALL1 

  • Optimal dose of ICLUSIG has not been identified 
  • Recommended starting dosage is 45 mg orally once daily  
  • Consider reducing dosage for patients with AP-CML who have achieved a major cytogenetic response  
  • Continue treatment with ICLUSIG until loss of response or unacceptable toxicity 
  • Consider discontinuing ICLUSIG if response has not occurred by 3 months

Guidance for dose modifications

ICLUSIG (ponatinib) dose modifications
Recommended Dose Modifications for ICLUSIG for Adverse Reactions1
Recommended ICLUSIG dosing modifications for specific adverse reactions.

Based on CTCAE v5.0: Grade 1 mild, Grade 2 moderate, Grade 3 severe, Grade 4 life-threatening

ICLUSIG (ponatinib) dose reductions
Recommended Dose Reductions for ICLUSIG for Adverse Reactions1
Recommended ICLUSIG dose reductions for patients with CP-CML, AP-CML, BP-CML, resistant or intolerant Ph+ ALL, or newly diagnosed Ph+ ALL.
ICLUSIG (ponatinib) dosage with strong CYP3A inhibitors
Recommended ICLUSIG Dosage for Coadministration of Strong CYP3A Inhibitors1
Dose reduction for ICLUSIG patients with a strong CYP3A inhibitor.

Dosing for patients with hepatic impairment

For patients with CP-CML, AP-CML, BP-CML, and Ph+ ALL receiving monotherapy, reduce the starting dose of ICLUSIG from 45 mg orally once daily to 30 mg orally once daily in patients with pre-existing hepatic impairment (Child-Pugh A, B, or C).

For patients with newly diagnosed Ph+ ALL, no dosage adjustment is recommended when administering ICLUSIG to patients with mild hepatic impairment (Child-Pugh A). Closely monitor patients with moderate or severe hepatic impairment (Child-Pugh B or C) and modify the ICLUSIG dosage in the event of adverse reactions.

CP-CML

OPTIMIZE BENEFIT:RISK THROUGH INNOVATIVE DOSING APPROACH

CP-CML response-based dosing

Newly Diagnosed Ph+ ALL

EXPLORE DOSE REDUCTIONS OF ICLUSIG WITH CHEMOTHERAPY

1L Ph+ ALL response-based dosing

ALT=alanine transaminase; ANC=absolute neutrophil count; AOE=arterial occlusive events; AP-CML=accelerated-phase chronic myeloid leukemia; AST=aspartate aminotransferase; BP-CML=blast-phase chronic myeloid leukemia; CP-CML=chronic-phase chronic myeloid leukemia; CTCAE=Common Terminology Criteria for Adverse Events; Ph+ ALL=Philadelphia chromosome-positive acute lymphoblastic leukemia; ULN=upper limit of normal; VTE=venous thromboembolic events.

IMPORTANT SAFETY INFORMATION, INDICATION, AND USAGE

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