Iclusig

Iclusig Manufacturers

• Ariad Pharmaceuticals, Inc.
  

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  Iclusig | Ariad Pharmaceuticals, Inc.

  

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  2.1 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.

  2.2 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.

  Table 1: Suggested Dose Modifications for Myelosuppression * ANC = absolute neutrophil count ANC* < 1 × 109/L
  or
  platelet < 50 × 109/L First occurrence: Interrupt Iclusig and resume initial 45 mg dose after recovery to ANC ≥ 1.5 × 109/L and platelet ≥ 75 × 109/L Second occurrence: Interrupt Iclusig and resume at 30 mg after recovery to ANC ≥ 1.5 × 109/L and platelet ≥ 75 × 109/L Third occurrence: Interrupt Iclusig and resume at 15 mg after recovery to ANC ≥ 1.5 × 109/L and platelet ≥ 75 × 109/L 2.3 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.

  Table 2: Recommended Dose Modifications for Hepatic Toxicity * ULN = Upper Limit of Normal for the lab Elevation of liver transaminase > 3 × ULN* (Grade 2 or higher) Occurrence at 45 mg: Interrupt Iclusig and monitor hepatic function Resume Iclusig at 30 mg after recovery to ≤ Grade 1 (< 3 × ULN) Occurrence at 30 mg: Interrupt Iclusig and resume at 15 mg after recovery to ≤ Grade 1 Occurrence at 15 mg: Discontinue Iclusig
  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.

  Table 3: Recommended Dose Modifications for Pancreatitis and Elevation of Lipase * ULN = Upper Limit of Normal for the lab 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: Interrupt Iclusig and resume at 30 mg after recovery to ≤ Grade 1 (< 1.5 × ULN) Occurrence at 30 mg: Interrupt Iclusig and resume at 15 mg after recovery to ≤ Grade 1 Occurrence at 15 mg: Discontinue Iclusig Symptomatic Grade 3 pancreatitis Occurrence at 45 mg: Interrupt Iclusig and resume at 30 mg complete resolution of symptoms and after recovery of lipase elevation to ≤ Grade 1 Occurrence at 30 mg: Interrupt Iclusig and resume at 15 mg after complete resolution of symptoms and after recovery of lipase elevation to ≤ Grade 1 Occurrence at 15 mg: Discontinue Iclusig Grade 4 pancreatitis Discontinue Iclusig 2.4 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)].

  2.5 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)].

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