ICLUSIG (ponatinib)

ICLUSIG (ponatinib)

SELF ADMINISTRATION - ORAL

Indications for Prior Authorization:

• Treatment of adult patients with chronic, accelerated, or blast phase chronic myeloid leukemia (CML)
• Treatment of adult patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)

Patients must meet the following criteria for the indication(s) above:

• Patient is resistant or intolerant to prior tyrosine kinase inhibitor therapy
  • CML: Gleevec, Sprycel, Tasigna and Bosulif
  • Ph+ ALL: Gleevec and Sprycel
• For ALL, patients must undergo genetic testing to confirm Ph+ status
• Patient must not be pregnant or planning on becoming pregnant

The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P & T Committee:

• All non-FDA approved uses not listed in the approved indications

Dosing:

• 45 mg orally once a day

Box warnings: 

• For arterial/venous thrombosis, hepatotoxicity, congestive heart failure, pancreatitis, cardiac arrhythmias and myelosuppression

Approval:

One year or until disease progression or intolerable side effects