POTELIGEO (mogamulizumab-kpkc injection)

POTELIGEO (mogamulizumab-kpkc injection)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary Syndrome (SS) after at least one prior systmeic therapy.

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

Diagnosis of Mycosis Fungoides:

• The patient has relapse or refractory mycosis fungoides, AND
• Is prescribed by, or in consultation with, an oncologist or dermatologist, AND
• The patient has received at least one prior systemic therapy (e.g., extracorporeal photopheresis, oral retinoid [bexarotene, tretinoin capsules, isotretinoin, acitretin], Interferons [Intron-A®/Pegasys®, Actimmune®], HDAC inhibitors [Zolinza®, Istodax ®], methotrexate, Adcetris®, cyclophosphamide tablets or injection, or Folotyn®)

Diagnosis of Sézary Syndrome:

• The patient has relapsed or refractory Sézary Syndrome, AND
• Is prescribed by, or in consultation with, an oncologist or dermatologist, AND
• The patient has received at least one prior systemic therapy (e.g., extracorporeal photopheresis, oral retinoid [bexarotene, tretinoin capsules, isotretinoin, acitretin], Interferons [Intron-A®/Pegasys®, Actimmune®], HDAC inhibitors [Zolinza®, Istodax ®], methotrexate, Adcetris®, cyclophosphamide tablets or injection, or Folotyn®)

Dosing:

• The recommended dose of Poteligeo is 1 mg/kg administered as an intravenous (IV) infusion. It is administered on Days 1, 8, 15, and 22 of the first 28-day cycle, then on Days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity.

Approval:

• One year