GAMIFANT (emapalumab-izsg)

GAMIFANT (emapalumab-izsg)

OFFICE ADMINISTRATION

Indication for Prior Authorization:

• Indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent, or progressive disease or intolerance with conventional HLH therapy

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

• Diagnosis of primary HLH as confirmed by chart note documentation, AND
• Prescribed by or in consultation with a hematologist, oncologist, immunologist, transplant specialist, or physician who specializes in HLH or related disorders, AND
• Patient has tried at least one conventional therapy (e.g. etoposide, cyclosporine A, or anti-thymocyte globulin), AND
• Patient has experienced at least one of the following:
  • Refractory, recurrent, or progressive disease during conventional therapy (e.g. etoposide, cyclosporine A, or anti-thymocyte globulin), OR
  • Intolerance to conventional therapy (e.g. etoposide, cyclosporine A, or anti-thymocyte globulin), AND
• Documentation of a scheduled bone marrow or hematopoietic stem cell transplantation (HSCT) or identification of a transplant donor is in process

Dosing:

• Recommended starting dosage: 1 mg/kg as an intravenous infusion over 1 hour twice per week
• Maximum dose: 10 mg/kg IV per infusion
• Administer dexamethasone concomitantly with Gamifant®
• Administer prophylactic treatment against Herpes Zoster, Pneumocystis jiroveci, and fungal infections

Approval:

• Initial: 8 weeks
• Renewal: 6 months