metreleptin (Myalept®)

SELF ADMINISTRATION

Indications for Prior Authorization:

  • Adjunct therapy to diet for treatment of leptin deficiency in patients with congenital or acquired lipodystrophy

Patients must meet the following criteria for the indications above:

  • Patient must have generalized lipodystrophy with inadequate leptin secreted by adipocytes

The drug is not approved for any use not mentioned above including:

  • Human immunodeficiency virus related lipodystrophy
  • Liver disease
  • Partial lipodystrophy

Dosing:

  • Patients less than 40 kg the starting dose is 0.06 mg/kg SC once daily
  • For males greater than 40 kg the dose is 2.5 mg SC once daily
  • For females greater than 40 kg the dose is 5 mg SC once daily
  • Titrate based on clinical response
  • Max dose patients < 40 kg is 0.13 mg/kg/day
  • Max dose patients >40 kg is 10 mg/day

Approval:

One year


   

Last review date: May 5, 2014