MYALEPT (metreleptin)

MYALEPT (metreleptin)

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