Medical Uses
Myalept (metreleptin) is a leptin replacement therapy used as a doctor-recommended adjunct to diet to treat problems caused by not having enough leptin (leptin deficiency) in individuals with generalized lipodystrophy (GL).
Limitations of Use:
- It is not known if this therapeutic drug is safe and effective when used for treating complications caused by partial lipodystrophy or for treating liver disease, including non-alcoholic steatohepatitis (NASH).
- This drug should not be used to treat individuals with HIV-related lipodystrophy or individuals with metabolic disease, including diabetes mellitus and hypertriglyceridemia, without signs or symptoms of congenital or acquired generalized lipodystrophy.
Recommended Dosage: The recommended daily dosages are administered as a subcutaneous injection (SC) once daily after the lyophilized cake is reconstituted with Bacteriostatic Water for Injection (BWFI) or preservative-free sterile Water for Injection (WFI).
- Body weight 40 kg or less: The starting recommended dose is 0.06 mg/kg/day. The dosage can be increased or decreased by 0.02 mg/kg to a maximum daily dose of 0.13 mg/kg.
- Males greater than 40 kg body weight: The starting recommended dose is 2.5 mg/day. The dosage can be increased or decreased by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day.
- Females greater than 40 kg body weight: The starting recommended dose is 5 mg/day. The dosage can be increased or decreased by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day.