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MYALEPT® (metreleptin)

It is a leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. (202. 203) 

  • Body weight 40 kg or less: starting dose 0.06 mg/kg/day, increase or decrease by 0.02 mg/kg to a maximum daily dose of 0.13 mg/kg.
  • Males greater than 40 kg body weight: starting dose 2.5 mg/day, increase or decrease by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day. 
  • Females greater than 40 kg body weight: starting dose 5 mg/day, increase or decrease by 1.25 mg to 2.5 mg/day to a maximum dose of 10 mg/day. (202. 203) 

Sterile, white, solid, lyophilized cake of 11.3 mg metreleptin per vial to deliver 5 mg per mL when reconstituted in 2.2 mL of Bacteriostatic Water for Injection (BWFI) or preservativefree sterile Water for Injection (WFI). (202. 203) 

Subcutaneous injection once daily. (202. 203) 

Most common in clinical trials (≥10%): headache, hypoglycemia, decreased weight, abdominal pain.(202. 203) 

1b.

 

202. Beltrand J;,Beregszaszi M;,Chevenne D;,Sebag G; ,DeKerdanet M;,Huet F; ,etal. Metabolic Correction Induced by Leptin Replacement Treatment in Young Children With Berardinelli-Seip Congenital Lipoatrophy. Pediatrics (2007) 120:e291–6.doi:10.1542/peds.2006-3165.

203.Tchang BG, Shukla AP, Aronne LJ. Metreleptin and Generalized Lipodystrophy and Evolving Therapeutic Perspectives. Expert Opin Biol Ther (2015)15(7):1061–75.doi:10.1517/14712598.2015.1052789.

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