Metreleptin

Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above • with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.

MYALEPTA (metreleptin for injection) is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above • with confirmed familial partial LD (PL) or acquired PL (Barraquer-Simons syndrome), in adults and children 12 years of age and above with persistent significant metabolic disease for whom standard treatments have failed to achieve adequate metabolic control.

1 Pediatrics The safety and efficacy of Myalepta in children aged 0 to 2 years with generalised LD and children aged 0 to 12 years with partial LD has not been established. Very limited data are available in children with generalised LD < 6 years of age (n=5; range: 1-4 years).

Very limited data are available in children with partial LD <18 years of age (n=5; range: 15-17 years). Myalepta lyophilized powder when reconstituted with the diluent Bacteriostatic Water for Injection (benzyl alcohol preserved) is not indicated in patients under 3 years of age or in patients with a known sensitivity to benzyl alcohol (see 7 WARNINGS AND PRECAUTIONS).

Myalepta is indicated as an adjunct to diet as a replacement therapy to treat the complications of leptin deficiency in lipodystrophy (LD) patients: • with confirmed congenital generalised LD (Berardinelli-Seip syndrome) or acquired generalised LD (Lawrence syndrome) in adults and children 2 years of age and above 3 • with confirmed familial partial LD or acquired partial LD (Barraquer-Simons syndrome), in adults and children 12 years of age and above for whom standard treatments have failed to achieve adequate metabolic control.