Safety of MYALEPT

Most common adverse reactions occurring in ≥5% of patients

aHypoglycemic events were assessed as mild, moderate, severe, or life threatening based on the protocol-specific definitions: Mild: Documentation of low plasma glucose values with no symptoms; Moderate: Presence of clinical symptoms requiring ingestion of glucose, self-alleviated; Severe: Presence of neuroglycopenic symptoms requiring assistance from others for alleviation; Life threatening: Loss of conciousness and/or requiring intervention by administration of intravenous glucose or intramuscular glucagon.

  • Six patients (13%) had 7 adverse reactions of hypoglycemia. Six events occurred in the setting of concomitant insulin use, with or without oral antihyperglycemic agents.
  • Two patients (4%) with generalized lipodystrophy reported injection-site erythema and uticaria.
  • Two patients (4%) had events of pancreatitis. Both patients had a medical history of pancreatitis.

Immunogenicity

  • As with all therapeutic proteins, there is potential for immunogenicity.
  • Anti-metreleptin antibodies were detected in 84% (36/43) of patients with generalized lipodystrophy studied in the MYALEPT trials. The magnitude and persistence of the observed anti-drug antibody responses is not understood.
  • Anti-metreleptin antibodies associated with adverse events consistent with loss of endogenous leptin activity and/or loss of MYALEPT efficacy were observed in 6% (2/33) of the patients with generalized lipodystrophy tested.
  • Adverse events reported in these 2 patients included severe infections and worsening of metabolic control (increases in HbA1c and/or triglycerides).

Test for anti-metreleptin antibodies with neutralizing activity in patients who develop severe infections or show signs suspicious for loss of MYALEPT efficacy during treatment. Call 1-866-216-1526 for neutralizing antibody testing.

The recommended daily dose for MYALEPT is determined by weight, gender, and other considerations. Learn about MYALEPT dosing