MYALEPT Safety Data

Adverse reactions of 5% or greater incidence in patients with generalized lipodystrophy receiving MYALEPT in an open-label, single-arm study

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.

Hypoglycemia with concomitant use of insulin or insulin secretagogues

  • Dosage adjustments, including possible large reductions, of insulin or insulin secretagogue (eg, sulfonylurea) may be necessary in some patients to minimize the risk of hypoglycemia. Closely monitor blood glucose in patients on concomitant insulin therapy, especially those on high doses, or insulin secretagogue, when treating with MYALEPT