Understanding Important Risks

Lipodystrophy causes significant metabolic abnormalities and use or discontinuation of Myalepta may potentially be associated with specific risks. You should aim to minimise these risks by being aware of them and utilising the information below and referring to the brochure.

  • Hypersensitivity: The risk of severe consequences can be minimised by the supervision of a qualified healthcare professional when the first dose of Myalepta is administered
  • Acute pancreatitis: Patients should be encouraged to remain compliant and, if Myalepta is discontinued, the dose should be steadily tapered down over a two-week period
  • Hypoglycaemia: Blood glucose should be monitored and patients need to be made aware of the signs of hypoglycaemia
  • Lymphoma: If a patient presents with acquired lipodystrophy or significant haematological abnormalities, the benefits and risks of Myalepta treatment should be carefully considered
  • Unplanned pregnancy: Unplanned pregnancies may occur due to restoration of luteinising hormone release. As Myalepta should not be used during pregnancy, women receiving Myalepta need to be instructed to use effective, non-hormonal, contraception while on treatment including non-hormonal methods such as condoms 
  • Loss of efficacy, potentially due to neutralising antibodies and serious and severe infections secondary to neutralising antibodies:  In patients with serious and severe infections, continuation of Myalepta should be at the discretion of the prescriber.  Neutralising antibodies could in theory affect the activity of endogenous leptin
  • Medication errors: Training is required before self-administration and the patient’s self-injection technique should be reviewed every six months

Further information about Myalepta and risk minimisation can be found in the brochure Information for Healthcare Professionals and the Summary of Product Characteristics.

Suspected adverse reactions and adverse events should be reported.

Reporting forms and information can be found on the MHRA Yellow Card reporting site or yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse reactions should also be reported to Aegerion by calling 00800 23437466 or e-mail: medinfo.emea@aegerion.com