Italian Medicines Agency Agenzia Italiana del Farmaco

Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy - Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy

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Lojuxta (lomitapide): Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy

Summary:

Healthcare professionals are reminded of the following in order to minimize the risks of Lojuxta (lomitapide):

  • Lomitapide is contraindicated in patients with moderate or severe hepatic impairment and those with unexplained persistent abnormal liver function tests.
  • Liver function should be monitored before and during treatment with lomitapide (see table below for specific recommendations).
  • Screening for steatohepatitis/fibrosis should be performed before starting treatment with lomitapide and on an annual basis thereafter (see section below).
  • Lomitapide is contraindicated during pregnancy.
  • Before starting treatment with lomitapide in women of child-bearing potential:
    • the absence of pregnancy should be confirmed,
    • advice on effective methods of contraception should be provided,
    • start and maintain effective contraception.


Published on: 17 February 2021

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