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.