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
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