EMA issued DHPC for Lomitapide

by Global Pharmacovigilance Team
February 17, 2021
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European Medicines Agency (EMA) has published Direct healthcare professional communication (DHPC) contains important information for healthcare professionals prescribing, dispensing or administering the medicine(s).

DHPC also includes a communication plan with details of intended recipients and the dissemination date.

The DHPC is regarding “Reminder to monitor the liver function of patients treated with Lojuxta (lomitapide) and to avoid use in pregnancy”.

EMA issued DHPC for Lomitapide

Key facts of DHPC

Medicine name	Lojuxta
Active substance	Lomitapide
Therapeutic area (MeSH)	Hypercholesterolemia
DHPC type	Post-authorisation measure
Date Dissemination	17 Feb 2021

Lojuxta is a medicine that contains the active substance lomitapide. It is used to treat adult patients with homozygous familial hypercholesterolaemia, an inherited disease causing high blood levels of cholesterol (a type of fat). It is used together with a low fat diet and other medicines to reduce the level of fats in the blood. The patient’s disease should be confirmed by genetic testing whenever possible.

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: o the absence of pregnancy should be confirmed, o advice on effective methods of contraception should be provided, o start and maintain effective contraception.

DHPC Communication Plan

Medicinal product(s)/active substance(s)	Lojuxta (lomitapide) capsules
Safety concern and purpose of the communication	Reminder to monitor the liver function of patients treated with Lojuxta and to avoid use in pregnancy.
DHPC recipients	Prescribing physicians to be agreed at member state level based upon the recipients agreed previously for distribution of the educational pack.
Member States where the DHPC will be distributed	Austria, Czech Republic, Denmark, France, Germany, Greece, Hungary, Italy, Netherlands, Norway, Spain, Sweden, plus United Kingdom.