Lomitapide Disease Interactions

The use of lomitapide is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C), and patients with active liver disease, including unexplained elevations of serum transaminases. Lomitapide increases hepatic fat, with or without concomitant increases in transaminases. Hepatic steatosis associated with the use of lomitapide may be a risk factor for progressive liver disease including steatohepatitis and cirrhosis. Patients with mild liver impairment should not exceed 40 mg daily as exposure can increase up to 50% compared with healthy volunteers.

Alcohol may increase the levels of hepatic fat and induce or exacerbate liver injury. It is recommended that patients taking lomitapide should not consume more than one alcoholic drink per day.

Patients with rare, hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should avoid lomitapide as this may result in diarrhea or malabsorption.

Patients with end-stage renal disease receiving dialysis should not exceed 40 mg daily of lomitapide, as exposure can increase up to 50% compared with healthy volunteers. Effects of mild, moderate, and severe renal impairment, including end-stage renal disease not yet receiving dialysis, on lomitapide exposure have not been studied. Caution is advised.

Lomitapide may reduce the absorption of fat soluble nutrients. Patients on clinical trials were provided with daily dietary supplements of vitamin E, linoleic acid, alpha- linoleic acid (ALA), eicosapentaenoic acid (EPA), and docosahexaenoic acid (DHA). Patients with chronic bowel or pancreatic diseases that predispose to malabsorption may be at increased risk for deficiencies in these nutrients with the use of lomitapide. Patients receiving treatment should take daily vitamin supplements.