Eluxadoline Disease Interactions

The use of eluxadoline is contraindicated in patients with history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical gastrointestinal obstruction. These patients may be at risk for severe complications of bowel obstruction.

Pancreatitis, with or without sphincter of Oddi spasm has been reported in patients taking either the 75 mg or 100 mg dosage of eluxadoline, including serious cases resulting in hospitalization, primarily in patients without a gallbladder. Fatal cases have also been reported. The use of eluxadoline is contraindicated in patients without a gallbladder and in other patients at risk of pancreatitis such as patients with alcoholism, patients with known or suspected bile duct obstruction, history of pancreatitis or structural disease of the pancreas. In patients with a gallbladder, the alcohol intake of the patient should be evaluated before starting treatment. Patients should be monitored for any signs or symptoms suggestive of pancreatitis. Patients should be instructed to stop treatment immediately and seek medical attention.

Eluxadoline is contraindicated in patients with severe hepatic impairment, as these patients are at risk for significantly increased plasma concentrations (16- fold), and there is no information to support the safety on these patients. In patients with mild to moderate hepatic impairment the plasma concentrations are increased to a lesser extent. It is recommended to decrease the dose to 75 mg twice a day on these patients and monitor regularly for impaired mental or physical abilities and for any other eluxadoline related adverse reactions.