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Drug Interactions between eluxadoline and simeprevir

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

simeprevir eluxadoline

Applies to: simeprevir and eluxadoline

ADJUST DOSE: Coadministration with inhibitors of organic anion transporting polypeptide (OATP) 1B1 may significantly increase the plasma concentrations of eluxadoline. Based on available data, inhibition of OATP1B1-mediated hepatic uptake appears to reduce both the hepatic first-pass extraction and systemic biliary clearance of eluxadoline. In 30 healthy volunteers, administration of a single 100 mg dose of eluxadoline with a single 600 mg dose of cyclosporine, a known OATP1B1 inhibitor, increased eluxadoline peak plasma concentration (Cmax) and systemic exposure (AUC) by 6.2- and 4.4-fold, respectively, compared to administration of eluxadoline alone. Adverse events were reported in 6 study subjects during coadministration of eluxadoline with cyclosporine and in 2 subjects during administration of eluxadoline alone.

MANAGEMENT: The recommended dosage of eluxadoline is 75 mg twice daily when used with OATP1B1 inhibitors. Patients should be monitored for adverse effects such as sedation, nausea, vomiting, constipation, abdominal pain, liver enzyme elevations, and pancreatitis.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2015) "Product Information. Viberzi (eluxadoline)." Actavis Pharma, Inc.
  3. Davenport JM, Covington P, Bonifacio L, McIntyre G, Venitz J (2015) "Effect of uptake transporters OAT3 and OATPIBI and efflux transporter MRP2 on the pharmacokinetics of eluxadoline." J Clin Pharmacol, 55, p. 534-42

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Drug and food interactions

Major

eluxadoline food

Applies to: eluxadoline

CONTRAINDICATED: Consumption of more than 3 alcoholic beverages per day may increase the risk of acute pancreatitis during treatment with eluxadoline. Pancreatitis has been reported rarely during clinical trials of eluxadoline, and may or may not be related to sphincter of Oddi spasm.

ADJUST DOSING INTERVAL: High-fat meals may reduce the oral bioavailability of eluxadoline. In 28 healthy volunteers, administration of a single 100 mg dose of eluxadoline with a high-fat meal (approximately 800 to 1000 total calories, 50% from fat) decreased eluxadoline peak plasma concentration (Cmax) and systemic exposure (AUC) by 50% and 60%, respectively, compared to administration in the fasted state. There was no significant effect on the time to peak concentration (Tmax). The clinical relevance of this interaction is unknown. It should be noted that phase 3 clinical trials were conducted under fed conditions.

MANAGEMENT: Chronic or acute excessive use of alcohol should be avoided during treatment with eluxadoline. Alcoholism, alcohol abuse, alcohol addiction, and consumption of more than 3 alcoholic beverages per day are considered contraindications to the use of eluxadoline. The product labeling recommends taking eluxadoline with food. Patients should be advised to stop taking eluxadoline and seek medical attention if they experience potential symptoms of pancreatitis such as persistent nausea, vomiting, abdominal tenderness, and upper abdominal pain, especially that which is made worse after eating or radiates to the back or shoulders.

References

  1. (2015) "Product Information. Viberzi (eluxadoline)." Actavis Pharma, Inc.

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Moderate

simeprevir food

Applies to: simeprevir

ADJUST DOSING INTERVAL: Food significantly enhances the oral bioavailability of simeprevir, although the type of food does not seem to matter. In healthy study subjects, administration of simeprevir after a high-fat, high-caloric (928 kcal) breakfast increased systemic exposure (AUC) by 61% and delayed absorption by 1 hour, while administration after a normal caloric (533 kcal) breakfast increased AUC by 69% and delayed absorption by 1.5 hours.

MANAGEMENT: To ensure maximal oral absorption, simeprevir should be administered with food.

References

  1. (2013) "Product Information. Olysio (simeprevir)." Janssen Pharmaceuticals

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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