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Drug Interactions between seladelpar and sodium phenylbutyrate / taurursodiol

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

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Interactions between your drugs

Moderate

taurursodiol seladelpar

Applies to: sodium phenylbutyrate / taurursodiol and seladelpar

MONITOR: Coadministration with inhibitors of the breast cancer resistance protein (BCRP) may increase the plasma concentrations and effects of seladelpar, which is a substrate of this efflux transporter. A clinical drug interaction study found that the systemic exposure (AUC) and maximum plasma concentration (Cmax) of a single dose of seladelpar (10 mg) increased by 2.1- and 2.9-fold, respectively, when administered with a single dose of the BCRP inhibitor cyclosporine (600 mg) in healthy subjects.

MANAGEMENT: Close monitoring for adverse reactions is advised if seladelpar is administered concurrently with a BCRP inhibitor. Liver tests should be monitored as clinically indicated and treatment with seladelpar may need to be held or permanently discontinued if liver tests worsen and/or clinical hepatitis develops. The labeling of the inhibitor should also be consulted as some inhibitors may continue to have effects on this transporter even after the agent has been discontinued.

References (2)
  1. (2024) "Product Information. Livdelzi (seladelpar)." Gilead Sciences
  2. Cymabay Therapeutics Inc (2024) Center for drug evaluation and research. Application Number: 217899Orig1s000 integrated review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/217899Orig1s000IntegratedR.pdf

Drug and food interactions

Moderate

sodium phenylbutyrate food

Applies to: sodium phenylbutyrate / taurursodiol

ADJUST DOSING INTERVAL: Coadministration with a high-fat meal may reduce the rate and extent of absorption of sodium phenylbutyrate. When a single 3 g-1 g dose of sodium phenylbutyrate-taurursodiol (sodium phenylbutyrate-ursodoxicoltaurine) was administered to healthy volunteers in the presence of a high-fat, high-calorie meal (approximately 800 to 1000 calories; 500 to 600 calories from fat, 250 calories from carbohydrate, 150 calories from protein), sodium phenylbutyrate peak plasma concentration (Cmax) decreased by 75% and systemic exposure (AUC) decreased by 55%. The Cmax for taurursodiol was not significantly affected, but AUC was increased by 46%. The clinical significance of these changes has not been established. In premarketing studies, patients were advised to take the drug before a meal.

MANAGEMENT: The prescribing information recommends administration of sodium phenylbutyrate-taurursodiol before a meal or snack, particularly in patients of low body weight (less than 70 kg).

References (2)
  1. (2022) "Product Information. Relyvrio (sodium phenylbutyrate-taurursodiol)." Amylyx Pharmaceuticals, 1
  2. (2022) "Product Information. Albrioza (sodium phenylbutyrate-ursodoxicoltaurine)." Innomar Strategies Inc.

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

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