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Drug Interactions between alpelisib and seladelpar

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

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Interactions between your drugs

Moderate

alpelisib seladelpar

Applies to: alpelisib 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

alpelisib food

Applies to: alpelisib

ADJUST DOSING INTERVAL: Food significantly enhances the oral absorption and bioavailability of alpelisib. When administered with a high-fat high-calorie meal (985 calories with 58.1 g of fat) or a low-fat low-calorie meal (334 calories with 8.7 g of fat) the AUC and Cmax of a single dose of alpelisib was increased by 73% and 84% and 77% and 145%, respectively. There were no clinically significant differences in alpelisib AUC between the two types of meals. In addition, food appears to have a more pronounced effect on the solubility of alpelisib than gastric pH. When coadministered with a single 300 mg dose of alpelisib, ranitidine decreased the absorption and overall exposure of alpelisib. Following administration of ranitidine with a low-fat low-calorie meal, the mean AUC and Cmax of alpelisib was decreased by 21% and 36%, respectively. Administration of ranitidine under fasting conditions reduced the mean AUC and Cmax of alpelisib by 30% and 51%, respectively.

MANAGEMENT: To ensure maximal oral absorption, alpelisib should be administered with a meal.

References (1)
  1. (2019) "Product Information. Piqray (alpelisib)." Novartis Pharmaceuticals

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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