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Drug Interactions between berotralstat and Olysio

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

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Interactions between your drugs

Moderate

simeprevir berotralstat

Applies to: Olysio (simeprevir) and berotralstat

Consumer information for this interaction is not currently available.

MONITOR: Coadministration with inhibitors of P-glycoprotein (P-gp) and/or breast cancer resistance protein (BCRP) may increase the plasma concentrations of berotralstat. Berotralstat is a substrate of both P-gp and BCRP. Coadministration with the potent P-gp and BCRP inhibitor cyclosporine increased berotralstat peak plasma concentration (Cmax) and total systemic drug exposure (AUC 0-inf) by 25% and 69%, respectively. However, other regulatory bodies reported that cyclosporine decreased the Cmax of a single 150 mg dose of berotralstat by 7% and increased the AUC by 24-27%. Increased plasma concentrations of berotralstat may increase the risk of adverse effects, including the potential for QT prolongation. Berotralstat may cause concentration-dependent prolongation of the Fridericia-corrected QT interval (QTcF). A mean increase in the QTcF interval of 15.9 milliseconds has been reported at 3-times the recommended dose of berotralstat; however, berotralstat has not been shown to prolong the QT interval to any clinically relevant extent when administered at the recommended daily dose of 150 mg. Data are not available for other, less potent P-gp and/or BCRP inhibitors.

MANAGEMENT: No dose adjustments of berotralstat are recommended; however, monitoring for adverse events may be advisable during concomitant use of berotralstat with P-gp and/or BCRP inhibitors. Patients should be advised to contact their physician if they experience undue adverse effects of berotralstat such as abdominal pain, vomiting, or diarrhea. Patients should seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitations, irregular heartbeat, shortness of breath, or syncope.

Drug and food interactions

Moderate

simeprevir food

Applies to: Olysio (simeprevir)

Food significantly increases the absorption of simeprevir. You should take each dose of simeprevir with food. Taking it on an empty stomach may lead to inadequate blood levels and reduced effectiveness of the medication.

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.