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Drug Interactions between Biktarvy and dronedarone

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

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Interactions between your drugs

Moderate

dronedarone bictegravir

Applies to: dronedarone and Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide)

MONITOR: Coadministration with inhibitors of CYP450 3A4 and/or uridine diphosphate glucuronosyltransferase (UGT) 1A1 may increase the plasma concentrations of bictegravir. According to the product labeling, bictegravir is a substrate of both CYP450 3A4 and UGT1A1; however, the extent to which each enzymatic pathway contributes to the metabolic clearance of bictegravir has not been reported. In healthy volunteers studied under fasted conditions, administration of a single 75 mg dose of bictegravir during treatment with the potent CYP450 3A4 inhibitor voriconazole (300 mg twice daily) increased mean bictegravir peak plasma concentration (Cmax) and systemic exposure (AUC) by 9% and 61%, respectively, compared to administration of bictegravir alone. In addition, in healthy volunteers studied under fed conditions, administration of a single 75 mg dose of bictegravir during treatment with the potent CYP450 3A4 and UGT1A1 inhibitor atazanavir (400 mg once daily) increased mean bictegravir AUC by 315%, compared to administration of bictegravir alone.

MANAGEMENT: Caution is advised when bictegravir is used with CYP450 3A4 and UGT1A1 inhibitors. Patients should be monitored for increased adverse effects such as diarrhea, nausea, and vomiting.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2018) "Product Information. Biktarvy (bictegravir/emtricitabine/tenofovir)." Gilead Sciences

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Drug and food interactions

Major

dronedarone food

Applies to: dronedarone

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of dronedarone. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. According to the product labeling, administration with grapefruit juice resulted in a 2.5-fold increase in dronedarone peak plasma concentration and a 3-fold increase in systemic exposure. Because dronedarone is associated with concentration-dependent prolongation of the QT interval, increased levels may potentiate the risk of ventricular arrhythmias such as torsade de pointes and sudden death.

ADJUST DOSING INTERVAL: Food increases the oral bioavailability of dronedarone. The mechanism of interaction is unknown. According to the product labeling, the absolute bioavailability of dronedarone increases from about 4% when administered in the fasted state to approximately 15% when administered with a high-fat meal.

MANAGEMENT: Patients treated with dronedarone should avoid consumption of grapefruit, grapefruit juice, and any supplement containing grapefruit extract. Dronedarone should be taken twice daily with the morning and evening meals.

References

  1. (2009) "Product Information. Multaq (dronedarone)." sanofi-aventis

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Minor

tenofovir food

Applies to: Biktarvy (bictegravir / emtricitabine / tenofovir alafenamide)

Food enhances the oral absorption and bioavailability of tenofovir, the active entity of tenofovir disoproxil fumarate. According to the product labeling, administration of the drug following a high-fat meal increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of tenofovir by approximately 14% and 40%, respectively, compared to administration in the fasting state. However, administration with a light meal did not significantly affect the pharmacokinetics of tenofovir compared to administration in the fasting state. Food delays the time to reach tenofovir Cmax by approximately 1 hour. Tenofovir disoproxil fumarate may be administered without regard to meals.

References

  1. (2001) "Product Information. Viread (tenofovir)." Gilead Sciences

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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.

See also

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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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