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Drug Interactions between afatinib and dronedarone

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

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Interactions between your drugs

Moderate

dronedarone afatinib

Applies to: dronedarone and afatinib

ADJUST DOSE: Coadministration with inhibitors of P-glycoprotein (P-gp) may increase the plasma concentrations of afatinib, which is a substrate of the efflux transporter. In study subjects, oral administration of the P-gp inhibitor ritonavir (200 mg twice daily) one hour before afatinib dosing resulted in a 48% increase in afatinib systemic exposure. There was no change in afatinib exposure when ritonavir was administered simultaneously with, or 6 hours after, the afatinib dose.

MANAGEMENT: Caution is advised if afatinib is used in combination with P-gp inhibitors. Patients should be monitored for potentially increased adverse effects such as diarrhea, which may lead to dehydration with or without renal impairment; cutaneous reactions including rash, erythema, and bullous, blistering, or exfoliating lesions; interstitial lung disease such as lung infiltration, pneumonitis, acute respiratory distress syndrome, and allergic alveolitis; hepatotoxicity, which may be life-threatening or fatal; keratitis characterized by acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain, red eye, and/or ulceration; and left ventricular dysfunction. The manufacturer recommends reducing the daily dose of afatinib by 10 mg if not tolerated. The previous dose may be resumed after discontinuation of the P-gp inhibitor as tolerated.

References (1)
  1. (2013) "Product Information. Gilotrif (afatinib)." Boehringer Ingelheim

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

afatinib food

Applies to: afatinib

ADJUST DOSING INTERVAL: Food may reduce the oral bioavailability of afatinib. According to the product labeling, administration of afatinib with a high-fat meal decreased peak plasma concentration (Cmax) by 50% and systemic exposure (AUC) by 39% compared to administration in the fasted state.

MANAGEMENT: Afatinib should be taken at least 1 hour before or 2 hours after a meal.

References (1)
  1. (2013) "Product Information. Gilotrif (afatinib)." Boehringer Ingelheim

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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