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Drug Interactions between naloxegol and sofosbuvir / velpatasvir / voxilaprevir

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

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Interactions between your drugs

Moderate

velpatasvir voxilaprevir

Applies to: sofosbuvir / velpatasvir / voxilaprevir and sofosbuvir / velpatasvir / voxilaprevir

MONITOR: Coadministration with inhibitors of organic anion transporting polypeptides (OATP) 1B1 and/or 1B3 may increase the plasma concentrations of voxilaprevir, which is a substrate of the hepatic uptake transporters. When a single 100 mg dose of voxilaprevir was administered with a single 600 mg dose of the potent OATP 1B1/1B3 inhibitor cyclosporine (n=24), mean voxilaprevir peak plasma concentration (Cmax) and systemic exposure (AUC) increased by approximately 19.0- and 9.4-fold, respectively. Inhibition of P-glycoprotein (P-gp)- and breast cancer resistance protein (BCRP)-mediated intestinal transport and CYP450 3A4-mediated metabolism of voxilaprevir may also contribute to the overall interaction with cyclosporine. The safety of such high levels of voxilaprevir has not been established.

MANAGEMENT: Caution and monitoring are advised when voxilaprevir is used with OATP 1B1 or 1B3 inhibitors.

References

  1. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." Gilead Sciences

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Minor

naloxegol velpatasvir

Applies to: naloxegol and sofosbuvir / velpatasvir / voxilaprevir

Coadministration with inhibitors of P-glycoprotein (P-gp) and/or weak inhibitors of CYP450 3A4 may increase the plasma concentrations of naloxegol, which is a substrate of both the efflux transporter and the isoenzyme. When a single 25 mg dose of naloxegol was administered with a single 600 mg dose of quinidine, a potent P-gp inhibitor and weak CYP450 3A4 inhibitor, naloxegol peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 147% and 39%, respectively. These changes are not considered clinically significant; therefore, no dosage adjustments are necessary.

References

  1. (2014) "Product Information. Movantik (naloxegol)." Astra-Zeneca Pharmaceuticals

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Minor

naloxegol voxilaprevir

Applies to: naloxegol and sofosbuvir / velpatasvir / voxilaprevir

Coadministration with inhibitors of P-glycoprotein (P-gp) and/or weak inhibitors of CYP450 3A4 may increase the plasma concentrations of naloxegol, which is a substrate of both the efflux transporter and the isoenzyme. When a single 25 mg dose of naloxegol was administered with a single 600 mg dose of quinidine, a potent P-gp inhibitor and weak CYP450 3A4 inhibitor, naloxegol peak plasma concentration (Cmax) and systemic exposure (AUC) increased by 147% and 39%, respectively. These changes are not considered clinically significant; therefore, no dosage adjustments are necessary.

References

  1. (2014) "Product Information. Movantik (naloxegol)." Astra-Zeneca Pharmaceuticals

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Drug and food interactions

Major

naloxegol food

Applies to: naloxegol

GENERALLY AVOID: Grapefruit juice may significantly increase the plasma concentrations of naloxegol. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruit. In pharmacokinetic studies, naloxegol systemic exposure (AUC) was increased approximately 3.5-fold by the moderate CYP450 3A4 inhibitor diltiazem and nearly 13-fold by the potent inhibitor ketoconazole. The interaction has not been studied with grapefruit juice. In general, the effect of grapefruit juice is concentration-, dose- and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased exposure to naloxegol may precipitate opioid withdrawal symptoms such as hyperhidrosis, lacrimation, rhinorrhea, chills, diarrhea, abdominal pain, anxiety, insomnia, irritability, restlessness, and yawning.

ADJUST DOSING INTERVAL: Food may increase the rate and extent of naloxegol absorption. When administered with a high-fat meal, naloxegol peak plasma concentration (Cmax) and systemic exposure (AUC) increased by approximately 30% and 45%, respectively. In clinical trials, naloxegol was given on an empty stomach approximately 1 hour prior to the first meal in the morning.

MANAGEMENT: Patients treated with naloxegol should avoid consumption of grapefruit and grapefruit juice. Naloxegol should be taken on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.

References

  1. (2014) "Product Information. Movantik (naloxegol)." Astra-Zeneca Pharmaceuticals

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Moderate

voxilaprevir food

Applies to: sofosbuvir / velpatasvir / voxilaprevir

ADJUST DOSING INTERVAL: Administration with food enhances the oral bioavailability of sofosbuvir, velpatasvir, and voxilaprevir. Relative to fasting conditions, mean sofosbuvir systemic exposure (AUC) increased by 64% to 144%, mean velpatasvir AUC increased by 40% to 166%, and mean voxilaprevir AUC increased by 112% to 435% when the combined sofosbuvir/velpatasvir/voxilaprevir formulation is administered with food.

MANAGEMENT: Sofosbuvir/velpatasvir/voxilaprevir should be administered with food.

References

  1. (2017) "Product Information. Vosevi (sofosbuvir/velpatasvir/voxilaprevir)." 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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