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Drug Interactions between Savaysa and Viekira XR

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

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Interactions between your drugs

Major

ritonavir edoxaban

Applies to: Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir) and Savaysa (edoxaban)

ADJUST DOSE: Coadministration with inhibitors of P-glycoprotein (P-gp) such as ritonavir may increase the plasma concentrations of edoxaban, which is a substrate of the efflux transporter. In healthy volunteers, single-dose edoxaban systemic exposure (AUC) increased approximately 80% to 90% by erythromycin, dronedarone, and ketoconazole; 70% to 80% by cyclosporine and quinidine; 50% by verapamil; and 40% by amiodarone. The peak plasma concentration (Cmax) of edoxaban also increased by approximately 45% to 90% with these drugs. In another study, dabigatran etexilate (150 mg), another P-gp substrate, and ritonavir (100 mg) were administered simultaneously and separately (2 hours apart). When administered together, thrombin time (TT) at 24 hours post-dose increased by 31% while no significant changes in dabigatran pharmacokinetic parameters were observed. When dabigatran was given 2 hours before ritonavir, dabigatran AUC decreased by 29% while no significant changes in TT were observed.

MANAGEMENT: When used for the treatment of deep vein thrombosis and pulmonary embolism, the manufacturer recommends that edoxaban dosage be reduced to 30 mg once daily in patients receiving concomitant treatment with certain P-gp inhibitors including azithromycin, clarithromycin, erythromycin, oral itraconazole, oral ketoconazole, quinidine, and verapamil. This dosage recommendation is based on data from a clinical study, the Hokusai VTE study, and is limited to use with the specific P-gp inhibitors mentioned. Other P-gp inhibitors were not permitted in the study, and patients on antiretroviral therapy (ritonavir, nelfinavir, indinavir, saquinavir) as well as cyclosporine were excluded from the study. Following discontinuation of the P-gp inhibitor, edoxaban dosage should be returned to the regular dosage of 60 mg once daily. No dosage adjustment is recommended for edoxaban when used in the treatment of nonvalvular atrial fibrillation.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical
  2. (2001) "Product Information. Kaletra (lopinavir-ritonavir)." Abbott Pharmaceutical
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  4. (2006) "Product Information. Prezista (darunavir)." Ortho Biotech Inc
  5. Cerner Multum, Inc. "Australian Product Information."
  6. (2014) "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals
  7. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC
  8. (2015) "Product Information. Savaysa (edoxaban)." Daiichi Sankyo, Inc.
  9. (2015) "Product Information. Technivie (ombitasvir/paritaprevir/ritonavir)." AbbVie US LLC
  10. Cerner Multum, Inc. (2015) "Canadian Product Information."
  11. (2018) "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenofovir)." Janssen Pharmaceuticals
  12. Kumar P, Gordon LA, et al. (2017) "Differential influence of the antiretroviral pharmacokinetic enhancers ritonavir and cobicistat on intestinal p-glycoprotein transport and the pharmacokinetic/pharmacodynamics disposition of dabigatran." Antimicrob Agents Chemother, 61, p. 1-12
View all 12 references

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Drug and food interactions

Moderate

ritonavir food

Applies to: Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Administration with food may modestly affect the bioavailability of ritonavir from the various available formulations. When the oral solution was given under nonfasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption decreased 7% relative to fasting conditions. Dilution of the oral solution (within one hour of dosing) with 240 mL of chocolate milk or a nutritional supplement (Advera or Ensure) did not significantly affect the extent and rate of ritonavir absorption. When a single 100 mg dose of the tablet was administered with a high-fat meal (907 kcal; 52% fat, 15% protein, 33% carbohydrates), approximately 20% decreases in mean peak concentration (Cmax) and systemic exposure (AUC) were observed relative to administration after fasting. Similar decreases in Cmax and AUC were reported when the tablet was administered with a moderate-fat meal. In contrast, the extent of absorption of ritonavir from the soft gelatin capsule formulation was 13% higher when administered with a meal (615 KCal; 14.5% fat, 9% protein, and 76% carbohydrate) relative to fasting.

MANAGEMENT: Ritonavir should be taken with meals to enhance gastrointestinal tolerability.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical

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Moderate

paritaprevir food

Applies to: Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ombitasvir, paritaprevir, ritonavir, and dasabuvir. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a moderate-fat meal (approximately 600 Kcal; 20% to 30% calories from fat) increased the mean systemic exposure (AUC) by 82%, 211%, 49%, and 30%, respectively. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a high-fat meal (approximately 900 Kcal; with 60% calories from fat) increased the mean AUC by 76%, 180%, 44%, and 22%, respectively.

MANAGEMENT: Ombitasvir/paritaprevir/ritonavir plus dasabuvir should always be administered with a meal. The fat or calorie content does not matter.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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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

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