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Drug Interactions between cobicistat / darunavir and Pradaxa

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

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Interactions between your drugs

Moderate

dabigatran cobicistat

Applies to: Pradaxa (dabigatran) and cobicistat / darunavir

MONITOR: Coadministration with cobicistat may increase the plasma concentrations of dabigatran, particularly in patients with renal impairment. The mechanism is inhibition of P-glycoprotein (P-gp) by cobicistat. In a single-center, two-arm, single-sequence, open-label study, dabigatran AUC and Cmax each increased by 127% when administered simultaneously with cobicistat (p-value less than 0.001 for AUC and Cmax). When administration of dabigatran and cobicistat was separated by 2 hours, dabigatran AUC and Cmax increased by 110% and 99%, respectively (p-value less than 0.001 for AUC and Cmax). In addition, thrombin time (TT) at 24 hours post-dose increased by 51% and 46% when cobicistat was given simultaneously and separated, respectively, compared to dabigatran alone (p-value less than 0.001 for both).

MANAGEMENT: Coadministration of dabigatran with cobicistat is not recommended in certain patients with renal impairment. If concomitant use is necessary, clinical and laboratory monitoring is recommended and the dabigatran dosage should be adjusted as necessary. Patients should be monitored closely for the development of bleeding complications.

References

  1. (2003) "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2010) "Product Information. Pradaxa (dabigatran)." Boehringer-Ingelheim
  5. (2012) "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences
  6. (2014) "Product Information. Tybost (cobicistat)." Gilead Sciences
  7. (2014) "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals
  8. (2015) "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb
  9. (2015) "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences
  10. (2018) "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenofovir)." Janssen Pharmaceuticals
  11. 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 11 references

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Drug and food interactions

Moderate

darunavir food

Applies to: cobicistat / darunavir

ADJUST DOSING INTERVAL: Food enhances the absorption and oral bioavailability of darunavir administered in combination with low-dose ritonavir. The mechanism is unknown. When administered with food, the peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) of darunavir were approximately 30% higher than when administered in the fasting state. Darunavir exposure was similar for the range of meals studied. The total caloric content of the various meals evaluated ranged from 240 Kcal (12 grams fat) to 928 Kcal (56 grams fat).

MANAGEMENT: To ensure maximal oral absorption, darunavir coadministered with ritonavir should be taken with food. The type of food is not important.

References

  1. (2006) "Product Information. Prezista (darunavir)." Ortho Biotech Inc

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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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