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Dabigatran Etexilate and Darunavir and Cobicistat

Determining the interaction of Dabigatran Etexilate and Darunavir and Cobicistat and the possibility of their joint administration.

Check result:
Dabigatran Etexilate <> Darunavir and Cobicistat
Relevance: 06.08.2023 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Cobicistat may increase the blood levels and effects of dabigatran. Combining these medications may increase the risk of bleeding complications. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. Call your doctor promptly if you experience paleness of skin, fatigue, dizziness, fainting, unusual bleeding or bruising, swelling, vomiting, blood in your urine or stools, headache, or weakness during treatment with these medications. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

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
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • Cerner Multum, Inc. "Australian Product Information." O 0
  • "Product Information. Tybost (cobicistat)." Gilead Sciences, Foster City, CA.
  • "Product Information. Prezcobix (cobicistat-darunavir)." Janssen Pharmaceuticals, Titusville, NJ.
  • "Product Information. Pradaxa (dabigatran)." Boehringer-Ingelheim, Ridgefield, CT.
  • "Product Information. Symtuza (cobicistat/darunavir/emtricitabine/tenof)." Janssen Pharmaceuticals, Titusville, NJ.
  • "Product Information. Stribild (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.
  • "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb, Princeton, NJ.
  • "Product Information. Genvoya (cobicistat/elvitegravir/emtricitabine/tenofov)." Gilead Sciences, Foster City, CA.
  • Kumar P, Gordon LA, et. al "Differential influence of the antiretroviral pharmacokinetic enhancers ritonavir and cobicistat on intestinal p-glycoprotein transport and the pharmacokinetic/pharmacodynamics disposition of dabigatran. Available from: URL: https://www.ncbi.nlm.nih.gov/pm" Antimicrob Agents Chemother 61 (2017): 1-12
  • "Product Information. Evotaz (atazanavir-cobicistat)." Bristol-Myers Squibb, Princeton, NJ.
Dabigatran Etexilate

Generic Name: dabigatran

Brand name: Pradaxa

Synonyms: Dabigatran

Darunavir and Cobicistat

Generic Name: cobicistat / darunavir

Brand name: Prezcobix

Synonyms: Cobicistat and darunavir

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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