HTB

Interactions between oral anticoagulants and Genvoya, Stribild and cobicistat: FDA label updates

24 August 2018. Related: Antiretrovirals, PK and drug interactions.

Simon Collins, HIV i-Base

On 15 August 2018, the FDA listserv announced label changes to several HIV combinations based on drug interactions with oral anticoagulants.

A summary of the changes is bulleted below, but please check updated package inserts for full details.

Genvoya and Stribild

Genvoya and Stribild are both expected to increase the exposures of apixaban, rivaroxaban, betrixaban, dabigatran and edoxaban. The specific recommendations are as follows:

  • Apixaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration with Genvoya or Stribild depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.
  • Rivaroxaban:  Coadministration of rivaroxaban with Genvoya or Stribild is not recommended because it may lead to an increased bleeding risk.
  • Betrixaban, dabigatran, edoxaban: Due to potentially increased bleeding risk, dosing recommendation for coadministration of betrixaban, dabigatran or edoxaban with a P-gp inhibitor such as Genvoya or Stribild depends on the direct oral anticoagulant indication and renal function. Refer to the direct oral anticoagulant dosing instructions for coadministration with P-gp inhibitors in the direct oral anticoagulant prescribing information.        

Tybost coadministered with atazanavir or darunavir

  • Apixaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration of apixaban with Tybost depends on the apixaban dose. Refer to apixaban dosing instructions for coadministration with strong CYP3A and P-gp inhibitors in apixaban prescribing information.
  • Rivaroxaban: Coadministration of rivaroxaban with Tybost is not recommended because it may lead to an increased bleeding risk.

Tybost coadministered with atazanavir

  • Betrixaban, dabigatran and edoxaban: Due to potentially increased bleeding risk, dosing recommendations for coadministration of betrixaban, dabigatran, or edoxaban with a P-gp inhibitor such as Tybost coadministered with atazanavir depends on DOAC indication and renal function. Refer to DOAC dosing instructions for coadministration with P-gp inhibitors in DOAC prescribing information.

Tybost coadministered with darunavir

  • Betrixaban, dabigatran and edoxaban: No dose adjustment.

Reference

FDA list serve (13 August 2018).

Links to other websites are current at date of posting but not maintained.