Dabigatran Etexilate and Sofosbuvir, velpatasvir, and voxilaprevir

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.

Voxilaprevir can significantly increase the blood levels of dabigatran. This may increase the risk of side effects such as anemia and bleeding complications. Talk to your doctor if you have any questions or concerns. Your doctor may be able to prescribe alternatives that do not interact, or you may need a dose adjustment or more frequent monitoring to safely use both medications. Let your doctor know if you have kidney disease, as you may need a dose adjustment of dabigatran, or you may not be able to take the medication at all. You should seek immediate medical attention if you experience any unusual bleeding or bruising, or have other signs and symptoms of bleeding such as dizziness; lightheadedness; red or black, tarry stools; coughing up or vomiting fresh or dried blood that looks like coffee grounds; severe headache; and weakness. 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.

MONITOR CLOSELY: Coadministration of dabigatran etexilate with sofosbuvir/velpatasvir/voxilaprevir may significantly increase the plasma concentrations of dabigatran. The proposed mechanism is inhibition of the P-glycoprotein (P-gp)-mediated renal tubular secretion of dabigatran by velpatasvir and voxilaprevir, both of which are inhibitors of the transporter. In 36 study subjects, administration of a single 75 mg dose of dabigatran etexilate with sofosbuvir/velpatasvir/voxilaprevir 400 mg/100 mg/100 mg plus voxilaprevir 100 mg once daily increased mean dabigatran peak plasma concentration (Cmax) and systemic exposure (AUC) by approximately 2.9- and 2.6-fold, respectively, compared to administration of dabigatran etexilate alone.

MANAGEMENT: Caution is advised if dabigatran is used in combination with sofosbuvir/velpatasvir/voxilaprevir. Pharmacologic response to dabigatran should be monitored more closely whenever sofosbuvir/velpatasvir/voxilaprevir is added to or withdrawn from therapy, and the dabigatran dosage adjusted as necessary. Patients should be monitored for the development of anemia and bleeding complications during coadministration. In patients with moderate renal impairment (CrCl 30 to 50 mL/min), concomitant use with potent P-gp inhibitors can generally be expected to produce dabigatran exposure similar to that observed in severe renal impairment. Therefore, a reduction in the dabigatran dosage to 75 mg twice daily should be considered. Based on the magnitude of interaction reported, concomitant use of dabigatran with sofosbuvir/velpatasvir/voxilaprevir in patients with severe renal impairment (CrCl 15 to 30 mL/min) should probably be avoided.

Dabigatran Etexilate

Generic Name: dabigatran

Brand name: Pradaxa

Synonyms: Dabigatran

What is Dabigatran Etexilate?

Sofosbuvir, velpatasvir, and voxilaprevir

Generic Name: sofosbuvir / velpatasvir / voxilaprevir

Brand name: Vosevi

Synonyms: Sofosbuvir, Velpatasvir, and Voxilaprevir

What is Sofosbuvir, velpatasvir, and voxilaprevir?