Astagraf XL and Dabigatran Etexilate

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.

Tacrolimus may increase the blood levels and effects of dabigatran. Combining these medications may increase the risk of anemia and 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, 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.

MONITOR: Coadministration with potent inhibitors of P-glycoprotein (P-gp) may increase the bioavailability of dabigatran following oral administration of dabigatran etexilate, which is a substrate of the efflux transporter. Ketoconazole, a potent P-gp inhibitor, increased dabigatran peak plasma concentration (Cmax) and systemic exposure (AUC) by 135% and 138%, respectively, after a single dose of 400 mg, and 149% and 153%, respectively, after multiple daily doses of 400 mg. In three female study subjects administered dabigatran with 600 mg quinidine sulfate, another potent P-gp inhibitor, systemic exposure to dabigatran was approximately twice that expected with dabigatran alone. In a separate study, administration of dabigatran over 3 days following pretreatment with quinidine (200 mg every 2 hours up to a total dose of 1000 mg) resulted in a 56% increase in dabigatran Cmax and a 53% increase in AUC compared to administration without quinidine. When dabigatran etexilate was coadministered with a single 600 mg oral dose of amiodarone, also considered a potent P-gp inhibitor, dabigatran Cmax and AUC increased by 50% and 58%, respectively. Another P-gp inhibitor, dronedarone, increased dabigatran AUC by 1.7- to 2-fold. In contrast, when dabigatran etexilate was coadministered with the potent P-gp inhibitor clarithromycin (500 mg twice a day) in healthy volunteers, dabigatran Cmax increased by only 15% and AUC by only 19%.

MANAGEMENT: Pharmacologic response to dabigatran should be monitored more closely whenever a potent P-gp inhibitor 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. The use of dabigatran with potent P-gp inhibitors in patients with severe renal impairment (CrCl 15 to 30 mL/min) should be avoided.

Astagraf XL

Generic Name: tacrolimus

Brand name: Astagraf XL, Envarsus XR, Prograf, Hecoria

Synonyms: n.a.

What is Astagraf XL?

Dabigatran Etexilate

Generic Name: dabigatran

Brand name: Pradaxa

Synonyms: Dabigatran

What is Dabigatran Etexilate?