FDA and EMA recommendations for anticoagulant dosing for AF or VTE in individuals with liver disease

Oral anticoagulant agent	Child-Pugh class	US Food and Drug Administration (FDA)	European Medicines Agency (EMA)
Warfarin	A	Therapeutic INR	Therapeutic INR
	B	Therapeutic INR	Therapeutic INR
	C	Therapeutic INR	Therapeutic INR
Apixaban	A	No dose adjustment	Use with caution; no dose adjustment
	B	Use with caution; no dose adjustment	Use with caution; no dose adjustment
	C	Not recommended	Not recommended
Dabigatran	A	No dose adjustment	Not recommended if AST/ALT >2 × ULN or liver disease expected to affect survival
	B	Use with caution; no dose adjustment	Not recommended if AST/ALT >2 × ULN or liver disease expected to affect survival
	C	Not recommended	Not recommended if AST/ALT >2 × ULN or liver disease expected to affect survival
Edoxaban	A	No dose adjustment	Use with caution, particularly if AST/ALT >2 × ULN or total bilirubin >1.5 × ULN; no dose adjustment
	B	Not recommended	Use with caution, particularly if AST/ALT >2 × ULN or total bilirubin >1.5 × ULN; no dose adjustment
	C	Not recommended	Not recommended
Rivaroxaban	A	No dose adjustment	No dose adjustment
	B	Not recommended	Not recommended
	C	Not recommended	Not recommended

Recommendations from the FDA and the EMA are shown for each Child-Pugh class. These generally apply to patients with a relatively stable clinical status. Refer to UpToDate for specific clinical scenarios and additional factors in the choice and dosing of anticoagulants in individuals with liver disease.

FDA: US Food and Drug Administration; EMA: European Medicines Agency; AF: atrial fibrillation; VTE: venous thromboembolism; INR: international normalized ratio; AST: aspartate aminotransferase; ALT: alanine aminotransferase; ULN: upper limit of normal.

Original table modified for this publication. From: Qamar A, Vaduganathan M, Greenberger NJ, Giugliano RP. Oral anticoagulation in patients with liver disease. J Am Coll Cardiol 2018; 71:2162. Table used with the permission of Elsevier Inc. All rights reserved.

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