Dosing considerations for patients with renal or hepatic impairment
|
Renal impairment1 |
|
|
Mild (CrCl 51–80 ml/min) or moderate |
No dose adjustment required in the absence of other dose reduction criteria* |
|
Severe renal impairment |
Dose reduction to 2.5 mg BD |
|
Renal failure (CrCl <15 ml/min) |
Not recommended |
|
Dialysis |
Not recommended |
*In NVAF patients with serum creatinine ≥ 1.5 mg/dL (133 micromole/L) associated with age ≥ 80 years or body weight ≤ 60 kg, a dose reduction to 2.5mg twice daily is necessary. In the absence of other criteria for dose reduction (age, body weight), no dose adjustment is necessary
Only ELIQUIS (apixaban) is suggested as a consideration by NICE CG182 over warfarin for patients with NVAF and moderate renal impairment2
NICE CKD Clinical Guideline (CG182, 2014)2
“Consider apixaban in preference to warfarin in people with confirmed eGFR of 30–50 ml/min/1.73 m2 and NVAF who have =1 of the following risk factors: prior stroke or transient ischaemic attack; age =75; hypertension; diabetes mellitus; symptomatic heart failure”
ELIQUIS, dabigatran etexilate, rivaroxaban and VKA are all recommended by NICE Clinical Guideline 180 (NICE CG180, 2014) as anticoagulation therapy options for the prevention of stroke in patients with NVAF (in line with their respective marketing authorisations).3 Edoxaban was not considered for inclusion in either of the NICE guidelines (NICE CG180, 2014 and NICE CG182, 2014) as it did not have EU marketing authorisation at the time of publication. However, edoxaban has now received NICE Technology Appraisal guidance and is recommended as an option for preventing stroke and systemic embolism in patients with NVAF and one or more risk factors, in line with its marketing authorisations.4
|
Hepatic impairment1 |
|
|
Mild or moderate hepatic impairment |
Use with caution |
|
Severe hepatic impairment |
Not recommended |
|
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk |
Contraindicated |
Patients with elevated liver enzymes ALT / AST >2 x ULN or total bilirubin ≥1.5 x ULN were excluded in clinical trials. Therefore, ELIQUIS should be used cautiously in this population. Prior to initiating ELIQUIS, liver function testing should be performed.1
|
Renal impairment1 |
|
|
Mild (CrCl 51–80 ml/min) or moderate (CrCl 30–50 ml/min) renal impairment |
No dose adjustment required |
|
Severe renal impairment (CrCl 15–29 ml/min) |
ELIQUIS to be used with caution |
|
Renal failure (CrCl <15 ml/min) |
Not recommended |
|
Dialysis |
Not recommended |
|
Hepatic impairment1 |
|
|
Mild or moderate hepatic impairment |
ELIQUIS is to be used with caution |
|
Severe hepatic impairment |
Not recommended |
|
Hepatic disease associated with coagulopathy and clinically relevant bleeding risk |
Contraindicated |
Patients with elevated liver enzymes ALT / AST >2 x ULN or total bilirubin ≥1.5 x ULN were excluded in clinical trials. Therefore, ELIQUIS should be used cautiously in this population. Prior to initiating ELIQUIS, liver function testing should be performed.1
Please click here to access the ELIQUIS Patient Information Leaflet.
ALT = Alanine Aminotransferase
AST = Aspartate Aminotransferase
BD = Twice Daily
CKD = Chronic Kidney Disease
CrCl = Creatinine Clearance
eGFR = Estimated Glomerular Filtration Rate
NICE = National Institute for Health and Care Excellence
NVAF = Non-Valvular Atrial Fibrillation
ULN = Upper Limit of Normal
VKA = Vitamin K Antagonist
* Not all patients who start on ELIQUIS for acute DVT / PE will stay on ELIQUIS; some acute DVT / PE patients who receive treatment do not require treatment for the prevention of recurrent DVT / PE. Other patients may be prescribed ELIQUIS for the prevention of recurrent VTE after initial treatment for acute DVT / PE with another anticoagulant.1 This is a decision for the prescribing clinician together with patient involvement in the decision-making.
References
- ELIQUIS® (apixaban) Summary of Product Characteristics.
- NICE clinical guideline 182.Chronic kidney disease in adults: assessment and management. July 2014. Last updated January 2015. Available at https://www.nice.org.uk/guidance/cg182. Last accessed February 2019.
- NICE clinical guideline 180. Atrial fibrillation: management. June 2014. Last updated August 2014. Available at https://www.nice.org.uk/guidance/cg180. Last accessed February 2019.
- NICE technology appraisal guidance TA355. Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation. September 2015. Available at https://www.nice.org.uk/guidance/ta355. Last accessed February 2019.