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Medicines Monitoring

DOACs (Direct Oral Anticoagulants) monitoring

Last updated
Topics: ApixabanDabigatran etexilateEdoxaban · MonitoringRivaroxaban ·
Using this page · Individualise medicines monitoring

This medicines monitoring page has been written using publications and expert opinion. It is designed to save clinician time, but not replace professional responsibility. When using this page you should: ensure an individualised monitoring plan is developed in partnership with the patient and take account of any locally agreed advice and guidance.

Contents

  1. Before starting
    1. Required
    2. Consider
  3. After started or dose changed
    1. Required
  5. Ongoing once stable
    1. Required
  7. Abnormal results
    1. Apixaban
    2. Dabigatran
    3. Edoxaban
    4. Rivaroxaban
  9. Notes
    1. What to assess at a review appointment
  11. Bibliography
  12. Update history

Before starting

Required

  • Baseline
    • Baseline clotting screening
    • Body weightFor NVAF use actual body weight in the Cockcroft-Gault equation from the last 12 months (unless there is recent weight loss or gain). Consider using adjusted bodyweight if patient more than 120kg or has BMI greater 40, unless otherwise advised by local guidance or anticoagulation clinic.
    • Full blood count
    • Liver function tests
    • Serum creatinine (for creatinine clearance)
    • Urea and electrolytes

Monitoring renal function

Cockcroft and Gault is recommended for calculating creatinine clearance for DOACs. Estimated glomerular filtration rate can overestimate renal function and increase risk of bleeding events.

HAS-BLED

If the patient’s HAS-BLED score is more than 3, there is high risk of bleeding and DOAC should be used cautiously, with regular reviews.

ORBIT

If the patient’s ORBIT score is more than 4, there is high risk of bleeding and DOAC should be used cautiously, with regular reviews.

Consider

  • Baseline
    • Blood pressurefor calculation of HAS-BLED score if required

After started or dose changed

Required

  • After 1 month
    • DOAC review appointment

Ongoing once stable

Required

  • Annually; more frequently if clinical concerns
    • Full blood count
    • Liver function tests
    • Urea and electrolytes
    • Serum creatinine (for creatinine clearance)
    • DOAC review appointmentA more frequent review may be required depending on patient factors, such as renal impairment, age, and comorbidities.

When to consider more frequent monitoring

Consider monitoring more frequently instead of annually in the following people at increased risk of bleeding, for example people who:

  • are over 75 years or frail; for example, expert opinion suggests monitoring every 4 months
  • are prescribed concomitant medicines or have an intercurrent illness which may affect renal or hepatic function
  • have renal impairment (creatinine clearance below 60mL/min); for example, expert opinion suggests the frequency of renal function monitoring (in months) may be guided by creatinine clearance divided by 10

Abnormal results

Responding to abnormal results for DOACs is dependent on the individual medicine prescribed.

Apixaban

Renal function

Take action if creatinine or creatinine clearance abnormal:

  • CrCL less than 15mL/min: avoid apixaban; assess for bleeding or anaemia; seek advice regarding alternative anticoagulant therapy
  • CrCL 15-29mL/min and apixaban prescribed for prevention of recurrent DVT, PE, and treatment of DVT or PE, then continue with caution
  • CrCL 15-29mL/min and apixaban prescribed for prophylaxis of stroke and systemic embolism in a person with NVAF, reduce dose to 2.5mg twice daily

Reduce dose for old age, low body weight, high creatinine

Use 2.5 mg twice daily if NVAF and two or more of:

  • age ≥ 80 years
  • body weight ≤ 60 kg
  • serum creatinine ≥ 1.5 mg/dL (133 micromol/L)

Decreased haemoglobin or bleeding

If there is an unexplained fall in haemoglobin or haematocrit, occult bleeding may be present (apixaban can cause bleeding from any site). Consider the need for stopping treatment and seek specialist advice.

Hepatic impairment

Use with caution in those with:

  • mild or moderate hepatic impairment (Child Pugh A or B)
  • ALT or AST over 2 times the upper limit of normal
  • total bilirubin over 1.5 times the upper limit of normal

Use is not recommended in:

  • severe hepatic impairment

Avoid in:

  • hepatic disease associated with coagulopathy and clinically relevant bleeding risk

Dabigatran

Renal function

Take action if creatinine clearance abnormal:

  • CrCL less than 30mL/min: avoid dabigatran
  • CrCL 30-50mL/min: a reduction in dose may be required, consult product literature

Hepatic function

Use is not recommended when:

  • ALT or AST greater than 2 times the upper limit of normal

Avoid in:

  • severe impairment
  • hepatic disease expected to have any impact on life expectancy

Reduce dose in elderly or if verapamil prescribed

If the person is elderly or taking concomitant verapamil, consult product literature for advice on dose reduction.

Edoxaban

Renal function

Take action if creatinine clearance abnormal:

  • CrCL less than 15mL/min: edoxaban is not recommended, assess for bleeding or anaemia and seek advice regarding alternative anticoagulant therapy
  • CrCL 15-50mL/min: reduce dose to 30mg once daily
  • CrCL over 100mL/min: re-evaluate treatment choice and consider alternative. A trend towards decreasing efficacy with increasing creatinine clearance has been observed compared to well managed warfarin. Edoxaban should only be used in NVAF after a careful evaluation of the individual thromboembolic and bleeding risk.

Hepatic function

Use with caution in:

  • mild to moderate impairment
  • ALT or AST over 2 times the upper limit of normal
  • total bilirubin over 1.5 times the upper limit of normal

Use is not recommended in:

  • severe impairment

Avoid in:

  • hepatic disease associated with coagulopathy and clinically relevant bleeding risk

Rivaroxaban

Renal function

Take action if creatinine clearance abnormal:

  • CrCL less than 15mL/min: rivaroxaban not recommended
  • CrCL 15-49mL/min: see product literature for indication specific advice

Hepatic impairment

Manufacturer advises avoid in hepatic disease with coagulopathy and clinically-relevant bleeding risk including patients with Child Pugh B and C.

Notes

What to assess at a review appointment

No routine anticoagulation monitoring is needed for DOACs; however, conduct review appointments regularly at which you should:

  • assess adherence to treatment
  • look for signs of bleeding or anaemia
  • ask about other adverse effects of DOAC
  • assess for features of thromboembolic events, such as symptoms of stroke, or breathlessness (which may suggest a pulmonary embolism)
  • ask about the use of other medications, including over-the-counter (OTC) products, to identify possible drug interactions with DOAC
  • assess and minimise modifiable risk factors for bleeding, such as uncontrolled hypertension, medication predisposing for bleeding (such as aspirin), and excessive alcohol intake and falls
  • give appropriate information and advice on DOAC treatment

Bibliography

Update history

  1. Republished
  2. Full review and update. Minor changes to wording and structure, but no significant changes to clinical content.
  1. Creatinine clearance when treatment choice should be re-evaluated for edoxaban and an alternative considered changed from over 80mL/min to over 100mL/min.
  1. Further clarity added to which patients require more frequent monitoring.
  1. Updates made to 'Ongoing once stable' section following updates to NICE CKS.
  1. Updated to reflect the 2021 European Heart Rhythm Association Practical Guide on the Use of Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation and MHRA Drug Safety Update. Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents (June 2020) Hepatic function related advice added for edoxaban.
  1. Published