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Medicines Monitoring

Dronedarone monitoring

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Topics: DronedaroneMonitoring
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. After started or dose changed
    1. Required
  3. Ongoing once stable
    1. Required
  4. Abnormal results
    1. Hepatic function
  5. Notes
    1. Advice to patients
  6. Bibliography

Before starting

Required

  • Baseline
    • ECG
    • Liver function testscontraindicated if severe hepatic impairment
    • Urea and electrolytes
    • Serum creatinine (for creatinine clearance) or Estimated glomerular filtration ratedo not initiate if CrCl or eGFR less than 30ml/min/1.73m2
    • Serum magnesiumcorrect as necessary before initiation
    • Serum potassiumcorrect as necessary before initiation

After started or dose changed

Required

  • At 7 day intervals as necessary
    • Serum creatinine (for creatinine clearance)if raised, wait 7 days and measure again; consider stopping if continues to rise
  • After 7 days; then after 1 month
    • Liver function testscontraindicated if severe hepatic impairment

Renal function during early treatment

A slight increase in creatinine (average 10 micromoles/L) has been observed early on in treatment; in most cases reaching a plateau after 7 days. If an increase is observed, creatinine should be remeasured after another 7 days. Further increases should prompt consideration of further investigation and treatment discontinuation.

Ongoing once stable

Required

  • At 6 months
    • ECG
  • Annually
    • Serum creatinine (for creatinine clearance)
  • Monthly for the first 6 months; then at month 9 and 12; then annually
    • Liver function testscontraindicated if severe hepatic impairment
  • Periodically
    • Symptoms of heart failure
    • Lung disease screening

Responding to ECG results

  • If AF recurs during treatment, consider cessation of dronedarone. If permanent AF develops, dronedarone should be stopped
  • If QTc Bazett interval is above 500 milliseconds, dronedarone should be stopped

When to consider lung disease screening

Onset of dyspnoea or non-productive cough may indicate pulmonary toxicity. Consider lung examinations and discontinued if suspected.

Abnormal results

Hepatic function

Dronedarone is contraindicated in patients with severe hepatic impairment.

  • If ALT (alanine aminotransferase) levels are greater than 3 x the upper limit of normal, ALT levels should be re-measured within 48 to 72 hours.
  • After re-measure, if ALT levels are confirmed to be greater than 3 x the upper limit of normal, treatment with dronedarone should be withdrawn. Appropriate investigation and close observation of patients should continue until normalisation of ALT.

Notes

Advice to patients

Advise patients to be aware of:

  • signs of heart failure, such weight gain, dependent oedema, or dyspnoea and to seek prompt medical attention if these develop
  • signs of liver disorder such as abdominal pain, anorexia, nausea, vomiting, fever, malaise, itching, dark urine, or jaundice and to seek prompt medical attention if these develop

Bibliography

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