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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
  3. After started or dose changed
    1. Required
  5. Ongoing once stable
    1. Required
  7. Abnormal results
    1. Liver function
    2. Renal function
    3. Electrolyte imbalances
    4. Cardiovascular effects
  9. Notes
    1. Advice to patients
  11. Bibliography
  12. Update history

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

  • After 7 days
    • Serum creatinine (for creatinine clearance)if raised, measure again after a further 7 days; consider stopping if continues to rise
  • After 7 days; then after 1 month
    • Liver function tests

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. If there is no further increase, this should be used as the new reference baseline.

Ongoing once stable

Required

  • Every 6 months
    • Urea and electrolytesincluding magnesium and potassium
    • Serum creatinine (for creatinine clearance)
    • ECGmonitor at least every 6 months
  • Monthly for the first 6 months; then at month 9 and 12; then every 6 months
    • Liver function tests
  • Periodically
    • Symptoms of heart failuresuch as, development of or worsening weight gain, dependent oedema or increased dyspnoea
    • Chest X-ray and pulmonary function testsif pulmonary toxicity is suspected

When to consider lung disease screening

New or worsening non-productive cough, shortness of breath or deterioration in general health such as, fatigue, weight loss, fever may indicate pulmonary toxicity. Continue treatment but refer urgently to the initiating specialist and respiratory specialist.

Abnormal results

Liver function

Treatment should be discontinued if severe liver function abnormalities or clinical signs of liver disease develop.

Serum transaminases more than 3 times upper limit of normal, but no symptoms of hepatic injury

Continue dronedarone and repeat liver function tests in 48 to 72 hours. If still elevated, stop dronedarone and discuss with initiating specialist urgently.

Serum transaminases more than 5 times upper limit of normal or any symptoms of hepatic injury

Stop dronedarone. Urgently refer to initiating specialist and hepatologist.

Renal function

  • If creatinine level is elevated from baseline, stop dronedarone and discuss urgently with the specialist.
  • If creatinine clearance falls below 30 mL/minute/ 1.73m2, stop dronedarone and refer urgently to the specialist

Electrolyte imbalances

Hypokalaemia or hypomagnesaemia, refer to SPS guidance Treating acute hypokalaemia in adults or Treating acute hypomagnesaemia in adults. Alternatively, correct as per local guidance and continue dronedarone.

Cardiovascular effects

Bradycardia

  • Heart rate 50 to 60 bpm and not symptomatic – continue to monitor heart rate; no action required unless symptoms develop or heart rate decreases further.
  • Heart rate less than or equal to 50bpm, or less than or equal to 60bpm and symptomatic – seek specialist advice; dose reduction may be required.

Worsening of arrhythmia, new arrhythmia or heart block

  • Stop dronedarone; seek urgent specialist advice.

Recurrence of atrial fibrillation

  • If atrial fibrillation recurs during treatment, consider cessation of dronedarone.
  • Discontinue treatment if permanent atrial fibrillation for 6 months or longer develops.

QTc interval prolongation

  • Stop dronedarone if QTc Bazett interval is 500 milliseconds or above and refer urgently to the specialist team.

Symptoms of heart failure

  • Stop treatment if congestive heart failure develops and refer urgently to the specialist team.

Notes

Advice to patients

Advise patients to be aware of and report any of the following to their primary care prescriber without delay:

  • Signs or symptoms of pulmonary toxicity, such as breathlessness, non-productive cough or deterioration in general health (fatigue, weight loss, fever)
  • Signs or symptoms of liver injury, such as abdominal pain, loss of appetite, nausea, vomiting, fever, malaise, fatigue, itching, dark urine, or yellowing of skin or eyes
  • Signs or symptoms of heart failure, such as development or worsening of weight gain, dependent oedema, or increased dyspnoea
  • Signs or symptoms of bradycardia, such as dizziness, fatigue, fainting, shortness of breath, chest pain or palpitations, confusion or trouble concentrating

Bibliography

Update history

  1. Full review and update. Additional information in abnormal results section added for renal function, electrolyte imbalances and cardiovascular effects.
  1. Published

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