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if ALT levels are confirmed to be greater than 3 x the upper limit of normal, treatment with dronedarone should be withdrawn.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
- Medicines and Healthcare products Regulatory Agency. Dronedarone (Multaq▼): cardiovascular, hepatic and pulmonary adverse events – new restrictions and monitoring requirements. Drug Safety Update Oct 2011, vol 5 issue 3: A1. [cited 01/07/2000]
- Dronedarone for the maintenance of sinus rhythm in patients with non-permanent (paroxysmal/ persistent) atrial fibrillation (AF). South London Cardiac and Stroke Network. Published Nov 2011. [cited 30/07/2020]
- Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [cited 31/05/2020]
- Aventis Pharma Limited. Summary of Product Characteristics – Multaq 400mg film-coated tablets. Last revised 09/2019 [cited 30/07/2020]
- Guys and St Thomas’ NHS Foundation Trust Clinical Guideline: Prescribing dronaderone for the maintenance of sinus rhythm after successful cardioversion of atrial fibrillation (June 2018; due for review June 2021).