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Dronedarone

Class
Antiarrhythmics
Subclass
Class III antiarrhythmics
Substance name
Dronedarone
Brand names
Multaq®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
Treatment
AF • Paroxysmal or persistent, maintenance of rhythm control
•
400 mg PO BID
Administered in patients in sinus rhythm.
Secondary prevention
Secondary prevention of atrial flutter • Paroxysmal, associated with disabling symptoms • Off-label
•
400 mg PO BID
Indications for use
Labeled indications
Adults
•
Treatment of AF (paroxysmal or persistent, maintenance of rhythm control)
Off-label indications
Adults
•
Secondary prevention of atrial flutter (paroxysmal, associated with disabling symptoms)
Safety risks
Boxed warnings
Exacerbation of HF
HF
Contraindications
Hypersensitivity to dronedarone or any of its components
Bradycardia <50 bpm
Liver or lung toxicity related to the previous use of amiodarone
QTc interval >500 ms or PR interval >280 ms
Second or third-degree AV block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker)
Concomitant use of a strong CYP3A inhibitor
Concomitant use of drugs or herbal products that prolong the QT interval and may induce torsade de pointes
Concomitant use of erythromycin
Warnings and precautions
Cardiovascular risk
•
Use caution in all patients. Monitor cardiac rhythm no less often than every 3 months.
Hepatocellular injury
•
Maintain a high level of suspicion, as hepatocellular liver injury, including ALF requiring transplant, has been reported in patients treated with dronedarone.
HF
•
Maintain a high level of suspicion, as new onset or worsening of HF has been reported during treatment with dronedarone.
Hypokalemia, hypomagnesemia
•
Use caution in patients with concomitant administration of potassium-depleting diuretics.
ILD
•
Maintain a high level of suspicion, as cases of ILD including pneumonitis and pulmonary fibrosis have been reported in patients treated with dronedarone.
Prolonged QT interval
•
Use caution in patients with an uncorrected electrolyte imbalance or use of medications known to cause electrolyte imbalances.
Specific populations
Renal impairment
eGFR 30-50 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required. Monitor serum creatinine.
eGFR 10-30 mL/min/1.73 m²
•
Avoid use as much as possible. Use with caution. Monitor serum creatinine. Contraindicated by manufacturer in the UK but no dose alteration in the USA for severe renal impairment.
eGFR < 10 mL/min/1.73 m²
•
Avoid use as much as possible. Use with caution. Monitor serum creatinine. Contraindicated by manufacturer in the UK but no dose alteration in the USA for severe renal impairment.
Renal replacement therapy
Continuous renal replacement
•
Use with caution. Monitor serum creatinine.
Intermittent hemodialysis
•
Use with caution. Monitor serum creatinine.
Peritoneal dialysis
•
Use with caution. Monitor serum creatinine.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: D
•
Avoid use. Evidence of fetal harm in humans. Adequate methods of contraception should be encouraged.
•
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
Breastfeeding
Acceptable for use during breastfeeding.
•
Do not use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
↑QTc interval
Common 1-10%
•
Atrial flutter, bradycardia, heart failure, ↑ serum creatinine, maculopapular rash, photosensitivity of skin, abdominal pain, asthenia, diarrhea, dysgeusia, dyspepsia, itching, nausea, skin rash, vomiting, stroke
Uncommon < 1%
•
Hepatitis, hypothyroidism, peripheral neuropathy
Unknown frequency
•
Acute liver failure, angioedema, coagulopathy, ↓ serum magnesium, ↓ serum potassium, exacerbation of arrhythmia, hepatic encephalopathy, hepatic necrosis, ↑ BUN, ↑ serum TBIL, jaundice, pneumonitis, pulmonary fibrosis, renal failure, weakness, torsade de pointes, vasculitis
Interactions
Drug(s)
Check Interactions
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