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Multaq (DRONEDARONE)
Multaq works by blocking abnormal electrical signals in the heart to restore a normal heartbeat.
Multaq (Dronedarone) is a small molecule antiarrhythmic drug developed by Sanofi Aventis US, targeting the potassium voltage-gated channel subfamily KQT member 2. It was FDA-approved in 2009 for the treatment of atrial fibrillation and paroxysmal atrial fibrillation. As a commercial product, its status is patented, with a single generic manufacturer available. Key safety considerations include its potential to increase the risk of heart failure and other cardiovascular events. The drug has a half-life of 16 hours.
At a glance
| Generic name | DRONEDARONE |
|---|---|
| Sponsor | Sanofi |
| Drug class | Antiarrhythmic [EPC] |
| Target | Potassium voltage-gated channel subfamily KQT member 2 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2009 |
Mechanism of action
The mechanism of action of dronedarone is unknown. Dronedarone has antiarrhythmic properties belonging to all four Vaughan-Williams classes, but the contribution of each of these activities to the clinical effect is unknown.
Approved indications
- Atrial fibrillation
- Paroxysmal atrial fibrillation
Boxed warnings
- WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION In patients with symptomatic heart failure and recent decompensation requiring hospitalization or NYHA Class IV heart failure, MULTAQ doubles the risk of death [see Clinical Studies (14.3) ] . MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure [see Contraindications (4) , Warnings and Precautions (5.1) ] . In patients with permanent atrial fibrillation, MULTAQ doubles the risk of death, stroke and hospitalization for heart failure [see Clinical Studies (14.4) ] . MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm [see Contraindications (4) , Warnings and Precautions (5.2) ] . WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION See full prescribing information for complete boxed warning. MULTAQ is contraindicated in patients with symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV heart failure. MULTAQ doubles the risk of death in these patients. ( 4 , 5.1 , 14.3 ) MULTAQ is contraindicated in patients in atrial fibrillation (AF) who will not or cannot be cardioverted into normal sinus rhythm. In patients with permanent AF, MULTAQ doubles the risk of death, stroke, and hospitalization for heart failure. ( 4 , 5.2 , 14.4 )
Common side effects
- QTc prolonged
- Early increases in creatinine >=10%
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Dyspeptic signs and symptoms
- Asthenic conditions
- Bradycardia
- Skin and subcutaneous tissue rashes
- Photosensitivity reaction
- Dysgeusia
Drug interactions
- High Risk QT Prolonging Agents
- P-glycoprotein Substrates
- atazanavir
- boceprevir
- ciclosporin
- conivaptan
- erythromycin
- indinavir
- ketoconazole
- mibefradil
- nalidixic acid
- nefazodone
Key clinical trials
- Efficacy of Early Rhythm Control Therapy in Patients With Subclinical Atrial Fibrillation (NA)
- Pulsed Field Ablation (PFA) vs Anti-Arrhythmic Drug (AAD) Therapy as a First Line Treatment for Persistent Atrial Fibrillation (NA)
- Bioequivalence Study of Dronedarone Hydrochloride Tablets in Healthy Subjects Under Fasting Conditions (NA)
- Bioequivalence Study of Dronedarone Hydrochloride Tablets (NA)
- Dronedarone Rhythm Intervention for Early Atrial Fibrillation (PHASE4)
- Effect of Dronedarone on Atrial Fibrosis Progression and Atrial Fibrillation Recurrence (PHASE4)
- Pacing of Left Bundle Branch Area and Atroventricular Node ablatIon in Patients With Symptomatic Atrial Fibrillation (NA)
- Non-vitamin K Antagonist Oral Anticoagulants in Patients With Atrial High Rate Episodes (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Multaq CI brief — competitive landscape report
- Multaq updates RSS · CI watch RSS
- Sanofi portfolio CI