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For US Residents Only


 * Prescribing Information
 * Medical Information
 * Patient Website
 * Request Samples

 * Indication: MULTAQ is an antiarrhythmic drug indicated to reduce the risk of
   hospitalization for atrial fibrillation (AFib) in patients in sinus rhythm
   with a history of paroxysmal or persistent AFib.

 * For US Residents Only

 * 
 * 

 * Request Samples

 * Home
 * Efficacy
   
   * skip Safety
   * Study Design
   * AFib Recurrence
   * CV Hospitalization
 * Safety
 * Dosing
   
   * skip Access & Support
   * Dosing
   * Administration
 * Access & Support
   
   * skip Resources
   * Access
   * Formulary Coverage
 * Resources
   
   * skip exit
   * AFib Guidelines
   * All Resources

 * Prescribing Information
 * Medical Information
 * Patient Website
 * Request Samples

MULTAQ® IS RECOMMENDED 1ST-LINE FOR SINUS RHYTHM MAINTENANCE





 *   AHA/ACC/HRS

 *   ESC


 * FROM THE 2014 AHA/ACC/HRS GUIDELINE FOR THE MANAGEMENT OF PATIENTS WITH
   ATRIAL FIBRILLATION: EXECUTIVE SUMMARY1
   
    * When a rhythm-control strategy is desired, AAD therapy may be selected
      based on patient characteristics1
    * Risks of AAD therapy should be considered before initiating therapy1
    * Strategies for drug and procedure selection can be guided by the presence
      or absence of structural heart disease
    * MULTAQ is recommended for patients with AFib to maintain sinus rhythm,
      depending on underlying heart disease and comorbidities
      (Class 1A)1
      * Before initiating AAD therapy, treatment of precipitating or reversible
        causes of AFib is recommended
   
   
   RECOMMENDED STRATEGIES FOR RHYTHM CONTROL IN PATIENTS WITH PAROXYSMAL AND
   PERSISTENT AF1
   
   
   
   NOTE: Amiodarone should only be used after consideration of risks and when
   other agents have failed or are contraindicated due to its potential
   toxicities (Class 1C).
   
   
   
   Graphic created by Sanofi and adapted from guidelines.
   The above are excerpts only. Click here for full AHA/ACC/HRS Guideline. 
   
   a Catheter ablation is only recommended as first-line therapy for patients
   with paroxysmal AF (class IIa recommendation).
   b Drugs are listed alphabetically.
   c Depending on patient preference when performed in experienced centers.
   d Not recommended with severe LVH (wall thickness >1.5 cm).
   e Should be used with caution in patients at risk for torsades de pointes
   ventricular tachycardia.
   f Should be combined with atrioventricular nodal-blocking agents.
   
   
   


 * FROM THE 2020 ESC GUIDELINES FOR THE DIAGNOSIS AND MANAGEMENT OF ATRIAL
   FIBRILLATION DEVELOPED IN COLLABORATION WITH THE EUROPEAN ASSOCIATION FOR
   CARDIO-THORACIC SURGERY (EACTS)2
   
    * Strategies for drug and procedure selection can be based on the underlying
      disease:
   
   
   RECOMMENDED STRATEGIES FOR LONG-TERM RHYTHM CONTROL THERAPY:
   
   
   
   The above are excerpts only. Click here for full ESC Guidelines.
   
   






MULTAQ HAS PROVEN EFFICACY ACROSS MULTIPLE MEASURES3

View efficacy







AAD=antiarrhythmic drug
ACC=American College of Cardiology
AFib=atrial fibrillation
AHA=American Heart Association
ECG=electrocardiogram
ESC=European Society of Cardiology
RRR=relative risk reduction


REFERENCES

 1. January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the
    management of patients with atrial fibrillation. J Am Coll Cardiol.
    2014;64(21):e1-e76.

 2. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC guidelines for the
    diagnosis and management of atrial fibrillation developed in collaboration
    with the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart
    J. 2020;42(5):373-498.

 3. MULTAQ [package insert]. Bridgewater, NJ. sanofi-aventis U.S. LLC; 2017.
    USPI - NOV-2020 (v2.0).


INDICATION

MULTAQ is an antiarrhythmic drug indicated to reduce the risk of hospitalization
for atrial fibrillation (AFib) in patients in sinus rhythm with a history of
paroxysmal or persistent AFib.








IMPORTANT SAFETY INFORMATION


IMPORTANT SAFETY INFORMATION

WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH
DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION

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.

MULTAQ is contraindicated in patients in atrial fibrillation (AFib) who will not
or cannot be cardioverted into normal sinus rhythm. In patients with permanent
AFib, MULTAQ doubles the risk of death, stroke, and hospitalization for heart
failure.


MULTAQ is also contraindicated in patients:

 * With second- or third-degree atrioventricular (AV) block or sick sinus
   syndrome (except when used in conjunction with a functioning pacemaker),
   bradycardia <50 bpm, QTc Bazett interval ≥500 ms or PR interval >280 ms
 * Who are or may become pregnant (Category X) or nursing. MULTAQ may cause
   fetal harm when administered to a pregnant woman
 * With concomitant use of strong CYP 3A inhibitors, such as ketoconazole,
   itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin,
   nefazodone, ritonavir, or drugs or herbal products that prolong the QT
   interval and might 
 * increase the risk of Torsade de Pointes, such as phenothiazine
   antipsychotics, tricyclic antidepressants, certain oral macrolide 
 * antibiotics, and Class I and III antiarrhythmics
 * With liver or lung toxicity related to the previous use of amiodarone
 * With severe hepatic impairment
 * With hypersensitivity to the active substance or to any of the excipients

Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure

MULTAQ is contraindicated in patients with NYHA Class IV heart failure or
symptomatic heart failure with recent decompensation requiring hospitalization
because it doubles the risk of death.

Cardiovascular Death and Heart Failure in Permanent AFib

MULTAQ doubles the risk of cardiovascular death (largely arrhythmic) and heart
failure events in patients with permanent AFib. Patients treated with MULTAQ
should undergo monitoring of cardiac rhythm no less often than every 3 months.
Cardiovert patients who are in AFib (if clinically indicated) or discontinue
MULTAQ. MULTAQ offers no benefit in subjects in permanent AFib.

Increased Risk of Stroke in Permanent AFib

In a placebo-controlled study in patients with permanent AFib, dronedarone was
associated with an increased risk of stroke, particularly in the first two weeks
of therapy. MULTAQ should only be initiated in patients in sinus rhythm who are
receiving appropriate antithrombotic therapy.

New Onset or Worsening Heart Failure

New onset or worsening of heart failure has been reported during treatment with
MULTAQ in the postmarketing setting. In a placebo-controlled study in patients
with permanent AFib, increased rates of heart failure were observed in patients
with normal left ventricular function and no history of symptomatic heart
failure, as well as those with a history of heart failure or left ventricular
dysfunction.

Advise patients to consult a physician if they develop signs or symptoms of
heart failure, such as weight gain, dependent edema, or increasing shortness of
breath. If heart failure develops or worsens and requires hospitalization,
discontinue MULTAQ.

Liver Injury

Hepatocellular liver injury, including acute liver failure requiring transplant,
has been reported in patients treated with MULTAQ in the postmarketing setting.
Advise patients treated with MULTAQ to report immediately symptoms suggesting
hepatic injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue,
right upper quadrant pain, jaundice, dark urine, or itching). Consider obtaining
periodic hepatic serum enzymes, especially during the first 6 months of
treatment. It is not known whether routine periodic monitoring of serum enzymes
will prevent the development of severe liver injury. If hepatic injury is
suspected, promptly discontinue MULTAQ and test serum enzymes, aspartate
aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
phosphatase, as well as serum bilirubin, to establish whether there is liver
injury. If liver injury is found, institute appropriate treatment and
investigate the probable cause. Do not restart MULTAQ in patients without
another explanation for the observed liver injury.

Pulmonary Toxicity

Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis
have been reported in patients treated with MULTAQ in the post-marketing
setting. Onset of dyspnea or non-productive cough may be related to pulmonary
toxicity and patients should be carefully evaluated clinically. If pulmonary
toxicity is confirmed, MULTAQ should be discontinued.

Hypokalemia and Hypomagnesemia with Potassium-Depleting Diuretics

Hypokalemia and hypomagnesemia may occur with concomitant administration of
potassium-depleting diuretics. Potassium levels should be within the normal
range prior to administration of MULTAQ and maintained in the normal range
during administration of MULTAQ.

QT Interval Prolongation

MULTAQ induces a moderate (average of about 10 ms but much greater effects have
been observed) QTc (Bazett) prolongation. If the QTc Bazett interval is ≥500 ms,
discontinue MULTAQ.

Renal Impairment and Failure

Marked increase in serum creatinine, pre-renal azotemia and acute renal failure,
often in the setting of heart failure or hypovolemia, have been reported in
patients taking MULTAQ. In most cases, these effects appear to be reversible
upon drug discontinuation and with appropriate medical treatment. Monitor renal
function periodically.

Small increases in creatinine levels (about 0.1 mg/dL) following MULTAQ
treatment initiation have been shown to be a result of inhibition of
creatinine’s tubular secretion. The elevation has a rapid onset, reaches a
plateau after 7 days and is reversible after discontinuation.

Women of Childbearing Potential

Premenopausal women who have not undergone a hysterectomy or oophorectomy must
use effective contraception while using MULTAQ. Dronedarone caused fetal harm in
animal studies at doses equivalent to recommended human doses. Counsel women of
childbearing potential regarding appropriate contraceptive choices.

Drug-Drug Interactions

 * Treatment with Class I or III antiarrhythmics or drugs that are strong
   inhibitors of CYP 3A must be stopped before starting MULTAQ (see
   Contraindications)
 * Patients should be instructed to avoid grapefruit juice beverages while
   taking MULTAQ
 * Calcium channel blockers with depressant effects and beta-blockers could
   increase the bradycardia effects of MULTAQ on conduction

 * In the ANDROMEDA (patients with recently decompensated heart failure) and
   PALLAS (patients with permanent AFib) trials, baseline use of digoxin was
   associated with an increased risk of arrhythmic or sudden death in
   MULTAQ-treated patients 
   compared to placebo. In patients not taking digoxin, no difference in risk of
   sudden death was observed in the MULTAQ vs 
   placebo groups. 
   
   Digoxin can potentiate the electrophysiologic effects of MULTAQ (such as
   decreased AV-node conduction). MULTAQ increases exposure to digoxin. 
   
   Consider discontinuing digoxin. If digoxin treatment is continued, halve the
   dose of digoxin, monitor serum levels closely, and observe for toxicity. 

 * Postmarketing cases of increased INR with or without bleeding events have
   been reported in warfarin-treated patients initiated with MULTAQ. Monitor INR
   after initiating MULTAQ in patients taking warfarin
 * Statins: Avoid simvastatin doses greater than 10 mg daily. Follow statin
   label recommendations for use with CYP 3A and P-gP inhibitors such as MULTAQ

Adverse Reactions

In studies, the most common adverse reactions observed with MULTAQ were
diarrhea, nausea, abdominal pain, vomiting, and asthenia.

Click here for full Prescribing Information, including boxed WARNING.

Click here to learn more about Sanofi’s commitment to fighting counterfeit
drugs.


IMPORTANT SAFETY INFORMATION


IMPORTANT SAFETY INFORMATION

WARNING: INCREASED RISK OF DEATH, STROKE AND HEART FAILURE IN PATIENTS WITH
DECOMPENSATED HEART FAILURE OR PERMANENT ATRIAL FIBRILLATION

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.

MULTAQ is contraindicated in patients in atrial fibrillation (AFib) who will not
or cannot be cardioverted into normal sinus rhythm. In patients with permanent
AFib, MULTAQ doubles the risk of death, stroke, and hospitalization for heart
failure.


MULTAQ is also contraindicated in patients:

 * With second- or third-degree atrioventricular (AV) block or sick sinus
   syndrome (except when used in conjunction with a functioning pacemaker),
   bradycardia <50 bpm, QTc Bazett interval ≥500 ms or PR interval >280 ms
 * Who are or may become pregnant (Category X) or nursing. MULTAQ may cause
   fetal harm when administered to a pregnant woman
 * With concomitant use of strong CYP 3A inhibitors, such as ketoconazole,
   itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin,
   nefazodone, ritonavir, or drugs or herbal products that prolong the QT
   interval and might 
 * increase the risk of Torsade de Pointes, such as phenothiazine
   antipsychotics, tricyclic antidepressants, certain oral macrolide 
 * antibiotics, and Class I and III antiarrhythmics
 * With liver or lung toxicity related to the previous use of amiodarone
 * With severe hepatic impairment
 * With hypersensitivity to the active substance or to any of the excipients

Cardiovascular Death in NYHA Class IV or Decompensated Heart Failure

MULTAQ is contraindicated in patients with NYHA Class IV heart failure or
symptomatic heart failure with recent decompensation requiring hospitalization
because it doubles the risk of death.

Cardiovascular Death and Heart Failure in Permanent AFib

MULTAQ doubles the risk of cardiovascular death (largely arrhythmic) and heart
failure events in patients with permanent AFib. Patients treated with MULTAQ
should undergo monitoring of cardiac rhythm no less often than every 3 months.
Cardiovert patients who are in AFib (if clinically indicated) or discontinue
MULTAQ. MULTAQ offers no benefit in subjects in permanent AFib.

Increased Risk of Stroke in Permanent AFib

In a placebo-controlled study in patients with permanent AFib, dronedarone was
associated with an increased risk of stroke, particularly in the first two weeks
of therapy. MULTAQ should only be initiated in patients in sinus rhythm who are
receiving appropriate antithrombotic therapy.

New Onset or Worsening Heart Failure

New onset or worsening of heart failure has been reported during treatment with
MULTAQ in the postmarketing setting. In a placebo-controlled study in patients
with permanent AFib, increased rates of heart failure were observed in patients
with normal left ventricular function and no history of symptomatic heart
failure, as well as those with a history of heart failure or left ventricular
dysfunction.

Advise patients to consult a physician if they develop signs or symptoms of
heart failure, such as weight gain, dependent edema, or increasing shortness of
breath. If heart failure develops or worsens and requires hospitalization,
discontinue MULTAQ.

Liver Injury

Hepatocellular liver injury, including acute liver failure requiring transplant,
has been reported in patients treated with MULTAQ in the postmarketing setting.
Advise patients treated with MULTAQ to report immediately symptoms suggesting
hepatic injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue,
right upper quadrant pain, jaundice, dark urine, or itching). Consider obtaining
periodic hepatic serum enzymes, especially during the first 6 months of
treatment. It is not known whether routine periodic monitoring of serum enzymes
will prevent the development of severe liver injury. If hepatic injury is
suspected, promptly discontinue MULTAQ and test serum enzymes, aspartate
aminotransferase (AST), alanine aminotransferase (ALT), and alkaline
phosphatase, as well as serum bilirubin, to establish whether there is liver
injury. If liver injury is found, institute appropriate treatment and
investigate the probable cause. Do not restart MULTAQ in patients without
another explanation for the observed liver injury.

Pulmonary Toxicity

Cases of interstitial lung disease including pneumonitis and pulmonary fibrosis
have been reported in patients treated with MULTAQ in the post-marketing
setting. Onset of dyspnea or non-productive cough may be related to pulmonary
toxicity and patients should be carefully evaluated clinically. If pulmonary
toxicity is confirmed, MULTAQ should be discontinued.

Hypokalemia and Hypomagnesemia with Potassium-Depleting Diuretics

Hypokalemia and hypomagnesemia may occur with concomitant administration of
potassium-depleting diuretics. Potassium levels should be within the normal
range prior to administration of MULTAQ and maintained in the normal range
during administration of MULTAQ.

QT Interval Prolongation

MULTAQ induces a moderate (average of about 10 ms but much greater effects have
been observed) QTc (Bazett) prolongation. If the QTc Bazett interval is ≥500 ms,
discontinue MULTAQ.

Renal Impairment and Failure

Marked increase in serum creatinine, pre-renal azotemia and acute renal failure,
often in the setting of heart failure or hypovolemia, have been reported in
patients taking MULTAQ. In most cases, these effects appear to be reversible
upon drug discontinuation and with appropriate medical treatment. Monitor renal
function periodically.

Small increases in creatinine levels (about 0.1 mg/dL) following MULTAQ
treatment initiation have been shown to be a result of inhibition of
creatinine’s tubular secretion. The elevation has a rapid onset, reaches a
plateau after 7 days and is reversible after discontinuation.

Women of Childbearing Potential

Premenopausal women who have not undergone a hysterectomy or oophorectomy must
use effective contraception while using MULTAQ. Dronedarone caused fetal harm in
animal studies at doses equivalent to recommended human doses. Counsel women of
childbearing potential regarding appropriate contraceptive choices.

Drug-Drug Interactions

 * Treatment with Class I or III antiarrhythmics or drugs that are strong
   inhibitors of CYP 3A must be stopped before starting MULTAQ (see
   Contraindications)
 * Patients should be instructed to avoid grapefruit juice beverages while
   taking MULTAQ
 * Calcium channel blockers with depressant effects and beta-blockers could
   increase the bradycardia effects of MULTAQ on conduction

 * In the ANDROMEDA (patients with recently decompensated heart failure) and
   PALLAS (patients with permanent AFib) trials, baseline use of digoxin was
   associated with an increased risk of arrhythmic or sudden death in
   MULTAQ-treated patients 
   compared to placebo. In patients not taking digoxin, no difference in risk of
   sudden death was observed in the MULTAQ vs 
   placebo groups. 
   
   Digoxin can potentiate the electrophysiologic effects of MULTAQ (such as
   decreased AV-node conduction). MULTAQ increases exposure to digoxin. 
   
   Consider discontinuing digoxin. If digoxin treatment is continued, halve the
   dose of digoxin, monitor serum levels closely, and observe for toxicity. 

 * Postmarketing cases of increased INR with or without bleeding events have
   been reported in warfarin-treated patients initiated with MULTAQ. Monitor INR
   after initiating MULTAQ in patients taking warfarin
 * Statins: Avoid simvastatin doses greater than 10 mg daily. Follow statin
   label recommendations for use with CYP 3A and P-gP inhibitors such as MULTAQ

Adverse Reactions

In studies, the most common adverse reactions observed with MULTAQ were
diarrhea, nausea, abdominal pain, vomiting, and asthenia.

Click here for full Prescribing Information, including boxed WARNING.

Click here to learn more about Sanofi’s commitment to fighting counterfeit
drugs.



© 2022 sanofi-aventis U.S. LLC. All rights reserved.

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