dronedarone (Rx)

Brand and Other Names:Multaq
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Dosing & Uses

AdultPediatric

Dosing Forms & Strength

tablet

  • 400mg

Atrial Fibrillation/Flutter

Reduces the risk of hospitalization for atrial fibrillation (AF) in patients in sinus rhythm with history of paroxysmal or persistent AF

400 mg PO twice daily with meals

Dosing Considerations

Discontinue class I or III antiarrhythmics or strong CYP3A inhibitors before initiating therapy

Dosing Modifications

Renal impairment: Dose adjustment not necessary

Mild to moderate hepatic impairment: Dose adjustment not necessary

Severe hepatic impairment: Containdicated

Safety and efficacy not established

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Interactions

Interaction Checker

and dronedarone

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            QTc prolongation (28%)

            Early increase in SCr of >10% (51%)

            1-10%

            Diarrhea (9%)

            Asthenia (7%)

            Nausea (5%)

            Skin reactions (eg, rash, pruritus, eczema, allergic dermatitis) (5%)

            Abdominal pain (4%)

            Bradycardia (3%)

            Vomiting (2%)

            Dyspepsia (2%)

            Postmarketing Reports

            New/worsening HF

            Hepatic injury

            Cardiac failure

            Pulmonary fibrosis

            Interstitial lung disease including pneumonitis and PF

            Anaphylactic reactions (eg, angioedema)

            Vasculitis (eg, leukocytoclastic vasculitis)

            Interstitial lung disease, including pneumonitis and pulmonary fibrosis, have been reported

            Atrial flutter with 1:1 atrioventricular conduction

            Photosensitivity

            Dysgeusia

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            Warnings

            Black Box Warnings

            Increased risk of death, stroke, and heart failure in patients with decompensated HF or permanent AF

            Heart failure

            • Symptomatic HF with recent decompensation requiring hospitalization
            • NYHA class IV HF
            • Referral to specialized HF clinic
            • ANDROMEDA study showed mortality increased 2-fold in patients with severe HF requiring hospitalization or those referred to HF clinic for worsening symptoms

            Permanent atrial fibrillation

            • In patients with permanent AF, risk of death or stroke (particularly in the first 2 weeks of therapy) and hospitalization for HF is doubled; contraindicated in permanent AF (ie, patients who cannot be cardioverted into normal sinus rhythm)
            • Patients should undergo cardiac rhythm monitoring at least every 3 months
            • Cardiovert patients who are in atrial fibrillation (if clinically indicated) or discontinue drug
            • Dronedarone offers no benefit in permanent AF

            Contraindications

            Hypersensitivity

            Permanent AF in patients in whom normal sinus rhythm cannot be restored

            Symptomatic HF with recent decompensation requiring hospitalization, or symptoms of NYHA class IV HF due to doubled risk of death

            Concomitant strong CYP3A4 inhibitors (eg, grapefruit juice, itraconazole, clarithromycin, erythromycin)

            Symptomatic HF with recent decompensation requiring hospitalization

            NYHA class IV HF

            Referral to HF program

            2nd or 3rd degree heart block or sick sinus syndrome (unless used with functioning pacemaker)

            Bradycardia <50 bpm

            QTc interval >500 ms or PR interval >280 ms

            Coadministration with drugs that prolong QT interval may cause torsade de Pointes-type ventricular tachycardia (eg, phenothiazine, TCAs, macrolide antibiotics, class I and III antiarrhythmic agents [amiodarone, flecainide, propafenone, quinidine, disopyramide, dofetilide, sotalol])

            Liver toxicity related to previous use of amiodarone

            Severe hepatic impairment (ie, Child-Pugh Class C)

            Pregnancy (category X)

            Breastfeeding women

            Cautions

            Several cases of hepatocellular liver injury and hepatic failure, including 2 postmarketing reports of acute hepatic failure requiring transplantation; discontinue immediately if hepatic injury is suspected; obtain periodic hepatic serum enzymes, especially during the first 6 months of treatment

            Interstitial lung disease (pneumonitis, PF); if pulmonary toxicity is suspected, discontinue immediately

            Postmarketing cases of increased INR with or without bleeding events have been reported in warfarin-treated patients initiated on dronedarone; monitor INR after initiating in patients taking warfarin

            Increased risk of hypomagnesemia/hypokalemia with potassium-depleting diuretics

            Dronedarone induces moderate prolongation of the QT interval; monitor

            Discontinue if new or worsening HF develops

            Marked increase in serum creatinine, prerenal azotemia, and acute renal failure, often in the setting of heart failure or hypovolemia, reported; typically reversible when drug discontinued; monitor renal function

            Small increase in SCr following initiation; elevation has a rapid onset, reaches plateau after 7 days, and is reversible upon discontinuation

            Not approved for permanent atrial fibrillation (phase III PALLAS trial halted because preliminary analysis showed 2-fold increase in death, as well as 2-fold increases in stroke and hospitalization for HF)

            Women of childbearing potential must exercise caution while on therapy and must be counseled on appropriate contraceptive choices

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            Pregnancy & Lactation

            Pregnancy category: X

            Lactation: Unknown if distributed in breast milk; contraindicated

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Unknown; noniodinated antiarrhythmic agent structurally related to amiodarone; has properties belonging to all 4 Vaughn-Williams antiarrhythmic classes

            Blocks sodium channels, blocks beta1-adrenergic site, and alters adenyl cyclase generation (ie, negative inotropic effects); blocks potassium channels (eg, hERG) and therefore prolongs cardiac repolarization

            Absorption

            Bioavailability: 4% (without food); 15% (with high-fat meal)

            Peak plasma time: 3-6 hr (including major active metabolite); at steady state: 2.6-4.5 hr

            Distribution

            Protein bound: >98%

            Vd: 1400 L (steady state)

            Metabolism

            CYP3A4 (extensive)

            Initial metabolic pathway includes N-debutylation to form active N-debutyl metabolite, oxidative deamination to form the inactive propanoic acid metabolite, and direct oxidation

            Metabolites undergo further metabolism to yield over 30 uncharacterized metabolites; N-debutyl metabolite exhibits pharmacodynamic activity (1/10 to 1/3 as potent as dronedarone)

            Elimination

            Half-life, elimination: 13-19 hr

            Clearance: 130-150 L/hr

            Excretion: Feces (84%); urine (6%)

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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