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Rythmol

Generic Name: Propafenone Hydrochloride
Class: Class Ic Antiarrhythmics
VA Class: CV300
Chemical Name: 1-Propanone,1-[2-[2-hydroxy-3-(propylamino)propoxy]phenyl]-3- phenylpropan-1-one hydrochloride
Molecular Formula: C21H27NO3
CAS Number: 34183-22-7

Medically reviewed on November 14, 2016

Introduction

Propafenone is a local anesthetic type Ic antiarrhythmic agent.1 3 38 134 289

Uses for Rythmol

Supraventricular Tachyarrhythmias

Used (as conventional [immediate-release] tablets) to prolong the time to recurrence of symptomatic, disabling paroxysmal supraventricular tachycardia (PSVT) (e.g., AV nodal reentrant tachycardia or AV reentrant tachycardia [Wolff-Parkinson-White, WPW, syndrome]) and symptomatic, disabling paroxysmal atrial fibrillation/flutter (PAF) in patients without structural heart disease.1 3 67 68 90 91 92 93 94 99 101 102 105 107 108 109 110 132 133 173 187 206 211

Used (as extended-release capsules) to prolong the time to recurrence of symptomatic PAF in patients without structural heart disease.289 Safety and efficacy of extended-release capsules not established in patients with exclusively PSVT or atrial flutter.289

One of several drugs that may be used for ongoing management of patients with PSVT who do not have structural or ischemic heart disease; generally reserved for patients in whom other therapies (e.g., catheter ablation, β-adrenergic blocking agents, diltiazem, verapamil) are ineffective or contraindicated.700

Comparably effective to quinidine, disopyramide, flecainide, procainamide, sotalol in preventing recurrences of PAF and maintaining sinus rhythm following successful cardioversion of atrial fibrillation.3 68 89 129 133 183 200 201 202 204 205

Safety and efficacy not established in patients with chronic atrial fibrillation.1 289

Has been used for pharmacologic cardioversion of atrial fibrillation or flutter.15 68 88 89 90 101 103 104 109 110 111 195 196 197 198 199 207 208 211 272 701

May be used for ongoing management of other supraventricular tachycardias (SVTs) (e.g., focal atrial tachycardia, junctional tachycardia).700

Because of risk of proarrhythmia, do not use in patients with structural heart disease or ischemic heart disease.700

Ventricular Arrhythmias

As conventional (immediate-release) tablets, suppresses and prevents recurrence of documented life-threatening ventricular arrhythmias (e.g., sustained VT, VF).1 3 (See Mortality under Cautions.)

Rythmol Dosage and Administration

General

  • Individualize dosage according to individual requirements, response, tolerance, general condition, and cardiovascular status.1 2 3 9 15 28 47 68

  • Initiate therapy (conventional [immediate-release] tablets) for life-threatening ventricular arrhythmias in a hospital.1 273

  • Clinical and ECG evaluation (e.g., Holter monitoring) is recommended during propafenone therapy.1 3 289

Administration

Administer orally.

Has been administered IV,3 17 31 76 88 89 90 95 96 97 98 100 102 104 106 110 119 122 133 183 but parenteral dosage form not commercially available in US.

Oral Administration

Administer conventional (immediate-release) tablets in a consistent manner relative to food intake.6 9 128 256 272 273

Administer conventional (immediate-release) tablets in 3 equally divided doses daily at 8-hour intervals.1

Administer extended-release capsules in equally divided doses every 12 hours without regard to meals.289

Swallow extended-release capsules whole; do not crush.289

Avoid grapefruit juice.272 273 (See Drugs, Foods, and Herbal Supplements under Interactions.)

Dosage

Adjust dosage carefully according to individual requirements and response, patient tolerance, and the general condition and cardiovascular status of the patient.1 2 3 9 15 28 47 68 289

Consider dosage reduction in patients who develop excessive prolongation of the PR interval, excessive QRS widening, or second- or third-degree AV block.1 2 3 15 90

Usually do not use oral loading doses (conventional [immediate-release] tablets) since acute toxicity may occur.3 6 272 273 However, oral loading doses (e.g., 450–750 mg as conventional [immediate-release] tablets) have been used with apparent safety for conversion of recent-onset atrial fibrillation to normal sinus rhythm in individuals without heart failure.68 89 90 101 109 160 195 196 208 272

Pediatric Patients

Supraventricular Arrhythmias
Oral (conventional [immediate-release] tablets)

Some clinicians suggest maximum daily dosage 600 mg/m2.272

Adults

Paroxysmal Atrial Fibrillation/Flutter and Paroxysmal Supraventricular Tachyarrhythmias
Oral (conventional [immediate-release] tablets)

Initially, 150 mg every 8 hours.1 2 68

Increase dosage after 3–4 days to 225 mg 3 times daily (every 8 hours) if necessary.1 68 90

If desired therapeutic response is not attained after an additional 3–4 days, increase dosage to 300 mg 3 times daily (every 8 hours).1 68 90

Oral (extended-release capsules)

Initially, 225 mg every 12 hours.289

Increase dosage after ≥5 days to 325 mg every 12 hours if necessary.289

If desired therapeutic response is not attained after an additional 5 days, increase dosage to 425 mg every 12 hours.289

If a dose is missed, only administer the next scheduled dose; do not double next dose.289

When switching from conventional (immediate-release) tablets to extended-release capsules, the dosage conversion ratio is not a 1:1 substitution (e.g., a patient who currently is receiving 150 mg every 8 hours of conventional (immediate-release) tablets may be switched to 325 mg of extended-release capsules every 12 hours).289 308

Conversion of Atrial Fibrillation to Normal Sinus Rhythm
Oral (conventional [immediate-release] tablets)

150–600 mg, as a single dose.158 211

IV

2 mg/kg (over 10 minutes) as a single dose.158 211

Self-administration for Conversion of PAF
Oral (conventional [immediate-release] tablets)

Adults weighing 70 kg or more: May use a single oral loading dose of 600 mg 5 minutes after noting the onset of palpitations.290 309

Adults weighing < 70 kg: May use a single oral loading dose of 450 mg 5 minutes after noting the onset of palpitations.290 309

Do not take more than a single oral dose during a 24-hour period.290

Ventricular Arrhythmias
Oral (conventional [immediate-release] tablets)

Initially, 150 mg every 8 hours.1 2 68

Increase dosage after 3–4 days to 225 mg 3 times daily if necessary.1 68 90

If desired therapeutic response is not attained after an additional 3–4 days, increase dosage to 300 mg 3 times daily.1 68 90

Prescribing Limits

Pediatric Patients

Supraventricular Arrhythmias
Oral (conventional [immediate-release] tablets)

Some clinicians suggest maximum daily dosage of 600 mg/m2.272

Adults

Supraventricular Arrhythmias
Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 900 mg.1 9 90 272 273

Life-threatening Ventricular Arrhythmias
Oral (conventional [immediate-release] tablets)

Maximum daily dosage is 900 mg.1 9 90 272 273

Special Populations

Hepatic Impairment

When conventional (immediate-release) tablets are used, reduce dosage by approximately 70–80%; monitor patients for signs of toxicity, including hypotension, somnolence, bradycardia, conduction disturbances, seizures, and/or ventricular arrhythmias.1 115 193

Geriatric Patients and Those with Myocardial Damage

During initiation of therapy (conventional [immediate-release] tablets), gradual dosage escalation should be performed in geriatric patients and those with marked previous myocardial ischemia.1 3

Cautions for Rythmol

Contraindications

  • Patients with uncontrolled CHF (conventional [immediate-release] tablets),1 CHF (extended-release capsules).289

  • Cardiogenic shock.1 3 289

  • Sinoatrial, AV, or intraventricular disorders of impulse generation and/or conduction (e.g., sick sinus node syndrome, AV block) unless an artificial pacemaker is present.1 3 6 234 289

  • Bradycardia.1 3 289

  • Severe hypotension.1 3 289

  • Bronchospastic disorders.1 289

  • Marked electrolyte imbalance.1 3 289

  • Known hypersensitivity to propafenone.1 289

Warnings/Precautions

Warnings

Mortality

In CAST study, excessive rate of mortality and nonfatal cardiac arrest reported in patients with asymptomatic or mildly symptomatic non-life-threatening ventricular arrhythmias and recent MI (>6 days but <2 years previously) who were receiving encainide or flecainide compared with placebo.1 116 117 149 155 234 235 289 The applicability of these results to other populations (e.g., those without recent MI) or to other antiarrhythmic drugs is uncertain.1 6 48 62 118 168 234 235

Limit use of propafenone or other class I agents in patients with ventricular arrhythmias to those with life-threatening arrhythmias;1 116 117 use in patients with less severe ventricular arrhythmias, even when symptomatic, is not recommended.1

Arrhythmogenic and Cardiac Conduction Effects

Potential for new and/or more severe arrhythmias,1 2 3 4 6 9 15 16 17 18 47 58 67 68 75 113 116 168 230 232 233 234 235 especially in those with CHF (NYHA class III or IV) or myocardial ischemia.289

Risk of clinically important conduction disturbances;1 6 75 136 151 degree of lengthening of PR and QRS intervals may increase progressively with increasing dosage and plasma propafenone concentrations.1 2 47 233 289 1 2 6 9 47 68 168 233 289

Reduce dosage or discontinue the drug if 2nd- or 3rd-degree AV block occurs.1 (See Contraindications under Cautions.)

Evaluate clinical status and ECG prior to and during propafenone therapy to monitor for appearance of arrhythmias and to determine the need for continued therapy.1 2 168

Monitor patients with permanent artificial pacemakers and, if necessary, reprogram pacemakers.1 2 3 225 229 289

Cardiovascular Effects

Potential for new or worsened CHF, particularly in patients with preexisting heart failure or ejection fraction <30%.1 2 3 4 9 13 17 47 68 75 117 289

Use with caution (conventional [immediate-release] tablets) in patients with a history of CHF or myocardial dysfunction.1 117 168 235 236

Discontinue therapy if CHF worsens (unless caused by the cardiac arrhythmia); fully compensate CHF before therapy is reinitiated.1

Hematologic Effects

Possible reversible granulocytopenia3 47 and agranulocytosis.1 47

Carefully evaluate patients in whom unexplained fever and/or decreased WBC counts occur (especially during the initial 3 months of therapy).1 289 WBC counts generally return to normal within 2 weeks following discontinuance.1 289

Bronchospastic Disease

Possible inhibition of bronchodilation produced by endogenous catecholamines; use generally not recommended in patients with asthma/bronchospastic disease or nonallergic bronchospastic disease (e.g., chronic bronchitis, emphysema).1 3 15 40 67 68 173 215 289 (See Contraindications under Cautions.)

General Precautions

Hepatic Impairment

Extensively metabolized in liver; use with caution in those with hepatic impairment.1 3 8 11 15 33 68 178 289

Renal Impairment

Several metabolites excreted by kidneys; use with caution in those with renal impairment.1 13 289

Antinuclear Antibodies.

Possible positive antinuclear antibody (ANA) titers.1 289

Monitor carefully patients who develop an abnormal ANA test following initiation of therapy; consider discontinuation of therapy if titers remain elevated or increase further.1 289

Impaired Spermatogenesis

Transient, reversible decreases (within normal range) in sperm count may occur.1 289

Myasthenia Gravis

Possible exacerbation of myasthenia gravis.1 52 289 Avoid use in patients with this condition.3

Specific Populations

Pregnancy

Category C.1 289

Lactation

Distributed into milk.3 289 Caution if used in nursing women.289

Pediatric Use

Safety and efficacy not established in children <18 years of age.1 273 289

Has been used successfully and without unusual adverse effects in a limited number of infants and children for the management of various refractory supraventricular (e.g., PSVT, junctional ectopic tachycardia, atrial fibrillation or flutter) and ventricular (e.g., VPCs, VT) arrhythmias.3 68 146 212 213 214 216 217 218 220 272

Geriatric Use

Conventional (immediate-release) tablets: Insufficient experience to determine whether geriatric patients ≥65 years of age respond differently than younger adults.1 Select dosage with caution; start at the lower end of dosing range due to greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy.1

Extended-release capsules: No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.289

Hepatic Impairment

Extensively metabolized in liver; use with caution.1 3 8 11 15 33 68 178 289 Careful monitoring for excessive pharmacological effects recommended.1 Reduce dosage.1 3 8 11 15 33 68 178 289 (See Special Populations under Dosage and Administration.)

Renal Impairment

Use with caution.1 Careful monitoring for excessive pharmacological effects recommended.1

Common Adverse Effects

Conventional (immediate-release) tablets: Unusual taste, nausea and/or vomiting, dizziness, constipation, headache, fatigue, blurred vision, and weakness.1 First-degree AV block and intraventricular conduction delay in patients with ventricular arrhythmia.1

Extended-release capsules: Constipation, diarrhea, dry mouth, nausea, vomiting, unusual taste, fatigue, weakness, dizziness, headache, somnolence, anxiety, dyspnea, ecchymosis, upper respiratory infection, abnormalities in liver function tests (e.g., increased serum concentrations of alkaline phosphatase), hematuria.289

Interactions for Rythmol

Metabolized by CYP2D6 and to a lesser extent by CYP1A2, CYP3A4.1 131 190 285 286 289

Inhibits CYP2D6.1 289

Drugs and Foods Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions likely with drugs that are inhibitors, inducers, or substrates of CYP2D6, CYP1A2, or CYP3A4 with possible alteration in metabolism of propafenone and/or other drugs.1 131 190 285 286 289 Monitor patients.1

Drugs Metabolized by p-Glycoprotein Transporter

Effect of propafenone on the p-glycoprotein transport system not evaluated.1 289

Drugs Affecting QT Interval

Do not use with drugs that prolong the QT interval.289

Antiarrhythmic Agents

Use extreme caution when propafenone is administered with other antiarrhythmic agents.3 68 Reserve concomitant use for management of life-threatening arrhythmias unresponsive to propafenone monotherapy.3 68 Do not use propafenone (extended-release capsules) with class Ia or III antiarrhythmic agents.289

Specific Drugs and Foods

Drug or Food

Interaction

Comments

Amiodarone

Possible increased incidence of cardiovascular effects1 13 287 289

Increased propafenone concentrations1 289

Concomitant use not recommended 1 289

β-adrenergic blocking agents (e.g., metoprolol, propranolol)

Increased β-adrenergic blocking agent concentrations and terminal elimination half-life1 246 247 289

Use concomitantly with caution; consider β-adrenergic blocking agent dosage reduction1 6 9 13 247 289

Calcium channel-blocking agents

No evidence of clinically important adverse interactions1 289

Cimetidine

Increased propafenone steady-state plasma concentrations1 289

Cyclosporine

Increased cyclosporine concentrations1 250 289

Desipramine

Increased propafenone concentrations1 289

Increased desipramine serum concentrations1

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Consider desipramine dosage reduction1

Digoxin

Increased serum or plasma digoxin concentrations1 3 9 85 124 125 245 279 280 281 282 283 289

Carefully monitor serum digoxin concentrations and adjust digoxin dosage 1 3 9 85 124 125 245 283 289

Diuretics

No evidence of clinically important adverse interactions1 289

Erythromycin

Increased propafenone concentrations1 289 1 131 190 285 286 289

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Fluoxetine

In extensive-metabolizer phenotypes, increased peak plasma concentrations and AUC of propafenone1 289

Grapefruit juice

Possible increased plasma concentrations of unchanged propafenone and potential adverse effects1 257 258 259 260 261 262 289

Avoid concomitant use272 273

Haloperidol

Increased haloperidol concentrations1 289

Use concomitantly with caution; consider haloperidol dosage reduction1 289

Imipramine

Increased imipramine concentrations1 289

Use concomitantly with caution; consider imipramine dosage reduction1 289

Ketoconazole

Increased propafenone concentrations1 131 190 285 286 289

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Lidocaine

Possible pharmacologic interaction (additive or antagonistic cardiac effects and additive toxicity) 1 2 9 13 122 289

Orlistat

Possible limited absorption of propafenone1 289

Possibility of severe adverse effects with abrupt discontinuance of orlistat1 289

Paroxetine

Increased propafenone concentrations1 131 190 285 286 289

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Phenobarbital

Decreased plasma propafenone concentrations3

Quinidine

Increased plasma propafenone concentrations1 3 123 289

Concomitant use not recommended 1 289

Rifampin

Increased metabolism of propafenone resulting in decreased plasma propafenone concentrations and antiarrhythmic activity1

Ritonavir

Increased propafenone concentrations1 131 190 285 286 289

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Saquinavir

Increased propafenone concentrations1 131 190 285 286 289

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Sertraline

Increased propafenone concentrations1 131 190 285 286 289

Use concomitantly with caution; reduce propafenone hydrochloride dosage1 131 190 285 286 289

Theophylline

Increased serum theophylline concentrations and toxicity1 289

Venlafaxine

Increased venlafaxine concentrations1 289

Use concomitantly with caution; consider venlafaxine dosage reduction1 289

Warfarin

Increased plasma warfarin concentrations and corresponding PTs1 3 6 9 13 15 248 289

Monitor PTs or INRs;275 adjust warfarin dosage 1 3 9 13 248 289

Rythmol Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration of conventional (immediate-release) tablets.1 3 15 17 33 40 67 68 133 136

Absolute bioavailability of conventional (immediate-release) tablets is 5–50%.33 174 180

Bioavailability of 325-mg extended-release capsules (given twice daily) similar to 150-mg conventional (immediate-release) tablets (given 3 times daily).289

Food

Food does not appear to affect bioavailability of conventional (immediate-release) tablets or extended-release capsules during multiple-dose administration.2 289

Special Populations

In patients with marked hepatic impairment, bioavailability of conventional (immediate-release) tablets is about 60–70%.1 2 178 289

Distribution

Extent

Rapidly distributed into lung, liver, and heart tissue.3 4 15

Propafenone crosses the placenta and is distributed into milk.3 64 72

Plasma or Serum Protein Binding

81–97% (mainly α1 acid glycoprotein).3 138 187 188 289

Special Populations

In patients with severe hepatic dysfunction, approximately 88% of propafenone is bound to plasma proteins.289

Elimination

Metabolism

Extensively metabolized by first-pass metabolism (hydroxylation) in the liver,1 33 132 133 136 via CYP2D6 to an active metabolite (5-hydroxypropafenone [5-OHP])1 131 190 289 and dealkylation via CYP1A2 and CYP3A4 to another active metabolite (N-depropylpropafenone [NDPP]).1 131 289

Elimination Route

Eliminated principally in feces via biliary excretion as metabolites and in urine or feces as unchanged drug (<1%).2 3 4 33 67 68 136

Half-life

Immediate-release tablets: Averages 1–3 hours (range: 2–10 hours).1 2 4 6 7 10 11 12 14 15 16 28 33 37 39 67 68 71 129 133 138 181 187

Special Populations

In patients with poor metabolizer phenotypes (approximately 5–10% of Caucasians), propafenone is metabolized principally via CYP3A4 and CYP1A2;1 131 CYP2D6 is subject to genetic polymorphism.1 131 190

Extensive metabolizers convert propafenone rapidly into 5-OHP and NDPP,1 15 33 37 41 68 70 129 130 131 136 189 190 289 while poor metabolizers convert it slowly to NDPP and 5-OHP usually not detectable.1 33 37 184 186 289

Poor metabolizers have increased plasma propafenone concentrations relative to individuals with the extensive-metabolizer phenotype3 13 15 33 40 67 69 130 and are more likely to experience β-blocking and adverse effects of the drug.13 36 39 129

In poor metabolizers, plasma elimination half-life and steady-state half-life average about 8-13 (range: 10–32 hours)1 2 3 4 6 10 16 33 37 39 40 68 133 and 17 hours, respectively; decreased clearance of the drug observed.33 67 175

In patients with moderate to severe hepatic impairment, half-life is about 9 hours.1 2 3 4 6 15 33 178

Stability

Storage

Oral

Conventional (immediate-release) Tablets

Tight, light-resistant containers at 25°C (may be exposed to 15-30°C).1 2 65 66

Extended-release Capsules

Tight containers at 25°C (may be exposed to 15-30°C).289

Actions

  • Membrane-stabilizing antiarrhythmic agent; exhibits local anesthetic effects.3 4 17 62 67 289

  • Combines with fast sodium channels within the myocardium and inhibits rapid sodium influx, which decreases the maximal rate of depolarization of phase 0 of the action potential.1 2 3 4 7 9 10 12 14 15 22 28 33 38 39 45 56 62 63 67 68 129 133 134 180 289

  • Combines with fast sodium channels in both their active and inactive state3 135 and inhibits recovery after repolarization in a time- and voltage-dependent manner, which is associated with subsequent dissociation of the drug from the sodium channels.1 2 4 6 7 10 11 12 13 14 15 16 18 19 33 38 39 62 67 68 90 134 135 168 180

  • Exhibits electrophysiologic effects characteristic of class Ic antiarrhythmic agents, which slowly attach to and dissociate from transmembrane sodium channels.139 140 141 168

  • Produces dose-related decrease in intracardiac conduction within the His-Purkinje system, AV node, and intraventricular pathways.3 4 10 17 134 289

  • Produces dose-related increases in PR, QRS, AH, and HV intervals;1 3 6 7 62 96 129 133 134 180 289 at higher workload and heart rates, dose-related increases in QT interval occur.28 67 68

  • Increases effective refractory period (ERP) during ventricular pacing.3 27 67

  • Exhibits a dose-dependent negative inotropic effect.1 3 39 68 144 168 272 289

  • Exhibits β-adrenergic blocking activity.1 2 3 4 6 7 8 9 10 11 12 13 14 15 16 18 22 24 25 26 27 33 36 37 38 39 42 45 46 47 56 62 63 67 68 129 133 137 289

Advice to Patients

  • Importance of taking propafenone in a consistent manner relative to food.6 9 128 256 272 273

  • Importance of not ingesting grapefruit juice concomitantly with propafenone.272 273

  • If a dose of extended-release capsules is missed, only administer the next scheduled dose; do not double next dose.289

  • Advise patients who self-administer conventional (immediate-release) tablets for conversion of paroxysmal atrial fibrillation to remain in a supine or sitting position until resolution of palpitations or for a period of ≥4 hours following the dose.290 309 Importance of informing clinician if palpitations do not resolve within 6–8 hours, if new symptoms (e.g., dyspnea, presyncope, syncope) occur, or a marked increase in heart rate develops.290

  • Advise patients to promptly report fever, sore throat, chills, or any other manifestation of infection.1 3 289

  • Importance of immediately informing clinician if excessive or prolonged diarrhea, sweating, vomiting, loss of appetite or thirst occurs.289 289

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.1 289

  • Importance of women informing clinician if they are or plan to become pregnant or plan to breast-feed.1 290

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Propafenone Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, extended-release

225 mg

RythmolSR

Reliant

325 mg

RythmolSR

Reliant

425 mg

RythmolSR

Reliant

Tablets, film-coated

150 mg*

Propafenone Hydrochloride Tablets

Rythmol (scored)

Reliant

225 mg*

Propafenone Hydrochloride Tablets

Rythmol (scored)

Reliant

300 mg*

Propafenone Hydrochloride Tablets

Rythmol (scored)

Reliant

AHFS DI Essentials. © Copyright 2018, Selected Revisions November 14, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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