CHF and arrhythmias:

Indications for CORLANOR ORAL SOLUTION:

To reduce the risk of hospitalization for worsening heart failure in adults with stable, symptomatic chronic heart failure with LVEF ≤35%, who are in sinus rhythm with resting heart rate ≥70bpm and either are on maximally tolerated doses of beta-blockers or have a contraindication to beta-blocker use. Treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in children ≥6mos old who are in sinus rhythm with an elevated heart rate.

Adult:

Take with food. May use oral soln if unable to swallow tabs. ≥18yrs: Initially 5mg twice daily. Adjust dose after 2 weeks to achieve resting heart rate 50–60bpm (see full labeling); then adjust dose as needed based on resting heart rate and tolerability. Max: 7.5mg twice daily. History of conduction defects or if bradycardia can lead to hemodynamic compromise: initially 2.5mg twice daily.

Children:

<6mos: not established. Take with food. ≥6mos: <40kg (use oral soln with calibrated oral syringe): initially 0.05mg/kg twice daily. Adjust dose at 2-week intervals by 0.05mg/kg to achieve target heart rate reduction of ≥20%, based on tolerability. Max: 6mos–<1yr: 0.2mg/kg twice daily; ≥1yr: 0.3mg/kg twice daily, up to total of 7.5mg twice daily. ≥40kg (use tabs or oral soln): initially 2.5mg twice daily. Adjust dose at 2-week intervals by 2.5mg to achieve target heart rate reduction of ≥20%, based on tolerability. Max: 7.5mg twice daily. If bradycardia develops, reduce dose to the previous titration step. If bradycardia develops at the initial dose: consider reducing to 0.02mg/kg twice daily.

Contraindications:

Acute decompensated heart failure. Clinically significant hypotension. Sick sinus syndrome, sinoatrial block, or 3rd degree AV block, unless paced. Clinically significant bradycardia. Severe hepatic impairment. Pacemaker dependence. Concomitant strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, telithromycin, nelfinavir, nefazodone).

Warnings/Precautions:

Monitor cardiac rhythm regularly; discontinue if atrial fibrillation develops. Increased risk of bradycardia with sinus node dysfunction, conduction defects (eg, 1st or 2nd degree AV block, bundle branch block), ventricular dyssynchrony. Avoid in 2nd degree AV block, unless paced. Demand pacemakers set to rates ≥60bpm: not recommended. Embryo-fetal toxicity. Pregnancy: monitor (esp. 3rd trimester for preterm birth). Advise females of reproductive potential to use effective contraception during treatment. Nursing mothers: not recommended.

See Also:

Pharmacologic Class:

Hyperpolarization-activated cyclic nucleotide-gated (HCN) channel blocker.

Interactions:

See Contraindications. Avoid concomitant moderate CYP3A4 inhibitors (eg, diltiazem, verapamil, grapefruit juice). Avoid concomitant CYP3A4 inducers (eg, St. John's wort, rifampicin, barbiturates, phenytoin). Increased risk of bradycardia with concomitant negative chronotropes (eg, digoxin, amiodarone, beta-blockers); monitor.

Adverse Reactions:

Bradycardia, hypertension, atrial fibrillation, luminous phenomena (phosphenes); conduction disturbances.

Generic Availability:

NO

How Supplied:

Tabs—60, 180; Ampules (5mL)—28