11. Corlanor (ivabradine) tablets and oral solution contains ivabradine as the active pharmaceutical ingredient. Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the I f current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility. The chemical name for ivabradine hydrochloride is 3-(3-{[((7 S )-3...

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1. Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated: To reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. For the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older. 1.1 Heart Failure in Adult Patients Corlanor is indicated to reduce the risk of hos...

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3. DOSAGE FORMS AND STRENGT HS Corlanor Tablets 5 mg: salmon-colored, oval-shaped, film-coated tablet, functionally scored on both edges, debossed with “5” on one face and bisected on the other face. The tablet is scored and can be divided into equal halves to provide a 2.5 mg dose. 7.5 mg: salmon-colored, triangular-shaped, film-coated tablet debossed with “7.5” on one face and plain on the other face. Corlanor Oral Solution Corlanor 5 mg/5 mL (1 mg/mL) oral solution is a colorless liquid in an opa...

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2. DOSAGE AND ADMINIST R ATION Adult and pediatric patients greater than 40 kg Starting dose is 2.5 (pediatrics and vulnerable adults) or 5 mg twice daily with food. After 2 weeks of treatment, adjust dose based on heart rate. The maximum dose is 7.5 mg twice daily. Pediatric patients less than 40 kg Starting dose is 0.05 mg/kg twice daily with food. Adjust dose at two-week intervals by 0.05 mg/kg based on heart rate. Maximum dose is 0.2 mg/kg (patients 6 months to less than 1 year old) or 0.3 mg/kg (...

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4. Corlanor is contraindicated in patients with: • Acute decompensated heart failure • Clinically significant hypotension • Sick sinus syndrome, sinoatrial block or 3 rd degree AV block, unless a functioning demand pacemaker is present • Clinically significant bradycardia • Severe hepatic impairment • Pacemaker dependence (heart rate maintained exclusively by the pacemaker) • Concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors Acute decompensated heart failure Clinically signifi...

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5. Fetal toxicity: Females should use effective contraception. Monitor patients for atrial fibrillation. Monitor heart rate decreases and bradycardia symptoms during treatment. Not recommended in patients with 2 nd degree AV block. 5.1 Fetal Toxicity Corlanor may cause fetal toxicity when administered to a pregnant woman based on findings in animal studies. Embryo-fetal toxicity and cardiac teratogenic effects were observed in fetuses of pregnant rats treated during organogenesis at exposures 1 to 3 t...

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7. Avoid CYP3A4 inhibitors or inducers. Negative chronotropes increase risk of bradycardia; monitor heart rate. 7.1 Cytochrome P450-Based Interactions Corlanor is primarily metabolized by CYP3A4. Concomitant use of CYP3A4 inhibitors increases ivabradine plasma concentrations and use of CYP3A4 inducers decreases them. Increased plasma concentrations may exacerbate bradycardia and conduction disturbances. The concomitant use of strong CYP3A4 inhibitors is contraindicated [ s ee Contraindications and Cli...

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Based on findings in animals, Corlanor may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Corlanor in pregnant women to inform any drug-associated risks. In animal reproduction studies, oral administration of ivabradine to pregnant rats during organogenesis at a dosage providing 1 to 3 times the human exposure (AUC 0-24hr ) at the MRHD resulted in embryo-fetal toxicity and teratogenicity manifested as abnormal shape of the heart, interv...

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