Leaders in Pharmaceutical Business Intelligence (LPBI) Group

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Contraindications: Corlanor^® is contraindicated in patients with acute decompensated heart failure, blood pressure < 90/50 mmHg, sick sinus syndrome, sinoatrial block, 3^rd degree atrioventricular block (unless a functioning demand pacemaker is present), a resting heart rate < 60 bpm prior to treatment, severe hepatic impairment, pacemaker dependence (heart rate maintained exclusively by the pacemaker), and concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors.

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Fetal Toxicity: Corlanor^® may cause fetal toxicity when administered to a pregnant woman based on embryo-fetal toxicity and cardiac teratogenic effects observed in animal studies. Advise females to use effective contraception when taking Corlanor^®.

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Atrial Fibrillation: Corlanor^® increases the risk of atrial fibrillation. The rate of atrial fibrillation in patients treated with Corlanor^® compared to placebo was 5% vs. 3.9% per patient-year, respectively. Regularly monitor cardiac rhythm. Discontinue Corlanor^® if atrial fibrillation develops.

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Bradycardia and Conduction Disturbances: Bradycardia, sinus arrest and heart block have occurred with Corlanor^®. The rate of bradycardia in patients treated with Corlanor^® compared to placebo was 6% (2.7% symptomatic; 3.4% asymptomatic) vs. 1.3% per patient-year, respectively. Risk factors for bradycardia include sinus node dysfunction, conduction defects, ventricular dyssynchrony, and use of other negative chronotropes. Concurrent use of verapamil or diltiazem also increases Corlanor^® exposure, contributes to heart rate lowering, and should be avoided. Avoid use of Corlanor^® in patients with 2^nd degree atrioventricular block unless a functioning demand pacemaker is present.

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Adverse Reactions: The most common adverse drug reactions reported at least 1% more frequently with Corlanor^® than placebo and that occurred in more than 1% of patients treated with Corlanor^® were bradycardia (10% vs. 2.2%), hypertension or increased blood pressure (8.9% vs. 7.8%), atrial fibrillation (8.3% vs. 6.6%), and luminous phenomena (phosphenes) or visual brightness (2.8% vs. 0.5%).