CardioSource WorldNews October 2015 | Page 60
Add Corlanor ® to maximally tolerated doses of beta-blockers and help
give appropriate patients with stable, symptomatic chronic heart failure...
MORE HOME. LESS HOSPITAL.
Learn how you can DO MORE with Corlanor® to reduce the risk
of hospitalization for worsening heart failure
1
CorlanorHCP.com
Indication
Corlanor® (ivabradine) is indicated to reduce the risk of hospitalization
for worsening heart failure in patients with stable, symptomatic chronic
heart failure with left ventricular ejection fraction ≤ 35%, who are in sinus
rhythm with resting heart rate ≥ 70 beats per minute and either are on
maximally tolerated doses of beta-blockers or have a contraindication
to beta-blocker use.
Important Safety Information
Contraindications: Corlanor® is contraindicated in patients with acute
decompensated heart failure, blood pressure < 90/50 mmHg, sick sinus
syndrome, sinoatrial block, 3rd 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.
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®.
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.
© 2015 Amgen Inc. All rights reserved. Not for reproduction. USA-998-108642
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 2nd degree
atrioventricular block unless a functioning demand pacemaker is present.
Adverse Reactions: The most common adverse 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%).
Please see Brief Summary of full Prescribing Information on
adjacent page.
Reference: 1. Corlanor® (ivabradine) Prescribing Information, Amgen.