CardioSource WorldNews | Page 3
Add Corlanor ® to maximally tolerated doses of beta-blockers and help give
appropriate patients with heart rate ≥ 70 bpm and stable, symptomatic chronic HF...
MORE HOME. LESS HOSPITAL.
Learn how you can DO MORE with Corlanor® to reduce the risk
of hospitalization for worsening heart failure (HF)
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-998-115485 11-15
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 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%).
Please see Brief Summary of full Prescribing Information
on adjacent page.
BPM = beats per minute; HF = heart failure.
Reference: 1. Corlanor® (ivabradine) Prescribing Information, Amgen.