INDICATIONS

Heart Failure in Adult Patients
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with left ventricular ejection fraction 35%, who are in sinus rhythm with resting Read More.

Heart Failure in Adult Patients
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure adult 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.

Heart Failure in Pediatric Patients
Corlanor® is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy [DCM] in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

Corlanor®: Twice-daily dosing with meals1

In Adult Patients

RECOMMENDED STARTING DOSE

5 mg  2x/day

OR
2.5 mg 2x/day
 

For patients in whom bradycardia could lead to hemodynamic compromise or with a history of conduction defects.

 

MAXIMUM DOSE

7.5 mg  2x/day

 
AFTER 2 WEEKS, CHECK RESTING HEART RATE1
> 60 bpm Increase dose by 2.5 mg 2x/day
up to a max of 7.5 mg 2x/day
TARGET RANGE
50-60 bpm
Maintain dose
< 50 bpm
OR SYMPTOMS OF BRADYCARDIA
Decrease dose by 2.5 mg 2x/day Discontinue therapy if current dose is 2.5 mg 2x/day
  • No dosage adjustment is required for patients with moderate to severe renal impairment (CrCl 15 to 60 mL/min)1
  • Does not require additional routine lab monitoring
  • Corlanor® shows no clinically significant blood pressure lowering1,3

BPM = beats per minute; CrCl = creatinine clearance; mL/min = milliliter(s) per minute; mg = milligram(s); SOC = standard of care; x=times.

References
  1. Corlanor® (ivabradine) prescribing information, Amgen.
  2. Yancy CW, Januzzi JL Jr, Allen LA, et al. 2017 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment: Answers to 10 Pivotal Issues About Heart Failure With Reduced Ejection Fraction. J Am Coll Cardiol. 2018;71:201-230.
  3. Swedberg K, Komajda M, Böhm, et al. Ivabradine and outcomes in chronic heart failure (SHIFT): A randomised placebo-controlled study. Lancet. 2010;376:875-885.

IMPORTANT SAFETY INFORMATION

Contraindications
Corlanor® is contraindicated in patients with acute decompensated heart failure, clinically significant hypotension, sick sinus syndrome, sinoatrial block, 3rd degree atrioventricular block (unless a functioning demand pacemaker is present), clinically significant bradycardia, 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 of reproductive potential 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.

Bradycardia and Conduction Disturbances

Adult Heart Failure Patients 
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. Bradycardia may increase the risk of QT prolongation which may lead to severe ventricular arrhythmias, including torsades de pointes, especially in patients with risk factors such as use of QTc prolonging drugs.

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.

Pediatric Heart Failure Patients 
Bradycardia and first-degree heart block were observed in pediatric patients treated with Corlanor®. Asymptomatic and symptomatic bradycardia were observed in 6.8% and 4.1% of pediatric patients treated with Corlanor®, respectively. In the placebo treatment arm, 2.4% of pediatric patients had asymptomatic bradycardia, but none had symptomatic bradycardia. Bradycardia was managed through dose titration but did not result in study drug discontinuation.

Adverse Reactions

Adult Heart Failure Patients 
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%).

In postmarketing experience, torsades de pointes has been observed.

Pediatric Heart Failure Patients 
Bradycardia (symptomatic and asymptomatic) occurred at rates similar to those in adults. Phosphenes were observed in pediatric patients treated with Corlanor®.

Please see full Prescribing Information and Medication Guide.

INDICATIONS

Heart Failure in Adult Patients 
Corlanor® is indicated to reduce the risk of hospitalization for worsening heart failure in adult 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.

Heart Failure in Pediatric Patients 
Corlanor® is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate.

IMPORTANT SAFETY INFORMATION
Corlanor® is contraindicated in patients with acute decompensated heart failure, clinically significant hypotension, sick sinus syndrome, sinoatrial block, 3rd degree atrioventricular block (unless a functioning demand pacemaker is present), clinically significant bradycardia, severe hepatic impairment, pacemaker dependence (heart rate maintained exclusively by the pacemaker), and concomitant use of strong cytochrome P450 3A4 (CYP3A4) inhibitors.