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 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.

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Corlanor® (ivabradine) for Pediatric Heart Failure Due to Dilated Cardiomyopathy

ORDER DOSING PEDIATRIC STUDY

Corlanor® is indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy in pediatric patients ages 6 months and older.

Corlanor® is available in both a tablet
and an oral solution.

How to order Corlanor® 5 mg/5 mL oral solution

For VA/DOD or hospital in-patient use, please refer to Amgen's USA Authorized Wholesaler listing on Amgen’s website.

Click here to view Wholesaler listing .

For out-patient use, Corlanor® oral solution is exclusively distributed through Optum Specialty Pharmacy.1

Call 1-844-6CORLANOR and select "oral solution" for additional information or to prescribe Corlanor® oral solution.

Click here for the intake form to send to the specialty pharmacy to enable them to fill the prescription.

 

Optum Specialty Pharmacy can provide resources to help support access to Corlanor® oral solution for your patients.

 

Optum Specialty Pharmacy will ship the oral solution directly to your patient’s home or to your office.

Image of Oral Solution Image of Oral Solution

Dosing and Administration1

Corlanor® tablets can be used for those pediatric patients weighing 40 kg and greater who are able to swallow tablets. Corlanor® tablets are available through most retail pharmacies.

PEDIATRIC PATIENTS LESS THAN 40 KG:

Starting dose: 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:
0.2 mg/kg
(patients 6 months to less than 1 year old) Maximum dose: 0.2 mg/kg (patients 6 months to less than 1 year old)

0.3 mg/kg
0.3 mg/kg (patients 1 year old and older),
up to a total of
7.5 mg twice daily. (patients 1 year old and older),up to a total of7.5 mg twice daily.

PEDIATRIC PATIENTS GREATER THAN 40 KG:

Starting dose: 2.5 mg
twice daily with food.

Adjust dose after two weeks
of treatment
based on heart rate.

 

Maximum dose:
7.5 mg twice daily.

 
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Corlanor® Oral Solution Product Fact Sheet

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Corlanor® Pediatric Trial1,2

In order to make the Corlanor® oral solution available to pediatric patients with dilated cardiomyopathy, Amgen is proud to have made a significant commitment to process development, manufacturing, and infrastructure.

Chart of Pediatric Trial Chart of Pediatric Trial
  • Pediatric patients in the trial received either ivabradine or placebo in addition to an optimized and stable clinical regimen
  • 72% of pediatric patients receiving ivabradine (versus 16% receiving placebo) were able to obtain a ≥ 20% reduction in heart rate compared to baseline
  • Pediatric patients receiving ivabradine had a change from baseline to month 6 (mean +/- SD) in left ventricular ejection fraction (%) as measured by echocardiography, 11.4+/-11.6 vs. placebo 5.3+/-10.3 (mean difference 5.11 [0.87-9.35])

About the pediatric study1,2

  • The study collected data from 116 patients ages 6 months to less than 18 years with heart failure due to DCM in sinus rhythm, NYHA/Ross class II to IV heart failure, and left ventricular ejection fraction ≤ 45%. Patients were randomized in a 2:1 ratio to receive Corlanor® or placebo. Doses of study medication were titrated over a 2- to 8-week period to achieve ≥ 20% heart rate reduction without inducing bradycardia
  • The safety of Corlanor® is based on this clinical trial, with experience in 73 patients treated with Corlanor® for a median duration of 397 days, and 42 patients given placebo.
    • Adverse events were reported in 86.3% of ivabradine-treated patients and 88.1% of placebo-treated patients. Bradycardia (symptomatic and asymptomatic) occurred at rates similar to those in adults. Phosphenes were observed in pediatric patients treated with Corlanor®.
  • The safety and efficacy of Corlanor® have not been established in patients less than 6 months of age.
References
  1. Corlanor® (ivabradine) prescribing information, Amgen.
  2. Bonnet D, Berger F, Jokinen E, Kantor PF, Daubeney PEF. Ivabradine in children with dilated cardiomyopathy and symptomatic chronic heart failure. J Am Coll Cardiol. 2017;70:1262-1272.

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

  • 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