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.

See patients who may be
appropriate for Corlanor®

Click on a patient type below:
 

For patients with stable, symptomatic chronic HF with LVEF 35% and in sinus rhythm with resting heart rate 70 bpm:

Add Corlanor® for stabilized patients after recent hospitalization1
LINDA

Recently hospitalized for worsening HF

Hemodynamically stable after discharge 7 days ago

WORSENING SYMPTOM OF HF

Continued shortness of breath

ELEVATED RESTING HR

84 bpm sinus rhythm

MAX-TOLERATED BETA-BLOCKER DOSE

Carvedilol 12.5 mg 2x/day
Corlanor patient
 

LVEF

BP (mm/Hg)

NYHA CLASSIFICATION

32%

100/60

Class III

 

ADDITIONAL MEDICATIONS

  • Enalapril 10 mg 2x/day
  • Spironolactone 25 mg once daily
  • Furosemide 40 mg 2x/day
This is a hypothetical patient.
 

For patients with stable, symptomatic chronic HF with LVEF 35% and in sinus rhythm with resting heart rate 70 bpm:

Add Corlanor® for
symptomatic patients1
JAMES

Unable to Tolerate Max Dose Beta-Blocker

Patient is also renally impaired and has an ICD implant

Worsening symptoms of HF

  • Persistent dyspnea and two-pillow orthopnea
  • Experiencing increased fatigue
  • Diminishing exercise capacity

ELEVATED RESTING HR

88 bpm sinus rhythm

MAX-TOLERATED BETA-BLOCKER DOSE

Carvedilol 6.25 mg 2x/day
Corlanor patient
 

LVEF

BP (mm/Hg)

NYHA CLASSIFICATION

30%

95/60

Class III

 

ADDITIONAL MEDICATIONS

  • Furosemide 80 mg once daily
  • Hydralazine 75 mg 3x/day
  • Isosorbide dinitrate 40 mg 3x/day
This is a hypothetical patient.
 

SUSAN

Recently hospitalized for worsening HF

Hospitalized < 6 months ago

ICD device (implanted pre-hospitalization)

Worsening symptoms of HF

  • Shortness of breath
  • Fatigue

ELEVATED RESTING HR

81 bpm sinus rhythm

MAX-TOLERATED BETA-BLOCKER DOSE

Carvedilol 12.5 mg 2x/day
Max beta-blocker dose due to symptomatic hypotension

Corlanor patient
 

LVEF

BP (mm/Hg)

NYHA CLASSIFICATION

32%

95/65

Class III

 

ADDITIONAL MEDICATIONS

  • Sacubitril/
    valsartan 97/103 mg
    2x/day
  • Spironolactone 25 mg 1x/day
  • Furosemide 40 mg 2x/day
This is a hypothetical patient.
 

For patients with stable, symptomatic chronic HF with LVEF 35% and in sinus rhythm with resting heart rate 70 bpm:

Add Corlanor® for patients unable to tolerate max dose of beta-blocker1
GEORGE

Unable to tolerate max dose beta-blocker

Due to symptomatic hypotension and erectile dysfunction

WORSENING SYMPTOMS OF HF

  • Shortness of breath
  • Increased fatigue

ELEVATED RESTING HR

78 bpm sinus rhythm

MAX-TOLERATED BETA-BLOCKER DOSE

Metoprolol succinate 25 mg once daily [recently reduced to lower dose]
Corlanor patient
 

LVEF

BP (mm/Hg)

NYHA CLASSIFICATION

34%

94/65

Class II

 

ADDITIONAL MEDICATIONS

  • Enalapril 10 mg 2x/day
  • Furosemide 80 mg/day
This is a hypothetical patient.
 

BP = blood pressure; BPM = beats per minute; CrCl = creatinine clearance; HF = heart failure; HR = heart rate; ICD = implantable cardioverter defibrillator; LVEF = left ventricular ejection fraction; mg=milligram(s); mm/Hg =millimeter(s) of mercury; NYHA = New York Heart Association; x =times.

Reference
  1. Corlanor® (ivabradine) prescribing information, Amgen.

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.