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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The 2016/2017 ACC/AHA/HFSA Guideline
Updates include Corlanor® as a
recommended treatment option for
stage C and D HFrEF1,2

Recommendation for Ivabradine1

 
COR
LOE
lla*
B-R†
Recommendation
Ivabradine can be beneficial to reduce HF hospitalization for patients with symptomatic (NYHA Class II-III) stable chronic HFrEF (LVEF ≤ 35%) who are receiving Guideline Directed Evaluation and Management, including a beta- blocker at maximum-tolerated dose, and who are in sinus rhythm with a heart rate of 70 bpm or greater at rest.
 

*Class IIa (moderate) is defined as useful, effective, or beneficial, and the benefit is greater than the risk.
†Level B-R is defined as moderate-quality evidence from 1 or more randomized control trials.

ACC = American College of Cardiology; ACCF = American College of Cardiology Foundation; AHA = American Heart Association; BPM = beats per minute; COR = class of recommendation; HF = heart failure; HFrEF = heart failure with reduced ejection fraction; HFSA = Heart Failure Society of America; LOE = level of evidence; NYHA = New York Heart Association.

Corlanor® recommended as part of standard of care in the treatment of HFrEF stage C and D in the 2016/2017 ACC/AHA/HFSA Guideline Updates for patients with HR ≥ 70 bpm on maximally-tolerated beta blocker therapy1,2

STEP 1

Establish Dx of HFrEF;
assess volume; initiate GDMT

HFrEF
NYHA class I-IV
(stage C)
ACEI or ARB AND
GDMT beta-blocker;
diuretics as
needed (COR I)

STEP 2

Consider the following patient scenarios

STEP 3

Implement indicated GDMT
Choices are not mutually exclusive, and no order is inferred

NYHA class II-III, NSR,
heart rate ≥ 70 bpm on maximally tolerated dose
beta-blocker
Ivabradine
(COR IIa)
NYHA class II-IV,
provided est. CrCI > 30 mL/min & K+ < 5.0 mEq/L
Aldosterone
antagonist (COR I)
NYHA class II-III HF adequate BP on ACEI or ARB*; no C/I to ARB or sacubitril
Discontinue
ACEI or ARB; initiate
ARNI* (COR I)
NYHA class III-IV,
in black patients
Hydral-Nitrates†
(COR I)
NYHA class II-III, LVEF ≤ 35%; (caveat: > 1 y
survival, > 40 d post MI)
ICD
(COR I)
NYHA class II-IV, LVEF ≤ 35%, NSR & QRS ≥ 150 ms with LBBB pattern
CRT or CRT-D
(COR I)

STEP 4

Reassess symptoms

Refractory
NYHA class III-IV
(stage D)

STEP 5

Consider additional therapy

Palliative care (COR I)

Transplant (COR I)

LVAD (COR IIa)

Investigational studies‡

 

For all medical therapies, dosing should be optimized and serial assessment exercised.

*ARNI to replace ACEi or ARB.
†Hydral-Nitrates: The combination of ISDN/HYD with ARNI has not been robustly tested. BP response should be carefully monitored.
‡Participation in investigational studies is also appropriate for stage C, NYHA class II and III HF.

ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin receptor-blocker;
ARNI = angiotensin receptor-seprilysin; BP = blood pressure; bpm = beats per minute; C/I = contraindication; COR = class of recommendation; CrCl = creatinine clearance; CRT = cardiac resynchronization therapy;
CRT-D = cardiac resynchronization therapy-device; d = day(s); Dx = diagnosis; est. = estimate(d); GDMT = guideline-directed management and therapy; HF = heart failure; HFrEF = heart failure with reduced ejection fraction; ICD = implantable cardioverter-defibrillator; ISDN/HYD = isosorbide dinitrate hydral-nitrates; K+ = potassium cation;
LBBB = left bundle-branch block; LVAD = left ventricular assist device; LVEF = left ventricular ejection fraction; mEq/L = milliequivalent(s) per liter; MI = myocardial infarction;
mL/min = milliliter(s) per minute;
ms = millisecond(s); NSR = normal sinus rhythm; NYHA = New York Heart Association; QRS = QRS complex (electrocardiogram Q, R, S waves depicting ventricular depolarization);
y = year(s).

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Note:

All references to the ACC/AHA/HFSA guidelines herein are informational only and should not be viewed as an endorsement of Corlanor® and/or Amgen by ACC/AHA/HFSA.

References
  1. Yancy CW, Jessup M, Bozkurt B, et al. 2016 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: An update of the 2013 ACCF/AHA Guidelines for the Management of Heart Failure: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2016;134:e282–e293.
  2. Yancy CW, Jessup M, Bozkurt B, et al. 2017 ACC/AHA/HFSA focused update on new pharmacological therapy for heart failure: An update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2017;136:e137–e161. doi: 10.1161/CIR.0000000000000509.

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