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.
Important considerations:
A change of 5 units in the KCCQ overall summary score is generally considered to be clinically meaningful.2,3
KCCQ description:2,4
*Net proportion with 5-unit advantage is calculated by adding the differences in the proportion that improved by at least 5 units on Corlanor® compared with placebo.2
LIVE:LIFE was a multicenter, open-label, prospective observational cohort study assessing HQoL in 240 patients ≥ 70 years with chronic HF following the initiation of Corlanor®. The primary endpoint was change in HQoL total score as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHFQ) after 6 months.5
Important considerations:
A 5-point change in the MLWHFQ is generally
considered to be clinically meaningful.7
MLWHFQ description:5,6
BPM = beats per minute; CI = confidence interval; FDA = Food and Drug Administration; HR = heart rate; HQoL = health-related quality of life; If = pacemaker/funny curent; n = sample size; SOC = standard of care; SHIFT = Systolic Heart Failure Treatment with the If Inhibitor Ivabradine Trial.
IMPORTANT SAFETY INFORMATION
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.
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