New Corlanor (Ivabradine) Formulation Approved by FDA

May 22, 2019
Drew Boxler

Oral solution now approved for adults and pediatric patients.

The FDA has recently approved Corlanor (ivabradine, Amgen) oral solution for the reduction of hospitalization for worsening heart failure in adults with stable symptomatic chromic heart failure with reduced left ventricular ejection fraction, as well as for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older.

Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker, originally approved in the United States in 2015. 

Starting dose for adults and pediatric patients who weigh more than 40 kg is 2.5 mg (for pediatrics and vulnerable adults) or 5 mg twice daily with food. After two weeks, dosage should be adjusted based on heart rate, with a maximum dose of 7.5 mg twice daily. 

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For pediatric patients six months of age and older who weigh less than 40 kg, the starting dose of the oral solution is 0.05 mg/kg twice daily with food. Dosage should be adjusted in two-week intervals by 0.05 mg/kg based on heart rate, with a maximum dosage being 0.2 mg/kg for patients six months to 1 year old or 0.3 mg/kg for patients 1 year and older. The maximum dose for pediatric patients is 7.5 mg twice daily.

Contraindications for ivabradine include acute decompensated heart failure, clinically significant hypotension; sick sinus syndrome, sinoatrial block or third degree AV block, unless a functioning demand pacemaker is present, clinically significant bradycardia, severe hepatic impairment, heart rate maintained exclusively by a pacemaker, or patients who are also taking CYP3A4 inhibitors.

The most common adverse reactions to ivabradine include bradycardia, hypertensions, atrial fibrillation, and luminous phenomena (phosphenes). 

 

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