Medication Monitor

Generic Name (Trade Name—Company)
October 30, 2019


Sacubitril/valsartan receives approval for treatment of pediatric heart failure

On October 1, FDA approved sacubitril/valsartan to treat symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients ages 1 year and older. Sacubitril/valsartan reduces N-terminal prohormone brain natriuretic peptide (NT-proBNP) and is expected to improve cardiovascular outcomes.

Approval in children ages 1 year and older was based on an analysis of 110 patients that evaluated the reduction from baseline to 12 weeks in NT-proBNP. The analysis included 90 patients ages 6 to 18 years old and 20 patients ages 1 to 6 years.

Taken twice daily, the agent works by enhancing the beneficial neurohormonal systems (natriuretic peptide system) while simultaneously inhibiting the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS). Most other heart failure medicines block only the harmful effects of the overactive RAAS.

The film-coated tablets are available in three dosage strengths: 50 mg, 100 mg and 200 mg. An oral solution also may be compounded. In pediatric patients, the target maintenance dose is dependent on body weight.

Serious adverse effects include severe allergic reactions causing swelling of the face, lips, tongue, and throat that may result in trouble breathing and death.

Common adverse effects are low blood pressure, high potassium, cough, dizziness, and kidney problems.