— Christine M. Kukka, Project Manager, HBV Advocate
The U.S. Food and Drug Administration has approved the antiviral
entecavir (brand name Baraclude) for use in children and teens age
2 and older. This robust antiviral is the first to be approved by
the FDA for children in several years, and is considered one of
the top two antivirals available to adults today.
Previously, the only FDA-approved drug treatments for treating
children with hepatitis B-related liver damage (including high
viral load and signs of liver damage) were considered relatively
ineffectively, including conventional interferon that requires a
weekly injection (which has been replaced by more effective
pegylated interferon for adults) and the antiviral lamivudine
(Epivir-HBV), which is considered a substandard because of its
high rate of drug resistance.
According to the FDA-approved package insert, children with body weight greater
than 30 kg should receive 10 mL (0.5 mg) of oral solution or one
0.5 mg tablet once daily. Children with body weight greater than
30 kg should receive 20 mL (1 mg) of oral solution or one 1 mg
tablet once daily. Higher doses of entecavir are recommended for
children who have already developed drug resistance to the
antiviral lamivudine, — Chris
Download Package Insert:
Labels: Baraclude (Entacavir), package insert, pediatric use
