March 21, 2014
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Entecavir approved for children 2 years and older for hepatitis B virus infection
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The FDA has announced that entecavir is now approved for use in children aged 2 years and older with chronic hepatitis B virus infection, according to an FDA press release.
In this age group, entecavir (Baraclude, Bristol-Myers Squibb) can now be used in patients with evidence of active viral replication and either evidence of persistent elevations in serum aminotranferases or histologically active disease.
The changes were made based on clinical trial data in nucleoside-inhibitor-naïve children and a limited number of lamivudine-experienced children with chronic hepatitis B infection and compensated liver disease.
Drug related adverse reactions from include abdominal pain, rash, poor palatability, nausea, diarrhea and vomiting.