EATG » FDA revises Stribild label

FDA revises Stribild label

The Stribild (elvitegravir, cobicistat, emtrictiabine, tenofovir disoproxil fumarate) tablet label was revised to expand the patient population to include pediatric patients 12 years of age and older weighting at least 35 kg based upon the week 48 results from Study GS-US-236-0112. The WARNINGS and PRECAUTIONS, New Onset or Worsening Renal Impairment section was updated to include serum creatinine and serum phosphorus as part of renal function testing prior to and during administration of Stribild. The Bone Loss and Mineralization Defects subsection was updated with information about the effects of tenofovir DF on bone mineral density in pediatric and adolescent patients. The WARNINGS and PRECAUTIONS was also revised to emphasize severe acute exacerbations of Hepatitis B in coinfected patients. Additionally USE IN SPECIFIC POPULATIONS section of the labeling was reformatted for sections 8.1 and 8.2 according to the Pregnancy and Lactation Labeling Rule.

The major changes are outlined here.

News categories: EMA/FDA