OCTOBER 28, 2019

FDA Changes Label for DTG-Based ART

By Marie Rosenthal, MS

The FDA recently approved changes to the dolutegravir (DTG)-containing antiretroviral drugs to include updated information about the possible risk for neural tube defects based on final results from the Tsepamo study. 

There is increasing evidence of fetal toxicity from DTG when the antiretroviral therapy (ART) agents were started before conception or during the first trimester. Similar changes were made to all four labels for Tivicay, Triumeq