FDA Posts Updated Genvoya Prescribing Information

genvoya label updated by FDA
genvoya label updated by FDA
Genvoya is indicated for adult and pediatric patients 12 years or older with HIV-1 infection who have no history of antiretroviral treatment.

The Food and Drug Administration (FDA) has posted updated prescribing information for Genvoya (elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg tablets; Gilead), removing the warnings regarding bone loss and mineralization defects.

Previously, the labeling included information stating that the assessment of bone mineral density (BMD) should be considered for adults and pediatric patients treated with Genvoya who have a history of pathologic bone fracture or other risk factors for osteoporosis or bone loss. Also, hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy have occurred in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving products containing tenofovir disoproxil fumarate, but the effect was yet unknown in patients receiving Genvoya.

Both of these statements have now been removed from the Warnings and Precautions section. In addition, the labeling has been updated with longer term safety, efficacy and resistance data from 96 weeks of treatment in adults with mild to moderate renal impairment. 

Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya.

For more information visit Gilead.com.

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Genvoya® [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2016.

This article originally appeared on MPR