HIV Drug Gets New Labeling
Initially, FDA labeling for Genvoya (150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofovir alafenamide tablets) stated that a bone mineral density (BMD) assessment should be considered by any patients treated with Genvoya—especially patients with a history of pathologic bone fracture, other risk factors for bone loss or osteoporosis. Additionally, patients who received products containing tenofovir disoproxil fumarate were at risk for developing hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy. However, at the time, these effects were not yet known for Genvoya.
The FDA has now posted updated prescribing information for Genvoya, which have removed the warnings regarding bone loss.4 Both of these statements have been removed from the Warnings and Precautions section. Genvoya labeling has also been updated with longer-term safety, efficacy and resistance data from 96 weeks of treatment in adults with mild to moderate renal impairment.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
References
- Stendahl M. Fast-growing Burlington biotech Flexion files for approval of lead drug. Boston Business Journal. 2016 Dec 12.
- Flexion Therapeutics Inc. News release: Flexion Therapeutics announces presentation of Phase 3 data demonstrating that extended-release Zilretta achieves clinically significant improvement of pain, stiffness and function in patients with osteoarthritis of the knee. 2016 Nov 11.
- U.S. Food and Drug Administration. FDA drug safety communication: Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. 2016 Dec 12.
- Ernst D. Updated labeling for combo HIV drug Genvoya. MPR. 2016 Dec 12.
