Counterfeit Symtuza® (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) has been identified in 3 pharmacies in the US according to a warning issued by Janssen.
Symtuza is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 40 kg who have no history of antiretroviral or who are virologically suppressed (HIV-1 RNA <50 copies / ml) antiretroviral Regimen for at least 6 months and no known substitutions related to darunavir or tenofovir resistance. The counterfeit products obtained from unauthorized dealers are being investigated by Janssen and the Food and Drug Administration (FDA).
In a statement, the company made it clear that Symtuza, obtained from authorized dealers, should be considered safe for use. The authentic product is supplied as yellow to yellowish-brown, capsule-shaped, film-coated tablets embossed with “8121” on one side and “JG” on the other. If the product does not match this description, it should be reported to the FDA Criminal Investigation Office (800-551-3989) or Janssen Medical Information (800-526-7736).
There are currently no reports of adverse events related to the use of the counterfeit product. Adverse events related to Symtuza or the counterfeit drug should be reported to the FDA’s MedWatch program or Janssen Medical Information.
Janssen alerts counterfeit Symtuza® (darunavir / cobicistat, emtricitabine, tenofovir alafenamide) is being sold in the USA. [press release]. December 24, 2020.
This article originally appeared on MPR