Counterfeit Symtuza® (darunavir, cobicistat, emtricitabine, tenofovir alafenamide) has been identified in 3 pharmacies in the US, according to an alert 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 40kg who have no prior antiretroviral treatment history or who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen for at least 6 months, and have no known substitutions associated with resistance to darunavir or tenofovir. The counterfeit products, which were procured from unauthorized distributors, are being investigated by Janssen and the Food and Drug Administration (FDA).
In a statement, the Company clarified that Symtuza obtained from authorized distributors should be considered safe for use. The authentic product is supplied as yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with “8121” on one side and “JG” on the other side. If the product does not match this description, it should be reported to the FDA’s Office of Criminal Investigations (800-551-3989) or Janssen Medical Information (800-526-7736).
Currently, there have been 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 FDA’s MedWatch Program or Janssen Medical Information.
Janssen alerts counterfeit Symtuza® (darunavir/cobicistat,/emtricitabine,/tenofovir alafenamide) is being distributed in the United States. [press release]. December 24, 2020.