A counterfeit version of HIV med Symtuza has been distributed to three pharmacies in the United States, warns Janssen Pharmaceutical Companies, which manufactures the single-tablet regimen.
The pharmacies received the counterfeit medication from distributors not authorized by Janssen. So far, no adverse health events resulting from the products have been reported, according to Janssen. The company says it is working with the Food and Drug Administration (FDA) to stop further distribution of the counterfeit meds.
“Nothing is more important to Janssen than ensuring the health and safety of the patients who rely on our medicines,” said Rick Nettles MD, vice president of U.S. Medical Affairs, Infectious Diseases & Vaccines at Janssen, in the media statement. “We have begun informing prescribers and pharmacists about the situation and are providing guidance on how to identify authentic Symtuza tablets. We are also enlisting the help of the strong HIV-patient advocacy community to ensure patients receive this information in a timely manner.”
Janssen describes the FDA-approved Symtuza tablets as “yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with ‘8121’ on one side and ‘JG’ on the other side.” Tablets not matching this description should be reported to the FDA’s Office of Criminal Investigations by calling 800-551-3989 or visiting www.FDA.gov/OCI.
Symtuza is a single-tablet regimen, meaning that it is a complete one-pill, once-daily treatment for HIV. Symtuza includes Janssen’s protease inhibitor darunavir plus Gilead Sciences’ boosting agent cobicistat as well as the nucleoside reverse transcriptase inhibitor emtricitabine and the nucleotide reverse transcriptase inhibitor tenofovir alafenamide. The FDA approved Symtuza for HIV treatment in July 2018. For a collection of content in POZ about the HIV drug, click #Symtuza.
To learn more about HIV treatment and antiretrovirals, visit the POZ Basics on HIV Medications, which includes pages on single-tablet regimens such as Janssen’s Symtuza as well as info on experimental HIV medications and other approved drugs.