Brand Medications with Generic Alternatives Anticipated to be Approved in January
November 17, 2018Temixys Approved to Treat HIV
November 16, 2018 – The U.S. FDA has approved TemixysTM (300mg lamivudine/300mg tenofovir disoproxil fumarate), manufactured by Celltrion, for use in combination with other antiretroviral agents to treat HIV-1 infection in adults and pediatric patients who weigh at least 35kg (77 pounds).
Temixys combines two nucleoside reverse transcriptase inhibitors into a single pill. The recommendeddosing is one tablet per day with food. Patients should be tested for hepatitis B virus infection before treatment begins. The prescriber should also obtain an estimated creatinine clearance, urine glucose, and urine protein for the patient. According to a black box warning, discontinuing treatment with either active ingredient in Temixys can exacerbate hepatitis B virus (HBV) in patients co-infected with HBV and HIV.
Celltrion plans to launch Temixys early in 2019. Pricing information is not yet available.
