Temixys, a single-tablet therapy combining 2 nucleoside reverse transcriptase inhibitors for the treatment of HIV-1 infection, will be available in the coming weeks, according to Celltrion.
The treatment, which is approved for patients weighing ≥35kg in combination with other antiretroviral agents, combines lamivudine 300mg and tenofovir disoproxil fumarate 300mg into a fixed-dose tablet. Because Temixys is a fixed-dose combination formulation and the dose cannot be adjusted, it is not recommended for patients with impaired renal function or patients with end-stage renal disease requiring hemodialysis.
Temixys carries a Boxed Warning regarding posttreatment exacerbations of hepatitis B. Prior to initiating treatment, patients should be tested for hepatitis B virus infection.
The Company stated that the treatment will be available at a “significantly discounted and competitive” wholesale acquisition cost (WAC) compared with other tenofovir-based double combination products. It will be supplied as 300mg/300mg fixed-dose tablets in 30-count bottles. A companion app called TuneUpTogether will also be available to patients to support medication adherence.
For more information visit Celltrion.com.