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On June 8, 2017, the Food and Drug Administration approved the first generic version of emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, determined to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Truvada Tablets, 200 mg/300 mg.
The drug is indicated for the treatment of HIV-1, in combination with
other antiretroviral agents in adults and pediatric
patients weighing at least 17 kg, and for pre-exposure prophylaxis (PrEP) in
combination with safer sex practices to prevent sexually-acquired HIV infection
in adults at high risk.
Emtricitabine and tenofovir disoproxil
fumarate must be dispensed with a Medication Guide for patients, which provides
important information about the medication’s use and risks.
Emtricitabine and tenofovir disoproxil
fumarate must be used as directed by the physician and should be taken by mouth
only. If you have kidney problems, your healthcare provider may tell you to
take emtricitabine and tenofovir
disoproxil fumarate less often. Do not change your dose or stop taking emtricitabine and tenofovir disoproxil fumarate without first talking with your healthcare
provider. Stay under a healthcare provider’s care when taking emtricitabine and tenofovir disoproxil
fumarate.
Emtricitabine and tenofovir disoproxil
fumarate used for PrEP must
only be prescribed to individuals confirmed to be HIV-negative immediately
prior to initial use and periodically during use. Drug-resistant HIV-1 variants
have been identified with the use of emtricitabine and tenofovir disoproxil fumarate for PrEP following undetected acute HIV-1
infection. Do not initiate emtricitabine
and tenofovir disoproxil fumarate
for a PrEP indication if signs or symptoms of acute HIV infection are present
unless negative infection status is confirmed.
Women infected with HIV-1 should
be instructed not to breastfeed while taking emtricitabine and tenofovir disoproxil fumarate.
More
information on emtricitabine and
tenofovir disoproxil fumarate may be found within the drug label at Drugs@FDA.
The generic formulation is a product of Teva Pharmaceuticals USA.
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