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What is the generic name?
TENOFOVIR DISOPROXIL FUMARATE
What is the Trade Name for TENOFOVIR DISOPROXIL FUMARATE?
Tenofovir Disoproxil Fumarate
What are the Indications for TENOFOVIR DISOPROXIL FUMARATE?
- 1 INDICATIONS AND USAGE Tenofovir disoproxil fumarate tablets are a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor. Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. ( 1 ) Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older. ( 1 ) 1.1 HIV-1 Infection Tenofovir disoproxil fumarate tablets are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older. The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HIV-1 infection: Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA ®, COMPLERA ®, DESCOVY ®, GENVOYA ®, ODEFSEY ®, STRIBILD ®, TRUVADA ®, or VEMLIDY ® [See Warnings and Precautions (5.4)] .Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA ®, COMPLERA ®, DESCOVY ®, GENVOYA ®, ODEFSEY ®, STRIBILD ®, TRUVADA ®, or VEMLIDY ® [See Warnings and Precautions (5.4)] . 1.2 Chronic Hepatitis B Tenofovir disoproxil fumarate tablets are indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older . The following points should be considered when initiating therapy with tenofovir disoproxil fumarate tablets for the treatment of HBV infection: The indication in adults is based on safety and efficacy data from treatment of subjects who were nucleoside-treatment-naïve and subjects who were treatment-experienced with documented resistance to lamivudine. Subjects were adults with HBeAg-positive and HBeAg-negative chronic hepatitis B with compensated liver disease [See Clinical Studies (14.2) ]. Tenofovir disoproxil fumarate tablets were evaluated in a limited number of subjects with chronic hepatitis B and decompensated liver disease [See Adverse Reactions (6.1) , Clinical Studies (14.2) ] . The numbers of subjects in clinical trials who had adefovir resistance-associated substitutions at baseline were too small to reach conclusions of efficacy [See Microbiology (12.4) , Clinical Studies (14.2) ].
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References: https://open.fda.gov/
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