TENOFOVIR DISOPROXIL FUMARATE (Tenofovir Disoproxil Fumarate) Nursing Considerations

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 ¬Æ, COMPLERA ¬Æ, DESCOVY ¬Æ, GENVOYA ¬Æ, ODEFSEY ¬Æ, STRIBILD ¬Æ, TRUVADA ¬Æ, or VEMLIDY ¬Æ [See Warnings and Precautions (5.4)] .Tenofovir disoproxil fumarate tablets should not be used in combination with ATRIPLA ¬Æ, COMPLERA ¬Æ, DESCOVY ¬Æ, GENVOYA ¬Æ, ODEFSEY ¬Æ, STRIBILD ¬Æ, TRUVADA ¬Æ, or VEMLIDY ¬Æ [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-na√Øve 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) ].

References: https://open.fda.gov/