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Indications and Purposes

1 Indications And Usage Emtricitabine And Tenofovir Disoproxil Fumarate Tablets Are A Two-Drug Combination Of Emtricitabine (Ftc) And Tenofovir Disoproxil Fumarate (Tdf), Both Hiv-1 Nucleoside Analog Reverse Transcriptase Inhibitors, And Is Indicated: In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 17 Kg. ( 1.1 ) In Combination With Safer Sex Practices For Hiv-1 Pre-Exposure Prophylaxis (Prep) To Reduce The Risk Of Sexually Acquired Hiv-1 In At-Risk Adults And Adolescents Weighing At Least 35 Kg. ( 1.2 ) 1.1 Treatment Of Hiv-1 Infection Emtricitabine And Tenofovir Disoproxil Fumarate Tablets Are Indicated In Combination With Other Antiretroviral Agents For The Treatment Of Hiv-1 Infection In Adults And Pediatric Patients Weighing At Least 17 Kg [See Clinical Studies (14) ] . 1.2 Hiv-1 Pre-Exposure Prophylaxis (Prep) Emtricitabine And Tenofovir Disoproxil Fumarate Tablets Are Indicated In Combination With Safer Sex Practices For Pre-Exposure Prophylaxis (Prep) To Reduce The Risk Of Sexually Acquired Hiv-1 In At-Risk Adults And Adolescents Weighing At Least 35 Kg. Individuals Must Have A Negative Hiv-1 Test Immediately Prior To Initiating Emtricitabine And Tenofovir Disoproxil Fumarate For Hiv-1 Prep [See Dosage And Administration (2.2) ]. If Clinical Symptoms Consistent With Acute Viral Infection Are Present And Recent (<1 Month) Exposures Are Suspected, Delay Starting Prep For At Least One Month And Reconfirm Hiv-1 Status Or Use A Test Cleared By The Fda As An Aid In The Diagnosis Of Hiv-1 Infection, Including Acute Or Primary Hiv-1 Infection [See Warnings And Precautions (5.2) , Use In Specific Populations (8.4) And Clinical Studies (14.3 , 14.4 )] . When Considering Emtricitabine And Tenofovir Disoproxil Fumarate Tablets For Hiv-1 Prep, Factors That Help To Identify Individuals At Risk May Include: Has Partner(S) Known To Be Hiv-1 Infected, Or Engages In Sexual Activity Within A High Prevalence Area Or Social Network And Has Additional Risk Factors For Hiv-1 Acquisition, Such As: Inconsistent Or No Condom Use Diagnosis Of Sexually Transmitted Infections Exchange Of Sex For Commodities (Such As Money, Food, Shelter, Or Drugs) Use Of Illicit Drugs Or Alcohol Dependence Incarceration Partner(S) Of Unknown Hiv-1 Status With Any Of The Factors Listed Above

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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