HIGHLIGHTS OF PRESCRIBING INFORMATION for DESCOVY. …

1 Gilead Sciences 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use DESCOVY safely and effectively. See full PRESCRIBING INFORMATION for DESCOVY. DESCOVY (emtricitabine and tenofovir alafenamide) tablets, for oral use Initial Approval: 2015 WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full PRESCRIBING INFORMATION for complete boxed warning. Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of DESCOVY.

2 Hepatic function should be monitored closely in these individuals. If appropriate, anti-hepatitis B therapy may be warranted. ( ) DESCOVY used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of FTC/TDF for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate DESCOVY for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed. ( ) ----------------------------RECENT MAJOR CHANGES-------------------------- Indications and Usage ( ) 01/2022 dosage and Administration ( ) 01/2022 Warnings and Precautions ( ) 03/2021 ----------------------------INDICATIONS AND USAGE---------------------------- HIV-1 Treatment ( ): DESCOVY is a two-drug combination of emtricitabine (FTC) and tenofovir alafenamide (TAF), both HIV nucleoside analog reverse transcriptase inhibitors (NRTIs), and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg.

3 In combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg. HIV-1 PrEP ( ): DESCOVY is indicated in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection from sexual acquisition, excluding individuals at risk from receptive vaginal sex. Individuals must have a negative HIV-1 test immediately prior to initiating DESCOVY for HIV-1 PrEP. Limitations of Use ( ): The indication does not include use of DESCOVY in individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated. ------------------------ dosage AND ADMINISTRATION---------------------- Testing: Prior to or when initiating DESCOVY, test for hepatitis B virus infection.

4 Prior to or when initiating DESCOVY, and during use on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all individuals. In individuals with chronic kidney disease, also assess serum phosphorus. ( ) HIV-1 Screening: Screen all individuals for HIV-1 infection immediately prior to initiating DESCOVY for HIV-1 PrEP and at least once every 3 months while taking DESCOVY, and upon diagnosis of any other sexually transmitted infections (STIs). ( ) Recommended dosage : Treatment of HIV-1 Infection: o Adult and pediatric patients weighing at least 35 kg: One 200 mg/25 mg tablet once daily with or without food. ( ) o Pediatric patients not receiving a protease inhibitor administered with ritonavir or cobicistat, and weighing: at least 25 to less than 35 kg: One 200 mg/25 mg tablet once daily with or without food.

5 ( ) at least 14 to less than 25 kg: One 120 mg/15 mg tablet once daily with or without food. ( ) HIV-1 PrEP: One 200 mg/ 25 mg tablet once daily with or without food in individuals with body weight at least 35 kg. ( ) Renal impairment: DESCOVY is not recommended in individuals with estimated creatinine clearance of 15 to below 30 mL per minute, or below 15 mL per minute who are not receiving chronic hemodialysis. ( ) ---------------------- dosage FORMS AND STRENGTHS--------------------- Tablets: 200 mg/25 mg and 120 mg/15 mg of FTC and TAF respectively (3) -------------------------------CONTRAIND ICATIONS------------------------------- DESCOVY for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status. (4) -----------------------WARNINGS AND PRECAUTIONS------------------------ Comprehensive management to reduce the risk of sexually transmitted infections (STIs), including HIV-1, when DESCOVY is used for HIV-1 PrEP: Counsel on adherence to daily dosing and safer sex practices, including condoms, to reduce the risk of STIs.

6 ( ) Management to reduce the risk of acquiring HIV-1 drug resistance when DESCOVY is used for HIV-1 PrEP: refer to full PRESCRIBING INFORMATION for additional detail. ( ) Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment. ( ) New onset or worsening renal impairment: Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein when initiating DESCOVY and during use on a clinically appropriate schedule in all individuals. Also assess serum phosphorus in individuals with chronic kidney disease. ( ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue DESCOVY in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity.

7 ( ) -------------------------------ADVERSE REACTIONS------------------------------ In HIV-1 infected patients, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea. ( ) In HIV-1 uninfected adults in a PrEP trial, the most common adverse reaction (incidence greater than or equal to 5%, all grades) was diarrhea. ( ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or -------------------------------DRUG INTERACTIONS---------------------------- --- Consult the Full PRESCRIBING INFORMATION prior to and during use for potential drug interactions. (7, ) ------------------------USE IN SPECIFIC POPULATIONS----------------------- Lactation: Mothers infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV transmission.

8 ( ) Pediatrics: Treatment of HIV-1 Infection: Not recommended for patients weighing less than 14 kg. ( ) HIV-1 PrEP: Not recommended for individuals weighing less than 35 kg. ( ) See 17 for PATIENT COUNSELING INFORMATION and Medication Guide. Revised: 01/2022 Gilead Sciences 2 FULL PRESCRIBING INFORMATION : CONTENTS* WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B AND RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION 1 INDICATIONS AND USAGE Treatment of HIV-1 Infection HIV-1 Pre-Exposure Prophylaxis (PrEP) 2 dosage AND ADMINISTRATION Testing When Initiating and During Use of DESCOVY for Treatment of HIV-1 Infection or for HIV-1 PrEP HIV-1 Screening for Individuals Receiving DESCOVY for HIV-1 PrEP Recommended dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg Recommended dosage for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 14 kg to Less than 35 kg Recommended dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg Not Recommended in Individuals with Severe Renal Impairment for Treatment of HIV-1 Infection or for HIV-1 PrEP 3 dosage FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection

9 Comprehensive Management to Reduce the Risk of Sexually Transmitted Infections, Including HIV-1, and Development of HIV-1 Resistance When DESCOVY Is Used for HIV-1 PrEP Immune Reconstitution Syndrome New Onset or Worsening Renal Impairment Lactic Acidosis/Severe Hepatomegaly with Steatosis 6 ADVERSE REACTIONS Clinical Trials Experience Postmarketing Experience 7 DRUG INTERACTIONS Potential for Other Drugs to Affect One or More Components of DESCOVY Drugs Affecting Renal Function Established and Other Potentially Significant Interactions Drugs without Clinically Significant Interactions with DESCOVY 8 USE IN SPECIFIC POPULATIONS Pregnancy Lactation Pediatric Use Geriatric Use Renal Impairment Hepatic Impairment 10 OVERDOSAGE 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY Mechanism of Action Pharmacodynamics Pharmacokinetics Microbiology

10 13 NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES Overview of Clinical Trials Clinical Trial Results for Treatment of HIV-1 Clinical Trial Results for HIV-1 PrEP 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the full PRESCRIBING INFORMATION are not listed. Gilead Sciences 3 FULL PRESCRIBING INFORMATION WARNING: POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF DESCOVY FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of DESCOVY.