For: HIV Infection, Pre-Exposure Prophylaxis
Descovy (emtricitabine and tenofovir alafenamide) is a nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection, and for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection. DESCOVY 200 mg/25 mg tablets are blue, rectangular-shaped, and film-coated with "GSI" debossed on one side and "225" on the other side. Each bottle contains 30 tablets (NDC 61958-2002-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure.
Store at 25�C (77�F); excursions permitted to 15�C to 30�C (59�F to 86�F) (see USP Controlled Room Temperature).
Keep container tightly closed.
Dispense only in original container.
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 U.S. 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. Hepatic function should be monitored closely in these individuals. If appropriate, anti-hepatitis B therapy may be warranted. (5.1)
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. (5.2)
RECENT MAJOR CHANGES
Boxed Warning 10/2019
Indications and Usage (1.2) 10/2019
Dosage and Administration (2.1, 2.2) 10/2019
Dosage and Administration (2.3, 2.4, 2.5) 12/2019
Contraindications (4) 10/2019
Warnings and Precautions (5.2) 10/2019
Warnings and Precautions (5.4) 12/2019
INDICATIONS AND USAGE
HIV-1 Treatment (1.1):
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.
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 25 kg and less than 35 kg.
HIV-1 PrEP (1.2):
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 (1.2):
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. 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. (2.1)
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). (2.2)
Recommended dosage:
Treatment of HIV-1 Infection: One tablet taken once daily with or without food in patients with body weight at least 25 kg. (2.3)
HIV-1 PrEP: One tablet taken once daily with or without food in individuals with body weight at least 35 kg. (2.4)
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. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg of FTC and 25 mg of TAF (3)
CONTRAINDICATIONS
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. (5.2)
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. (5.2)
Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment. (5.3)
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. (5.4)
Lactic acidosis/severe hepatomegaly with steatosis: Discontinue DESCOVY in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. (5.5)
ADVERSE REACTIONS
In HIV-1 infected patients, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea. (6.1)
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Consult the Full Prescribing Information prior to and during use for potential drug interactions. (7, 12.3)
USE IN SPECIFIC POPULATIONS
Lactation: Mothers infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV transmission. (8.2)
Pediatrics:
Treatment of HIV-1 Infection: Not recommended for patients weighing less than 25 kg. (8.4)
HIV-1 PrEP: Not recommended for individuals weighing less than 35 kg. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 12/2019
