Medically reviewed by Drugs.com. Last updated on Sep 21, 2021.
Generic name: EMTRICITABINE 200mg, TENOFOVIR ALAFENAMIDE FUMARATE 25mg
Dosage form: tablet
Testing When Initiating and During Use of DESCOVY for Treatment of HIV-1 Infection or for HIV-1 PrEP
Prior to or when initiating DESCOVY, test individuals for hepatitis B virus infection [see Warnings and Precautions (5.1)].
Prior to or when initiating DESCOVY, and during use of DESCOVY 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 [see Warnings and Precautions (5.4)].
HIV-1 Screening for Individuals Receiving DESCOVY for HIV-1 PrEP
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) [see Indications and Usage (1.2), Contraindications (4), and Warnings and Precautions (5.2)].
If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute or primary HIV-1 infection [see Warnings and Precautions (5.2), Use in Specific Populations (8.4), and Clinical Studies (14.3)].
Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 25 kg
DESCOVY is a two-drug fixed dose combination product containing 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). The recommended dosage of DESCOVY for treatment of HIV-1 is one tablet taken orally once daily with or without food in:
- adults and pediatric patients with body weight at least 25 kg and creatinine clearance greater than or equal to 30 mL per minute; or
- adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of DESCOVY after completion of hemodialysis treatment [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
For specific dosing recommendations for coadministered third agents, refer to their respective prescribing information [see Drug Interactions (7)].
The safety and effectiveness of DESCOVY coadministered with an HIV-1 protease inhibitor that is administered with either ritonavir or cobicistat have not been established in:
- pediatric subjects weighing less than 35 kg; or
- adult subjects with creatinine clearance below 15 mL per minute, with or without hemodialysis.
Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg
The dosage of DESCOVY for HIV-1 PrEP is one tablet (containing 200 mg of FTC and 25 mg of TAF) once daily taken orally with or without food in HIV-1 uninfected:
- adults and adolescents weighing at least 35 kg and with a creatinine clearance greater than or equal to 30 mL per minute; or
- adults with creatinine clearance below 15 mL per minute who are receiving chronic hemodialysis. On days of hemodialysis, administer the daily dose of DESCOVY after completion of hemodialysis treatment [see Indications and Usage (1.2) and Clinical Pharmacology (12.3)].
Not Recommended in Individuals with Severe Renal Impairment for Treatment of HIV-1 Infection or for HIV-1 PrEP
DESCOVY is not recommended in individuals with:
- severe renal impairment (estimated creatinine clearance of 15 to below 30 mL per minute); or
- end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are not receiving chronic hemodialysis [see Dosage and Administration (2.3, 2.4) and Use in Specific Populations (8.6)].
Frequently asked questions
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More about Descovy (emtricitabine / tenofovir alafenamide)
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- Drug class: antiviral combinations
- FDA Approval History
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