Descovy

What is Descovy?

11 DESCRIPTION DESCOVY (emtricitabine and tenofovir alafenamide) is a fixed dose combination tablet containing emtricitabine (FTC) and tenofovir alafenamide (TAF) for oral administration. FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. DESCOVY tablets are available in two dose strengths: 200 mg/25 mg tablets: 200 mg of FTC and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate). 120 mg/15 mg tablets: 120 mg of FTC and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate). Both dose strengths of DESCOVY tablets include the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 200 mg/ 25 mg tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 120 mg/15 mg tablets are film-coated with a coating material containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, and talc. Em

Uses of Descovy

Established uses

• 1 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 adolescent patients weighing at least 35 kg.
• for the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor.
• 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.
• 1.1 Treatment of HIV-1

How Descovy works

In more detail: 12.1 Mechanism of Action DESCOVY is a fixed dose combination of antiretroviral drugs emtricitabine (FTC) and tenofovir alafenamide (TAF) [see Microbiology (12.4) ] .

How to take Descovy

2 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: Adult and pediatric patients weighing at least 35 kg: One 200 mg/25 mg tablet once daily with or without food. ( 2.3 ) Pediatric patients receiving DESCOVY with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors administered with either 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. ( 2.4 ) at least 14 to less than 25 kg: One 120 mg/15 mg tablet once daily with or without foo

Dosage

Follow the dose prescribed by your doctor or pharmacist. The ranges below are general information, not a personal prescription.

Adults

2 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: Adult and pediatric patients weighing at least 35 kg: One 200 mg/25 mg tablet once daily with or without food. ( 2.3 ) Pediatric patients receiving DESCOVY with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors administered with either 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. ( 2.4 ) at least 14 to less than 25 kg: One 120 mg/15 mg tablet once daily with or without foo

Side effects of Descovy

Common

• 6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B [see Warnings and Precautions (5.1) ] .
• Immune Reconstitution Syndrome [see Warnings and Precautions (5.3) ] .
• New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.4) ] .
• Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.5) ].
• In participants with HIV-1, the most common adverse reaction (incidence greater than or equal to 10%, all grades) was nausea.
• ( 6.1 ) In adults without HIV-1 in a PrEP trial, the most common adverse reaction (incidence greater than or equal to 5%, all grades) was diarrhea.

Warnings and who should not take it

Who should NOT take Descovy?

• 4 CONTRAINDICATIONS DESCOVY for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2) ].
• DESCOVY for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status.
• ( 4 )

Overdose

10 OVERDOSAGE No data are available on overdose of DESCOVY in patients. If overdose occurs, monitor the individual for evidence of toxicity. Treatment of overdose with DESCOVY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the individual. Emtricitabine (FTC): Limited clinical experience is available at doses higher than the recommended dose of FTC in DESCOVY. In one clinical pharmacology study, single doses of FTC 1200 mg (6 times the FTC dose in DESCOVY) were administered to 11 participants. No severe adverse reactions were reported. The effects of higher doses are not known. Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL per minute and a dialysate flow rate of 600 mL per minute). It is not known whether FTC can be removed by peritoneal dialysis. Tenofovir Alafenamide (TAF) : Limited clinical experience is available at doses higher than the recommended dose of TAF. A single dose of 125 mg TAF (5 times the TAF dose in 200/25 mg DESCOVY) was administered to 48 healthy participants; no serious

Safety at a glance

Children and elderly

Interactions

Medicine and medicine

• 7 DRUG INTERACTIONS Consult the Full Prescribing Information prior to and during use for potential drug interactions.
• ( 7 , 12.3 ) 7.1 Potential for Other Drugs to Affect One or More Components of DESCOVY TAF, a component of DESCOVY, is a substrate of P-gp, BCRP, OATP1B1, and OATP1B3.
• Drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption (see Table 6 ).
• Drugs that induce P-gp activity are expected to decrease the absorption of TAF, resulting in decreased plasma concentration of TAF, which may lead to loss of therapeutic effect of DESCOVY and development of resistance.
• Coadministration of DESCOVY with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of TAF.
• TAF is not an inhibitor of CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or UGT1A1.

Frequently asked questions