DESCOVY emtricitabine and tenofovir alafenamide 200 mg; 25 mg Tablet, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nucleoside and nucleotide reverse transcriptase inhibitors class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
The combination of emtricitabine and tenofovir AF is used to treat human immunodeficiency virus (HIV) infection. Emtricitabine and tenofovir AF is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection. Emtricitabine and tenofovir AF are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine and tenofovir AF will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-...
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $74.942 | $2,248.25 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $71.16 | $2,134.85 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $71.36 | $2,140.75 / 30 tablets |
| Medicare Part B allowsASP · J0751 | $71.427 / J0751 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Descovy 200 mg/1; 25 mgthis 61958-2002-02 | Gilead | 30 tablets | $74.942 | AB | Availability likely | — |
Where does this data come from?
⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 9296769 ↗ | Drug substance | U-257 | Aug 15, 2032 |
| US 8754065 ↗ | Drug substance | U-1259 | Aug 15, 2032 |
| US 9296769 ↗ | Drug substance | U-1259 | Aug 15, 2032 |
| US 9296769 ↗ | Drug substance | U-1663 | Aug 15, 2032 |
| US 8754065 ↗ | Drug substance | U-1663 | Aug 15, 2032 |
| US 8754065 ↗ | Drug substance | U-257 | Aug 15, 2032 |
| US 8754065 ↗ | Drug substance | U-1663 | Aug 15, 2032 |
| US 9296769 ↗ | Drug substance | U-1663 | Aug 15, 2032 |
| US 12648911 ↗ | Method of use | U-1663 | Jun 29, 2036 |
| US 12648911 ↗ | Method of use | U-1259 | Jun 29, 2036 |
| US 12629338 ↗ | Drug product | — | Jun 29, 2036 |
| US 12661323 ↗ | Drug product | — | Jun 29, 2036 |
| US 12678408 ↗ | Drug product | — | Jun 29, 2036 |
| US 12661323 ↗ | Drug product | — | Jun 29, 2036 |
| US 9296769*PED ↗ | Drug product | — | Feb 15, 2033 |
| US 8754065*PED ↗ | Drug product | — | Feb 15, 2033 |
| US 8754065*PED ↗ | Drug product | — | Feb 15, 2033 |
| US 9296769*PED ↗ | Drug product | — | Feb 15, 2033 |
| Code | What it grants | Expires |
|---|---|---|
| M-316 | New indication / labeling change (3-year) | Jun 20, 2028 |
| ODE-556 | Orphan Drug Exclusivity (7-year) | Jun 20, 2032 |
| M-316 | New indication / labeling change (3-year) | Jun 20, 2028 |
| ODE-554 | Orphan Drug Exclusivity (7-year) | Jan 7, 2029 |
| ODE-556 | Orphan Drug Exclusivity (7-year) | Jun 20, 2032 |
Is there a generic version of DESCOVY 200-25 MG TABLET?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 61958-2002-01 | 30 TABLET in 1 BOTTLE, PLASTIC (61958-2002-1) | $74.94 / ea | $2,248.25 | 2016-04-04 | Active |
| 61958-2002-02 You're viewing this | 30 TABLET in 1 BLISTER PACK (61958-2002-2) | $74.94 / ea | $2,248.25 | 2020-01-22 | Active |
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($74.94 NADAC).
This pack accounts for about 2.5% of this product's recent Medicaid fills; most go to the 30 tablets pack. See all packs ↓
Pack size FAQ
What quantity is in NDC 61958-2002-02?
What is the difference between NDC 61958-2002-02 and NDC 61958-2002-01?
What NDC number is used to bill for this package of DESCOVY emtricitabine and tenofovir alafenamide 200 mg; 25 mg Tablet?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 individuals with HBV 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 with both clinical and laboratory follow-up for at least several months in individuals with HBV who discontinue DESCOVY.
If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions (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 [see Warnings and Precautions (5.2) ]. 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 individuals with HBV 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 )
🎯 Indications and Usage ▾
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.
1.1Treatment of HIV-1 Infection DESCOVY 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. DESCOVY is indicated 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.
1.2HIV-1 Pre-Exposure Prophylaxis (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 [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ]. 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 [see Clinical Studies (14.3) ].
⏱️ Dosage and Administration ▾
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 food. ( 2.4 ) HIV-1 PrEP: One 200 mg/25 mg tablet once daily with or without food in individuals with body weight at least 35 kg. ( 2.5 ) 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.
( 2.6 )
2.1Testing 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) ].
2.2HIV-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) ].
2.3Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg DESCOVY is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir alafenamide (TAF). The recommended dosage of DESCOVY for treatment of HIV-1 is one tablet containing 200 mg FTC and 25 mg of TAF taken orally once daily with or without food in: adults and pediatric patients with body weight at least 35 kg and estimated 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) ] . 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 adults with creatinine clearance below 15 mL per minute, with or without hemodialysis. For specific dosing recommendations for coadministered antiretroviral drugs, refer to their respective presc…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS DESCOVY tablets are available in two dose strengths: 200 mg/25 mg tablets: 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF) (equivalent to 28 mg of tenofovir alafenamide fumarate). These tablets are blue, rectangular-shaped, film-coated, debossed with “GSI” on one side and “225” on the other side. 120 mg/15 mg tablets: 120 mg of FTC and 15 mg of TAF (equivalent to 16.8 mg of tenofovir alafenamide fumarate).
These tablets are white, round-shaped, film coated, debossed with “GSI” on one side and “15” on the other side. Tablets: 200 mg/25 mg and 120 mg/15 mg of FTC and TAF respectively ( 3 )
⛔ Contraindications ▾
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 )
⚠️ Warnings and Cautions ▾
5 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 )
5.1Severe Acute Exacerbation of Hepatitis B in Individuals with HBV All individuals should be tested for the presence of hepatitis B virus (HBV) before or when initiating DESCOVY [see Dosage and Administration (2.1) ] . Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in individuals with HBV who have discontinued products containing FTC and/or tenofovir disoproxil fumarate (TDF) and may occur with discontinuation of DESCOVY. Individuals with HBV who discontinue DESCOVY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment.
If appropriate, anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis, since post-treatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. Individuals without HBV should be offered vaccination.
5.2Comprehensive 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 Use DESCOVY for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy, including adherence to daily administration and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). The time from initiation of DESCOVY for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown.
Risk for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including but not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use, knowledge of partner(s)’ HIV-1 status, including viral suppression status, regular testing for STIs that can facilitate HIV-1 transmission).
Inform individuals without HIV-1 about, and support their efforts in, reducing sexual risk behavior . Use DESCOVY to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only DESCOVY, because DESCOVY alone does not constitute a complete regimen for HIV-1 treatment [see Microbiology (12.4) ]; therefore, care should be taken to minimize the risk of initiating or continuing DESCOVY before confirming the individual is HIV-1 negative.
Some HIV-1 tests only detect anti-HIV antibodies and may not identify HIV-1 during the acute stage of infection. Prior to initiating DESCOVY for HIV-1 PrEP, ask seronegative individuals about recent (in past month) potential exposure events (e.g., condomless sex or condom breaking during sex with a partner of unknow…
🤒 Adverse Reactions ▾
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.
( 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 .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug (or a drug given in various combinations with other concomitant therapy) cannot be directly compared to rates in the clinical trials of another drug (or drug given in the same or different combination therapy) and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of FTC+TAF with Elvitegravir (EVG) plus Cobicistat (COBI) in Treatment-Naïve Adults with HIV-1 In pooled 48-week trials of antiretroviral treatment-naïve adult participants with HIV-1, the most common adverse reaction in participants treated with FTC+TAF with EVG+COBI (N=866) (incidence greater than or equal to 10%, all grades) was nausea (10%).
In this treatment group, 0.9% of participants discontinued FTC+TAF with EVG+COBI due to adverse events during the 48-week treatment period [see Clinical Studies (14.2) ] . The safety profile was similar in virologically-suppressed adults with HIV-1 who were switched to FTC+TAF with EVG+COBI (N=799). Antiretroviral treatment-naïve adult participants with HIV-1 treated with FTC+TAF with EVG+COBI experienced mean increases of 30 mg/dL of total cholesterol, 15 mg/dL of LDL cholesterol, 7 mg/dL of HDL cholesterol, and 29 mg/dL of triglycerides after 48 weeks of use.
Renal Laboratory Tests In two 48-week trials in antiretroviral treatment-naïve adults with HIV-1 treated with FTC+TAF with EVG+COBI (N=866) with a median baseline eGFR of 115 mL per minute, mean serum creatinine increased by 0.1 mg per dL from baseline to Week 48. Median urine protein-to-creatinine ratio (UPCR) was 44 mg per gram at baseline and at Week 48. In a 48-week trial in virologically-suppressed TDF-treated adults with HIV-1 who switched to FTC+TAF with EVG+COBI (N=959) with a mean baseline eGFR of 112 mL per minute, mean serum creatinine was similar to baseline at Week 48; median UPCR was 61 mg per gram at baseline and 46 mg per gram at Week 48.
Across these trials, renal serious adverse events or discontinuations due to renal adverse reactions were encountered in less than 1% of participants treated with FTC+TAF with EVG+COBI. In a 24-week trial in adults with HIV-1 and renal impairment (baseline eGFR 30 to 69 mL per minute) who received FTC+TAF with EVG+COBI (N=248), mean serum creatinine was 1.5 mg per dL at both baseline and Week 24. Median UPCR was 161 mg per gram at baseline and 93 mg per gram at Week 24.
FTC+TAF with EVG+COBI was permanently discontinued due to worsening renal function in two of 80 (3%) participants. Bone Mineral Density Effects In the pooled analysis of two 48-week trials of antiretroviral treatment-naïve adult participants with HIV-1, bone mineral density (BMD) from baseline to Week 48 was assessed by dual-energy X-ray absorptiometry (DXA). Mean BMD decreased from baseline to Week 48 −1.30% with FTC+TAF with EVG+COBI at the lumbar spine and −0.66% at the total hip.
BMD declines of 5% or greater at the lumbar spine were experienced by 10% of FTC+TAF with EVG+COBI participants. BMD declines of 7% or greater at t…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Consult the Full Prescribing Information prior to and during use for potential drug interactions. ( 7 , 12.3 )
7.1Potential 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. TAF is a weak inhibitor of CYP3A in vitro .
TAF is not an inhibitor or inducer of CYP3A in vivo .
7.2Drugs Affecting Renal Function Because FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion, coadministration of DESCOVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC, tenofovir, and other renally eliminated drugs and this may increase the risk of adverse reactions. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.4) ] .
7.3Established and Other Potentially Significant Interactions Table 6 provides a listing of established or potentially clinically significant drug interactions with recommended steps to prevent or manage the drug interaction (the table is not all inclusive). The drug interactions described are based on studies conducted with either DESCOVY, the components of DESCOVY (emtricitabine and tenofovir alafenamide) as individual agents, or are predicted drug interactions that may occur with DESCOVY. For magnitude of interaction, see Clinical Pharmacology (12.3) .
Table 6 Established and Other Potentially Significant This table is not all inclusive. Drug Interactions Concomitant Drug Class: Drug Name Effect on Concentration ↓=Decrease Clinical Comment ↑= Increase Antiretroviral Agents: Protease Inhibitors (PI) tipranavir/ritonavir ↓ TAF Coadministration with DESCOVY is not recommended. atazanavir/cobicistat ↑ TAF Coadministration with DESCOVY in pediatric patients weighing 14 to < 35 kg is not recommended [see Use in Specific Populations (8.4) ] . Other Agents Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin ↓ TAF Consider alternative anticonvulsant.
Antimycobacterials: rifabutin rifampin rifapentine ↓ TAF Coadministration of DESCOVY with rifabutin, rifampin, or rifapentine is not recommended. Herbal Products: St. John’s wort (Hypericum perforatum) ↓ TAF Coadministration of DESCOVY with St.
John’s wort is not recommended.
7.4Drugs without Clinically Significant Interactions with DESCOVY Based on drug interaction studies conducted with the components of DESCOVY, no clinically significant drug interactions have been either observed or are expected when DESCOVY is combined with the following antiretroviral agents: atazanavir with ritonavir, atazanavir with cobicistat (in those weighing ≥35 kg), darunavir with ritonavir or cobicistat, dolutegravir, efavirenz, ledipasvir, lopinavir/ritonavir, maraviroc, nevirapine, raltegravir, rilpivirine, and sofosbuvir.
No clinically significant drug interactions have been either observed or are expected when DESCOVY is combined with the following drugs: buprenorphine, itraconazole, ketoconazole, lorazepam, methadone, midazolam, naloxone, norbuprenorphine, norgestimate/ethinyl estradiol, and sertraline.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatrics: Treatment of HIV-1 Infection: Not recommended for patients weighing less than 14 kg. ( 8.4 ) HIV-1 PrEP: Not recommended for individuals weighing less than 35 kg. ( 8.4 )
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to DESCOVY during pregnancy. Healthcare providers are encouraged to register individuals by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no statistically significant difference in the overall risk of major birth defects for emtricitabine (FTC) or tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ) .
The rate of miscarriage for individual drugs is not reported in the APR. The estimated background rate of miscarriage in the clinically recognized pregnancies in the U.S. general population is 15–20%. In animal studies, no adverse developmental effects were observed when the components of DESCOVY were administered separately during the period of organogenesis at exposures 60 and 108 times (mice and rabbits, respectively) the FTC exposure and at exposure equal to or 53 times (rats and rabbits, respectively) the TAF exposure at the recommended daily dose of DESCOVY (see Data ).
Likewise, no adverse developmental effects were seen when FTC was administered to mice through lactation at exposures up to approximately 60 times the exposure at the recommended daily dose of DESCOVY. No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 14 times the exposure at the recommended daily dosage of DESCOVY. Data Human Data Prospective reports from the APR of overall major birth defects in pregnancies exposed to the components of DESCOVY are compared with a U.S. background major birth defect rate.
Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. Emtricitabine (FTC): Based on prospective reports to the APR of over 7300 exposures to FTC-containing regimens during pregnancy resulting in live births (including over 5400 exposed in the first trimester and over 1800 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% CI: 2.5% to 3.5%) and 2.7% (95% CI: 2.0% to 3.6%) following first and second/third trimester exposure, respectively, to FTC-containing regimens.
Tenofovir Alafenamide (TAF): Based on prospective reports to the APR of over 1600 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 1300 exposed in the first trimester and over 300 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.9% (95% CI: 2.9% to 5.2%) and 4.7% (95% CI: 2.6% to 7.7%) following first and second/third trimester exposure, respectively, to TAF-containing regimens. Animal Data Emtricitabine: FTC was administered orally to pregnant mice (250, 500, or 1000 mg/kg/day) and rabbits (100, 300, or 1000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively).
No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (area under the curve [AUC]) approximately 60 times higher and in rabbits at approximately 108 times higher than human exposures at the recommended daily dose. In a pre/postnatal development study with FTC, mice were administered doses up to 1000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from bef…
🤰 Pregnancy ▾
8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to DESCOVY during pregnancy. Healthcare providers are encouraged to register individuals by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no statistically significant difference in the overall risk of major birth defects for emtricitabine (FTC) or tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ) .
The rate of miscarriage for individual drugs is not reported in the APR. The estimated background rate of miscarriage in the clinically recognized pregnancies in the U.S. general population is 15–20%. In animal studies, no adverse developmental effects were observed when the components of DESCOVY were administered separately during the period of organogenesis at exposures 60 and 108 times (mice and rabbits, respectively) the FTC exposure and at exposure equal to or 53 times (rats and rabbits, respectively) the TAF exposure at the recommended daily dose of DESCOVY (see Data ).
Likewise, no adverse developmental effects were seen when FTC was administered to mice through lactation at exposures up to approximately 60 times the exposure at the recommended daily dose of DESCOVY. No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 14 times the exposure at the recommended daily dosage of DESCOVY. Data Human Data Prospective reports from the APR of overall major birth defects in pregnancies exposed to the components of DESCOVY are compared with a U.S. background major birth defect rate.
Methodological limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at less than 20 weeks gestation. Emtricitabine (FTC): Based on prospective reports to the APR of over 7300 exposures to FTC-containing regimens during pregnancy resulting in live births (including over 5400 exposed in the first trimester and over 1800 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.0% (95% CI: 2.5% to 3.5%) and 2.7% (95% CI: 2.0% to 3.6%) following first and second/third trimester exposure, respectively, to FTC-containing regimens.
Tenofovir Alafenamide (TAF): Based on prospective reports to the APR of over 1600 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 1300 exposed in the first trimester and over 300 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.9% (95% CI: 2.9% to 5.2%) and 4.7% (95% CI: 2.6% to 7.7%) following first and second/third trimester exposure, respectively, to TAF-containing regimens. Animal Data Emtricitabine: FTC was administered orally to pregnant mice (250, 500, or 1000 mg/kg/day) and rabbits (100, 300, or 1000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively).
No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (area under the curve [AUC]) approximately 60 times higher and in rabbits at approximately 108 times higher than human exposures at the recommended daily dose. In a pre/postnatal development study with FTC, mice were administered doses up to 1000 mg/kg/day; no significant adverse effects directly related to drug were observed in the offspring exposed daily from before birth ( in utero ) through sexual maturity at daily exposures (AUC) of approximately 60-fold higher than human exposures at the recommended daily dose.
Tenofovir Alafenamide: TAF was administered orally to pre…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of DESCOVY for the treatment of HIV-1 infection have been established in pediatric patients weighing at least 14 kg [see Indications and Usage (1.1) and Dosage and Administration (2.2) ] . Treatment of HIV-1 Infection Adolescent Patients Weighing at Least 35 kg: The safety and effectiveness of DESCOVY in combination with other antiretroviral agents for the treatment of HIV-1 infection was established in adolescent patients weighing at least 35 kg. Use of DESCOVY in adolescent patients is supported by adequate and well controlled trials of FTC+TAF with EVG+COBI in adults and by an open-label trial in antiretroviral treatment-naïve pediatric participants with HIV-1 aged 12 to less than 18 years and weighing at least 35 kg through Week 48 (N=50; Study 106 [cohort 1]) administered FTC+TAF with EVG+COBI.
The safety and effectiveness of FTC+TAF with EVG+COBI in adolescent participants was similar to that in adults on this regimen [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.2) ] . Pediatric Patients Weighing at least 14 kg and Less than 35 kg: The safety and effectiveness of DESCOVY in combination with other antiretroviral agents, including darunavir and cobicistat (DRV+COBI) but not including other protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection was established in pediatric patients weighing at least 14 kg to less than 35 kg [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.2) ] .
Use of DESCOVY in pediatric patients weighing at least 14 kg to less than 35 kg is supported by: adequate and well controlled trials of FTC+TAF with EVG+COBI in adults; an open-label trial in virologically-suppressed pediatric participants aged 6 to less than 12 years and weighing at least 25 kg (N=52; Study 106 [cohort 2]) administered FTC+TAF with EVG+COBI through Week 48; an open-label trial of DESCOVY administered in combination with DRV+COBI in virologically-suppressed pediatric participants at least 2 years of age and weighing at least 14 kg to less than 40 kg (n=20; Study 128 [cohort 2 and 3]) through Week 48; an open-label trial of FTC+TAF with bictegravir in virologically-suppressed pediatric participants at least 2 years of age and weighing at least 14 to less than 25 kg through Week 24 (N=22; Study 1474 [cohort 3]).
Overall, the safety and effectiveness of FTC+TAF in pediatric participants in these trials were similar to that observed in adults. Specifically, the safety and efficacy of FTC+TAF with EVG+COBI in participants 6 to 12 years of age and weighing at least 25 kg were similar to that in antiretroviral treatment-naïve adults and adolescents receiving this regimen, with the exception of a decrease from baseline in CD4+ cell count. The safety and effectiveness of DESCOVY when administered with DRV+COBI in pediatric participants weighing at least 14 kg to less than 40 kg were similar to that in adults.
Use of DESCOVY with Other Protease Inhibitors that Require CYP3A Inhibition in Pediatric Patients Weighing at least 14 kg to Less than 35 kg: The use of DESCOVY with atazanavir and cobicistat (ATV+COBI) is not recommended in pediatric patients weighing at least 14 kg to less than 35 kg. The use of DESCOVY with ATV+COBI was studied in pediatric patients weighing at least 14 kg to less than 35 kg. In Study 128, participants who received ATV+COBI in cohort 2 (25 kg to <40 kg, n=14) and cohort 3 (14 kg to <25 kg, n=15) showed TAF exposures (C max and AUC) that exceeded adult exposures by 4–5-fold in cohort 2, and 2–3-fold in cohort 3.
Limited safety data were available to support the increased TAF exposures. Therefore, the use of DESCOVY with ATV+COBI is not recommended in pediatric patients weighing at least 14 kg to less than 35 kg. Safety and effectiveness of DESCOVY in combination with protease inhibitors that require ritonavir in pediatric patients weighing at least 14 kg to le…
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical trials of an FTC+TAF-containing regimen for treatment of HIV-1, 80 of the 97 participants enrolled aged 65 years and over received FTC+TAF and EVG+COBI. No differences in safety or efficacy have been observed between elderly participants and adults between 18 and less than 65 years of age.
🆘 Overdosage ▾
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 adverse reactions were reported. The effects of higher doses are unknown.
Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action DESCOVY is a fixed dose combination of antiretroviral drugs emtricitabine (FTC) and tenofovir alafenamide (TAF) [see Microbiology (12.4) ] .
12.2Pharmacodynamics Cardiac Electrophysiology In a thorough QT/QTc study in 48 healthy participants, TAF at the recommended dose or at a dose approximately 5 times the recommended dose, did not affect the QT/QTc interval and did not prolong the PR interval. The effect of the other component of DESCOVY, FTC, or the combination of FTC and TAF on the QT interval is not known.
12.3Pharmacokinetics Absorption, Distribution, Metabolism, and Excretion The pharmacokinetic (PK) properties of the components of DESCOVY are provided in Table 7 . The multiple dose PK parameters of FTC and TAF and its metabolite tenofovir are provided in Table 8 . HIV status has no effect on the pharmacokinetics of FTC and TAF in adults.
Table 7 Pharmacokinetic Properties of the Components of DESCOVY Emtricitabine Tenofovir Alafenamide PBMCs=peripheral blood mononuclear cells; CES1=carboxylesterase 1 Absorption T max (h) 3 1 Effect of high fat meal (relative to fasting) Values refer to geometric mean ratio [High-fat meal/ fasting] in PK parameters and (90% confidence interval). High-calorie/high-fat meal = ~800 kcal, 50% fat. AUC Ratio = 0.91 (0.89, 0.93) C max Ratio = 0.74 (0.69, 0.78) AUC Ratio = 1.75 (1.64, 1.88) C max Ratio= 0.85 (0.75, 0.95) Distribution % Bound to human plasma proteins <4 ~80 Source of protein binding data In vitro Ex vivo Blood-to-plasma ratio 0.6
1.0Metabolism Metabolism Not significantly metabolized Cathepsin A In vivo , TAF is hydrolyzed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate. In vitro studies have shown that TAF is metabolized to tenofovir by cathepsin A in PBMCs and macrophages; and by CES1 in hepatocytes. Upon coadministration with the moderate CYP3A inducer probe efavirenz, TAF exposure was unaffected.
(PBMCs) CES1 (hepatocytes) CYP3A (minimal) Elimination Major route of elimination Glomerular filtration and active tubular secretion Metabolism (>80% of oral dose) t 1/2 (h) t 1/2 values refer to median terminal plasma half-life. Note that the pharmacologically active metabolite, tenofovir diphosphate, has a half-life of 150-180 hours within PBMCs. 10 0.51 % Of dose excreted in urine Dosing in mass balance studies: FTC (single dose administration of [ 14 C] emtricitabine after multiple dosing of emtricitabine for 10 days); TAF (single dose administration of [ 14 C] tenofovir alafenamide).
70 <1 % Of dose excreted in feces 13.7
31.7Table 8 Multiple Dose PK Parameters of Emtricitabine, Tenofovir Alafenamide and its Metabolite Tenofovir Following Oral Administration with Food in Adults with HIV-1 Parameter Mean (CV%) Emtricitabine From Intensive PK analysis in a phase 2 trial in adults with HIV-1 treated with FTC+TAF and EVG+COBI. Tenofovir Alafenamide From Population PK analysis in two trials of treatment-naïve adults with HIV-1 treated with FTC+TAF with EVG+COBI (N=539). Tenofovir From Population PK analysis in two trials of treatment-naïve adults with HIV-1 treated with FTC+TAF with EVG+COBI (N=841).
CV=Coefficient of Variation; NA=Not Applicable C max (microgram per mL) 2.1 (20.2) 0.16 (51.1) 0.02 (26.1) AUC tau (microgram•hour per mL) 11.7 (16.6) 0.21 (71.8) 0.29 (27.4) C trough (microgram per mL) 0.10 (46.7) NA 0.01 (28.5) Specific Populations Geriatric Patients Pharmacokinetics of FTC and TAF have not been fully evaluated in the elderly (65 years of age and older). Population pharmacokinetics analysis of participants with HIV in Phase 2 and Phase 3 trials of FTC+TAF and EVG+COBI showed that age did not have a clinically relevant effect on exposures of TAF up to 75 years of age [see Use in Specific Populations (8.5) ] .
Pediatric Patients Treatment of HIV-1 Infection: Mean exposures of TAF in 24 pediatric participants with HIV-1 aged 12 to less than 1…
🧬 Mechanism of Action ▾
12.1Mechanism of Action DESCOVY is a fixed dose combination of antiretroviral drugs emtricitabine (FTC) and tenofovir alafenamide (TAF) [see Microbiology (12.4) ] .
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING DESCOVY tablets are available in bottles and blister packs containing 30 tablets: Bottles 200 mg/25 mg tablets each contain 200 mg of emtricitabine (FTC) and 25 mg of tenofovir alafenamide (TAF). These tablets are blue, rectangular-shaped, and film-coated with “GSI” debossed on one side and “225” on the other side (NDC 61958-2002-1). 120 mg/15 mg tablets each contain 120 mg of FTC and 15 mg of TAF.
These tablets are white, round-shaped, and film coated with “GSI” debossed on one side and “15” on the other side (NDC 61958-2005-1). Bottles contain a silica gel desiccant, polyester coil, and child resistant closure. Keep bottle tightly closed.
The bottle containing 200 mg/25 mg tablets (NDC 61958-2002-1) may have a tamper-evident seal over the cap. If a tamper-evident seal is present, do not use if the seal is opened or damaged. Blister Pack 200 mg/25 mg tablets each contain 200 mg of FTC and 25 mg of TAF.
These tablets are blue, rectangular-shaped, and film-coated with “GSI” debossed on one side and “225” on the other side (NDC 61958-2002-2). Blister packs are sealed with a child-resistant laminated foil lidding material (peel-push) and each blister cavity contains a die-cut desiccant film which is heat staked to the foil lidding material. Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).
Dispense only in original container.
📦 Storage and Handling ▾
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature). Dispense only in original container.
📋 Description ▾
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. Emtricitabine: The chemical name of FTC is 4-amino-5-fluoro-1-(2 R -hydroxymethyl-1,3-oxathiolan-5 S -yl)-(1H)-pyrimidin-2-one.
FTC is the (-)enantiomer of a thio analog of cytidine, which differs from other cytidine analogs in that it has a fluorine in the 5 position. FTC has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24 and has the following structural formula: FTC is a white to off-white powder with a solubility of approximately 112 mg per mL in water at 25 °C. Chemical Structure Tenofovir Alafenamide: The chemical name of tenofovir alafenamide fumarate drug substance is L-alanine, N -[( S )-[[(1 R )-2-(6-amino-9 H -purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1-methylethyl ester, (2 E )-2-butenedioate (2:1).
Tenofovir alafenamide fumarate has an empirical formula of C 21 H 29 O 5 N 6 P•½(C 4 H 4 O 4 ) and a formula weight of 534.50 and has the following structural formula: Tenofovir alafenamide fumarate is a white to off-white or tan powder with a solubility of 4.7 mg per mL in water at 20 °C. Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide ). Important Information for Individuals Without HIV-1 Taking DESCOVY for HIV-1 PrEP Advise individuals without HIV-1 about the following [see Warnings and Precautions (5.2) ]: The need to confirm that they are HIV-negative before starting to take DESCOVY to reduce the risk of acquiring HIV-1. That HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking DESCOVY, because DESCOVY alone does not constitute a complete regimen for HIV-1 treatment.
The importance of taking DESCOVY on a regular dosing schedule and strict adherence to the recommended dosing schedule to reduce the risk of acquiring HIV-1. Individuals without HIV-1 who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses. That DESCOVY does not prevent other sexually acquired infections and should be used as part of a complete prevention strategy including other prevention measures.
To use condoms consistently and correctly to lower the chances of sexual contact with any body fluids such as semen, vaginal secretions, or blood. The importance of knowing their HIV-1 status and the HIV-1 status of their partner(s). The importance of virologic suppression in their partner(s) with HIV-1.
The need to get tested regularly for HIV-1 (at least every 3 months, or more frequently for some individuals such as adolescents) and to ask their partner(s) to get tested as well. To report any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately. That the signs and symptoms of acute infection include fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal).
To get tested for other sexually transmitted infections, such as syphilis, chlamydia, and gonorrhea, that may facilitate HIV-1 transmission. To assess their sexual risk behavior and get support to help reduce sexual risk behavior. Post-treatment Acute Exacerbation of Hepatitis B in Patients with HBV Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued products containing FTC and/or TDF and may likewise occur with discontinuation of DESCOVY [see Warnings and Precautions (5.1) ] .
Advise individuals with HBV to not discontinue DESCOVY without first informing their healthcare provider. Immune Reconstitution Syndrome Advise patients with HIV-1 to inform their healthcare provider immediately of any symptoms of infection. In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started [see Warnings and Precautions (5.3) ] .
New Onset or Worsening Renal Impairment Advise patients with HIV-1 and individuals without HIV-1 to avoid taking DESCOVY with concurrent or recent use of nephrotoxic agents. Postmarketing cases of renal impairment, including acute renal failure, have been reported [see Warnings and Precautions (5.4) ]. Lactic Acidosis and Severe Hepatomegaly Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to DESCOVY.
Advise patients with HIV-1 and individuals without HIV-1 that they should stop DESCOVY if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.5) ] . Dosage Recommendations for Treatment of HIV-1 Infection Inform patients with HIV-1 that it is important to take DESCOVY with other antiretroviral drugs for the treatment of HIV-1 on a regular dosing schedule with or without food and to avoid missing doses as it can result in development of resistance [see Dosage and Administration (2.3 , 2.4) ] .
Pregnancy Registry Inform individuals using DESCOVY that there is an antiretroviral pregnancy…
💬 Medication Guide ▾
This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 07/2026 MEDICATION GUIDE DESCOVY ® (des-KOH-vee) (emtricitabine and tenofovir alafenamide) tablets This Medication Guide provides information about two different ways that DESCOVY may be used. See the section “ What is DESCOVY? ” for detailed information about how DESCOVY may be used.
What is the most important information I should know about DESCOVY? DESCOVY can cause serious side effects, including: Worsening of hepatitis B virus (HBV). Your healthcare provider will test you for HBV before or when you start treatment with DESCOVY.
If you have HBV and take DESCOVY, your HBV may get worse (flare-up) if you stop taking DESCOVY. A “flare-up” is when your HBV suddenly returns in a worse way than before. Do not run out of DESCOVY.
Refill your prescription or talk to your healthcare provider before your DESCOVY is all gone. Do not stop taking DESCOVY without first talking to your healthcare provider. If you stop taking DESCOVY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver, and may give you a medicine to treat hepatitis B.
Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking DESCOVY. For more information about side effects, see the section “ What are the possible side effects of DESCOVY? ” Other important information for people who take DESCOVY to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1), also called pre-exposure prophylaxis or “PrEP”: Before taking DESCOVY to reduce your risk of getting HIV-1: You must be HIV-1 negative to start DESCOVY. You must get tested to make sure that you do not already have HIV-1.
Do not take DESCOVY for HIV-1 PrEP unless you are confirmed to be HIV-1 negative. Some HIV-1 tests can miss HIV-1 in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1.
Tell your healthcare provider if you had a flu-like illness within the last month before starting DESCOVY or at any time while taking DESCOVY. Symptoms of new HIV-1 include: tiredness fever joint or muscle aches headache sore throat vomiting or diarrhea rash night sweats enlarged lymph nodes in the neck or groin While you are taking DESCOVY for HIV-1 PrEP: DESCOVY does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
You must stay HIV-1 negative to keep taking DESCOVY for HIV-1 PrEP. Know your HIV-1 status and the HIV-1 status of your partners. Ask your partners with HIV-1 if they are taking HIV-1 medicines and have an undetectable viral load.
An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment.
Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you. Get tested for other STIs such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.
If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative. Get information and support to help reduce sexual risk behaviors.
Do not miss any doses of DESCOVY. Missing doses increases your risk of getting HIV-1. If you do become HIV-1 positive, you need more medicine than DESCOVY alone to treat HIV-1.
DESCOVY by itself is not a complete treatment for HIV-1. If you have HIV-1 and take only DESCOVY, over time your HIV-1 may become harder to treat. What is DESCOVY?
DESCOVY is a prescription medicine that may be used in two different ways. DESCOVY is used: to treat HIV-1 in adults and children who weigh at…