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Truvada emtricitabine and tenofovir disoproxil fumarate 200 mg; 300 mg Tablet, Film Coated, 3-count — NDC 68071-2112-3 (Billing 68071-2112-03)

by NuCare Pharmaceuticals,Inc. · 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

This is a package of 3 tablets of Truvada emtricitabine and tenofovir disoproxil fumarate 200 mg; 300 mg Tablet, Film Coated from NuCare Pharmaceuticals,Inc., marketed since Aug 2004 and currently FDA-listed. It is this product's only package size.

NDC 68071-2112-03
🏷️ FDA NDC (as labeled) 68071-2112-3 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68071-2112-3 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68071 labeler · 2112 product · 3 package
Package marketed since
Jan 24, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
3 EA per package
Barcode (UPC)
0368071211238
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-2112-3
Product NDC 68071-2112
11-digit billing NDC 68071211203
NCPDP billing unit EA — each (per item)
RxCUI 476556, 639888
UNII G70B4ETF4S, OTT9J7900I
UPC 0368071211238
Application # NDA021752
SPL Set ID 46e06df0-654d-43cc-e054-00144ff8d46c
Established class (EPC) Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Nucleoside Reverse Transcriptase Inhibitors
Chemical class Nucleosides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-08-02
Route ORAL
Dosage form TABLET, FILM COATED
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 057883
GCN 23152
HICL code 026515
Ingredient (HICL) Emtricitabine/Tenofovir (Tdf)
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5O
Therapeutic class — specific (HIC3) Antivirals, Hiv-Spec, Nucleoside-Nucleotide Analog
AHFS code 08:18.08.20
AHFS class Hiv Nucleoside, Nucleotide Rt Inhibitors
FDB label name TRUVADA 200 MG-300 MG TABLET
FDB brand name Truvada
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 057883
  • GCN: 23152
  • HICL (First Databank): 026515
  • AHFS class code: 08:18.08.20
  • RxCUI (RxNorm): 476556
Why two NDCs? The FDA registers this code as 68071-2112-3 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68071-2112-03. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor class.

Pharmacologic class Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Drug family (ATC) Nucleoside and nucleotide reverse transcriptase inhibitors
How it works Nucleoside Reverse Transcriptase Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name TRUVADA 200 MG-300 MG TABLET Ingredient Emtricitabine/Tenofovir (Tdf)
📗 Our plain-language guide HelloPharmacist
  • It treats HIV-1 infection when taken with other HIV medicines. It can also be used as PrEP to lower the risk of getting HIV-1 sexually. Truvada is approved for PrEP in adults at hi...
  • You take it by mouth once a day, with or without food. Follow your prescriber's directions on dose and timing. For PrEP, taking it every day matters because protection is strongly...
  • Some people get diarrhea, nausea, tiredness, headache, or dizziness. Some also have trouble sleeping, vivid dreams, depression, or rash. Call your doctor if you notice signs of kid...
  • Please don't stop without talking to your doctor. Hepatitis B can flare severely after stopping this medicine. Your liver needs close monitoring for several months afterward.
📖 Read our full Emtricitabine and Tenofovir guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $59.35 $178.04 / 3 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68071-2112-03 You're viewing this Main listing 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2017-01-24 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 42543-0719-04 Strides 30 tablets $0.451 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 64380-0719-04 Strides 30 tablets $0.451 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 00093-7704-56 Teva 30 tablets $0.529 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 00904-7172-07 Major 1 tablet $0.529 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 16714-0534-01 NorthStar 30 tablets $0.529 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 31722-0560-30 Camber 30 tablets $0.529 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 33342-0106-07 Macleods 30 tablets $0.529 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 42385-0953-30 Laurus 30 tablets $0.529 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 65862-0354-30 Aurobindo 30 tablets $0.529 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 69238-2095-03 Amneal 30 tablets $0.529 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 70710-1367-03 Zydus 30 tablets $0.529 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 82009-0109-30 QUALLENT 30 tablets $0.529 AB Availability likely —
Emtricitabine And Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 76282-0677-30 Exelan 30 tablets $0.569 — FDA listed —
Emtricitabine And Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 69097-0209-02 Cipla 30 tablets $0.593 — FDA listed —
Emtricitabine And Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 69097-0741-02 Cipla 30 tablets $0.593 — FDA listed —
Truvada 200 mg/1; 300 mg 61958-0701-01 Gilead 30 tablets $59.710 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 42291-0980-30 AvKARE 30 tablets — AB FDA listed —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 50090-6494-01 A-S 30 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 50090-7719-01 A-S 30 tablets — AB FDA listed —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 51407-0112-30 Golden 30 tablets — AB FDA listed —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 60219-2095-03 Amneal 30 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 67296-2198-03 Redpharm 3 tablets — AB FDA listed —
Truvada 200 mg/1; 300 mgthis 68071-2112-03 NuCare 3 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 68071-3695-03 NuCare 3 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 68071-3831-03 NuCare 3 tablets — AB FDA listed —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 68071-3986-03 NuCare 3 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 70771-1709-03 Zydus 30 tablets — AB FDA listed —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 71205-0776-07 Proficient 7 tablets — AB FDA listed —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 71335-2650-01 Bryant 30 tablets — AB FDA listed —
Emtricitabine And Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 72189-0312-03 DirectRx 3 tablets — AB FDA listed —
Emtricitabine/TDF 300 mg/1; 200 mg 72189-0403-03 Direct_Rx 3 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 82804-0086-03 Proficient 3 tablets — AB FDA listed —
Emtricitabine And Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 68180-0287-01 Lupin 100 tablets — AB FDA listed —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 50090-8028-01 A-S 30 tablets — AB FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2004
On the market since
Aug 2004
📍
2026
Currently FDA-listed
22 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

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.

🧪 Avoiding an ingredient? See Emtricitabine and Tenofovir inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • 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.
  • 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.
  • 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.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • 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.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderGILEAD SCIENCES INC
FDA applicationNDA021752 (NDA)
Labeler code68071
First marketedAug 2004
Product typeHuman Prescription Drug
Portfolio1,015 products on file

More NDCs from NuCare Pharmaceuticals,Inc. labeler code 68071

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning ~2 min read ▾

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals [see Warnings and Precautions (5.1) ] . TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of TRUVADA have not been established in patients coinfected with HBV and HIV-1.

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued TRUVADA. Therefore, hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are infected with HBV and discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.2) ] .

TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use. Drug-resistant HIV-1 variants have been identified with use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions (5.9) ] .

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS, POST-TREATMENT ACUTE EXACERBATION OF HEPATITIS B, and RISK OF DRUG RESISTANCE WITH USE OF TRUVADA FOR PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA. ( 5.1 ) TRUVADA is not approved for the treatment of chronic hepatitis B virus (HBV) infection.

Severe acute exacerbations of hepatitis B have been reported in patients coinfected with HIV-1 and HBV who have discontinued TRUVADA. Therefore, hepatic function should be monitored closely in HBV-infected patients who discontinue TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

( 5.2 ) TRUVADA used for a PrEP indication must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use. Drug-resistant HIV-1 variants have been identified with the use of TRUVADA for a PrEP indication following undetected acute HIV-1 infection. Do not initiate TRUVADA for a PrEP indication if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed.

( 5.9 )

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE TRUVADA is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors. TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. ( 1 ) TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

( 1 )

1.1Treatment of HIV-1 Infection TRUVADA ® , a combination of EMTRIVA ® and VIREAD ® , is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg [see Dosage and Administration (2) and Clinical Studies (14) ] . The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection:The following points should be considered when initiating therapy with TRUVADA for the treatment of HIV-1 infection: It is not recommended that TRUVADA be used as a component of a triple nucleoside regimen.

TRUVADA should not be coadministered with ATRIPLA ® , COMPLERA ® , EMTRIVA, GENVOYA ® , ODEFSEY ® , STRIBILD ® , VIREAD or lamivudine-containing products [see Warnings and Precautions (5.4) ] . In treatment experienced patients, the use of TRUVADA should be guided by laboratory testing and treatment history [see Microbiology (12.4) ] .

1.2Pre-Exposure Prophylaxis TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples [see Clinical Studies (14.2 , 14.3) ] . When considering TRUVADA for pre-exposure prophylaxis the following factors may help to identify individuals at high risk: has partner(s) known to be HIV-1 infected, or engages in sexual activity within a high prevalence area or social network and one or more of the following: inconsistent or no condom use diagnosis of sexually transmitted infections exchange of sex for commodities (such as money, food, shelter, or drugs) use of illicit drugs or alcohol dependence incarceration partner(s) of unknown HIV-1 status with any of the factors listed above When prescribing TRUVADA for pre-exposure prophylaxis, healthcare providers must: prescribe TRUVADA as part of a comprehensive prevention strategy because TRUVADA is not always effective in preventing the acquisition of HIV-1 infection [see Warnings and Precautions (5.9) ] ; counsel all uninfected individuals to strictly adhere to the recommended TRUVADA dosing schedule because the effectiveness of TRUVADA in reducing the risk of acquiring HIV-1 was strongly correlated with adherence as demonstrated by measurable drug levels in clinical trials [see Warnings and Precautions (5.9) ] ; confirm a negative HIV-1 test immediately prior to initiating TRUVADA for a PrEP indication.

If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection [see Warnings and Precautions (5.9) ] ; and screen for HIV-1 infection at least once every 3 months while taking TRUVADA for PrEP.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Treatment of HIV-1 Infection ( 2.1 ) Recommended dose in adults and pediatric patients weighing greater than or equal to 35 kg: One TRUVADA tablet (containing 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate) once daily taken orally with or without food. ( 2.1 ) Recommended dose in pediatric patients weighing greater than or equal to 17 kg and able to swallow a whole tablet: one TRUVADA low strength tablet (100 mg/150 mg, 133 mg/200 mg, or 167 mg/250 mg based on body weight) once daily taken orally with or without food.

( 2.2 ) Recommended dose in renally impaired HIV-1 infected adult patients: Creatinine clearance 30–49 mL/min: 1 tablet every 48 hours. ( 2.4 ) CrCl below 30 mL/min or hemodialysis: Do not use TRUVADA. ( 2.4 ) Pre-exposure Prophylaxis ( 2.3 ) Recommended dose in HIV-1 uninfected adults: One tablet (containing 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate) once daily taken orally with or without food.

( 2.3 ) Recommended dose in renally impaired HIV-uninfected individuals: Do not use TRUVADA in HIV-uninfected individuals if CrCl is below 60 mL/min. If a decrease in CrCl is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use. ( 2.4 )

2.1Recommended Dose for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing 35 Kg or More The recommended dose of TRUVADA in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.2Recommended Dose for Treatment of HIV-1 Infection in Pediatric Patients Weighing at Least 17 kg and Able to Swallow a Whole Tablet The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet, is one TRUVADA low strength tablet (emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily with or without food. The recommended oral dosage of TRUVADA low strength tablets is presented in Table 1.

Weight should be monitored periodically and the TRUVADA dose adjusted accordingly. Table 1 Dosing for Pediatric Patients Weighing 17 kg to less than 35 kg using TRUVADA Low Strength Tablets Body Weight (kg) Dosing of FTC (mg)/TDF (mg) 17 to less than 22 one 100/150 tablet once daily 22 to less than 28 one 133/200 tablet once daily 28 to less than 35 one 167/250 tablet once daily

2.3Recommended Dose for Pre-exposure Prophylaxis The dose of TRUVADA in HIV-1 uninfected adults is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally with or without food.

2.4Dose Adjustment for Renal Impairment Treatment of HIV-1 Infection Significantly increased drug exposures occurred when EMTRIVA or VIREAD were administered to subjects with moderate to severe renal impairment [see EMTRIVA or VIREAD Package Insert] . Therefore, adjust the dosing interval of TRUVADA in HIV-1 infected adult patients with baseline creatinine clearance 30–49 mL/min using the recommendations in Table 2. These dosing interval recommendations are based on modeling of single-dose pharmacokinetic data in non-HIV infected subjects.

The safety and effectiveness of these dosing interval adjustment recommendations have not been clinically evaluated in patients with moderate renal impairment, therefore clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions (5.3) ] . No dose adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50–80 mL/min). No data are available to make dose recommendations in pediatric patients with renal impairment.

Table 2 Dosage Adjustment for HIV-1 Infected Adult… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 178 words ▾

3 DOSAGE FORMS AND STRENGTHS TRUVADA tablets are available in four dose strengths: Tablet: 100 mg of emtricitabine and 150 mg of tenofovir disoproxil fumarate (equivalent to 123 mg of tenofovir disoproxil): blue, oval-shaped, film-coated, debossed with "GSI" on one side and with "703" on the other side. Tablet: 133 mg of emtricitabine and 200 mg of tenofovir disoproxil fumarate (equivalent to 163 mg of tenofovir disoproxil): blue, rectangular-shaped, film-coated, debossed with "GSI" on one side and with "704" on the other side.

Tablet: 167 mg of emtricitabine and 250 mg of tenofovir disoproxil fumarate (equivalent to 204 mg of tenofovir disoproxil): blue, modified capsule-shaped, film-coated, debossed with "GSI" on one side and with "705" on the other side. Tablet: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil): blue, capsule-shaped, film-coated, debossed with "GILEAD" on one side and with "701" on the other side. Tablets: 200 mg/300 mg, 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg of emtricitabine and tenofovir disoproxil fumarate, respectively.

( 3 )

⛔ Contraindications 63 words ▾

4 CONTRAINDICATIONS Do not use TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-infected patients only in combination with other antiretroviral agents. Do not use TRUVADA for pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status. TRUVADA should be used in HIV-infected patients only in combination with other antiretroviral agents. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome. Assess estimated creatinine clearance before initiating treatment with TRUVADA. In patients at risk for renal dysfunction, assess estimated creatinine clearance, serum phosphorus, urine glucose and urine protein before initiating treatment with TRUVADA and periodically during treatment.

Avoid administering Truvada with concurrent or recent use of nephrotoxic drugs. ( 5.3 ) Coadministration with Other Products: Do not use with drugs containing emtricitabine, tenofovir alafenamide or tenofovir disoproxil fumarate including ATRIPLA, COMPLERA, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, VIREAD; or with drugs containing lamivudine. Do not administer in combination with HEPSERA.

( 5.4 ) Decreases in bone mineral density (BMD): Consider assessment of BMD in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss. ( 5.5 ) Redistribution/accumulation of body fat: Observed in patients receiving antiretroviral therapy. ( 5.6 ) Immune reconstitution syndrome: May necessitate further evaluation and treatment.

( 5.7 ) Triple nucleoside-only regimens: Early virologic failure has been reported in HIV-infected patients. Monitor carefully and consider treatment modification. ( 5.8 ) Comprehensive management to reduce the risk of acquiring HIV-1: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule.

( 5.9 ) Management to reduce the risk of acquiring HIV-1 drug resistance: Prior to initiating TRUVADA for PrEP - if clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least one month and reconfirm negative HIV-1 status or use a test approved by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection. While using TRUVADA for PrEP - HIV-1 screening tests should be repeated at least every 3 months.

( 5.9 )

5.1Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including VIREAD, a component of TRUVADA, in combination with other antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors.

Particular caution should be exercised when administering nucleoside analogs to any patient or uninfected individual with known risk factors for liver disease; however, cases have also been reported in HIV-1 infected patients with no known risk factors. Treatment with TRUVADA should be suspended in any patient or uninfected individual who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

5.2HBV Infection It is recommended that all individuals be tested for the presence of chronic hepatitis B virus (HBV) before initiating TRUVADA. TRUVADA is not approved for the treatment of chronic HBV infection and the safety and efficacy of TRUVADA have not been established in patients infected with HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued TRUVADA.

In some patients infected with HBV and treated with EMTRIVA, the exacerbations of hepatitis B were associated with liver decompensation and liver failure. Patients who are infected with HBV should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment with TRUVADA. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

HBV-uninfected individuals should be offered vaccination.

5.3New Onset or Worsening Renal Impairment Emtricitabine and tenofovir are principally elimi… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Boxed Warning , Warnings and Precautions (5.1) ] . Severe Acute Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions (5.2) ] . New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3) ] .

Bone Effects of Tenofovir DF [see Warnings and Precautions (5.5) ] . Immune Reconstitution Syndrome [see Warnings and Precautions (5.7) ] . In HIV-1 infected patients, the most common adverse reactions (incidence greater than or equal to 10%) are diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

( 6.1 ) In HIV-1 uninfected individuals in PrEP trials, adverse reactions that were reported by more than 2% of TRUVADA subjects and more frequently than by placebo subjects were headache, abdominal pain and weight decreased. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-445-3235 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Adult Subjects The most common adverse reactions (incidence greater than or equal to 10%, any severity) occurring in Study 934, an active-controlled clinical trial of efavirenz, emtricitabine, and tenofovir disoproxil fumarate, include diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash.

See also Table 3 for the frequency of treatment-emergent adverse reactions (Grades 2–4) occurring in greater than or equal to 5% of subjects treated in any treatment group in this trial. Skin discoloration, manifested by hyperpigmentation on the palms and/or soles, was generally mild and asymptomatic. The mechanism and clinical significance are unknown.

Study 934 - Treatment Emergent Adverse Reactions: In Study 934, 511 antiretroviral-naïve subjects received either VIREAD + EMTRIVA administered in combination with efavirenz (N=257) or zidovudine/lamivudine administered in combination with efavirenz (N=254) for 144 weeks. Subjects had a mean age of 40 years (range 20 to 73 years) and were predominantly male (88%). Overall, 65% were White, 17% were Black, and 13% were Hispanic.

Adverse reactions observed in this trial were generally consistent with those seen in other trials in treatment-experienced or treatment-naïve subjects receiving VIREAD and/or EMTRIVA (Table 3). Table 3 Selected Treatment-Emergent Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. (Grades 2–4) Reported in ≥5% in Any Treatment Group in Study 934 (0–144 Weeks) FTC+TDF+EFV From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of VIREAD + EMTRIVA with efavirenz.

AZT/3TC+EFV N=257 N=254 Gastrointestinal Disorder Diarrhea 9% 5% Nausea 9% 7% Vomiting 2% 5% General Disorders and Administration Site Condition Fatigue 9% 8% Infections and Infestations Sinusitis 8% 4% Upper respiratory tract infections 8% 5% Nasopharyngitis 5% 3% Nervous System Disorders Headache 6% 5% Dizziness 8% 7% Psychiatric Disorders Depression 9% 7% Insomnia 5% 7% Skin and Subcutaneous Tissue Disorders Rash event Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.

7% 9% Laboratory Abnormalities: Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of VIREAD and/or EMTRIVA (Table 4). Table 4 Significant Laboratory Abnormalities Reported in ≥1% of Subjects in Any Treatment Group… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS No drug interaction trials have been conducted using TRUVADA tablets. Drug interaction trials have been conducted with emtricitabine and tenofovir disoproxil fumarate, the components of TRUVADA. This section describes clinically relevant drug interactions observed with emtricitabine and tenofovir disoproxil fumarate [see Clinical Pharmacology (12.3) ] .

Didanosine: Tenofovir disoproxil fumarate increases didanosine concentrations. Use with caution and monitor for evidence of didanosine toxicity (e.g., pancreatitis, neuropathy) when coadministered. Consider dose reductions or discontinuations of didanosine if warranted.

( 7.1 ) HIV-1 protease inhibitors: Coadministration decreases atazanavir concentrations and increases tenofovir concentrations. When coadministered with TRUVADA, use atazanavir given with ritonavir. Coadministration of TRUVADA with atazanavir and ritonavir, darunavir and ritonavir, or lopinavir/ritonavir increases tenofovir concentrations.

Monitor for evidence of tenofovir toxicity. ( 7.2 )

7.1Didanosine Coadministration of TRUVADA and didanosine should be undertaken with caution and patients receiving this combination should be monitored closely for didanosine-associated adverse reactions. Didanosine should be discontinued in patients who develop didanosine-associated adverse reactions. When tenofovir disoproxil fumarate was administered with didanosine the C max and AUC of didanosine increased significantly [see Clinical Pharmacology (12.3) ] .

The mechanism of this interaction is unknown. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy. Suppression of CD4+ cell counts has been observed in patients receiving tenofovir DF with didanosine 400 mg daily.

In patients weighing greater than 60 kg, the didanosine dose should be reduced to 250 mg when it is coadministered with TRUVADA. Data are not available to recommend a dose adjustment of didanosine for adult or pediatric patients weighing less than 60 kg. When coadministered, TRUVADA and Videx EC may be taken under fasted conditions or with a light meal (less than 400 kcal, 20% fat).

7.2HIV-1 Protease Inhibitors Tenofovir decreases the AUC and C min of atazanavir [see Clinical Pharmacology (12.3) ] . When coadministered with TRUVADA, it is recommended that atazanavir 300 mg is given with ritonavir 100 mg. TRUVADA should not be coadministered with atazanavir without ritonavir .

Lopinavir/ritonavir, atazanavir coadministered with ritonavir, and darunavir coadministered with ritonavir have been shown to increase tenofovir concentrations [see Clinical Pharmacology (12.3) ] . Tenofovir disoproxil fumarate is a substrate of P-glycoprotein (Pgp) and breast cancer resistance protein (BCRP) transporters. When tenofovir disoproxil fumarate is co-administered with an inhibitor of these transporters, an increase in absorption may be observed.

Patients receiving TRUVADA concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir-boosted darunavir should be monitored for tenofovir disoproxil fumarate-associated adverse reactions. TRUVADA should be discontinued in patients who develop tenofovir disoproxil fumarate-associated adverse reactions .

7.3Hepatitis C Antiviral Agents Coadministration of tenofovir disoproxil fumarate and HARVONI ® (ledipasvir/sofosbuvir) has been shown to increase tenofovir exposure [see Clinical Pharmacology (12.3) ] . In patients receiving TRUVADA concomitantly with HARVONI without an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, monitor for adverse reactions associated with tenofovir disoproxil fumarate. In patients receiving TRUVADA concomitantly with HARVONI and an HIV-1 protease inhibitor/ritonavir or an HIV-1 protease inhibitor/cobicistat combination, consider an alternative HCV or antiretroviral therapy, as the safety of increased tenofovir concentrations in this setting has not… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Nursing mothers: Women infected with HIV-1 should be instructed not to breast feed. ( 8.3 )

8.1Pregnancy Pregnancy Category B Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to TRUVADA, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263. Risk Summary TRUVADA has been evaluated in a limited number of women during pregnancy and postpartum.

Available human and animal data suggest that TRUVADA does not increase the risk of major birth defects overall compared to the background rate. There are, however, no adequate and well-controlled trials in pregnant women. Because the studies in humans cannot rule out the possibility of harm, TRUVADA should be used during pregnancy only if clearly needed.

If an uninfected individual becomes pregnant while taking TRUVADA for a PrEP indication, careful consideration should be given to whether use of TRUVADA should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy. Clinical Considerations As of July 2011, the APR has received prospective reports of 764 and 1,219 exposures to emtricitabine- and tenofovir-containing regimens, respectively in the first trimester, 321 and 455 exposures, respectively, in second trimester, and 140 and 257 exposures, respectively, in the third trimester.

Birth defects occurred in 18 of 764 (2.4%) live births for emtricitabine-containing regimens and 27 of 1219 (2.2%) live births for tenofovir-containing regimens (first trimester exposure) and 10 of 461 (2.2%) live births for emtricitabine-containing regimens and 15 of 714 (2.1%) live births for tenofovir-containing regimens (second/third trimester exposure). Among pregnant women in the U.S. reference population, the background rate of birth defects is 2.7%. There was no association between emtricitabine or tenofovir and overall birth defects observed in the APR.

Animal Data Emtricitabine: The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (AUC) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. Tenofovir Disoproxil Fumarate: Reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to tenofovir.

8.3Nursing Mothers Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1. Studies in humans have shown that both tenofovir and emtricitabine are excreted in human milk. Because the risks of low level exposure to emtricitabine and tenofovir to infants are unknown, mothers should be instructed not to breast-feed if they are receiving TRUVADA, whether they are taking TRUVADA for treatment or to reduce the risk of acquiring HIV-1 .

Emtricitabine Samples of breast milk obtained from five HIV-1 infected mothers show that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in infants breastfed by mothers being treated with emtricitabine are unknown.

Tenofovir Disoproxil Fumarate Samples of breast milk obtained from five HIV-1 infected mothers show that tenofovir is secreted in human milk. Tenofovir-associated risks, including the risk of viral resistance to tenofovir, in infants breastfed by mothers being treated with tenofovir disoproxil fumarate are unknown.

8.4Pediatric Use No pediatric clinical trial was conducted to evaluate the safety and efficacy of TRUVADA. Data from previously conducted trials wi… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Category B Antiretroviral Pregnancy Registry: To monitor fetal outcomes of pregnant women exposed to TRUVADA, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to register patients by calling 1-800-258-4263. Risk Summary TRUVADA has been evaluated in a limited number of women during pregnancy and postpartum.

Available human and animal data suggest that TRUVADA does not increase the risk of major birth defects overall compared to the background rate. There are, however, no adequate and well-controlled trials in pregnant women. Because the studies in humans cannot rule out the possibility of harm, TRUVADA should be used during pregnancy only if clearly needed.

If an uninfected individual becomes pregnant while taking TRUVADA for a PrEP indication, careful consideration should be given to whether use of TRUVADA should be continued, taking into account the potential increased risk of HIV-1 infection during pregnancy. Clinical Considerations As of July 2011, the APR has received prospective reports of 764 and 1,219 exposures to emtricitabine- and tenofovir-containing regimens, respectively in the first trimester, 321 and 455 exposures, respectively, in second trimester, and 140 and 257 exposures, respectively, in the third trimester.

Birth defects occurred in 18 of 764 (2.4%) live births for emtricitabine-containing regimens and 27 of 1219 (2.2%) live births for tenofovir-containing regimens (first trimester exposure) and 10 of 461 (2.2%) live births for emtricitabine-containing regimens and 15 of 714 (2.1%) live births for tenofovir-containing regimens (second/third trimester exposure). Among pregnant women in the U.S. reference population, the background rate of birth defects is 2.7%. There was no association between emtricitabine or tenofovir and overall birth defects observed in the APR.

Animal Data Emtricitabine: The incidence of fetal variations and malformations was not increased in embryofetal toxicity studies performed with emtricitabine in mice at exposures (AUC) approximately 60-fold higher and in rabbits at approximately 120-fold higher than human exposures at the recommended daily dose. Tenofovir Disoproxil Fumarate: Reproduction studies have been performed in rats and rabbits at doses up to 14 and 19 times the human dose based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to tenofovir.

🧒 Pediatric Use 125 words ▾

8.4Pediatric Use No pediatric clinical trial was conducted to evaluate the safety and efficacy of TRUVADA. Data from previously conducted trials with the individual drug products, EMTRIVA and VIREAD, were relied upon to support dosing recommendations for TRUVADA. For additional information, consult the prescribing information for EMTRIVA and VIREAD.

TRUVADA should only be administered to HIV-1 infected pediatric patients with body weight greater than or equal to 17 kg and who are able to swallow a whole tablet. Because it is a fixed-dose combination tablet, TRUVADA cannot be adjusted for patients of lower weight [see Warnings and Precautions (5.5) , Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] . TRUVADA has not been evaluated for use in pediatric patients weighing less than 17 kg.

🧓 Geriatric Use 61 words ▾

8.5Geriatric Use Clinical trials of EMTRIVA or VIREAD did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for the elderly patients should be cautious, keeping in mind the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

🆘 Overdosage 189 words ▾

10 OVERDOSAGE If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Emtricitabine: Limited clinical experience is available at doses higher than the therapeutic dose of EMTRIVA. In one clinical pharmacology trial, single doses of emtricitabine 1200 mg were administered to 11 subjects.

No severe adverse reactions were reported. Hemodialysis treatment removes approximately 30% of the emtricitabine dose over a 3-hour dialysis period starting within 1.5 hours of emtricitabine dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether emtricitabine can be removed by peritoneal dialysis.

Tenofovir Disoproxil Fumarate: Limited clinical experience at doses higher than the therapeutic dose of VIREAD 300 mg is available. In one trial, 600 mg tenofovir disoproxil fumarate was administered to 8 subjects orally for 28 days, and no severe adverse reactions were reported. The effects of higher doses are not known.

Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%. Following a single 300 mg dose of VIREAD, a four-hour hemodialysis session removed approximately 10% of the administered tenofovir dose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY For additional information on Mechanism of Action, Antiviral Activity, Resistance and Cross Resistance, consult the EMTRIVA and VIREAD prescribing information.

12.1Mechanism of Action TRUVADA is a fixed-dose combination of antiviral drugs emtricitabine and tenofovir disoproxil fumarate [see Microbiology (12.4) ].

12.3Pharmacokinetics TRUVADA: One TRUVADA tablet was bioequivalent to one EMTRIVA capsule (200 mg) plus one VIREAD tablet (300 mg) following single-dose administration to fasting healthy subjects (N=39). Emtricitabine: The pharmacokinetic properties of emtricitabine are summarized in Table 7. Following oral administration of EMTRIVA, emtricitabine is rapidly absorbed with peak plasma concentrations occurring at 1–2 hours post-dose.

Less than 4% of emtricitabine binds to human plasma proteins in vitro and the binding is independent of concentration over the range of 0.02–200 µg/mL. Following administration of radiolabelled emtricitabine, approximately 86% is recovered in the urine and 13% is recovered as metabolites. The metabolites of emtricitabine include 3′-sulfoxide diastereomers and their glucuronic acid conjugate.

Emtricitabine is eliminated by a combination of glomerular filtration and active tubular secretion. Following a single oral dose of EMTRIVA, the plasma emtricitabine half-life is approximately 10 hours. Tenofovir Disoproxil Fumarate: The pharmacokinetic properties of tenofovir disoproxil fumarate are summarized in Table 7.

Following oral administration of VIREAD, maximum tenofovir serum concentrations are achieved in 1.0 ± 0.4 hour. Less than 0.7% of tenofovir binds to human plasma proteins in vitro and the binding is independent of concentration over the range of 0.01–25 µg/mL. Approximately 70–80% of the intravenous dose of tenofovir is recovered as unchanged drug in the urine.

Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion. Following a single oral dose of VIREAD, the terminal elimination half-life of tenofovir is approximately 17 hours. Table 7 Single Dose Pharmacokinetic Parameters for Emtricitabine and Tenofovir in Adults NC=Not calculated Emtricitabine Tenofovir Fasted Oral Bioavailability Median (range) (%) 92 (83.1–106.4) 25 (NC–45.0) Plasma Terminal Elimination Half-Life (hr) 10 (7.4–18.0) 17 (12.0–25.7) C max Mean (± SD) (μg/mL) 1.8±0.72 Data presented as steady state values 0.30±0.09 AUC (μg ∙ hr/mL) 10.0±3.12 2.29±0.69 CL/F (mL/min) 302±94 1043±115 CL renal (mL/min) 213±89 243±33 Effects of Food on Oral Absorption TRUVADA may be administered with or without food.

Administration of TRUVADA following a high fat meal (784 kcal; 49 grams of fat) or a light meal (373 kcal; 8 grams of fat) delayed the time of tenofovir C max by approximately 0.75 hour. The mean increases in tenofovir AUC and C max were approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state. In previous safety and efficacy trials, VIREAD (tenofovir) was taken under fed conditions.

Emtricitabine systemic exposures (AUC and C max ) were unaffected when TRUVADA was administered with either a high fat or a light meal. Special Populations Race Emtricitabine: No pharmacokinetic differences due to race have been identified following the administration of EMTRIVA. Tenofovir Disoproxil Fumarate: There were insufficient numbers from racial and ethnic groups other than Caucasian to adequately determine potential pharmacokinetic differences among these populations following the administration of VIREAD.

Gender Emtricitabine and Tenofovir Disoproxil Fumarate: Emtricitabine and tenofovir pharmacokinetics are similar in male and female subjects. Pediatric Patients The pharmacokinetic data for tenofovir and emtricitabine following administration of TRUVADA in pediatric subjects weighing 17 kg and above are not available. The dosing recommendations of TRUVADA in this population are based on the… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 21 words ▾

12.1Mechanism of Action TRUVADA is a fixed-dose combination of antiviral drugs emtricitabine and tenofovir disoproxil fumarate [see Microbiology (12.4) ].

📦 How Supplied / Storage and Handling 99 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING TRUVADA tablets are available in bottles containing 30 tablets with child-resistant closure as follows: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (equivalent to 245 mg of tenofovir disoproxil) are blue, capsule-shaped, film-coated, debossed with "GILEAD" on one side and "701" on the other side Bottle of 3 NDC 68071-2112-3 Store at 25 °C (77 °F), excursions permitted to 15 °C–30 °C (59 °F–86 °F) (see USP Controlled Room Temperature). Keep container tightly closed Dispense only in original container Do not use if seal over bottle opening is broken or missing

📦 Storage and Handling 41 words ▾

Store at 25 °C (77 °F), excursions permitted to 15 °C–30 °C (59 °F–86 °F) (see USP Controlled Room Temperature). Keep container tightly closed Dispense only in original container Do not use if seal over bottle opening is broken or missing

📋 Description ~2 min read ▾

11 DESCRIPTION TRUVADA tablets are fixed-dose combination tablets containing emtricitabine and tenofovir disoproxil fumarate. Emtricitabine is a synthetic nucleoside analog of cytidine. Tenofovir DF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate.

Both emtricitabine and tenofovir exhibit inhibitory activity against HIV-1 reverse transcriptase. Emtricitabine: The chemical name of emtricitabine is 5-fluoro-1-(2 R ,5 S )-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine. Emtricitabine 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.

It has a molecular formula of C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: Emtricitabine is a white to off-white crystalline powder with a solubility of approximately 112 mg/mL in water at 25 °C. The partition coefficient (log p) for emtricitabine is -0.43 and the pKa is 2.65.

Chemical Structure Tenofovir Disoproxil Fumarate: Tenofovir disoproxil fumarate is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir disoproxil fumarate is 9-[( R )-2 [[bis[[(isopropoxycarbonyl)oxy]-methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C 19 H 30 N 5 O 10 P ∙ C 4 H 4 O 4 and a molecular weight of 635.52.

It has the following structural formula: Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 13.4 mg/mL in water at 25 °C. The partition coefficient (log p) for tenofovir disoproxil is 1.25 and the pKa is 3.75. All dosages are expressed in terms of tenofovir disoproxil fumarate except where otherwise noted.

TRUVADA tablets are for oral administration, and are available in the following strengths: Film-coated tablet containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients Film-coated tablet containing 167 mg of emtricitabine and 250 mg of tenofovir disoproxil fumarate (which is equivalent to 204 mg of tenofovir disoproxil) as active ingredients Film-coated tablet containing 133 mg of emtricitabine and 200 mg of tenofovir disoproxil fumarate (which is equivalent to 163 mg of tenofovir disoproxil) as active ingredients Film-coated tablet containing 100 mg of emtricitabine and 150 mg of tenofovir disoproxil fumarate (which is equivalent to 123 mg of tenofovir disoproxil) as active ingredients All strength of TRUVADA tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch (gluten free).

The 200 mg/300 mg strength tablets are coated with Opadry II Blue Y-30-10701, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The 167 mg/250 mg, 133 mg/200 mg, and 100 mg/150 mg strength tablets are coated with Opadry II Blue, which contains FD&C Blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. Chemical Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION As a part of patient counseling, healthcare providers must review the TRUVADA Medication Guide with every uninfected individual taking TRUVADA to reduce the risk of acquiring HIV. Advise the patient to read FDA-approved patient labeling (Medication Guide). Important Information for All Patients and Uninfected Individuals Advise patients and uninfected individuals that: The long term effects of TRUVADA are unknown.

TRUVADA tablets are for oral ingestion only. Patients and uninfected individuals should not discontinue TRUVADA without first informing their physicians. Patients and uninfected individuals should remain under the care of a physician when using TRUVADA.

It is important to take TRUVADA on a regular dosing schedule to avoid missing doses. Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported. Treatment with TRUVADA should be suspended in patients or uninfected individuals who develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity (including nausea, vomiting, unusual or unexpected stomach discomfort, and weakness) [see Warnings and Precautions (5.1) ] .

Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with hepatitis B virus (HBV) and HIV-1 and have discontinued TRUVADA. Before initiating TRUVADA, test all patients and uninfected individuals for HBV. All patients who are infected with HBV need close medical follow-up for several months after stopping TRUVADA to monitor for exacerbations of hepatitis [see Warnings and Precautions (5.2) ] .

Renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of VIREAD. TRUVADA should be avoided with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Warnings and Precautions (5.3) ] . Dosing interval of TRUVADA may need adjustment in HIV-1 infected patients with renal impairment.

TRUVADA for a PrEP indication should not be used in HIV-1 uninfected individuals if estimated creatinine clearance is less than 60 mL/min. If a decrease in estimated creatinine clearance is observed in uninfected individuals while using TRUVADA for PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [see Dosage and Administration (2.4) ] . Do not administer TRUVADA with ATRIPLA, COMPLERA, EMTRIVA, GENVOYA, ODEFSEY, STRIBILD, or VIREAD; or with drugs containing lamivudine, including Combivir (lamivudine/zidovudine), Dutrebis (lamivudine/raltegravir) , Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Triumeq (abacavir sulfate/dolutegravir/lamivudine), or Trizivir (abacavir sulfate/lamivudine/zidovudine) [see Warnings and Precautions (5.4) ] .

Do not administer TRUVADA with HEPSERA [see Warnings and Precautions (5.4) ] . Decreases in bone mineral density have been observed with the use of VIREAD or TRUVADA. Consider bone monitoring in patients and uninfected individuals who have a history of pathologic bone fracture or at risk for osteopenia [see Warnings and Precautions (5.5) ].

Patients and uninfected individuals should avoid doing things that can spread HIV-1 or HBV infection: Do not share needles or other injection equipment. Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades. Do not have any kind of sex without protection.

Always practice safer sex by using a latex or polyurethane condom to lower the chance of sexual contact with semen, vaginal secretions, or blood. Patients and uninfected individuals should not breastfeed because the drugs in TRUVADA can be passed to the baby in breast milk, and it is not known whether they can harm the baby. HIV-positive women should also not breastfeed because of the risk of passing the HIV-1 virus to the baby.

Treatment of HIV-1 Infection When TRUVADA is used in the treatment of HIV-infection, advis… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: April 2016 Medication Guide TRUVADA ® (tru-VAH-dah) (emtricitabine and tenofovir disoproxil fumarate) tablets Read this Medication Guide before you start taking TRUVADA and each time you get a refill.

There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment. This Medication Guide provides information about two different ways that TRUVADA may be used (see the Medication Guide section " What is TRUVADA? " for important information about how TRUVADA may be used): to treat Human Immunodeficiency Virus-1 (HIV-1) infection, and to reduce the risk of getting HIV-1 infection in adults who are HIV-negative HIV is the virus that causes AIDS (Acquired Immune Deficiency Syndrome).

What is the most important information I should know about TRUVADA? TRUVADA can cause serious side effects, including: Too much lactic acid in your blood (lactic acidosis). Your body normally makes lactic acid, but too much lactic acid is a serious medical emergency.

It can be treated, but it can also lead to death. Call your healthcare provider right away if you get these symptoms: weakness or being more tired than usual unusual muscle pain being short of breath or fast breathing nausea, vomiting, and stomach-area pain cold or blue hands and feet feel dizzy or lightheaded fast or abnormal heartbeats Severe liver problems . Severe liver problems can happen in people who take TRUVADA.

In some cases these liver problems can lead to death. Your liver may become large and tender. You may develop fat in your liver when you take TRUVADA.

Call your healthcare provider right away if you get the following symptoms: your skin or the white part of your eyes turns yellow dark "tea-colored" urine light-colored stools loss of appetite for several days or longer nausea stomach-area pain You may be more likely to get lactic acidosis or severe liver problems if you are female, if you are very overweight (obese), or if you have been taking TRUVADA for a long time. If you also have hepatitis B virus (HBV) infection and take TRUVADA, your hepatitis B may become worse if you stop taking TRUVADA.

Do not stop taking TRUVADA without first talking to your healthcare provider. Do not run out of TRUVADA. Refill your prescription or talk to your healthcare provider before your TRUVADA is all gone.

If your healthcare provider stops TRUVADA, your healthcare provider will need to watch you closely for several months to check your hepatitis B infection, or give you a medication to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking TRUVADA. For more information about side effects, see the section " What are the possible side effects of TRUVADA? " in this Medication Guide.

Other important information for people who take TRUVADA to help reduce their risk of getting HIV-1 infection: Before taking TRUVADA to reduce your risk of getting HIV-1 infection: You must be HIV-negative to start TRUVADA. You must get tested to make sure that you do not already have HIV-1 infection. Do not take TRUVADA to reduce the risk of getting HIV-1 unless you are confirmed to be HIV-negative.

Many HIV-1 tests can miss HIV-1 infection 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 TRUVADA or at any time while taking TRUVADA.

Symptoms of new HIV-1 infection 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 TRUVADA to reduce your risk of getting HIV-1: Just taking TRUVADA may not keep you from getting HIV-1. You must continue using safer sex practices while you are taking TRU… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 182 words ▾

8.3Nursing Mothers Nursing Mothers: The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breast-feed their infants to avoid risking postnatal transmission of HIV-1. Studies in humans have shown that both tenofovir and emtricitabine are excreted in human milk. Because the risks of low level exposure to emtricitabine and tenofovir to infants are unknown, mothers should be instructed not to breast-feed if they are receiving TRUVADA, whether they are taking TRUVADA for treatment or to reduce the risk of acquiring HIV-1 .

Emtricitabine Samples of breast milk obtained from five HIV-1 infected mothers show that emtricitabine is secreted in human milk. Breastfeeding infants whose mothers are being treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in infants breastfed by mothers being treated with emtricitabine are unknown.

Tenofovir Disoproxil Fumarate Samples of breast milk obtained from five HIV-1 infected mothers show that tenofovir is secreted in human milk. Tenofovir-associated risks, including the risk of viral resistance to tenofovir, in infants breastfed by mothers being treated with tenofovir disoproxil fumarate are unknown.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics TRUVADA: One TRUVADA tablet was bioequivalent to one EMTRIVA capsule (200 mg) plus one VIREAD tablet (300 mg) following single-dose administration to fasting healthy subjects (N=39). Emtricitabine: The pharmacokinetic properties of emtricitabine are summarized in Table 7. Following oral administration of EMTRIVA, emtricitabine is rapidly absorbed with peak plasma concentrations occurring at 1–2 hours post-dose.

Less than 4% of emtricitabine binds to human plasma proteins in vitro and the binding is independent of concentration over the range of 0.02–200 µg/mL. Following administration of radiolabelled emtricitabine, approximately 86% is recovered in the urine and 13% is recovered as metabolites. The metabolites of emtricitabine include 3′-sulfoxide diastereomers and their glucuronic acid conjugate.

Emtricitabine is eliminated by a combination of glomerular filtration and active tubular secretion. Following a single oral dose of EMTRIVA, the plasma emtricitabine half-life is approximately 10 hours. Tenofovir Disoproxil Fumarate: The pharmacokinetic properties of tenofovir disoproxil fumarate are summarized in Table 7.

Following oral administration of VIREAD, maximum tenofovir serum concentrations are achieved in 1.0 ± 0.4 hour. Less than 0.7% of tenofovir binds to human plasma proteins in vitro and the binding is independent of concentration over the range of 0.01–25 µg/mL. Approximately 70–80% of the intravenous dose of tenofovir is recovered as unchanged drug in the urine.

Tenofovir is eliminated by a combination of glomerular filtration and active tubular secretion. Following a single oral dose of VIREAD, the terminal elimination half-life of tenofovir is approximately 17 hours. Table 7 Single Dose Pharmacokinetic Parameters for Emtricitabine and Tenofovir in Adults NC=Not calculated Emtricitabine Tenofovir Fasted Oral Bioavailability Median (range) (%) 92 (83.1–106.4) 25 (NC–45.0) Plasma Terminal Elimination Half-Life (hr) 10 (7.4–18.0) 17 (12.0–25.7) C max Mean (± SD) (μg/mL) 1.8±0.72 Data presented as steady state values 0.30±0.09 AUC (μg ∙ hr/mL) 10.0±3.12 2.29±0.69 CL/F (mL/min) 302±94 1043±115 CL renal (mL/min) 213±89 243±33 Effects of Food on Oral Absorption TRUVADA may be administered with or without food.

Administration of TRUVADA following a high fat meal (784 kcal; 49 grams of fat) or a light meal (373 kcal; 8 grams of fat) delayed the time of tenofovir C max by approximately 0.75 hour. The mean increases in tenofovir AUC and C max were approximately 35% and 15%, respectively, when administered with a high fat or light meal, compared to administration in the fasted state. In previous safety and efficacy trials, VIREAD (tenofovir) was taken under fed conditions.

Emtricitabine systemic exposures (AUC and C max ) were unaffected when TRUVADA was administered with either a high fat or a light meal. Special Populations Race Emtricitabine: No pharmacokinetic differences due to race have been identified following the administration of EMTRIVA. Tenofovir Disoproxil Fumarate: There were insufficient numbers from racial and ethnic groups other than Caucasian to adequately determine potential pharmacokinetic differences among these populations following the administration of VIREAD.

Gender Emtricitabine and Tenofovir Disoproxil Fumarate: Emtricitabine and tenofovir pharmacokinetics are similar in male and female subjects. Pediatric Patients The pharmacokinetic data for tenofovir and emtricitabine following administration of TRUVADA in pediatric subjects weighing 17 kg and above are not available. The dosing recommendations of TRUVADA in this population are based on the dosing recommendations of EMTRIVA and VIREAD in this population.

Refer to the EMTRIVA and VIREAD prescribing information for pharmacokinetic information on the individual products in pediatric patients. TRUVADA should not be administered to HIV-1 infected pediatric patients weighing less than 17 kg. Geriatric Patients Pharmacokinetics of… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Clinical Study 934 supports the use of TRUVADA tablets for the treatment of HIV-1 infection. Additional data in support of the use of TRUVADA are derived from clinical Study 903, in which lamivudine and tenofovir disoproxil fumarate (tenofovir DF) were used in combination in treatment-naïve adults, and clinical Study 303 in which emtricitabine and lamivudine demonstrated comparable efficacy, safety and resistance patterns as part of multidrug regimens. For additional information about these trials, consult the prescribing information for tenofovir DF and emtricitabine.

The iPrEx study and Partners PrEP study support the use of TRUVADA to help reduce the risk of acquiring HIV-1.

14.1Study 934 Data through 144 weeks are reported for Study 934, a randomized, open-label, active-controlled multicenter trial comparing emtricitabine + tenofovir DF administered in combination with efavirenz versus zidovudine/lamivudine fixed-dose combination administered in combination with efavirenz in 511 antiretroviral-naïve subjects. From Weeks 96 to 144 of the trial, subjects received TRUVADA with efavirenz in place of emtricitabine + tenofovir DF with efavirenz. Subjects had a mean age of 38 years (range 18–80), 86% were male, 59% were Caucasian and 23% were Black.

The mean baseline CD4+ cell count was 245 cells/mm 3 (range 2–1191) and median baseline plasma HIV-1 RNA was 5.01 log 10 copies/mL (range 3.56–6.54). Subjects were stratified by baseline CD4+ cell count (< or ≥200 cells/mm 3 ); 41% had CD4+ cell counts <200 cells/mm 3 and 51% of subjects had baseline viral loads >100,000 copies/mL. Treatment outcomes through 48 and 144 weeks for those subjects who did not have efavirenz resistance at baseline are presented in Table 12.

Table 12 Outcomes of Randomized Treatment at Week 48 and 144 (Study 934) Outcomes At Week 48 At Week 144 FTC + TDF + EFV (N=244) AZT/3TC + EFV (N=243) FTC + TDF + EFV (N=227) Subjects who were responders at Week 48 or Week 96 (HIV-1 RNA <400 copies/mL) but did not consent to continue trial after Week 48 or Week 96 were excluded from analysis. AZT/3TC + EFV (N=229) Responder Subjects achieved and maintained confirmed HIV-1 RNA <400 copies/mL through Weeks 48 and 144. 84% 73% 71% 58% Virologic failure Includes confirmed viral rebound and failure to achieve confirmed <400 copies/mL through Weeks 48 and 144.

2% 4% 3% 6% Rebound 1% 3% 2% 5% Never suppressed 0% 0% 0% 0% Change in antiretroviral regimen 1% 1% 1% 1% Death <1% 1% 1% 1% Discontinued due to adverse event 4% 9% 5% 12% Discontinued for other reasons Includes lost to follow-up, subject withdrawal, noncompliance, protocol violation and other reasons. 10% 14% 20% 22% Through Week 48, 84% and 73% of subjects in the emtricitabine + tenofovir DF group and the zidovudine/lamivudine group, respectively, achieved and maintained HIV-1 RNA <400 copies/mL (71% and 58% through Week 144).

The difference in the proportion of subjects who achieved and maintained HIV-1 RNA <400 copies/mL through 48 weeks largely results from the higher number of discontinuations due to adverse events and other reasons in the zidovudine/lamivudine group in this open-label trial. In addition, 80% and 70% of subjects in the emtricitabine + tenofovir DF group and the zidovudine/lamivudine group, respectively, achieved and maintained HIV-1 RNA <50 copies/mL through Week 48 (64% and 56% through Week 144). The mean increase from baseline in CD4 + cell count was 190 cells/mm 3 in the emtricitabine + tenofovir DF group and 158 cells/mm 3 in the zidovudine/lamivudine group at Week 48 (312 and 271 cells/mm 3 at Week 144).

Through 48 weeks, 7 subjects in the emtricitabine + tenofovir DF group and 5 subjects in the zidovudine/lamivudine group experienced a new CDC Class C event (10 and 6 subjects through 144 weeks). 14.2 iPrEx Trial The iPrEx trial was a randomized double-blind placebo-controlled multinational study evaluating TRUVADA in 2,499 HIV-seronegative men or transgender women who ha… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Emtricitabine: In long-term oral carcinogenicity studies of emtricitabine, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the therapeutic dose). Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse micronucleus assays.

Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose. Fertility was normal in the offspring of mice 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 200 mg daily dose. Tenofovir Disoproxil Fumarate: Long-term oral carcinogenicity studies of tenofovir disoproxil fumarate in mice and rats were carried out at exposures up to approximately 16 times (mice) and 5 times (rats) those observed in humans at the therapeutic dose for HIV-1 infection.

At the high dose in female mice, liver adenomas were increased at exposures 16 times that in humans. In rats, the study was negative for carcinogenic findings at exposures up to 5 times that observed in humans at the therapeutic dose. Tenofovir disoproxil fumarate was mutagenic in the in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test).

In an in vivo mouse micronucleus assay, tenofovir disoproxil fumarate was negative when administered to male mice. There were no effects on fertility, mating performance or early embryonic development when tenofovir disoproxil fumarate was administered to male rats at a dose equivalent to 10 times the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 15 days prior to mating through day seven of gestation. There was, however, an alteration of the estrous cycle in female rats.

13.2Animal Toxicology and/or Pharmacology Tenofovir and tenofovir disoproxil fumarate administered in toxicology studies to rats, dogs and monkeys at exposures (based on AUCs) greater than or equal to 6-fold those observed in humans caused bone toxicity. In monkeys the bone toxicity was diagnosed as osteomalacia. Osteomalacia observed in monkeys appeared to be reversible upon dose reduction or discontinuation of tenofovir.

In rats and dogs, the bone toxicity manifested as reduced bone mineral density. The mechanism(s) underlying bone toxicity is unknown. Evidence of renal toxicity was noted in four animal species.

Increases in serum creatinine, BUN, glycosuria, proteinuria, phosphaturia, and/or calciuria and decreases in serum phosphate were observed to varying degrees in these animals. These toxicities were noted at exposures (based on AUCs) 2–20 times higher than those observed in humans. The relationship of the renal abnormalities, particularly the phosphaturia, to the bone toxicity is not known.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Emtricitabine: In long-term oral carcinogenicity studies of emtricitabine, no drug-related increases in tumor incidence were found in mice at doses up to 750 mg/kg/day (26 times the human systemic exposure at the therapeutic dose of 200 mg/day) or in rats at doses up to 600 mg/kg/day (31 times the human systemic exposure at the therapeutic dose). Emtricitabine was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or mouse micronucleus assays.

Emtricitabine did not affect fertility in male rats at approximately 140-fold or in male and female mice at approximately 60-fold higher exposures (AUC) than in humans given the recommended 200 mg daily dose. Fertility was normal in the offspring of mice 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 200 mg daily dose. Tenofovir Disoproxil Fumarate: Long-term oral carcinogenicity studies of tenofovir disoproxil fumarate in mice and rats were carried out at exposures up to approximately 16 times (mice) and 5 times (rats) those observed in humans at the therapeutic dose for HIV-1 infection.

At the high dose in female mice, liver adenomas were increased at exposures 16 times that in humans. In rats, the study was negative for carcinogenic findings at exposures up to 5 times that observed in humans at the therapeutic dose. Tenofovir disoproxil fumarate was mutagenic in the in vitro mouse lymphoma assay and negative in an in vitro bacterial mutagenicity test (Ames test).

In an in vivo mouse micronucleus assay, tenofovir disoproxil fumarate was negative when administered to male mice. There were no effects on fertility, mating performance or early embryonic development when tenofovir disoproxil fumarate was administered to male rats at a dose equivalent to 10 times the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 15 days prior to mating through day seven of gestation. There was, however, an alteration of the estrous cycle in female rats.

📄 Recent Major Changes 29 words ▾

Indications and Usage Treatment of HIV-1 infection ( 1.1 ) 03/2016 Dosage and Administration ( 2.2 ) 03/2016 Warnings and Precautions Coadministration with Other Products ( 5.4 ) 03/2016

📄 Package Label / Principal Display Panel 6 words ▾

PRINCIPAL DISPLAY PANEL - < pdp

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Truvada — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Truvada. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$642.8K
Claims incl. refills
323
Beneficiaries
209
Spend / beneficiary
$3,075.53
Spend / claim
$1,990.05
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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← 68071-2074-05 · NuCare 68071-2113-06 · NuCare →
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