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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 200 mg; 300 mg Tablet, Film Coated, 3-count

by DirectRx · 3 TABLET, FILM COATED in 1 BOTTLE (72189-312-03)
NDC 72189-0312-03
🏷️ FDA NDC (as labeled) 72189-312-03 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Sep 10, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 72189-312-03
Product NDC 72189-312
11-digit billing NDC 72189031203
NCPDP billing unit EA — each (per item)
RxCUI 476556
UNII G70B4ETF4S, OTT9J7900I
Application # ANDA204131
SPL Set ID d67e2df4-4094-4f5a-e053-2a95a90ae4aa
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 ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-01-26
Route ORAL
Dosage form TABLET, FILM COATED
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
GPI-14 12109902300320
GPI class Emtricitabine-Tenofovir DF
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 EMTRICITABINE-TENOFV 200-300MG
FDB brand name Emtricitabine-Tenofovir Disop
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 72189-312-03 — a 5-3-2 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 product segment → 72189-0312-03. 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.

🏭 Manufacturer & labeler

LabelerDirectRx
Application holderCHARTWELL RX SCIENCES LLC
FDA applicationANDA204131 (ANDA)
Labeler code72189
First marketedJan 2022
Product typeHuman Prescription Drug
Portfolio49 products on file
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.

🩺 Clinical

Label name EMTRICITABINE-TENOFV 200-300MG Ingredient Emtricitabine/Tenofovir (Tdf)
📗 Our plain-language guide HelloPharmacist
  • If you already have HIV-1, this medication is part of your treatment — taken every day alongside other antivirals to keep the virus suppressed. PrEP is for people who are HIV-negat...
  • What exactly is the difference between using this for HIV treatment versus PrEP?
  • Please don't stop without talking to your doctor first. If you also have hepatitis B, stopping suddenly can trigger a serious and potentially dangerous flare-up of that infection....
  • Common things like nausea, headache, diarrhea, and trouble sleeping often improve in the first few weeks. The ones that need immediate attention are symptoms that could signal a ra...
📖 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.

💊 What it looks like

Color white
ShapeCapsule
ImprintLU;Q31
Size19 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

  • 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 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

9 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.

💲 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 $2.55 $7.65 / 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.

🔁 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 $0.505 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 00904-7172-07 Major 1 tablet $0.505 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 16714-0534-01 NorthStar 30 tablets $0.505 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 31722-0560-30 Camber 30 tablets $0.505 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 33342-0106-07 Macleods 30 tablets $0.505 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 42385-0953-30 Laurus 30 tablets $0.505 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 65862-0354-30 Aurobindo 30 tablets $0.505 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 69238-2095-03 Amneal 30 tablets $0.505 AB Availability likely —
Emtricitabine and tenofovir disoproxil fumarate 200 mg/1; 300 mg 70710-1367-03 Zydus 30 tablets $0.505 AB Availability likely —
Emtricitabine and Tenofovir Disoproxil Fumarate 200 mg/1; 300 mg 82009-0109-30 QUALLENT 30 tablets $0.505 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 $59.624 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 mg 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 mgthis 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 a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Jan 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
72189-0312-03 You're viewing this 3 TABLET, FILM COATED in 1 BOTTLE (72189-312-03) 2022-01-26 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 72189-312-03, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 72189-0312-03, written without dashes as 72189031203. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 72189-0312-03, the first segment (72189) is the labeler code FDA assigned to DirectRx; the middle segment (0312) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by DirectRx. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DirectRx is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 📦 How Supplied / Storage and Handling 📋 Description 💬 Medication Guide
🎯 Indications and Usage 106 words ▾

1.1Treatment of HIV-1 Infection Emtricitabine and tenofovir disoproxil fumarate tablets are 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 Clinical Studies (14)].

1.2HIV-1 Pre-Exposure Prophylaxis (PrEP) Emtricitabine and tenofovir disoproxil fumarate tablets are indicated in at – risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP [see Dosage and Administration (2.2), Warnings and Precautions (5.2)].

⏱️ Dosage and Administration ~3 min read ▾

2.1Testing Prior to Initiation of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for Treatment of HIV-1 Infection or for HIV-1 PrEP Prior to or when initiating emtricitabine and tenofovir disoproxil fumarate tablets, test individuals for hepatitis B virus infection [see Warnings and Precautions (5.1)]. Prior to initiation and during use of emtricitabine and tenofovir disoproxil fumarate tablets, 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 (5.3)].

2.2HIV-1 Screening for Individuals Receiving Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP Screen all individual for HIV-1 infection immediately prior to initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP and at least once every 3 months while taking emtricitabine and tenofovir disoproxil fumarate tablets, 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 and 14.4)].

2.3Recommended Dosage for Treatment of HIV-1 Infection in Adults and Pediatric Patients Weighing at Least 35 kg Emtricitabine and tenofovir disoproxil fumarate tablet is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommended dosage of emtricitabine and tenofovir disoproxil fumarate tablets in adults and in pediatric patients weighing at least 35 kg is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food [see Clinical Pharmacology (12.3)].

2.5Recommended Dosage for HIV-1 PrEP in Adults and Adolescents Weighing at Least 35 kg The dosage of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is one tablet (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food in HIV-1 uninfected adults and adolescents weighing at least 35 kg [see Clinical Pharmacology (12.3)].

2.6Dosage Adjustment in Individuals with Renal Impairment Treatment of HIV-1 Infection Table 2 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for HIV-1 infected patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). The safety and effectiveness of the dosing interval adjustment recommendations in patients with moderate renal impairment (creatinine clearance 30 to 49 mL/min) have not been clinically evaluated; therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions (5.3)].

No data are available to make dosage recommendations in pediatric patients with renal impairment. Table 2 Dosage Interval Adjustment for HIV-1 Infected Adult Patients with Altered Creatinine Clearance a.Calculated using ideal (lean) body weight Creatinine Clearance (mL/min)a 50 30 to 49 <30 (Including Patients Requiring Hemodialysis) Recommended Dosing Interval Every 24 hours Every 48 hours Emtricitabine and tenofovir disoproxil fumarate tablets are not recommended. HIV-1 PrEP Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are not recommended in HIV-1 uninfected individuals with estimated creatinine clearance below 60 mL/min [see Warnings and Precautions (5.3)].

If a decrease in estimated creatinine clearance is observed in uninfected individuals while using emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, evaluate po…

💊 Dosage Forms and Strengths 49 words ▾

Emtricitabine and tenofovir disoproxil fumarate tablets are available in one dose strength. 200 mg/300 mg Tablets: 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil): white, capsule shaped, biconvex film-coated, debossed with "LU" on one side and "Q31" on the other side.

⛔ Contraindications 24 words ▾

Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP are contraindicated in individuals with unknown or positive HIV-1 status [see Warnings and Precautions (5.2)].

⚠️ Warnings and Cautions ~3 min read ▾

5.1Severe Acute Exacerbation of Hepatitis B in Individuals with HBV Infection All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating emtricitabine and tenofovir disoproxil fumarate tablets [see Dosage and Administration (2.1)]. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Individuals infected with HBV who discontinue emtricitabine and tenofovir disoproxil fumarate tablets 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 posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. HBV-uninfected individuals 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 Emtricitabine and Tenofovir Disoproxil Fumarate Tablets are Used for HIV-1 PrEP Use emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to reduce the risk of HIV-1 infection as part of a comprehensive prevention strategy that includes other prevention measures, 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 emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP to maximal protection against HIV-1 infection is unknown. Risk of 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 uninfected individuals about and support their efforts in reducing sexual risk behavior. Use emtricitabine and tenofovir disoproxil fumarate tablets to reduce the risk of acquiring HIV-1 only in individuals confirmed to be HIV-negative. HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking only emtricitabine and tenofovir disoproxil fumarate tablets, because emtricitabine and tenofovir disoproxil fumarate tablets 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 emtricitabine and tenofovir disoproxil fumarate tablets 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 emtricitabine and tenofovir disoproxil fumarate tablets 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 unknown HIV-1 status or unknown viremic status, or a recent STI), and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash).

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. While using emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs.…

🤒 Adverse Reactions ~3 min read ▾

The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbations of Hepatitis B in Patients with HBV Infection [see Warnings and Precautions (5.1)] . New Onset or Worsening Renal Impairment [see Warnings and Precautions (5.3)] . Immune Reconstitution Syndrome [see Warnings and Precautions (5.4)] .

Bone Loss and Mineralization Defects [see Warnings and Precautions (5.5)] . Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.6)] .

6.1Clinical Trials Experience 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. Adverse Reactions from Clinical Trials Experience in HIV-1 Infected Subjects Clinical Trials in Adult Subjects: In Study 934, 511 antiretroviral-naïve subjects received efavirenz (EFV) administered in combination with either FTC+TDF (N=257) or zidovudine (AZT)/lamivudine (3TC) (N=254) for 144 weeks.

The most common adverse reactions (incidence greater than or equal to 10%, all grades) included diarrhea, nausea, fatigue, headache, dizziness, depression, insomnia, abnormal dreams, and rash. Table 3 provides the treatment-emergent adverse reactions (Grades 2 to 4) occurring in greater than or equal to 5% of subjects treated in any treatment group. Skin discoloration, manifested by hyperpigmentation, occurred in 3% of subjects taking FTC+TDF, and was generally mild and asymptomatic.

The mechanism and clinical significance are unknown. Table 3 Selected Adverse Reactionsa (Grades 2 to 4) Reported in 5% in Any Treatment Group in Study 934 (0 to 144 Weeks) a.Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug. b.From Weeks 96 to 144 of the trial, subjects received emtricitabine and tenofovir disoproxil fumarate tablets with efavirenz in place of FTC+TDF with efavirenz. c.Rash event includes rash, exfoliative rash, rash generalized, rash macular, rash maculo-papular, rash pruritic, and rash vesicular.

FTC+TDF+EFVb AZT/3TC+EFV N=257 N=254 Fatigue 9% 8% Depression 9% 7% Nausea 9% 7% Diarrhea 9% 5% Dizziness 8% 7% Upper respiratory tract infections 8% 5% Sinusitis 8% 4% Rash eventc 7% 9% Headache 6% 5% Insomnia 5% 7% Nasopharyngitis 5% 3% Vomiting 2% 5% Laboratory Abnormalities: Laboratory abnormalities observed in this trial were generally consistent with those seen in other trials of TDF and/or FTC (Table 4). Table 4 Significant Laboratory Abnormalities Reported in 1% of Subjects in Any Treatment Group in Study 934 (0 to 144 Weeks) a.From Weeks 96 to 144 of the trial, subjects received emtricitabine and tenofovir disoproxil fumarate tablets with efavirenz in place of FTC+TDF with efavirenz.

FTC+TDF+EFVa AZT/3TC+EFV N=257 N=254 Any Grade 3 Laboratory Abnormality 30% 26% Fasting Cholesterol (>240 mg/dL) 22% 24% Creatine Kinase (M: >990 U/L) (F: >845 U/L) 9% 7% Serum Amylase (>175 U/L) 8% 4% Alkaline Phosphatase (>550 U/L) 1% 0% AST (M: >180 U/L) (F: >170 U/L) 3% 3% ALT (M: >215 U/L) (F: >170 U/L) 2% 3% Hemoglobin (<8.0 mg/dL) 0% 4% Hyperglycemia (>250 mg/dL) 2% 1% Hematuria (>75 RBC/HPF) 3% 2% Glycosuria ( 3+) <1% 1% Neutrophils (<750/mm3) 3% 5% Fasting Triglycerides (>750 mg/dL) 4% 2% Clinical Trials in Pediatric Subjects: Emtricitabine In addition to the adverse reactions reported in adults, anemia and hyperpigmentation were observed in 7% and 32%, respectively, of pediatric subjects (3 months to less than 18 years of age) who received treatment with FTC in the larger of two open-label, uncontrolled pediatric trials (N=116).

Tenofovir Disoproxil Fumarate In pediatric clinical trials (Studies 352 and 321) conducted in 184 HIV 1 infected subjects 2 to less than 18 years of age, the adverse reactions observed in pediatric subjects who received treatment with TDF were consistent w…

🔄 Drug Interactions 214 words ▾

7.1Drugs Affecting Renal Function FTC and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion [see Clinical Pharmacology (12.3)]. No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration of emtricitabine and tenofovir disoproxil fumarate tablets with drugs that are eliminated by active tubular secretion may increase concentrations of FTC, tenofovir, and/or the coadministered drug. Some examples include, but are not limited to, acyclovir, adefovir dipivoxil, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3)].

Drugs that decrease renal function may increase concentrations of FTC and/or tenofovir.

7.2Established and Significant Interactions Table 7 provides a listing of established or clinically significant drug interactions. The drug interactions described are based on studies conducted with either emtricitabine and tenofovir disoproxil fumarate, the components of emtricitabine and tenofovir disoproxil fumarate tablets (FTC and TDF) as individual agents and/or in combination, or are predicted drug interactions that may occur with emtricitabine and tenofovir disoproxil fumarate tablets [see Clinical Pharmacology (12.3)].

Table 7 Established and Significanta Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Trials a.This table is not all inclusive. b.↑=Increase, ↓=Decrease c.Indicates that a drug-drug interaction trial was conducted.

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Teratogenic Effects Pregnancy Exposure Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Data on the use of emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy from observational studies have shown no increased risk of major birth defects.

Available data from the APR show no significant difference in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) or tenofovir disoproxil fumarate (TDF) (2.1%) 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. In the U.S. general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15 to 20%.

In animal reproduction studies, no adverse developmental effects were observed when the components of emtricitabine and tenofovir disoproxil fumarate tablets were administered separately at doses/exposures ≥60 (FTC), ≥14 (TDF) and 2.7 (tenofovir) times those of the recommended daily dose of emtricitabine and tenofovir disoproxil fumarate tablets (see Data). Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk: HIV-1 PrEP Published studies indicate an increased risk of HIV-1 infection during pregnancy and an increased risk of mother to child transmission during acute HIV-1 infection.

In women at risk of acquiring HIV-1, consideration should be given to methods to prevent acquisition of HIV, including continuing or initiating emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, during pregnancy. Data Human Data: Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP In an observational study based on prospective reports to the APR, 78 HIV-seronegative women exposed to emtricitabine and tenofovir disoproxil fumarate tablets during pregnancy delivered live-born infants with no major malformations.

All but one were first trimester exposures, and the median duration of exposure was 10.5 weeks. There were no new safety findings in the women receiving emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP compared with HIV-1 infected women treated with other antiretroviral medications. Emtricitabine Based on prospective reports to the APR of exposures to FTC-containing regimens during pregnancy resulting in live births (including over 3,300 exposed in the first trimester and over 1,300 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.6% (95% CI: 2.1% to 3.2%) and 2.3% (95% CI: 1.6% to 3.3%) following first and second/third trimester exposure, respectively to FTC-containing regimens.

Tenofovir Disoproxil Fumarate Based on prospective reports to the APR of exposures to TDF-containing regimens during pregnancy resulting in live births (including over 4,000 exposed in the first trimester and over 1,700 exposed in the second/third trimester), the prevalence of major birth defects in live births was 2.4% (95% CI: 2.0% to 2.9%) and 2.4% (95% CI: 1.7% to 3.2%) following first and second/third trimester exposure, respectively to TDF-containing regimens. Methodologic 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 <20 weeks gestation. Additionally, published observational studies on emtricitabine and tenofovir exposure in pregnancy have not shown an increased risk for major malformations. Animal Data: Emtricitabine FTC was…

📦 How Supplied / Storage and Handling 94 words ▾

Emtricitabine and tenofovir disoproxil fumarate tablets are available in bottles containing 30 and 100 tablets with child-resistant closure as follows: 200 mg of FTC and 300 mg of TDF (equivalent to 245 mg of tenofovir disoproxil) tablets are white, capsule shaped, biconvex, film-coated, debossed with "LU" on one side and "Q31" on the other side. Bottles of 30 68180-287-06 Bottles of 100 68180-287-01 Store at 25 C (77 F); excursions permitted to 15º to 30 C (59 to 86 F) [See USP Controlled Room Temperature]. Keep container tightly closed Dispense only in original container

📋 Description ~1 min read ▾

Emtricitabine and tenofovir disoproxil fumarate tablets are fixed-dose combination tablets containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). FTC is a synthetic nucleoside analog of cytidine. TDF is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate.

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

It has a molecular formula of C8H10FN3O3S and a molecular weight of 247.24. It has the following structural formula: [Image] FTC is a white to off-white colored 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.

Tenofovir Disoproxil Fumarate TDF is a fumaric acid salt of the bis-isopropoxycarbonyloxymethyl ester derivative of tenofovir. The chemical name of tenofovir DF is 9-[(R)-2 [[bis[[(isopropoxycarbonyl)oxy]- methoxy]phosphinyl]methoxy]propyl]adenine fumarate (1:1). It has a molecular formula of C19H30N5O10P • C4H4O4 and a molecular weight of 635.51.

It has the following structural formula: [Image] Tenofovir disoproxil fumarate is a white to off-white crystalline powder with a solubility of 9.78 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 TDF except where otherwise noted.

Emtricitabine and tenofovir disoproxil fumarate tablets are for oral administration, and are available in the following strengths: Film-coated tablet containing 200 mg of FTC and 300 mg of TDF (which is equivalent to 245 mg of tenofovir disoproxil) as active ingredients Emtricitabine and tenofovir disoproxil fumarate tablets also include the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol and microcrystalline cellulose. The tablets are coated with Opadry II White 32K180001, which contains hypromellose 2910, lactose monohydrate, titanium dioxide and triacetin.

💬 Medication Guide ~3 min read ▾

Medication Guide Emtricitabine and Tenofovir Disoproxil Fumarate (EM-trye-SYE-ta-been and ten-OF-oh-vir DYE-soe-PROX-il FUE-ma-rate) Tablets Read this Medication Guide before you start taking emtricitabine and tenofovir disoproxil fumarate tablets 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 emtricitabine and tenofovir disoproxil fumarate tablets may be used. See the section "What is emtricitabine and tenofovir disoproxil fumarate tablet?" for detailed information about how emtricitabine and tenofovir disoproxil fumarate tablets may be used. What is the most important information I should know about emtricitabine and tenofovir disoproxil fumarate tablets?

Emtricitabine and tenofovir disoproxil fumarate tablets can cause serious side effects, including: Worsening of hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV before start or when you start treatment with emtricitabine and tenofovir disoproxil fumarate tablets. If you have HBV infection and take emtricitabine and tenofovir disoproxil fumarate tablets, your HBV may get worse (flare-up) if you stop taking emtricitabine and tenofovir disoproxil fumarate tablets.

A "flare-up" is when your HBV infection suddenly returns in a worse way than before. Do not run out of emtricitabine and tenofovir disoproxil fumarate tablets. Refill your prescription or talk to your healthcare provider before your emtricitabine and tenofovir disoproxil fumarate tablets are all gone.

Do not stop taking emtricitabine and tenofovir disoproxil fumarate tablets without first talking to your healthcare provider. If you stop taking emtricitabine and tenofovir disoproxil fumarate tablets, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or 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 emtricitabine and tenofovir disoproxil fumarate tablets.

For more information about side effects, see the section "What are the possible side effects of emtricitabine and tenofovir disoproxil fumarate tablets?". Other important information for people who take emtricitabine and tenofovir disoproxil fumarate tablets to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or "PrEP": Before taking emtricitabine and tenofovir disoproxil fumarate tablets to reduce your risk of getting HIV-1: You must be HIV-1 negative to start emtricitabine and tenofovir disoproxil fumarate tablets.

You must get tested to make sure that you do not already have HIV-1 infection. Do not take emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP unless you are confirmed to be HIV-1 negative. Some 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 emtricitabine and tenofovir disoproxil fumarate tablets or at any time while taking emtricitabine and tenofovir disoproxil fumarate tablets. 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 emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP: Emtricitabine and tenofovir disoproxil fumarate tablets 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-negative to keep taking emtricitabine and tenofovir di…

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