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Emtricitabine and tenofovir disoproxil fumarate 200 mg; 300 mg Tablet, Film Coated, 30-count — NDC 50090-8028-01 package photo

Emtricitabine and tenofovir disoproxil fumarate 200 mg; 300 mg Tablet, Film Coated, 30-count

by A-S Medication Solutions · 30 TABLET, FILM COATED in 1 BOTTLE (50090-8028-1)
NDC 50090-8028-01
🏷️ FDA NDC (as labeled) 50090-8028-1 billing pads the package 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) 50090-8028-1
Product NDC 50090-8028
11-digit billing NDC 50090802801
RxCUI 476556
UNII G70B4ETF4S, OTT9J7900I
Application # ANDA203442
SPL Set ID 41bd03ea-b92e-459c-968b-c9095ae90aef
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 2022-03-09
Route ORAL
Dosage form TABLET, FILM COATED
Substance EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 50090-8028-1 — 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 → 50090-8028-01. 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

LabelerA-S Medication Solutions
Application holderMACLEODS PHARMACEUTICALS LTD
FDA applicationANDA203442 (ANDA)
Labeler code50090
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio2,774 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

📖 What it is MedlinePlus · NLM

The combination of emtricitabine and tenofovir DF is used to treat HIV. Emtricitabine and tenofovir DF is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection. Emtricitabine and tenofovir DF are in a class of medications called nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body. Although emtricitabine and tenofovir DF will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medication...

Read the full MedlinePlus article ↗

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
ImprintL24
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 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 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 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 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 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.

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 · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 16714-0534-01 NorthStar 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 42385-0953-30 Laurus 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 00904-7172-07 Major 1 tablet $0.505 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 33342-0106-07 Macleods 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 65862-0354-30 Aurobindo 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 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 60219-2095-03 Amneal 30 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 42291-0980-30 AvKARE 30 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 51407-0112-30 Golden 30 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 82804-0086-03 Proficient 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 71205-0776-07 Proficient 7 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 50090-6494-01 A-S 30 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 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 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 mgthis 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
Mar 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
50090-8028-01 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (50090-8028-1) 2026-08-03 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 ✓ Available
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 50090-8028-1, 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: 50090-8028-01, written without dashes as 50090802801. 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 50090-8028-01, the first segment (50090) is the labeler code FDA assigned to A-S Medication Solutions; the middle segment (8028) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
A-S Medication Solutions 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.
🚨 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 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~2 min read ▾

WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine and tenofovir disoproxil fumarate tablets.

If appropriate, anti-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1 )]. Emtricitabine and tenofovir disoproxil fumarate tablets used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection.

Do not initiate Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed [see Warnings and Precautions ( 5.2 )]. WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B and RISK OF DRUG RESISTANCE WITH USE OF EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE TABLETS FOR HIV-1 PRE-EXPOSURE PROPHYLAXIS (PrEP) IN UNDIAGNOSED EARLY HIV-1 INFECTION See full prescribing information for complete boxed warning. • Severe acute exacerbations of hepatitis B (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine and tenofovir disoproxil fumarate tablets.

Hepatic function should be monitored closely in these individuals who discontinue emtricitabine and tenofovir disoproxil fumarate tablets. If appropriate anti-hepatitis B therapy may be warranted. (5.1) • Emtricitabine and tenofovir disoproxil fumarate tablets used for HIV-1 PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use.

Drug-resistant HIV-1 variants have been identified with the use of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP following undetected acute HIV-1 infection. Do not initiate emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP if signs or symptoms of acute HIV infection are present unless negative infection status is confirmed. ( 5.2 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS & USAGE HIV-1 Treatment ( 1.1 ) Emtricitabine and Tenofovir Disoproxil Fumarate Tablets is a two-drug combination of emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF), both HIV-1 nucleoside analog reverse transcriptase inhibitors, and 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. HIV-1 PrEP ( 1.2 ): • Emtricitabine and Tenofovir Disoproxil Fumarate is 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 for HIV-1 PrEP.

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 DOSAGE & ADMINISTRATION • Testing: Prior to or when initiating emtricitabine and tenofovir disoproxil fumarate tablets test for hepatitis B virus infection. 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.

( 2.1 ) • HIV-1 Screening: Screen all individuals 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). ( 2.2 ) Treatment of HIV-1 Infection • Recommended dosage in adults and pediatric patients weighing at least 35 kg: One Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food.

( 2.3 ) • Recommended dosage in pediatric patients weighing at least 17 kg: One emtricitabine and tenofovir disoproxil fumarate tablets 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. ( 2.4 ) • Recommended dosage in renally impaired HIV-1 infected adult patients: o Creatinine clearance (CrCl) 30 to 49 mL/min: 1 tablet every 48 hours. ( 2.6 ) o CrCl below 30 mL/min or hemodialysis: Emtricitabine and tenofovir disoproxil fumarate tablets is not recommended.

( 2.6 ) HIV-1 Pre-Exposure Prophylaxis (PrEP) • Recommended dosage in HIV-1 uninfected adults and adolescents weighing at least 35 kg: One emtricitabine and tenofovir disoproxil fumarate tablets (containing 200 mg of FTC and 300 mg of TDF) once daily taken orally with or without food. ( 2.5 ) • Recommended dosage in renally impaired HIV-uninfected individuals: Emtricitabine and tenofovir disoproxil fumarate tablets is not recommended in HIV-uninfected individuals if CrCl is below 60 mL/min. ( 2.6 )

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 individuals 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 tablets is a two-drug fixed dose combination product containing emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF). The recommen…

💊 Dosage Forms and Strengths 65 words ▾

3 DOSAGE FORMS & STRENGTHS Emtricitabine and tenofovir disoproxil fumarate are available in single dose strength: • Tablet: 200 mg of emtricitabine and 300 mg of tenofovir DF (equivalent to 245 mg of tenofovir disoproxil): white, capsule shaped, film-coated tablets, debossed with “L-24” on one side and plain on the other surface. Tablets: 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate. (3)

⛔ Contraindications 49 words ▾

4 CONTRAINDICATIONS Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status [ see Warnings and Precautions ( 5.2 )]. Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP is contraindicated in individuals with unknown or positive HIV-1 status. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Comprehensive management to reduce the risk of acquiring HIV-1 when emtricitabine and tenofovir disoproxil fumarate is used for HIV-1 PrEP: Use as part of a comprehensive prevention strategy including other prevention measures; strictly adhere to dosing schedule. ( 5.2 ) • Management to reduce the risk of acquiring HIV-1 drug resistance when emtricitabine and tenofovir disoproxil fumarate is used for HIV-1 PrEP: refer to full prescribing information for additional detail. ( 5.2 ) • New onset or worsening renal impairment: Can include acute renal failure and Fanconi syndrome.

Avoid administering Emtricitabine and tenofovir disoproxil fumarate tablets with concurrent or recent use of nephrotoxic drugs. ( 5.3 ) • Immune reconstitution syndrome during treatment of HIV-1 infection: May necessitate further evaluation and treatment. ( 5.4 ) • Decreases in bone mineral density (BMD): Consider assessment of BMD in individuals with a history of pathologic fracture or other risk factors for osteoporosis or bone loss.

( 5.5 ) • Lactic acidosis/severe hepatomegaly with steatosis: Discontinue emtricitabine and tenofovir disoproxil fumarate tablets in individuals who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.6 )

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 Is 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 for HIV-1 acquisition includes behavioral, biological, or epidemiologic factors including but not limited to condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Counsel individuals on the use of other prevention measures (e.g., consistent and correct condom use, knowledge of partner(s)’ HIV-1 status, including viral suppression status, regular testing for STIs that can facilitate HIV-1 transmission).

Inform 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, bec…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS 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 )]. • 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 adults in PrEP trials, adverse reactions that were reported by more than 2% of emtricitabine and tenofovir disoproxil fumarate tablets participants and more frequently than by placebo participants were headache, abdominal pain, and weight decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug 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 2–4) 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 Reactions a (Grades 2-4) Reported in ≥5% in Any Treatment Group in Study 934 (0-144 Weeks) FTC+TDF+EFV b 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 event c 7% 9% Headache 6% 5% Insomnia 5% 7% Nasopharyngitis 5% 3% Vomiting 2% 5% 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. 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 (0-144 Weeks) FTC+TDF+EFV a 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% a.

From Weeks 96 to 144 of the trial, subjects received emtricitabine and tenofovir disoproxil fumarate…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • Tenofovir disoproxil fumarate increases didanosine concentrations. Dose reduction and close monitoring for didanosine toxicity are warranted. ( 7.2 ) • Coadministration decreases atazanavir concentrations.

When coadministered with emtricitabine and tenofovir disoproxil fumarate tablets, use atazanavir given with ritonavir. ( 7.2 ) • Coadministration of emtricitabine and tenofovir disoproxil fumarate tablets with certain HIV-1 protease inhibitors or certain drugs to treat HCV increases tenofovir concentrations. Monitor for evidence of tenofovir toxicity.

( 7.2 ) • Consult Full Prescribing Information prior to and during treatment for important drug interactions. ( 7.2 )

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 tablets, 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 Significant a Drug Interactions: Alteration in Dose or Regimen May Be Recommended Based on Drug Interaction Trials Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment NRTI didanosine c ↑ didanosine Patients receiving emtricitabine and tenofovir disoproxil fumarate tablets and didanosine should be didanosinec monitored closely for didanosine-associated adverse reactions. Discontinue didanosine in patients who develop didanosine-associated adverse reactions. Higher didanosine concentrations could potentiate didanosine-associated adverse reactions, including pancreatitis, and neuropathy.

Suppression of CD4+ cell counts has been observed in patients receiving TDF with didanosine 400 mg daily. In patients weighing greater than 60 kg, reduce the didanosine dose to 250 mg when it is coadministered with emtricitabine and tenofovir disoproxil fumarate tablets. Data are not available to recommend a dose adjustment of didanosine for adult or pediatric patients weighing less than 60 kg.

When coadministered, emtricitabine and tenofovir disoproxil fumarate tablets and Videx EC may be taken under fasted conditions or with a light meal (less than 400 kcal, 20% fat). HIV-1 Protease Inhibitors: atazanavir c lopinavir/ritonavir c atazanavir/ritonavir c darunavir /ritonavir c ↓ atazanavir ↑ tenofovir When coadministered with emtricitabine and tenofovir disoproxil fumarate tablets, atazanavir 300 mg should be given with ritonavir 100 mg. Monitor patients receiving emtricitabine and tenofovir disoproxil fumarate tablets concomitantly with lopinavir/ritonavir, ritonavir-boosted atazanavir, or ritonavir boosted darunavir for TDF-associated adverse reactions Discontinue emtricitabine and tenofovir disoproxil fumarate tablets in patients who develop TDF-associated adverse reactions.

Hepatitis C Antiviral Agents: sofosbuvir/velpatasvir c sofosbuvir/velpatasvir/ voxi…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Lactation: Mothers infected with HIV-1 or suspected of having acquired HIV-1 infection should be instructed not to breastfeed due to the potential for HIV transmission. ( 8.2 )

8.1Pregnancy 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.…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy 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 administered o…

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Treatment of HIV-1 Infection No pediatric clinical trial was conducted to evaluate the safety and efficacy of emtricitabine and tenofovir disoproxil fumarate tablets in patients with HIV-1 infection. Data from previously conducted trials with the individual drug products, FTC and TDF, were relied upon to support dosage recommendations for emtricitabine and tenofovir disoproxil fumarate tablets. For additional information, consult the prescribing information for EMTRIVA and VIREAD.

Emtricitabine and tenofovir disoproxil fumarate tablets 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 tablet. Because it is a fixed-dose combination tablet, emtricitabine and tenofovir disoproxil fumarate tablets cannot be adjusted for patients of lower weight [see Warnings and Precautions ( 5.5 ), Adverse Reactions ( 6.1 ) and Clinical Pharmacology ( 12.3 )]. Emtricitabine and tenofovir disoproxil fumarate tablets is not approved for use in pediatric patients weighing less than 17 kg.

HIV-1 PrEP The safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg is supported by data from adequate and well-controlled studies of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TDF, in HIV-1 infected adults and pediatric subjects [see Dosage and Administration ( 2.5 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 and 12.4 ), and Clinical Studies ( 14.3 and 14.4 )].

Safety, adherence, and resistance were evaluated in a single-arm, open-label clinical trial (ATN113) in which 67 HIV-1 uninfected at-risk adolescent men who have sex with men received emtricitabine and tenofovir disoproxil fumarate tablets once daily for HIV-1 PrEP. The mean age of subjects was 17 years (range 15 to 18 years); 46% were Hispanic, 52% Black, and 37% White. The safety profile of emtricitabine and tenofovir disoproxil fumarate tablets in ATN113 was similar to that observed in the adult HIV-1 PrEP trials [see Adverse Reactions ( 6.1 )].

In the ATN113 trial, HIV-1 seroconversion occurred in 3 subjects. Tenofovir diphosphate levels in dried blood spot assays indicate that these subjects had poor adherence. No tenofovir- or FTC-associated HIV-1 resistance substitutions were detected in virus isolated from the 3 subjects who seroconverted [see Microbiology ( 12.4 )].

Adherence to study drug, as demonstrated by tenofovir diphosphate levels in dried blood spot assays, declined markedly after Week 12 once subjects switched from monthly to quarterly visits, suggesting that adolescents may benefit from more frequent visits and counseling [see Warnings and Precautions ( 5.2 )]. Safety and effectiveness of emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP in pediatric patients weighing less than 35 kg have not been established.

🧓 Geriatric Use 35 words ▾

8.5Geriatric Use Clinical trials of FTC, TDF, or emtricitabine and tenofovir disoproxil fumarate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

🆘 Overdosage 105 words ▾

10 OVERDOSAGE If overdose occurs, the patient must be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Emtricitabine: Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether FTC can be removed by peritoneal dialysis.

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

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Emtricitabine and tenofovir disoproxil fumarate tablets are a fixed-dose combination of antiviral drugs FTC and TDF [see Microbiology ( 12.4 )].

12.3Pharmacokinetics Emtricitabine and tenofovir disoproxil fumarate tablets: One emtricitabine and tenofovir disoproxil fumarate tablets was comparable to one FTC capsule (200 mg) plus one TDF tablet (300 mg) following single-dose administration to fasting healthy subjects (N=39). Emtricitabine : The pharmacokinetic properties of FTC are summarized in Table 8. Following oral administration of FTC, FTC is rapidly absorbed with peak plasma concentrations occurring at 1- 2 hours postdose.

Less than 4% of FTC binds to human plasma proteins in vitro, and the binding is independent of concentration over the range of 0.02 - 200μg/mL. Following administration of radiolabelled FTC, approximately 86% is recovered in the urine and 13% is recovered as metabolites. The metabolites of FTC 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 FTC, the plasma FTC half-life is approximately 10 hours. Tenofovir Disoproxil Fumarate: The pharmacokinetic properties of TDF are summarized in Table 8.

Following oral administration of TDF, 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 TDF, the terminal elimination half-life of tenofovir is approximately 17 hours. Table 8 Single Dose Pharmacokinetic Parameters for FTC and Tenofovir in Adults a FTC Tenofovir Fasted Oral Bioavailability b (%) 92 (83.1–106.4) 25 (NC–45.0) Plasma Terminal Elimination Half-Life b (hr) 10 (7.4–18.0) 17 (12.0–25.7) C max c (μg/mL) 1.8±0.72 d 0.30±0.09 AUC c (μg · hr/mL) 10.0±3.12 d 2.29±0.69 CL/F c (mL/min) 302±94 1043±115 CL renal c (mL/min) 213±89 243±33 a.

NC=Not calculated b. Median (range) c. Mean (± SD) d.

Data presented as steady state values Effects of Food on Oral Absorption Emtricitabine and tenofovir disoproxil fumarate tablets may be administered with or without food. Administration of emtricitabine and tenofovir disoproxil fumarate tablets 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, TDF (tenofovir) was taken under fed conditions. FTC systemic exposures (AUC and C max ) were unaffected when emtricitabine and tenofovir disoproxil fumarate tablets was administered with either a high fat or a light meal. Specific Populations Race Emtricitabine: No pharmacokinetic differences due to race have been identified following the administration of FTC.

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 TDF. Gender Emtricitabine and Tenofovir Disoproxil Fumarate: FTC and tenofovir pharmacokinetics are similar in male and female subjects. Pediatric Patients Treatment of HIV-1 Infection: The pharmacokinetic data for tenofovir and FTC following administration of emtricitabine and tenofovir disoproxil fumarate tablets in pediatric subjects weighing 17 kg and above are not available.

The dosage recommendations of emtricitabine…

🧬 Mechanism of Action 25 words ▾

12.1Mechanism of Action Emtricitabine and tenofovir disoproxil fumarate tablets are a fixed-dose combination of antiviral drugs FTC and TDF [see Microbiology ( 12.4 )].

📦 How Supplied / Storage and Handling 16 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-8028 NDC: 50090-8028-1 30 TABLET, FILM COATED in a BOTTLE

📋 Description ~2 min read ▾

11 DESCRIPTION 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-(2 R ,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 C 8 H 10 FN 3 O 3 S and a molecular weight of 247.24. It has the following structural formula: FTC 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.

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 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 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 The tablets also include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide and pregelatinized starch.

The tablets are coated with Instacoat Universal White A05G14934, which contains hydroxypropyl methylcellulose 2910, lactose monohydrate, titanium dioxide, and triacetin. 123 134

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Important Information for Uninfected Individuals Taking Emtricitabine and Tenofovir Disoproxil Fumarate Tablets for HIV-1 PrEP Advise HIV-uninfected individuals about the following [see Warnings and Precautions ( 5.2 )]: • The need to confirm that they are HIV-negative before starting to take emtricitabine and tenofovir disoproxil fumarate tablets to reduce the risk of acquiring HIV-1. • That HIV-1 resistance substitutions may emerge in individuals with undetected HIV-1 infection who are taking emtricitabine and tenofovir disoproxil fumarate tablets, because emtricitabine and tenofovir disoproxil fumarate tablets alone does not constitute a complete regimen for HIV-1 treatment. • The importance of taking emtricitabine and tenofovir disoproxil fumarate tablets on a regular dosing schedule and strict adherence to the recommended dosing schedule to reduce the risk of acquiring HIV-1.

Uninfected individuals who miss doses are at greater risk of acquiring HIV-1 than those who do not miss doses. • That emtricitabine and tenofovir disoproxil fumarate tablets does not prevent other sexually acquired infections and should only be used as part of a complete prevention strategy including other prevention measures. • To use condoms consistently and correctly to lower the chances of sexual contact with any body fluids such as semen, vaginal secretions, or blood. • The importance of knowing their HIV-1 status and the HIV-1 status of their partner(s). • The importance of virologic suppression in their partner(s) with HIV-1. • The need to get tested regularly for HIV-1 (at least every 3 months, or more frequently for some individuals such as adolescents) and to ask their partner(s) to get tested as well. • To report any symptoms of acute HIV-1 infection (flu-like symptoms) to their healthcare provider immediately. • That the signs and symptoms of acute infection include fever, headache, fatigue, arthralgia, vomiting, myalgia, diarrhea, pharyngitis, rash, night sweats, and adenopathy (cervical and inguinal). • To get tested for other sexually transmitted infections, such as syphilis, chlamydia, and gonorrhea, that may facilitate HIV-1 transmission. • To assess their sexual risk behavior and get support to help reduce sexual risk behavior.

Severe Acute Exacerbation of Hepatitis B in Patients Infected with HBV Inform individuals that severe acute exacerbations of hepatitis B have been reported in patients who are infected with HBV and have discontinued emtricitabine and tenofovir disoproxil fumarate tablets [see Warnings and Precautions ( 5.1 )]. Advise HBV-infected individuals to not discontinue emtricitabine and tenofovir disoproxil fumarate tablets without first informing their healthcare provider. New Onset or Worsening Renal Impairment Inform HIV-1 infected patients and uninfected individuals that renal impairment, including cases of acute renal failure and Fanconi syndrome, has been reported in association with the use of TDF, a component of emtricitabine and tenofovir disoproxil fumarate tablets.

Advise patients to avoid emtricitabine and tenofovir disoproxil fumarate tablets with concurrent or recent use of a nephrotoxic agent (e.g., high-dose or multiple NSAIDs) [see Warnings and Precautions ( 5.3 )]. The dosing interval of emtricitabine and tenofovir disoproxil fumarate tablets may need adjustment in HIV-1 infected patients with renal impairment. Emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP 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 emtricitabine and tenofovir disoproxil fumarate tablets for HIV-1 PrEP, evaluate potential causes and re-assess potential risks and benefits of continued use [see Dosage and Administration ( 2.6 )]. Immune R…

💬 Medication Guide ~3 min read ▾

Medication Guide Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (EM-trye-SYE-ta-been and ten-OF-oh-vir DYE-soe-PROX-il FUEma-rate) 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 tablets ?” 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 is 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 • vomiting or diarrhea • fever • rash • joint or muscle aches • night sweats • headache • enlarged lymph nodes in the neck or groin • sore throat 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 e…

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