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Vemlidy tenofovir alafenamide 25 mg Tablet, 30-count — NDC 61958-2301-1 (Billing 61958-2301-01)

by Gilead Sciences, Inc. · 30 TABLET in 1 BOTTLE, PLASTIC

This is a package of 30 tablets of Vemlidy tenofovir alafenamide 25 mg Tablet from Gilead Sciences, Inc., marketed since Nov 2016 and currently FDA-listed; retail pharmacies pay about $51.98 per tablet (NADAC). It is this product's only package size.

NDC 61958-2301-01
🏷️ FDA NDC (as labeled) 61958-2301-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 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

NDC database record

One package, one record: these facts belong to NDC 61958-2301-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61958 labeler · 2301 product · 1 package
Package marketed since
Nov 10, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
30 EA per package
Barcode (UPC-A, from the NDC)
3 6195823011 7
Medicaid fills, this package
72,030 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61958-2301-1
Product NDC 61958-2301
11-digit billing NDC 61958230101
NCPDP billing unit EA — each (per item)
RxCUI 1858261, 1858267
UNII FWF6Q91TZO
Application # NDA208464
SPL Set ID 72e6b33c-0351-4070-9172-eeaa186c01d2
Established class (EPC) Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor; Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of action Nucleoside Reverse Transcriptase Inhibitors
Chemical class Nucleosides
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-10
Route ORAL
Dosage form TABLET
Substance TENOFOVIR ALAFENAMIDE FUMARATE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 12352083200320
GPI class Vemlidy
GCN Seq No 076823
GCN 42624
HICL code 043907
Ingredient (HICL) Tenofovir Alafenamide
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5F
Therapeutic class — specific (HIC3) Hepatitis B Treatment Agents
AHFS code 08:18.32.00
AHFS class Nucleoside And Nucleotide Antivirals
FDB label name VEMLIDY 25 MG TABLET
FDB brand name Vemlidy
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 076823
  • GCN: 42624
  • GPI-14 (Medi-Span): 12352083200320
  • HICL (First Databank): 043907
  • AHFS class code: 08:18.32.00
  • RxCUI (RxNorm): 1858261
Why two NDCs? The FDA registers this code as 61958-2301-1 — 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 → 61958-2301-01. 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 Nucleoside and nucleotide reverse transcriptase inhibitors class.

Drug family (ATC) Nucleoside and nucleotide reverse transcriptase inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name VEMLIDY 25 MG TABLET Ingredient Tenofovir Alafenamide
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $51.984 $1,559.51 / 30 tablets
Medicaid paysCMS SDUD · 12 mo $49.89 $1,496.82 / 30 tablets
Medicare drug plans payPart D · Q2 2026 $51.73 $1,551.98 / 30 tablets
NADAC price history (per ea) — tap or hover for the price & month
Nov 2021 Jan 2024 May 2026 Sep 2026 $51.984 $39.564
▲ Up 31% over the last 11 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61958-2301-01 You're viewing this Main listing 30 TABLET in 1 BOTTLE, PLASTIC 2016-11-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Vemlidy 25 mgthis 61958-2301-01 Gilead 30 tablets $51.984 AB Availability likely —
About this product: this is the brand-name version. Some generic versions are approved by the FDA, but we could not confirm current pharmacy availability from our pricing/market data.
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

🏛️
2016
First FDA approval
Nov 2016
📍
2026
Currently FDA-listed
10 years listed
🛡️
2033
Latest patent/protection listed
not a guaranteed launch date
🔒Generic approved by FDA, but pharmacy availability is not confirmed

The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Feb 2033. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Nov 10, 2016 AB TE-rated RLD RS ⏳ ~6.4 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8754065 — drug substance (U-999)
US 8754065 — drug substance (U-1275)
US 9296769 — drug substance (U-1275)
US 8754065 — drug substance (U-3880)
US 9296769 — drug substance (U-3880)
US 9296769 — drug substance (U-999)
US 9296769*PED — drug product
US 8754065*PED — drug product
Exclusivity NPP
2016 2018 2020 2022 2024 2026 2028 2030 2032
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (8)
PatentTypeUse codeExpires
US 8754065 ↗ Drug substance U-999 Aug 15, 2032
US 8754065 ↗ Drug substance U-1275 Aug 15, 2032
US 9296769 ↗ Drug substance U-1275 Aug 15, 2032
US 8754065 ↗ Drug substance U-3880 Aug 15, 2032
US 9296769 ↗ Drug substance U-3880 Aug 15, 2032
US 9296769 ↗ Drug substance U-999 Aug 15, 2032
US 9296769*PED ↗ Drug product — Feb 15, 2033
US 8754065*PED ↗ Drug product — Feb 15, 2033
FDA exclusivity
CodeWhat it grantsExpires
NPPNew Patient PopulationMar 27, 2027
Common questions
Is there a generic version of VEMLIDY 25 MG TABLET?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for VEMLIDY 25 MG TABLET. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 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 EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • 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 G2M7P15E5P
    Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
  • UNII 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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.

Manufacturer & labeler

LabelerGilead Sciences, Inc.
Application holderGILEAD SCIENCES INC
FDA applicationNDA208464 (NDA)
Labeler code61958
First marketedNov 2016
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Gilead Sciences, Inc. labeler code 61958

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

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 121 words ▾

WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted [see Warnings and Precautions (5.1) ] .

WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning. Discontinuation of anti-hepatitis B therapy may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely in patients who discontinue VEMLIDY.

If appropriate, resumption of anti-hepatitis B therapy may be warranted. ( 5.1 )

🎯 Indications and Usage 92 words ▾

1 INDICATIONS AND USAGE VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease [see Clinical Studies (14) ] . VEMLIDY is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients 6 years of age and older and weighing at least 25 kg with compensated liver disease.

( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Testing: Prior to initiation of VEMLIDY, test patients for HIV infection. VEMLIDY alone should not be used in patients with HIV infection. Prior to or when initiating VEMLIDY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients.

Also assess serum phosphorus in patients with chronic kidney disease. ( 2.1 ) Recommended dosage: 25 mg (one tablet) taken orally once daily with food. ( 2.2 ) Renal Impairment: VEMLIDY is not recommended in patients with estimated creatinine clearance below 15 mL per minute who are not receiving chronic hemodialysis.

In patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after hemodialysis. ( 2.3 ) Hepatic Impairment: VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment. ( 2.4 )

2.1Testing Prior to Initiation of VEMLIDY Prior to initiation of VEMLIDY, patients should be tested for HIV-1 infection. VEMLIDY alone should not be used in patients with HIV-1 infection [see Warnings and Precautions (5.2) ] . Prior to or when initiating VEMLIDY, and during treatment with VEMLIDY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients.

In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.3) ].

2.2Recommended Dosage in Adults and Pediatric Patients 6 Years of Age and Older and Weighing at Least 25 kg The recommended dosage of VEMLIDY in adults and pediatric patients 6 years of age and older and weighing at least 25 kg is one 25 mg tablet taken orally once daily with food [see Clinical Pharmacology (12.3) ].

2.3Dosage in Patients with Renal Impairment No dosage adjustment of VEMLIDY is required in patients with estimated creatinine clearance greater than or equal to 15 mL per minute, or in patients with end stage renal disease (ESRD; estimated creatinine clearance below 15 mL per minute) who are receiving chronic hemodialysis. On days of hemodialysis, administer VEMLIDY after completion of hemodialysis treatment. VEMLIDY is not recommended in patients with ESRD who are not receiving chronic hemodialysis [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] .

No data are available to make dose recommendations in pediatric patients with renal impairment.

2.4Dosage in Patients with Hepatic Impairment No dosage adjustment of VEMLIDY is required in patients with mild hepatic impairment (Child-Pugh A). VEMLIDY is not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3) ].

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate) — yellow, round, film-coated tablets, debossed with "GSI" on one side of the tablet and "25" on the other side. Tablets: 25 mg of tenofovir alafenamide. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS HBV and HIV-1 coinfection: VEMLIDY alone is not recommended for the treatment of HIV-1 infection. HIV-1 resistance may develop in these patients. ( 5.2 ) New onset or worsening renal impairment: Prior to or when initiating VEMLIDY, and during treatment on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients.

Also assess serum phosphorus in patients with chronic kidney disease. ( 5.3 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.4 )

5.1Severe Acute Exacerbation of Hepatitis B after Discontinuation of Treatment Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Patients who discontinue VEMLIDY should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

5.2Risk of Development of HIV-1 Resistance in Patients Coinfected with HBV and HIV-1 Due to the risk of development of HIV-1 resistance, VEMLIDY alone is not recommended for the treatment of HIV-1 infection. The safety and efficacy of VEMLIDY have not been established in patients coinfected with HBV and HIV-1. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for patients coinfected with HIV-1 should be used.

5.3New Onset or Worsening Renal Impairment Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with TAF-containing products; while most of these cases were characterized by potential confounders that may have contributed to the reported renal events, it is also possible these factors may have predisposed patients to tenofovir-related adverse events [see Adverse Reactions (6.2) ]. Patients taking tenofovir prodrugs who have impaired renal function and those taking nephrotoxic agents, including non-steroidal anti-inflammatory drugs, are at increased risk of developing renal-related adverse reactions [see Drug Interactions (7.2) ] .

Prior to or when initiating VEMLIDY, and during treatment with VEMLIDY on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome [see Adverse Reactions (6.1) and Use in Specific Populations (8.6) ] .

5.4Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF), another prodrug of tenofovir, alone or in combination with other antiretrovirals. Treatment with VEMLIDY should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B [see Warnings and Precautions (5.1) ] New Onset or Worsening of Renal Impairment [see Warnings and Precautions (5.3) ] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions (5.4) ] Most common adverse reaction (incidence greater than or equal to 10%, all grades) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in Adult Subjects with Chronic Hepatitis B and Compensated Liver Disease The safety assessment of VEMLIDY was based on pooled data through the Week 96 data analysis from 1298 subjects in two randomized, double-blind, active-controlled trials, Trial 108 and Trial 110, in adult subjects with chronic hepatitis B and compensated liver disease.

A total of 866 subjects received VEMLIDY 25 mg once daily [see Clinical Studies (14.2) ] . Further safety assessment was based on pooled data from Trials 108 and 110 from subjects who continued to receive their original blinded treatment through Week 120 and additionally from subjects who received open-label VEMLIDY from Week 96 through Week 120 (n = 361 remained on VEMLIDY; n = 180 switched from TDF to VEMLIDY at Week 96). Based on the Week 96 analysis, the most common adverse reaction (all Grades) reported in at least 10% of subjects in the VEMLIDY group was headache.

The proportion of subjects who discontinued treatment with VEMLIDY or TDF due to adverse reactions of any severity was 1.5% and 0.9%, respectively. Table 1 displays the frequency of the adverse reactions (all Grades) greater than or equal to 5% in the VEMLIDY group. Table 1 Adverse Reactions Frequencies of adverse reactions are based on all treatment-emergent adverse events, regardless of relationship to study drug.

(All Grades) Reported in ≥5% of Subjects with Chronic HBV Infection and Compensated Liver Disease in Trials 108 and 110 (Week 96 analysis Double-blind phase. ) VEMLIDY (N=866) TDF (N=432) Headache 12% 10% Abdominal pain Grouped term including abdominal pain upper, abdominal pain, abdominal pain lower, and abdominal tenderness. 9% 6% Cough 8% 8% Back pain 6% 6% Fatigue 6% 5% Nausea 6% 6% Arthralgia 5% 6% Diarrhea 5% 5% Dyspepsia 5% 5% Additional adverse reactions occurring in less than 5% of subjects in Trials 108 and 110 included vomiting, rash, and flatulence.

The safety profile of VEMLIDY in subjects who continued to receive blinded treatment through Week 120 was similar to that at Week 96. The safety profile of VEMLIDY in subjects who remained on VEMLIDY in the open-label phase through Week 120 was similar to that in subjects who switched from TDF to VEMLIDY at Week 96. Renal Laboratory Tests In a pooled analysis of Trials 108 and 110 in adult subjects with chronic hepatitis B and a median baseline estimated creatinine clearance between 106 and 105 mL per minute (for the VEMLIDY and TDF groups, respectively), mean serum creatinine increased by less than 0.1 mg/dL and median serum phosphorus decreased by 0.1 mg/dL in both treatment groups at Week 96.

Median change from baseline to Week 96 in estimated creatinine clearance was -1.2 mL per minute in the VEMLIDY group and -4.8 mL per minute in those receiving TDF. In subjects who remained on blinded treatment beyond Week 96 in Trials 108 and 110, change from baseline in renal laboratory parameter values in each group at Week 120 were similar to those at Week 96. In the open-label phase, median change in estimated creatinine clearance by Cockcroft-Gault method from Week 96 to Week… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS VEMLIDY is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption. Consult the full prescribing information prior to and during treatment for potential drug-drug interactions. ( 7 )

7.1Potential for Other Drugs to Affect VEMLIDY VEMLIDY is a substrate of P-glycoprotein (P-gp) and BCRP. Drugs that strongly affect P-gp and BCRP activity may lead to changes in tenofovir alafenamide absorption (see Table 4 ). Drugs that induce P-gp activity are expected to decrease the absorption of tenofovir alafenamide, resulting in decreased plasma concentrations of tenofovir alafenamide, which may lead to loss of therapeutic effect of VEMLIDY.

Coadministration of VEMLIDY with other drugs that inhibit P-gp and BCRP may increase the absorption and plasma concentration of tenofovir alafenamide.

7.2Drugs Affecting Renal Function Because tenofovir is primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion, coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and other renally eliminated drugs and this may increase the risk of adverse reactions. Some examples of drugs that are eliminated by active tubular secretion include, but are not limited to, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides (e.g., gentamicin), and high-dose or multiple NSAIDs [see Warnings and Precautions (5.3) ] .

7.3Established and Other Potentially Significant Interactions Table 4 provides a listing of established or potentially clinically significant drug interactions. The drug interactions described are based on studies conducted with tenofovir alafenamide or are predicted drug interactions that may occur with VEMLIDY [For magnitude of interaction, see Clinical Pharmacology (12.3) ] . Information regarding potential drug-drug interactions with HIV antiretrovirals is not provided (see the prescribing information for emtricitabine/tenofovir alafenamide for interactions with HIV antiretrovirals).

The table includes potentially significant interactions but is not all inclusive. Table 4 Established and Other Potentially Significant Drug Interactions This table is not all inclusive. Concomitant Drug Class: Drug Name Effect on Concentration ↓ = decrease.

Clinical Comment Anticonvulsants: ↓ tenofovir alafenamide When coadministered with carbamazepine, the tenofovir alafenamide dose should be increased to two tablets once daily. Coadministration of VEMLIDY with oxcarbazepine, phenobarbital, or phenytoin is not recommended. Carbamazepine Indicates that a drug interaction study was conducted.

P-gp inducer Oxcarbazepine Phenobarbital Phenytoin Antimycobacterials: ↓ tenofovir alafenamide Coadministration of VEMLIDY with rifabutin, rifampin or rifapentine is not recommended. Rifabutin Rifampin Rifapentine Herbal Products: ↓ tenofovir alafenamide Coadministration of VEMLIDY with St. John's wort is not recommended.

St. John's wort (Hypericum perforatum)

7.4Drugs without Clinically Significant Interactions with VEMLIDY Based on drug interaction studies conducted with VEMLIDY, no clinically significant drug interactions have been observed with: ethinyl estradiol, ledipasvir/sofosbuvir, midazolam, norgestimate, sertraline, sofosbuvir, sofosbuvir/velpatasvir, and sofosbuvir/velpatasvir/voxilaprevir.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VEMLIDY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no statistically significant difference in the overall risk of birth defects for tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ).

The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. In animal studies, no adverse developmental effects were observed when tenofovir alafenamide was administered during the period of organogenesis at exposure equal to or 51 times (rats and rabbits, respectively) the tenofovir alafenamide exposure at the recommended daily dose of VEMLIDY (see Data ).

No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 12 times the exposure at the recommended daily dosage of VEMLIDY. Data Human Data Based on prospective reports to the APR of over 1330 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 1080 exposed in the first trimester and over 240 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.9% (95% CI: 2.8% to 5.2%) and 4.8% (95% CI: 2.5% to 8.3%) following first and second/third trimester exposure, respectively, to TAF-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 less than 20 weeks gestation. Animal Data Embryonic fetal development studies performed in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus.

The embryo-fetal NOAELs (no observed adverse effect level) in rats and rabbits occurred at tenofovir alafenamide exposures similar to and 51 times higher than, respectively, the exposure in humans at the recommended daily dose. Tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposure in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. Tenofovir alafenamide was administered orally to pregnant rats (25, 100, or 250 mg/kg/day) and rabbits (10, 30, or 100 mg/kg/day) through organogenesis (on gestation days 6 through 17, and 7 through 20, respectively).

No adverse embryo-fetal effects were observed in rats and rabbits at tenofovir alafenamide exposures approximately similar to (rats) and 51 (rabbits) times higher than the exposure in humans at the recommended daily dose of VEMLIDY. Tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposures in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. Since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to TDF, another prodrug for tenofovir administration, a pre/postnatal development study in rats was conducted only with TDF.

Doses up to 600 mg/kg/day were administered through lactation; no adverse effects were observed in the offspring on gestation day 7 [and lactation day 20] at tenofovir exposures of approximately 12 [18] times higher than the exposures in humans at the recommended daily dose of VEMLIDY.

8.2Lactation Risk Summary Data from the published literature report the presen… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VEMLIDY during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no statistically significant difference in the overall risk of birth defects for tenofovir alafenamide (TAF) compared with the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data ).

The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. In animal studies, no adverse developmental effects were observed when tenofovir alafenamide was administered during the period of organogenesis at exposure equal to or 51 times (rats and rabbits, respectively) the tenofovir alafenamide exposure at the recommended daily dose of VEMLIDY (see Data ).

No adverse effects were observed in the offspring when TDF was administered through lactation at tenofovir exposures of approximately 12 times the exposure at the recommended daily dosage of VEMLIDY. Data Human Data Based on prospective reports to the APR of over 1330 exposures to TAF-containing regimens during pregnancy resulting in live births (including over 1080 exposed in the first trimester and over 240 exposed in the second/third trimester), the prevalence of birth defects in live births was 3.9% (95% CI: 2.8% to 5.2%) and 4.8% (95% CI: 2.5% to 8.3%) following first and second/third trimester exposure, respectively, to TAF-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 less than 20 weeks gestation. Animal Data Embryonic fetal development studies performed in rats and rabbits revealed no evidence of impaired fertility or harm to the fetus.

The embryo-fetal NOAELs (no observed adverse effect level) in rats and rabbits occurred at tenofovir alafenamide exposures similar to and 51 times higher than, respectively, the exposure in humans at the recommended daily dose. Tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposure in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. Tenofovir alafenamide was administered orally to pregnant rats (25, 100, or 250 mg/kg/day) and rabbits (10, 30, or 100 mg/kg/day) through organogenesis (on gestation days 6 through 17, and 7 through 20, respectively).

No adverse embryo-fetal effects were observed in rats and rabbits at tenofovir alafenamide exposures approximately similar to (rats) and 51 (rabbits) times higher than the exposure in humans at the recommended daily dose of VEMLIDY. Tenofovir alafenamide is rapidly converted to tenofovir; the observed tenofovir exposures in rats and rabbits were 54 (rats) and 85 (rabbits) times higher than human tenofovir exposures at the recommended daily dose. Since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to TDF, another prodrug for tenofovir administration, a pre/postnatal development study in rats was conducted only with TDF.

Doses up to 600 mg/kg/day were administered through lactation; no adverse effects were observed in the offspring on gestation day 7 [and lactation day 20] at tenofovir exposures of approximately 12 [18] times higher than the exposures in humans at the recommended daily dose of VEMLIDY.

🧒 Pediatric Use 108 words ▾

8.4Pediatric Use The pharmacokinetics, safety, and effectiveness of VEMLIDY for the treatment of chronic HBV infection have been established in pediatric patients between the ages of 6 to less than 18 years and weighing at least 25 kg (N=59) in Trial 1092 up to 96 weeks. No clinically meaningful differences in pharmacokinetics or safety were observed in comparison to those observed in adults [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14.5) ]. Safety and effectiveness of VEMLIDY has not been established in pediatric patients with chronic HBV infection who are less than 6 years of age or weigh less than 25 kg.

🧓 Geriatric Use 41 words ▾

8.5Geriatric Use In clinical trials, VEMLIDY was administered to 89 subjects aged 65 and over. No clinically significant differences in safety or efficacy have been observed between elderly subjects and subjects between 18 and less than 65 years of age.

🆘 Overdosage 50 words ▾

10 OVERDOSAGE If overdose occurs, monitor patient for evidence of toxicity. Treatment of overdosage with VEMLIDY consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. Tenofovir is efficiently removed by hemodialysis with an extraction coefficient of approximately 54%.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Tenofovir alafenamide is an antiviral drug against the hepatitis B virus [see Microbiology (12.4) ] .

12.2Pharmacodynamics Cardiac Electrophysiology In a thorough QT/QTc study in 48 healthy subjects, tenofovir alafenamide at the recommended dose or at a dose 5 times the recommended dose did not affect the QT/QTc interval and did not prolong the PR interval.

12.3Pharmacokinetics The pharmacokinetic properties of VEMLIDY are provided in Table 5. The multiple dose PK parameters of tenofovir alafenamide and its metabolite tenofovir are provided in Table 6. Table 5 Pharmacokinetic Properties of VEMLIDY Tenofovir Alafenamide CES1 = carboxylesterase 1; PBMCs = peripheral blood mononuclear cells. Absorption T max (h)

0.48Effect of high fat meal (relative to fasting): AUC last Ratio Values refer to geometric mean ratio in AUC last [fed/fasted] and (90% confidence interval). High fat meal = ~800 kcal, 50% fat. 1.65 (1.51, 1.81) Distribution % Bound to human plasma proteins 80% Source of protein binding data Ex vivo Blood-to-plasma ratio

1.0Metabolism Metabolism In vivo, TAF is hydrolyzed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate. In vitro studies have shown that TAF is metabolized to tenofovir by CES1 in hepatocytes, and by cathepsin A in PBMCs and macrophages. CES1 (hepatocytes) Cathepsin A (PBMCs) CYP3A (minimal) Elimination Major route of elimination Metabolism (>80% of oral dose) t 1/2 (h) t 1/2 values refer to median terminal plasma half-life.

0.51% Of dose excreted in urine Dosing in mass balance study: TAF 25 mg (single dose administration of [ 14 C] TAF). <1 % Of dose excreted in feces

31.7Table 6 Multiple Dose PK Parameters of Tenofovir Alafenamide and its Metabolite Tenofovir Following Oral Administration in Adults with Chronic Hepatitis B Parameter Mean (CV%) Tenofovir Alafenamide From Intensive PK analyses in Trial 108 and Trial 110; N = 8. Tenofovir CV = coefficient of variation; NA = not applicable C max (mcg per mL) 0.27 (63.3) 0.03 (24.6) AUC tau (mcg∙hour per mL) 0.27 (47.8) 0.40 (35.2) C trough (mcg per mL) NA 0.01 (39.6) Specific Populations Geriatric Patients, Race, and Gender Limited data in subjects aged 65 years and over suggest a lack of clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics.

No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics due to race or gender have been identified [see Use in Specific Populations (8.5) ] . Pediatric Patients Steady-state pharmacokinetics of tenofovir alafenamide and its metabolite tenofovir were evaluated in HBV-infected pediatric subjects aged 6 to less than 18 years (Table 7). Table 7 Multiple Dose PK Parameters of Tenofovir Alafenamide and Tenofovir Following Oral Administration of VEMLIDY 25 mg in HBV-Infected Pediatric Subjects Aged 6 to less than 18 Years Age Group Parameter Mean (CV%) Tenofovir Alafenamide From Intensive PK analyses in Trial 1092: Cohort 1, N=13 except N=11 for AUC tau ; Cohort 2, Group 1, N=5.

Tenofovir From Intensive PK analyses in Trial 1092: Cohort 1, N=13; Cohort 2, Group 1, N=5. CV = coefficient of variation; NA = not applicable 12 to <18 Years weighing ≥35 kg C max (mcg per mL) 0.188 (45.0) 0.015 (23.5) AUC tau (mcg∙hour per mL) 0.254 (36.4) 0.244 (28.3) C trough (mcg per mL) NA 0.0079 (35.0) 6 to <12 Years weighing ≥25 kg C max (mcg per mL) 0.388 (96.9) 0.017 (19.6) AUC tau (mcg∙hour per mL) 0.313 (64.8) 0.272 (17.5) C trough (mcg per mL) NA 0.0089 (10.2) Patients with Renal Impairment In a Phase 1, open-label study, tenofovir alafenamide and tenofovir systemic exposures (AUC inf ) were evaluated in subjects with severe renal impairment and in subjects with normal renal function (Table 8).

In an open-label trial of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg, tenofovir alafenamide and tenofovir AUC were eva… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 20 words ▾

12.1Mechanism of Action Tenofovir alafenamide is an antiviral drug against the hepatitis B virus [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 64 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VEMLIDY tablets containing 25 mg of tenofovir alafenamide are yellow, round, film-coated, debossed with "GSI" on one side and "25" on the other side. Each bottle contains 30 tablets (NDC 61958-2301-1), a silica gel desiccant, polyester coil, and is closed with a child-resistant closure. Store below 30 °C (86 °F). Keep container tightly closed. Dispense only in original container.

📦 Storage and Handling 15 words ▾

Store below 30 °C (86 °F). Keep container tightly closed. Dispense only in original container.

📋 Description 176 words ▾

11 DESCRIPTION VEMLIDY is a tablet containing tenofovir alafenamide for oral administration. Tenofovir alafenamide, a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5′-monophosphate. Each tablet contains 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate).

The tablets include the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The tablets are film coated with a coating material containing: iron oxide yellow, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The chemical name of tenofovir alafenamide fumarate drug substance is L-alanine, N -[( S )-[[(1 R )-2-(6-amino-9 H -purin-9-yl)-1-methylethoxy]methyl]phenoxyphosphinyl]-, 1-methylethyl ester, (2 E )-2-butenedioate (2:1).

It has an empirical formula of C 21 H 29 O 5 N 6 P∙½(C 4 H 4 O 4 ) and a formula weight of 534.50. It has the following structural formula: Tenofovir alafenamide fumarate is a white to off-white or tan powder with a solubility of 4.7 mg per mL in water at 20 °C. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Severe Acute Exacerbation of Hepatitis after Discontinuation of Treatment Inform patients that discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B . Advise the patient to not discontinue VEMLIDY without first informing their healthcare provider [see Warnings and Precautions (5.1) ] .

Risk of Development of HIV-1 Resistance in Patients with HIV-1 Coinfection Inform patients that if they have or develop HIV infection and are not receiving effective HIV treatment, VEMLIDY may increase the risk of development of resistance to HIV medication [see Dosage and Administration (2.1) and Warnings and Precautions (5.2) ] . New Onset or Worsening Renal Impairment Postmarketing cases of renal impairment, including acute renal failure, have been reported [see Warnings and Precautions (5.3) ]. Lactic Acidosis and Severe Hepatomegaly Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with use of drugs similar to VEMLIDY.

Advise patients to contact their healthcare provider immediately and stop VEMLIDY if they develop clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity [see Warnings and Precautions (5.4) ]. Drug Interactions Advise patients to report to their healthcare provider the use of any other prescription or non-prescription medication or herbal products including St. John's wort, as VEMLIDY may interact with other drugs [see Drug Interactions (7) ] .

Missed Dosage Inform patients that it is important to take VEMLIDY on a regular dosing schedule with food and to avoid missing doses, as it can result in development of resistance [see Dosage and Administration (2.2) ] . Pregnancy Registry Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to VEMLIDY [see Use in Specific Populations (8.1) ].

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetic properties of VEMLIDY are provided in Table 5. The multiple dose PK parameters of tenofovir alafenamide and its metabolite tenofovir are provided in Table 6. Table 5 Pharmacokinetic Properties of VEMLIDY Tenofovir Alafenamide CES1 = carboxylesterase 1; PBMCs = peripheral blood mononuclear cells. Absorption T max (h)

0.48Effect of high fat meal (relative to fasting): AUC last Ratio Values refer to geometric mean ratio in AUC last [fed/fasted] and (90% confidence interval). High fat meal = ~800 kcal, 50% fat. 1.65 (1.51, 1.81) Distribution % Bound to human plasma proteins 80% Source of protein binding data Ex vivo Blood-to-plasma ratio

1.0Metabolism Metabolism In vivo, TAF is hydrolyzed within cells to form tenofovir (major metabolite), which is phosphorylated to the active metabolite, tenofovir diphosphate. In vitro studies have shown that TAF is metabolized to tenofovir by CES1 in hepatocytes, and by cathepsin A in PBMCs and macrophages. CES1 (hepatocytes) Cathepsin A (PBMCs) CYP3A (minimal) Elimination Major route of elimination Metabolism (>80% of oral dose) t 1/2 (h) t 1/2 values refer to median terminal plasma half-life.

0.51% Of dose excreted in urine Dosing in mass balance study: TAF 25 mg (single dose administration of [ 14 C] TAF). <1 % Of dose excreted in feces

31.7Table 6 Multiple Dose PK Parameters of Tenofovir Alafenamide and its Metabolite Tenofovir Following Oral Administration in Adults with Chronic Hepatitis B Parameter Mean (CV%) Tenofovir Alafenamide From Intensive PK analyses in Trial 108 and Trial 110; N = 8. Tenofovir CV = coefficient of variation; NA = not applicable C max (mcg per mL) 0.27 (63.3) 0.03 (24.6) AUC tau (mcg∙hour per mL) 0.27 (47.8) 0.40 (35.2) C trough (mcg per mL) NA 0.01 (39.6) Specific Populations Geriatric Patients, Race, and Gender Limited data in subjects aged 65 years and over suggest a lack of clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics.

No clinically relevant differences in tenofovir alafenamide or tenofovir pharmacokinetics due to race or gender have been identified [see Use in Specific Populations (8.5) ] . Pediatric Patients Steady-state pharmacokinetics of tenofovir alafenamide and its metabolite tenofovir were evaluated in HBV-infected pediatric subjects aged 6 to less than 18 years (Table 7). Table 7 Multiple Dose PK Parameters of Tenofovir Alafenamide and Tenofovir Following Oral Administration of VEMLIDY 25 mg in HBV-Infected Pediatric Subjects Aged 6 to less than 18 Years Age Group Parameter Mean (CV%) Tenofovir Alafenamide From Intensive PK analyses in Trial 1092: Cohort 1, N=13 except N=11 for AUC tau ; Cohort 2, Group 1, N=5.

Tenofovir From Intensive PK analyses in Trial 1092: Cohort 1, N=13; Cohort 2, Group 1, N=5. CV = coefficient of variation; NA = not applicable 12 to <18 Years weighing ≥35 kg C max (mcg per mL) 0.188 (45.0) 0.015 (23.5) AUC tau (mcg∙hour per mL) 0.254 (36.4) 0.244 (28.3) C trough (mcg per mL) NA 0.0079 (35.0) 6 to <12 Years weighing ≥25 kg C max (mcg per mL) 0.388 (96.9) 0.017 (19.6) AUC tau (mcg∙hour per mL) 0.313 (64.8) 0.272 (17.5) C trough (mcg per mL) NA 0.0089 (10.2) Patients with Renal Impairment In a Phase 1, open-label study, tenofovir alafenamide and tenofovir systemic exposures (AUC inf ) were evaluated in subjects with severe renal impairment and in subjects with normal renal function (Table 8).

In an open-label trial of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide 150/150/200/10 mg, tenofovir alafenamide and tenofovir AUC were evaluated in a subset of virologically suppressed HIV-1 infected subjects with ESRD receiving chronic hemodialysis (Table 8). In a Phase 2, open-label trial, tenofovir alafenamide and tenofovir AUC were evaluated in a subset of virologically suppressed HBV-infected subjects with ESRD receiving chronic hemodialysis (Table 8) [see Use in Specific Populations (8.6) ]. The pharmacokinetics of tenofovir alafenamide… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 41 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology In a thorough QT/QTc study in 48 healthy subjects, tenofovir alafenamide at the recommended dose or at a dose 5 times the recommended dose did not affect the QT/QTc interval and did not prolong the PR interval.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Description of Clinical Trials The efficacy and safety of VEMLIDY were evaluated in the trials summarized in Table 11. Table 11 Trials Conducted with VEMLIDY in Subjects with Chronic HBV Infection Trial Population Trial Arms (N) Primary Endpoint (Week) TE = treatment-experienced, TN = treatment-naive Trial 108 Randomized, double-blind, active controlled trial. (NCT01940341) HBeAg-negative TN and TE adults with compensated liver disease VEMLIDY (285) TDF (140) 48 Trial 110 (NCT01940471) HBeAg-positive TN and TE adults with compensated liver disease VEMLIDY (581) TDF (292) 48 Trial 4018 (NCT02979613) HBeAg-negative and HBeAg-positive virologically suppressed HBV DNA <20 IU/mL at screening. adults with compensated liver disease VEMLIDY (243) TDF (245) 48 Trial 4035 (Part A, Cohort 1) Open-label trial.

(NCT03180619) Virologically suppressed adults with moderate to severe renal impairment Estimated creatinine clearance between 15 and 59 mL per minute by Cockcroft-Gault method. VEMLIDY (78) 24 Trial 4035 (Part A, Cohort 2) (NCT03180619) Virologically suppressed adults with ESRD End stage renal disease (estimated creatinine clearance of below 15 mL per minute by Cockcroft-Gault method). receiving chronic hemodialysis VEMLIDY (15) 24 Trial 1092 Randomized, double-blind, placebo-controlled trial. (NCT02932150) Pediatric subjects between the ages of 6 to less than 18 years (at least 25 kg) with compensated liver disease VEMLIDY (59) Placebo (29) 24

14.2Clinical Trials in Adults with Chronic Hepatitis B Virus Infection and Compensated Liver Disease The efficacy and safety of VEMLIDY in the treatment of adults with chronic hepatitis B virus infection with compensated liver disease are based on 48-week data from two randomized, double-blind, active-controlled trials, Trial 108 (N=425) and Trial 110 (N=873). In both trials, besides trial treatment, subjects were not allowed to receive other nucleosides, nucleotides, or interferon. In Trial 108, HBeAg-negative treatment-naïve and treatment-experienced subjects with compensated liver disease (no evidence of ascites, hepatic encephalopathy, variceal bleeding, INR <1.5× ULN, total bilirubin <2.5× ULN, and albumin >3.0 mg/dL) were randomized in a 2:1 ratio to receive VEMLIDY 25 mg (N=285) once daily or TDF 300 mg (N=140) once daily for 48 weeks.

The mean age was 46 years, 61% were male, 72% were Asian, 25% were White, 2% were Black, and 1% were other races. 24%, 38%, and 31% had HBV genotype B, C, and D, respectively. 21% were treatment experienced [previous treatment with oral antivirals, including entecavir (N=41), lamivudine (N=42), TDF (N=21), or other (N=18)].

At baseline, mean plasma HBV DNA was 5.8 log 10 IU/mL, mean serum ALT was 94 U/L, and 9% of subjects had a history of cirrhosis. In Trial 110, HBeAg-positive treatment-naïve and treatment-experienced subjects with compensated liver disease were randomized in a 2:1 ratio to receive VEMLIDY 25 mg (N=581) once daily or TDF 300 mg (N=292) once daily for 48 weeks. The mean age was 38 years, 64% were male, 82% were Asian, 17% were White, and 1% were Black or other races.

17%, 52%, and 23% had HBV genotype B, C, and D, respectively. 26% were treatment experienced [previous treatment with oral antivirals, including adefovir (N=42), entecavir (N=117), lamivudine (N=84), telbivudine (N=25), TDF (N=70), or other (n=17)]. At baseline, mean plasma HBV DNA was 7.6 log 10 IU/mL, mean serum ALT was 120 U/L, and 7% of subjects had a history of cirrhosis.

In both trials, randomization was stratified on prior treatment history (nucleoside naïve or experienced) and baseline HBV DNA (<7, ≥7 to <8, and ≥8 log 10 IU/mL in Trial 108; and <8 and ≥8 log 10 IU/mL in Trial 110). The efficacy endpoint in both trials was the proportion of subjects with plasma HBV DNA levels below 29 IU/mL at Week 48. Additional efficacy endpoints include the proportion of subjects with ALT normalization, HBsAg loss and seroconversion, and HBeAg loss and s… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~1 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to TDF administration, carcinogenicity studies were conducted only with TDF. Long-term oral carcinogenicity studies of TDF in mice and rats were carried out at exposures up to approximately 10 times (mice) and 4 times (rats) those observed in humans at the 300 mg therapeutic dose of TDF for chronic hepatitis B.

The tenofovir exposure in these studies was approximately 151 times (mice) and 50 times (rat) those observed in humans after administration of VEMLIDY treatment. At the high dose in female mice, liver adenomas were increased at tenofovir exposures approximately 151 times those observed after VEMLIDY administration in humans. In rats, the study was negative for carcinogenic findings.

Tenofovir alafenamide was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays. There were no effects on fertility, mating performance or early embryonic development when tenofovir alafenamide was administered to male rats at a dose equivalent to 155 times the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 14 days prior to mating through Day 7 of gestation.

13.2Animal Toxicology and/or Pharmacology Minimal to slight infiltration of mononuclear cells in the posterior uvea was observed in dogs with similar severity after three- and nine-month administration of tenofovir alafenamide; reversibility was seen after a three-month recovery period. At the NOAEL for eye toxicity, the systemic exposure in dogs was 5 (tenofovir alafenamide) and 14 (tenofovir) times the exposure seen in humans at the recommended daily VEMLIDY dosage.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 214 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Since tenofovir alafenamide is rapidly converted to tenofovir and a lower tenofovir exposure in rats and mice was observed after tenofovir alafenamide administration compared to TDF administration, carcinogenicity studies were conducted only with TDF. Long-term oral carcinogenicity studies of TDF in mice and rats were carried out at exposures up to approximately 10 times (mice) and 4 times (rats) those observed in humans at the 300 mg therapeutic dose of TDF for chronic hepatitis B.

The tenofovir exposure in these studies was approximately 151 times (mice) and 50 times (rat) those observed in humans after administration of VEMLIDY treatment. At the high dose in female mice, liver adenomas were increased at tenofovir exposures approximately 151 times those observed after VEMLIDY administration in humans. In rats, the study was negative for carcinogenic findings.

Tenofovir alafenamide was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays. There were no effects on fertility, mating performance or early embryonic development when tenofovir alafenamide was administered to male rats at a dose equivalent to 155 times the human dose based on body surface area comparisons for 28 days prior to mating and to female rats for 14 days prior to mating through Day 7 of gestation.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 03/2024 Patient Information VEMLIDY ® (VEM-lih-dee) (tenofovir alafenamide) tablets What is the most important information I should know about VEMLIDY?

VEMLIDY can cause serious side effects, including: Worsening of hepatitis B virus (HBV) infection. Your HBV infection may get worse (flare-up) if you take VEMLIDY and then stop taking it. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.

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

If you stop taking VEMLIDY, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking VEMLIDY. For more information about side effects, see the section " What are the possible side effects of VEMLIDY? " What is VEMLIDY?

VEMLIDY is a prescription medicine used to treat chronic (long-lasting) hepatitis B virus (HBV) in adults and children 6 years of age and older who weigh at least 55 pounds (25 kg) with stable (compensated) liver disease. VEMLIDY may lower the amount of HBV in your body. VEMLIDY may improve the condition of your liver.

It is not known if VEMLIDY is safe and effective in children with chronic HBV infection who are under 6 years of age or weigh less than 55 pounds (25 kg). What should I tell my healthcare provider before taking VEMLIDY? Before taking VEMLIDY, tell your healthcare provider about all of your medical conditions, including if you: have HIV-1 infection.

Your healthcare provider may test you for HIV-1 infection before you start VEMLIDY. If you have both HBV and HIV-1, and you only take VEMLIDY, the HIV-1 virus may develop resistance and become harder to treat. have end stage renal disease (ESRD). are pregnant or plan to become pregnant. It is not known if VEMLIDY will harm your unborn baby.

Tell your healthcare provider if you become pregnant during treatment with VEMLIDY. Pregnancy Exposure Registry: There is a pregnancy registry for women who take antiviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby.

Talk with your healthcare provider about how you can take part in this registry. are breastfeeding or plan to breastfeed. VEMLIDY may pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how VEMLIDY works. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

You can ask your healthcare provider or pharmacist for a list of medicines that interact with VEMLIDY. Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take VEMLIDY with other medicines.

How should I take VEMLIDY? Take VEMLIDY exactly as your healthcare provider tells you to take it. Take VEMLIDY 1 time each day.

Take VEMLIDY with food. If you are on dialysis, on your dialysis days, take your daily dose of VEMLIDY following dialysis. Do not change your dose or stop taking VEMLIDY without first talking with your healthcare provider.

Stay under a healthcare provider's care when taking VEMLIDY. Do not miss a dose of VEMLIDY. If you take too much VEMLIDY, call your healthcare provider or go to the nearest hospital emergency room right away.

When your VEMLIDY supply starts to run low, get more from your healthcare provider or pharmacy. This is very important because your HBV infection may get worse (flare-up) if you stop taking VEMLIDY. What are the… [Excerpted — this section continues on DailyMed.]

📄 Recent Major Changes 33 words ▾

Indications and Usage ( 1 ) 03/2024 Dosage and Administration: Recommended Dosage in Adults and Pediatric Patients 6 Years of Age and Older and Weighing at Least 25 kg ( 2.2 ) 03/2024

📄 Package Label / Principal Display Panel 46 words ▾

PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label NDC 61958- 2301 -1 30 tablets Vemlidy ® (tenofovir alafenamide) tablets, 25 mg Note to pharmacist: Do not cover ALERT box with pharmacy label. ALERT: Find out about medicines that should NOT be taken with Vemlidy vemlidy-02.jpg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
72K
Units reimbursed last 4 qtrs
2.4M
Gross reimbursed last 4 qtrs
$119.81M
Avg / prescription
$1,663.29
Avg / unit
$49.8941
Latest quarter Q1 2026
17.6KRx
Medicaid pays / ea
$49.8941
gross reimbursed
vs
NADAC / ea
$51.9838
acquisition cost
=
Spread
−$2.0897
-4% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
82% FFS 18% MCO
Fee-for-service · 59,118 Rx Managed care · 12,912 Rx
State Medicaid map
Alaska: 2,070 units · 282 per 100k residents AK Maine: 5,640 units · 404 per 100k residents ME Washington: 14,130 units · 181 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 6,566 units · 114 per 100k residents MN Wisconsin: 4,440 units · 75.1 per 100k residents WI Michigan: 11,430 units · 114 per 100k residents MI New York: 811,810 units · 4,148 per 100k residents NY Vermont: no data reported VT New Hampshire: 3,390 units · 242 per 100k residents NH Oregon: 6,158 units · 145 per 100k residents OR Nevada: 9,960 units · 312 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,800 units · 196 per 100k residents SD Iowa: 4,173 units · 130 per 100k residents IA Illinois: 22,290 units · 178 per 100k residents IL Indiana: 9,030 units · 132 per 100k residents IN Ohio: 54,405 units · 462 per 100k residents OH Pennsylvania: 27,552 units · 213 per 100k residents PA New Jersey: 16,320 units · 176 per 100k residents NJ Massachusetts: 63,300 units · 904 per 100k residents MA California: 1,073,236 units · 2,754 per 100k residents CA Utah: no data reported UT Colorado: 15,420 units · 262 per 100k residents CO Nebraska: 2,340 units · 118 per 100k residents NE Missouri: 1,200 units · 19.4 per 100k residents MO Kentucky: 7,735 units · 171 per 100k residents KY West Virginia: no data reported WV Virginia: 16,800 units · 193 per 100k residents VA Maryland: 19,860 units · 321 per 100k residents MD Connecticut: 44,546 units · 1,232 per 100k residents CT Rhode Island: 3,450 units · 315 per 100k residents RI Arizona: 17,820 units · 240 per 100k residents AZ New Mexico: 1,440 units · 68.1 per 100k residents NM Kansas: 1,230 units · 41.8 per 100k residents KS Arkansas: no data reported AR Tennessee: 3,450 units · 48.4 per 100k residents TN North Carolina: 12,120 units · 112 per 100k residents NC South Carolina: 2,490 units · 46.3 per 100k residents SC Delaware: 3,600 units · 349 per 100k residents DE Oklahoma: 14,190 units · 350 per 100k residents OK Louisiana: 45,030 units · 984 per 100k residents LA Mississippi: no data reported MS Alabama: 2,400 units · 47.0 per 100k residents AL Georgia: 3,390 units · 30.7 per 100k residents GA D.C.: 6,249 units · 920 per 100k residents DC Hawaii: 9,060 units · 631 per 100k residents HI Texas: 13,318 units · 43.7 per 100k residents TX Florida: 6,390 units · 28.3 per 100k residents FL
Units reimbursed · per 100k residents
19.44,148
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 4,148 /100k
2 California 2,754 /100k
3 Connecticut 1,232 /100k
4 Louisiana 984 /100k
5 D.C. 920 /100k
6 Massachusetts 904 /100k
7 Hawaii 631 /100k
8 Ohio 462 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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

Medicare Part D (outpatient prescription) spending for Vemlidy — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Vemlidy. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$61.77M
Claims incl. refills
36.6K
Beneficiaries
14.5K
Spend / beneficiary
$4,264.49
Spend / claim
$1,689.24
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 61958-2205-01 · Gilead 61958-2401-01 · Gilead →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.