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Blujepa gepotidacin 750 mg Tablet, Film Coated, 20-count

by GlaxoSmithKline LLC · 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45)
NDC 00173-0922-45
🏷️ FDA NDC (as labeled) 0173-0922-45 billing pads the labeler segment with a zero
This package
Contains20-count Cost per ea$91.33 NADAC Per package$1,826.55 / 20 tablets Pack sizes2 compare ↓
Also priced by: Part D plans $99.09/unit — full pricing hub ↓
Also comes in: 8 tablets 00173-0922-38
Rx only Brand On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 0173-0922-45
Product NDC 0173-0922
11-digit billing NDC 00173092245
NCPDP billing unit EA — each (per item)
RxCUI 2709218, 2709224
UNII 5P7X0H2O6B
UPC 0301730922458
Application # NDA218230
SPL Set ID 80b57cfe-7819-4d95-a57d-014af42f118d
Established class (EPC) Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor
Mechanism of action Cholinesterase Inhibitors; Cytochrome P450 3A4 Inhibitors; P-Glycoprotein Inhibitors; Topoisomerase 2 Inhibitors; Topoisomerase 4 Inhibitors
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-25
Route ORAL
Dosage form TABLET, FILM COATED
Substance GEPOTIDACIN MESYLATE
GPI-14 16800016200320
GCN Seq No 087487
GCN 57412
HICL code 050388
Ingredient (HICL) Gepotidacin Mesylate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W9
Therapeutic class — intermediate (HIC2) Antibiotics (Continued 1)
HIC3 code W9P
Therapeutic class — specific (HIC3) Novel Bacterial Topoisomerase Inhibitors (Nbti)
AHFS code 08:12.28.36
AHFS class Triazaacenaphthylenes
FDB label name BLUJEPA 750 MG TABLET
FDB brand name Blujepa
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 0173-0922-45 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00173-0922-45. 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 Other antibacterials class.

Drug family (ATC) Other antibacterials
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

LabelerGlaxoSmithKline LLC
Application holderGLAXOSMITHKLINE LLC
FDA applicationNDA218230 (NDA)
Labeler code00173
First marketedMar 2025
Product typeHuman Prescription Drug
Portfolio97 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BLUJEPA 750 MG TABLET Ingredient Gepotidacin Mesylate

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 Yellow
ShapeCapsule
ImprintG5;GU3
Size21 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 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 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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 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 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.

💲 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 $91.328 $1,826.55 / 20 tablets
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $99.09 $1,981.85 / 20 tablets
NADAC price history (per ea) — tap or hover for the price & month
Jul 2026 Aug 2026 $91.365 $91.328
Flat over the last 2 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Blujepa 750 mgthis 00173-0922-45 GlaxoSmithKline 20 tablets $91.328 — Availability likely —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2025
First FDA approval
Mar 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2042
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2042. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Mar 25, 2025 RLD RS ⏳ ~16.2 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 10702521 — method of use (U-4361)
US 12528809 — drug substance (U-4361)
US 12528809 — drug substance (U-4408)
US 8389524 — drug substance (U-4166)
US 11229646 — method of use (U-4361)
Exclusivity I-978
Exclusivity NCE
Exclusivity GAIN
2025 2027 2029 2031 2033 2035 2037 2039 2041 2043
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 (5)
PatentTypeUse codeExpires
US 10702521 ↗ Method of use U-4361 Aug 20, 2035
US 12528809 ↗ Drug substance U-4361 Dec 13, 2042
US 12528809 ↗ Drug substance U-4408 Dec 13, 2042
US 8389524 ↗ Drug substance U-4166 Feb 12, 2029
US 11229646 ↗ Method of use U-4361 Aug 20, 2035
FDA exclusivity
CodeWhat it grantsExpires
I-978New indication (3-year)Dec 11, 2028
NCENew Chemical Entity (5-year)Mar 25, 2030
GAINQualified Infectious Disease Product (+5-year)Mar 25, 2035
Common questions
Is there a generic version of BLUJEPA 750 MG TABLET?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for BLUJEPA 750 MG TABLET. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2042 — an estimate, not a guaranteed launch date.
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.

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

Medicare Part D (outpatient prescription) spending for Blujepa — 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 Blujepa. 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
$343.4K
Claims incl. refills
183
Beneficiaries
170
Spend / beneficiary
$2,019.97
Spend / claim
$1,876.47
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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
00173-0922-38 8 TABLET, FILM COATED in 1 BOTTLE (0173-0922-38) $91.33 / ea $730.62 2025-12-11 Active
00173-0922-45 You're viewing this 20 TABLET, FILM COATED in 1 BOTTLE (0173-0922-45) $91.33 / ea $1,826.55 2025-03-25 Active

You're viewing the largest of 2 pack sizes for this product.

This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($91.33 NADAC).

Pack size FAQ

What quantity is in NDC 00173-0922-45?
NDC 00173-0922-45 is a 20-count package — 20 tablet, film coated in 1 bottle.
What is the difference between NDC 00173-0922-45 and NDC 00173-0922-38?
Both are Blujepa gepotidacin 750 mg Tablet, Film Coated — the drug itself is identical. NDC 00173-0922-45 is the 20-count package, while NDC 00173-0922-38 is the 8 tablets package.
What NDC number is used to bill for this package of Blujepa gepotidacin 750 mg Tablet, Film Coated?
Bill NDC 00173-0922-45 — the 11-digit billing format is 00173092245. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options.

Approval of this indication is based on limited clinical safety data for this indication. ( 1.2 , 6.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.3 )

1.1Treatment of Uncomplicated Urinary Tract Infections BLUJEPA is indicated in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) for the treatment of uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli , Klebsiella pneumoniae , Citrobacter freundii complex, Staphylococcus saprophyticus , and Enterococcus faecalis .

1.2Treatment of Uncomplicated Urogenital Gonorrhea BLUJEPA is indicated in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms (kg) who have limited or no alternative options for the treatment of uncomplicated urogenital gonorrhea caused by susceptible strains of Neisseria gonorrhoeae. Approval of this indication is based on limited clinical safety data for BLUJEPA [see Adverse Reactions ( 6.1 )].

1.3Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • uUTI: The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart), for 5 days. ( 2.1 ) • Uncomplicated Urogenital Gonorrhea: The recommended dosage of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later. ( 2.2 ) • Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance.

( 2.3 )

2.1Recommended Dosage for Female Adult and Pediatric Patients 12 Years of Age and Older Weighing at Least 40 kg for Uncomplicated UTI The recommended dosage of BLUJEPA is 1,500 mg (two 750 mg tablets) taken orally, twice daily (approximately 12 hours apart) for 5 days in female adult and pediatric patients 12 years of age and older with uncomplicated uUTI [see Dosage and Administration ( 2.3 )] .

2.2Recommended Dosage for Adult and Pediatric Patients 12 Years of Age and Older Weighing at Least 45 kg for Uncomplicated Urogenital Gonorrhea The recommended dose of BLUJEPA is 3,000 mg (four 750 mg tablets) taken orally, followed by a second dose of 3,000 mg (four 750 mg tablets) approximately 12 hours later in adult and pediatric patients 12 years of age and older weighing at least 45 kg with uncomplicated urogenital gonorrhea [see Dosage and Administration ( 2.3 )]. Do not increase the dose, extend the duration of treatment, or reduce the interval between doses due to the risk of QTc interval prolongation [see Warnings and Precautions ( 5.1 )].

2.3Important Administration Instructions Administer BLUJEPA tablets after a meal to reduce the possibility of gastrointestinal intolerance [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 )] .

2.4Recommendations Regarding Missed Dose(s) If a dose is missed, instruct patients to take the missed dose as soon as possible. For uUTI, do not double the dose to make up for a missed dose.

💊 Dosage Forms and Strengths 44 words ▾

3 DOSAGE FORMS AND STRENGTHS Each film coated tablet of BLUJEPA contains 750 mg of gepotidacin. BLUJEPA tablets are yellow, capsule shaped, and debossed with “GS GU3” on one side and plain on the other side. Tablets: 750 mg of gepotidacin. ( 3 )

⛔ Contraindications 38 words ▾

4 CONTRAINDICATIONS BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA [see Warnings and Precautions ( 5.3 ), Adverse Reactions ( 6.1 )] . A history of severe hypersensitivity to BLUJEPA. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • QTc Prolongation: • Avoid use of BLUJEPA in patients with a history of QTc prolongation, or with relevant pre‑existing cardiac disease, or in patients receiving drugs that prolong the QTc interval. ( 5.1 ) • Due to an increase in gepotidacin exposure and the risk of QTc interval prolongation, avoid use of BLUJEPA in patients who have any of the following risk factors: ( 5.1 , 7.1 , 8.6 , 8.7 ) • Concomitant use of strong CYP3A4 inhibitors • Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min) • Severe hepatic impairment (Child-Pugh Class C) • Additionally, avoid BLUJEPA in uncomplicated urogenital gonorrhea patients, who have any of the following risk factors for increased gepotidacin exposure: ( 5.1 , 7.1 , 8.6 , 8.7 ) • Concomitant use of moderate CYP3A4 inhibitors • Two or more of the following risk factors: Body weight between 45 kilograms and 60 kilograms, Moderate renal impairment (eGFR 30 to 59 mL/min), Moderate hepatic impairment (Child-Pugh Class B) • Acetylcholinesterase Inhibition: Dysarthria and other adverse reactions have been reported in patients receiving BLUJEPA.

Monitor patients with underlying medical conditions that may be exacerbated by acetylcholinesterase inhibition and patients receiving succinylcholine‑type neuromuscular blocking agents, systemic anticholinergic medications, or non‑depolarizing neuromuscular blocking agents. ( 5.2 ) • Hypersensitivity Reactions: Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving BLUJEPA. If an allergic reaction to BLUJEPA occurs, discontinue the drug and institute appropriate supportive measures.

( 5.3 ) • Clostridioides difficile Infection (CDI): CDI has been reported with nearly all systemic antibacterial agents, including BLUJEPA. Evaluate patients who develop diarrhea. ( 5.4 )

5.1QTc Prolongation A dose and concentration-dependent prolongation of the QTc interval has been observed with BLUJEPA [see Clinical Pharmacology ( 12.2 )]. Avoid BLUJEPA in patients with a history of QTc interval prolongation or those with relevant pre ‑ existing cardiac disease, patients taking antiarrhythmic agents, or other medications that may potentially prolong the QTc interval [ see Drug Interactions ( 7.4 )]. Due to an increase in gepotidacin exposure (C max ), and the risk of QTc interval prolongation, avoid BLUJEPA in patients who have any of the following risk factors [see Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 , 8.7 )]: • Concomitant use of strong CYP3A4 inhibitors • Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min) • Severe hepatic impairment (Child-Pugh Class C) Additionally, avoid BLUJEPA in uncomplicated urogenital gonorrhea patients who also have any of the following risk factors for increased gepotidacin exposure [see Drug Interactions ( 7.1 ), Use in Specific Populations ( 8.6 , 8.7 )]: • Concomitant use of moderate CYP3A4 inhibitors • Two or more of the following risk factors: o Body weight between 45 kg and 60 kg o Moderate renal impairment (eGFR 30 to 59 mL/min) o Moderate hepatic impairment (Child ‑ Pugh Class B) If administration of BLUJEPA cannot be avoided in these patients, monitor and correct serum electrolyte abnormalities and collect an ECG prior to administration and during treatment, as clinically indicated.

5.2Acetylcholinesterase Inhibition BLUJEPA is a reversible acetylcholinesterase inhibitor in in vitro laboratory studies. Adverse reactions including dysarthria, syncope, presyncope, muscle spasms, diarrhea, nausea, vomiting, abdominal pain, hypersalivation, and hyperhidrosis which are potentially attributed to acetylcholinesterase inhibition, have been observed in clinical trials [see Adverse Reactions ( 6.1 )] . Increased cholinergic effects can be associated with severe adverse reactions including atrioventricular block, bradycardia, bronchospasm, and seizures/convulsions.

Monitor patients with medical…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • QTc Prolongation [see Warnings and Precautions ( 5.1 )] . • Acetylcholinesterase Inhibition [see Warnings and Precautions ( 5.2 )] . • Hypersensitivity Reactions [see Warnings and Precautions ( 5.3 )] . • Clostridioides difficile Infection [see Warnings and Precautions ( 5.4 )] . • uUTI: The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis.

( 6.1 ) • Uncomplicated Urogenital Gonorrhea: The most common adverse reactions occurring in ≥2% of patients are diarrhea, nausea, abdominal pain, vomiting, flatulence, dizziness, soft feces, headache, fatigue, and hyperhidrosis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 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 with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience in Patients with Uncomplicated UTI The safety of BLUJEPA was evaluated in 2 double‑blind, active‑controlled, randomized trials in female adult and pediatric patients 12 years of age and older with uUTI (Trial 1 and Trial 2).

A total of 1,570 patients were treated with BLUJEPA and 1,558 patients were treated with nitrofurantoin (pooled safety populations for BLUJEPA and nitrofurantoin, respectively). Patients received treatment for a median duration of 5 days. In Trials 1 and 2 (pooled, intent-to-treat [ITT] population), the median age of patients treated with BLUJEPA was 49 (range 13 to 89) years; <1% were <18 years, 77% of patients were 18 to 64 years, 14% were 65 to 74 years, and 8% were ≥75 years.

Patients were female (100%) and White (83%), Black or African American (7%), Asian (5%), or American Indian or Alaskan Native (4%); for ethnicity, 33% identified as Hispanic/Latino and 67% as non-Hispanic/Latino. The majority of patients were enrolled from the U.S. (55%).

Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation: In the pooled trials (Trials 1 and 2), serious adverse reactions occurred in 1/1,570 (<1%) uUTI patients treated with BLUJEPA and 1/1,558 (<1%) uUTI patients treated with nitrofurantoin. The serious adverse reaction reported with BLUJEPA was dysarthria. No adverse reaction led to death in either treatment group.

In the pooled trials, adverse reactions leading to discontinuation of treatment occurred in 79/1,570 (5%) uUTI patients treated with BLUJEPA and 30/1,558 (2%) uUTI patients treated with nitrofurantoin. Adverse reactions occurring in >1% of patients leading to treatment discontinuation in patients treated with BLUJEPA included diarrhea (3%) and nausea (1%). Common Adverse Reactions: Table 1 lists the adverse reactions occurring in ≥1% of uUTI patients receiving BLUJEPA in the pooled trials (Trials 1 and 2).

Table 1. Adverse Reactions Occurring in ≥1% of Uncomplicated Urinary Tract Infection Patients Treated with BLUJEPA (Trials 1 and 2 Pooled Data; Safety Population) a Abdominal pain includes abdominal pain, abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain. Adverse Reaction BLUJEPA N = 1,570 n (%) Nitrofurantoin N = 1,558 n (%) Diarrhea 258 (16) 51 (3) Nausea 146 (9) 64 (4) Abdominal pain a 60 (4) 34 (2) Flatulence 43 (3) 8 (<1) Headache 38 (2) 40 (3) Soft feces 37 (2) 8 (<1) Dizziness 29 (2) 19 (1) Vomiting 28 (2) 10 (<1) Vulvovaginal candidiasis 20 (1) 18 (1) Diarrhea: In Trials 1 and 2, diarrhea was reported in 258/1,570 (16%) uUTI patients receiving BLUJEPA; 11% mild, 5% moderate, and <1% severe.

The diarrhea started within the first 2 days of treatm…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS • CYP3A4 Inhibitors: Increase gepotidacin exposure. ( 7.1 ) • Strong CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with strong CYP3A4 inhibitors. ( 5.1 , 7.1 ) • Moderate CYP3A4 inhibitors: Avoid concomitant use of BLUJEPA with moderate CYP3A4 inhibitors in patients with uncomplicated urogenital gonorrhea.

( 5.1 , 7.1 ) • CYP3A4 Inducers: Decrease gepotidacin exposure. ( 7.1 ) • For uUTI: Avoid concomitant use of BLUJEPA with strong CYP3A4 inducers. ( 7.1 ) • For uncomplicated urogenital gonorrhea: Avoid concomitant use of BLUJEPA with strong and moderate CYP3A4 inducers.

( 7.1 ) • CYP3A4 Substrates: Avoid concomitant use of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions. ( 7.2 ) • Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA. ( 7.2 )

7.1Effect of Other Drugs on BLUJEPA CYP3A4 Inhibitors Table 3. Recommendations for Concomitant Administration of CYP3A4 Inhibitors with BLUJEPA Indication Moderate CYP3A4 Inhibitors Strong CYP3A4 Inhibitors Uncomplicated UTI No dosage adjustment Avoid concomitant administration of BLUJEPA with strong inhibitors of CYP3A4 due to an increase in gepotidacin exposure [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. Uncomplicated Urogenital Gonorrhea Avoid concomitant administration of BLUJEPA with moderate CYP3A4 inhibitors due to an increase in gepotidacin exposure [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )].

Avoid concomitant administration of BLUJEPA with strong inhibitors of CYP3A4 due to an increase in gepotidacin exposure [see Warnings and Precautions ( 5.1 ), Clinical Pharmacology ( 12.3 )]. CYP3A4 Inducers Due to decreased gepotidacin exposures, avoid coadministration of BLUJEPA with CYP3A4 inducers as follows: • Uncomplicated urinary tract infections: Avoid concomitant use of BLUJEPA with strong CYP3A4 inducers [see Clinical Pharmacology ( 12.3 )] . • Uncomplicated urogenital gonorrhea: Avoid concomitant use of BLUJEPA with strong and moderate CYP3A4 inducers [see Clinical Pharmacology ( 12.3 )] .

7.2Effect of BLUJEPA on Other Drugs CYP3A4 Substrates Avoid concomitant administration of BLUJEPA with drugs that are extensively metabolized by CYP3A4 where minimal concentration changes may lead to serious adverse reactions [see Clinical Pharmacology ( 12.3 )] . Digoxin Due to an increase in digoxin exposures, consider monitoring digoxin serum concentrations, as appropriate, with concomitant administration of BLUJEPA [see Clinical Pharmacology ( 12.3 )] .

7.3Cholinergic/Anticholinergic Drugs As gepotidacin is an acetylcholinesterase inhibitor, there is potential for an exaggerated effect of concomitantly administered succinylcholine‑type neuromuscular blocking agents resulting in a delay in recovery of neuromuscular function. BLUJEPA may augment the effect of other acetylcholinesterase inhibitors. Monitor for exaggerated neuromuscular blockade or excessive cholinergic effects [see Warnings and Precautions ( 5.2 )] .

There is potential for an antagonistic effect with systemic anticholinergic medications or non‑depolarizing neuromuscular blocking agents. Consider the potential for this interaction if BLUJEPA is administered concomitantly with anticholinergic medications [see Warnings and Precautions ( 5.2 )] .

7.4Drugs that Prolong the QTc Interval Due to the increased risk of QTc prolongation, avoid concomitant administration of BLUJEPA with other medications that have the potential to prolong the QTc interval [see Warnings and Precautions ( 5.1 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Renal Impairment: Avoid use of BLUJEPA in patients with severe renal impairment with eGFR <30 mL/min, including those receiving dialysis. ( 8.6 ) • Hepatic Impairment: Avoid use of BLUJEPA in patients with severe hepatic impairment (Child-Pugh Class C). ( 8.7 )

8.1Pregnancy Pregnancy Exposure Registry A pregnancy exposure registry will be established to monitor pregnancy outcomes in women exposed to BLUJEPA during pregnancy. Pregnant women exposed to BLUJEPA, and healthcare providers are encouraged to contact GlaxoSmithKline at 1‑888‑825‑5249. Risk Summary There are no available data on the use of BLUJEPA in pregnant women to evaluate for a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

In embryo‑fetal development studies in mice and rats, decreased fetal weights and increased fetal mortality (late resorptions) were observed at exposures less than the maximum recommended human dose (MRHD). In a mouse pre- and postnatal development study, there were no adverse developmental effects at exposures approximately equal to the MRHD (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage, in clinically recognized pregnancies, is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Gepotidacin did not cause malformations when orally administered in embryo‑fetal development studies during organogenesis.

Decreased fetal weights were seen in rats dosed orally with 450 mg/kg/day or greater (less than the MRHD based on AUC extrapolated from nonpregnant rats). Decreased fetal weights and increased late fetal resorptions were seen in mice at oral doses 500 mg/kg/day or greater (less than the MRHD based on AUC extrapolated from nonpregnant mice). In a pre- and post‑natal development study in mice given oral doses of up to 1,000 mg/kg/day (approximately equal to the MRHD), there were no gepotidacin effects on parturition, or post‑natal growth and development of the offspring.

8.2Lactation Risk Summary There are no data on the presence of gepotidacin in human milk, its effects on the breastfed child, or on milk production. Based on a study in lactating mice, gepotidacin is likely transferred into milk (see Data ). When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BLUJEPA and any potential adverse effects on the breastfed child from BLUJEPA or from the underlying maternal condition. Data Gepotidacin concentrations in milk have not been measured directly in animals. However, in a pre- and post‑natal development study when gepotidacin was orally administered to maternal mice during pregnancy and lactation, at all tested doses, gepotidacin was detected in the plasma of their nursing offspring (with dosing 200 mg/kg/day or greater, which was expected to result in maternal exposures as low as 0.2-times the MHRD as extrapolated from exposures in nonpregnant mice).

8.4Pediatric Use Uncomplicated UTI The safety and effectiveness of BLUJEPA for the treatment of uUTI have been established for the treatment of uncomplicated UTI in female pediatric patients 12 years of age and older, weighing at least 40 kg. Use of BLUJEPA in these patients is supported by evidence from adequate and well‑controlled studies of BLUJEPA in female adult and pediatric patients 12 years of age and older with uUTI and additional pharmacokinetic data in pediatric patients (12 to <18 years of age) [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 )] .

The safety profile of BLUJEPA in female pediatric patients 12 years of age and older was similar to female adults with uUTI…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Exposure Registry A pregnancy exposure registry will be established to monitor pregnancy outcomes in women exposed to BLUJEPA during pregnancy. Pregnant women exposed to BLUJEPA, and healthcare providers are encouraged to contact GlaxoSmithKline at 1‑888‑825‑5249. Risk Summary There are no available data on the use of BLUJEPA in pregnant women to evaluate for a drug‑associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

In embryo‑fetal development studies in mice and rats, decreased fetal weights and increased fetal mortality (late resorptions) were observed at exposures less than the maximum recommended human dose (MRHD). In a mouse pre- and postnatal development study, there were no adverse developmental effects at exposures approximately equal to the MRHD (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage, in clinically recognized pregnancies, is 2% to 4% and 15% to 20%, respectively. Data Animal Data: Gepotidacin did not cause malformations when orally administered in embryo‑fetal development studies during organogenesis.

Decreased fetal weights were seen in rats dosed orally with 450 mg/kg/day or greater (less than the MRHD based on AUC extrapolated from nonpregnant rats). Decreased fetal weights and increased late fetal resorptions were seen in mice at oral doses 500 mg/kg/day or greater (less than the MRHD based on AUC extrapolated from nonpregnant mice). In a pre- and post‑natal development study in mice given oral doses of up to 1,000 mg/kg/day (approximately equal to the MRHD), there were no gepotidacin effects on parturition, or post‑natal growth and development of the offspring.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use Uncomplicated UTI The safety and effectiveness of BLUJEPA for the treatment of uUTI have been established for the treatment of uncomplicated UTI in female pediatric patients 12 years of age and older, weighing at least 40 kg. Use of BLUJEPA in these patients is supported by evidence from adequate and well‑controlled studies of BLUJEPA in female adult and pediatric patients 12 years of age and older with uUTI and additional pharmacokinetic data in pediatric patients (12 to <18 years of age) [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.1 )] .

The safety profile of BLUJEPA in female pediatric patients 12 years of age and older was similar to female adults with uUTI treated with BLUJEPA [see Adverse Reactions ( 6.1 ), Clinical Studies ( 14.1 )] . The safety and effectiveness of BLUJEPA have not been established in pediatric patients less than 12 years of age or weighing less than 40 kg. Uncomplicated Urogenital Gonorrhea The safety and effectiveness of BLUJEPA for the treatment of uncomplicated urogenital gonorrhea have been established in pediatric patients 12 years of age and older weighing at least 45 kg who have limited or no alternative treatment options [see Indications and Usage ( 1.1 )] .

Use of BLUJEPA in these patients is supported by evidence from an adequate and well‑controlled study (Trial 3) in adult and pediatric patients with uncomplicated urogenital gonorrhea weighing at least 45 kg, and additional pharmacokinetic analyses showing similar drug exposure levels for pediatric patients (12 to <18 years of age) compared with adults [see Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.2 )] . The safety profile of BLUJEPA was similar between pediatric healthy volunteers 12 to <18 years of age (n = 12) who received two 3,000 mg doses compared to adults [see Adverse Reactions ( 6.1 )] .

The safety and effectiveness of BLUJEPA have not been established for the treatment of uncomplicated urogenital gonorrhea in pediatric patients less than 12 years of age or weighing less than 45 kg.

🧓 Geriatric Use 160 words ▾

8.5Geriatric Use Uncomplicated UTI Of the total number of patients who received treatment with BLUJEPA in the uUTI studies (Trials 1 and 2), 226 (14%) were 65 to less than 75 years of age and 127 (8%) were 75 years of age and older [see Clinical Studies ( 14.1 )] . No overall differences in safety or effectiveness of BLUJEPA were observed between patients 65 years of age and older and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. BLUJEPA is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function [see Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.6 ), Clinical Pharmacology ( 12.3 )] .

Uncomplicated Urogenital Gonorrhea Trial 3 did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

🆘 Overdosage 40 words ▾

10 OVERDOSAGE There is a risk of QTc prolongation with overdosage. Intermittent hemodialysis is not likely to substantially remove BLUJEPA from the systemic circulation. Consider contacting the Poison Help line (1‑800‑222‑1222) or a medical toxicologist for additional overdose management recommendations.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action BLUJEPA is an antibacterial drug [see Microbiology ( 12.4 )] .

12.2Pharmacodynamics The 24-hour free‑drug AUC to minimum inhibitory concentration (MIC) ratio has been shown in animal infection and in vitro pharmacokinetic ‑pharmacodynamic (PK‑PD) models to be the PK‑PD index predictive of gepotidacin antibacterial efficacy. Cardiac Electrophysiology The effect of gepotidacin on the QTc interval was evaluated in a randomized, active (moxifloxacin 400 mg) and placebo‑controlled, double‑blind cross‑over trial in healthy subjects who received single intravenous (IV) infusions of gepotidacin over 2 hours.

A dose- and concentration‑dependent QTc prolongation effect of gepotidacin was observed. The mean placebo‑corrected change from baseline heart rate values around T max were approximately 6 bpm at 1,000 mg IV (not an approved dosing regimen and route of administration) and approximately 10 bpm at 1,800 mg IV (not an approved dosing regimen and route of administration). The mean placebo‑corrected change from baseline QTcF values around T max were 12 msec at 1,000 mg IV and 22 msec at 1,800 mg IV [see Warnings and Precautions ( 5.1 )] .

The C max of gepotidacin following a single 1,000 mg IV dose (not an approved dosing regimen and route of administration) is approximately 1.2 times that of the C max at steady state for the 1,500 mg oral dose twice daily. The C max of gepotidacin following a single 1,800 mg IV dose (not an approved dosing regimen and route of administration) is approximately 1.2 times that of the C max after the second 3,000 mg oral dose given 12 hours after the first oral dose.

12.3Pharmacokinetics Pharmacokinetic Parameters The pharmacokinetic properties of gepotidacin are summarized in Table 4 as mean (standard deviation [SD]) unless otherwise specified. Table 4. Pharmacokinetic Parameters of Gepotidacin a Pharmacokinetic parameters are presented at steady state in patients with uUTI and eGFR greater than or equal to 90 mL/min after oral administration of BLUJEPA 1,500 mg every 12 hours over 5 days, and in simulated results in adults with eGFR greater than or equal to 90 mL/min after oral administration of 2 doses of BLUJEPA (3,000 mg) taken 12 hours apart. b AUC 0-12 at steady state in patients with uUTI; simulated AUC 0-24 on day 1 in simulated results with uncomplicated urogenital gonorrhea. c Studies evaluating the effect on food were performed with standard and moderate fat meal.

Clinical studies were not performed with a high fat meal (1,000 calories, 50% fat). Dosing Regimen 1,500 mg Every 12 Hours over 5 Days 2 Doses of 3,000 mg 12 Hours Apart Exposure C max (mcg/mL) a 6.3 (1.0) 11 (2.7) AUC (mcg*hour/mL) a,b 22.8 (4.8) 75.9 (25.9) Dose Proportionality Approximately dose proportional from 1,500 to 3,000 mg Accumulation 40% and steady state was achieved by day 3 Absorption Absolute Bioavailability ~45% T max (hours) ~2.0 Effect of food (moderate fat meal) c No clinically significant effect on PK Distribution V ss (L) a 172.9 (42.5) 188.0 (63.7) Plasma Protein Binding ~25 to ~41% Elimination Terminal Half-life (hours) a 9.3 (1.3) 9.4 (2.3) Total Clearance (L/hour) a 33.4 (6.7) 34.8 (8.7) Metabolism Primary Pathway Oxidative metabolism mediated by CYP3A4, producing several circulating metabolites Major Metabolite (%) M4 which is ~11% of circulating drug‑related materials Excretion Feces ~52% (30% unchanged drug) Urine ~31% (20% unchanged drug; major route of elimination for absorbed gepotidacin) Specific Populations Modelling and simulation analyses of gepotidacin showed that age, sex, and race have no clinically relevant effect on gepotidacin exposure.

Body weight alone does not result in clinically significant effects on gepotidacin exposure [see Use in Specific Populations ( 8.4 ), ( 8.5 )] . Patients with Renal Impairment: The pharmacokinetics of gepotidacin were evaluated in subjects with moderate renal impairment (eGFR 30 to 59 mL/min) and in subjects…

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action BLUJEPA is an antibacterial drug [see Microbiology ( 12.4 )] .

📦 How Supplied / Storage and Handling 66 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING BLUJEPA tablets are supplied as yellow, film-coated, capsule-shaped tablets debossed with “GS GU3” on one side and plain on the other side, containing 750 mg of gepotidacin. Bottle of 8 tablets (NDC 0173-0922-38). Bottle of 20 tablets (NDC 0173-0922-45). Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP Controlled Room Temperature].

📋 Description 112 words ▾

11 DESCRIPTION BLUJEPA tablets contain gepotidacin mesylate, a triazaacenaphthylene antibacterial that inhibits bacterial DNA gyrase and topoisomerase IV. The chemical name is ( R )-2-((4-(((3,4-dihydro-2 H -pyrano[2,3- c ]pyridin-6-yl)methyl)amino)piperidin-1-yl)methyl)-1,2-dihydro-3 H ,8 H -2a,5,8a-triazaacenaphthylene-3,8-dione methanesulfonate dihydrate. The molecular formula is C 24 H 28 N 6 O 3 ●CH 4 O 3 S●2H 2 O and its molecular mass is 580.66.

The structural formula is shown below. *stereogenic center Each BLUJEPA oral tablet contains gepotidacin 750 mg (equivalent to 910.7 mg of gepotidacin mesylate [anhydrous]). Inactive ingredients include colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide. Gepotidacin mesylate dihydrate chemical structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Important Administration Instructions Counsel patients to take BLUJEPA after a meal to reduce the possibility of gastrointestinal intolerance [see Dosage and Administration ( 2.3 )] . Prolongation of the QTc Interval Counsel patients to inform their healthcare provider of any personal or family history of QTc prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia, or if they are taking any antiarrhythmic agents.

Advise patients to notify their healthcare providers if they have any symptoms of prolongation of the QTc interval, including prolonged heart palpitations or a loss of consciousness [see Warnings and Precautions ( 5.1 )] . Acetylcholinesterase Inhibition Counsel patients that BLUJEPA can cause dysarthria and other symptoms such as syncope, presyncope, muscle spasms, diarrhea, nausea, vomiting, abdominal pain, hypersalivation, and hyperhidrosis. Advise patients to inform their healthcare provider if they experience these symptoms or if they have an underlying medical condition that may be exacerbated by acetylcholinesterase inhibition or are planning to receive anesthesia where they may receive neuromuscular blocking agents, or if they are receiving other acetylcholinesterase inhibitors, or systemic anticholinergic medications [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.3 )] .

Hypersensitivity Reactions Advise patients that hypersensitivity reactions, including anaphylaxis, could occur and require immediate treatment. Advise patients to inform their healthcare provider about any previous hypersensitivity reactions to BLUJEPA [see Warnings and Precautions ( 5.3 )] . Diarrhea Counsel patients that diarrhea is a common problem caused by antibacterials, including BLUJEPA.

Most reported cases of diarrhea with BLUJEPA were mild to moderate in severity. Diarrhea may occur early in treatment and usually ends when treatment with the antibacterial is discontinued. In most cases, the diarrhea resolved without treatment [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.1 )] .

Sometimes potentially serious diarrhea with frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, patients should contact their healthcare provider [see Warnings and Precautions ( 5.4 )] . Antibacterial Resistance Patients should be counseled that antibacterial drugs, including BLUJEPA, should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When BLUJEPA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by BLUJEPA or other antibacterial drugs in the future [see Warnings and Precautions ( 5.5 )] .

Drug Interactions Advise patients of the potential interactions other medications may have with BLUJEPA or the effect BLUJEPA may have on other medications, as these may result in decreased effectiveness or increased toxicities of either BLUJEPA or the other medications. Patients should alert their healthcare provider if they are currently taking any medications, including herbal nutritional supplements, or are prescribed new medications during treatment with BLUJEPA [see Warnings and Precautions ( 5.1 ), Drug Interactions ( 7 ), Clinical Pharmacology ( 12.3 )] .

Pregnancy Advise patients who are exposed to BLUJEPA during pregnancy to contact GlaxoSmithKline at 1‑888‑825‑5249 [see Use in Specific Populations ( 8.1 )] . Manufactured for: GlaxoSmithKline Durham, NC 27701 Trad…

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE BLUJEPA (blu – JEP – ah) (gepotidacin) tablets, for oral use What is the most important information I should know about BLUJEPA? BLUJEPA, an antibiotic, can cause serious side effects, including: • changes in electrical activity of your heart called QTc prolongation. BLUJEPA can cause QTc prolongation (also called prolonged QTc interval) that can lead to serious heart rhythm problems, including Torsade de Pointes.

There may be changes in your heartbeat (a fast or irregular heartbeat). Before starting BLUJEPA, tell your healthcare provider if you: o or anyone in your family has ever had a heart rhythm problem (problem with heart rate or heartbeat) or QTc prolongation. o are taking any medicines to treat heart rhythm problems. Using these medicines with BLUJEPA may cause serious side effects.

If you are not sure, ask your healthcare provider. o are taking medicines called moderate or strong CYP3A4 inhibitors. Using these medicines with BLUJEPA may cause serious side effects. If you are not sure, ask your healthcare provider.

Tell your healthcare provider right away if you have any of the following symptoms: ○fast, pounding, or uneven heartbeat ○feeling dizzy ○you lose consciousness (pass out) ○feeling lightheaded ○feeling faint • an increase of a certain chemical in your nervous system (cholinergic effects). BLUJEPA can cause an increase of a certain chemical in your nervous system, which may cause the following symptoms: ○diarrhea ○vomiting ○fainting ○trouble saying words clearly ○muscle spasms ○nausea ○more saliva in the mouth ○more sweating ○stomach pain Call your healthcare provider right away if you have trouble saying words clearly, have shortness of breath, or if you faint.

These symptoms may be cholinergic effects of BLUJEPA. The increased chemical in your nervous system can also be connected to other symptoms. Call your healthcare provider right away if you have any of these additional symptoms. ○irregular heartbeat (heart block) ○slow heartbeat (bradycardia) ○seizures ○fainting ○chest tightness causing difficulty breathing • allergic reactions.

Allergic reactions can happen in people who take BLUJEPA including a severe allergic reaction called anaphylaxis. Stop taking BLUJEPA and get medical help right away if you have any symptoms of a severe allergic reaction, including: ○hives ○feeling faint or dizzy ○rash ○swelling of your lips, tongue, or throat • diarrhea. Diarrhea is a common side effect caused by antibiotics including BLUJEPA.

The diarrhea may happen at the beginning of your treatment with BLUJEPA and usually stops after the antibiotic is stopped. In most cases the diarrhea will go away without treatment. In some cases, diarrhea may be caused by Clostridioides difficile infection (CDI).

CDI is a severe infection of the intestines (bowels) that can happen up to 2 months after finishing treatment with antibiotic medicines, including BLUJEPA. CDI can be life-threatening and can lead to death. Do not take medicines to treat diarrhea without checking first with your healthcare provider.

Call your healthcare provider right away if you have the following symptoms: ○stomach cramps ○fever ○watery diarrhea ○diarrhea that does not go away ○bloody stools What is BLUJEPA? BLUJEPA is an antibiotic used to treat: • Women and girls 12 years of age and older weighing at least 88 pounds who have an infection of the bladder (known as an uncomplicated urinary tract infection [uUTI]) caused by certain types of bacteria. • Adults and children 12 years of age and older weighing at least 99 pounds who have very few or no other medicine choices to treat a sexually transmitted disease called uncomplicated urogenital gonorrhea (gonorrhea) caused by a certain type of bacteria. • It is not known if BLUJEPA is safe and effective for the treatment of uUTI in children under 12 years of age or weighing less than 88 pounds. • It is not known if BLUJEPA is safe and effective for the treatment of gonorrhea in children under 12 ye…

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