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NUZOLVENCE zoliflodacin 3 g For Suspension, 1 packet — NDC 68547-0915-10 package photo

NUZOLVENCE zoliflodacin 3 g For Suspension, 1 packet

by La Jolla Pharmaceutical Company · 1 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET
NDC 68547-0915-10
🏷️ FDA NDC (as labeled) 68547-915-10 billing pads the product segment with a zero
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) 68547-915-10
Product NDC 68547-915
11-digit billing NDC 68547091510
RxCUI 2739783, 2739789
UNII FWL2263R77
Application # NDA219491
SPL Set ID 4beda35a-21b0-4b34-84ea-be6ea8cae50f
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-01
Route ORAL
Dosage form FOR SUSPENSION
Substance ZOLIFLODACIN
Why two NDCs? The FDA registers this code as 68547-915-10 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68547-0915-10. 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.

🏭 Manufacturer & labeler

LabelerLa Jolla Pharmaceutical Company
Application holderENTASIS THERAPEUTICS INC
FDA applicationNDA219491 (NDA)
Labeler code68547
First marketedApr 2026
Product typeHuman Prescription Drug
Portfolio5 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Zoliflodacin is used to treat gonorrhea (an infection passed along by sexual contact). Zoliflodacin is in a class of medications called antibacterials. It works by stopping the growth of bacteria.

Read the full MedlinePlus article ↗

Supplement & herbal interactions

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

💊 What it looks like

Color White
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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nuzolvence 3 gthis 68547-0915-10 La 1 packet — — FDA listed —
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
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🛡️
2035
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 2035. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Dec 12, 2025 RLD RS ⏳ ~9.3 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 9839641 — method of use (U-4369)
US 9540394 — method of use (U-4369)
US 9187495 — drug substance (U-4369)
US 9040528 — method of use (U-4369)
US 8889671 — drug substance (U-4369)
US 8658641 — drug substance
Exclusivity NCE
Exclusivity GAIN
2025 2027 2029 2031 2033 2035
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 (6)
PatentTypeUse codeExpires
US 9839641 ↗ Method of use U-4369 Jan 21, 2034
US 9540394 ↗ Method of use U-4369 Jan 21, 2034
US 9187495 ↗ Drug substance U-4369 Jan 21, 2034
US 9040528 ↗ Method of use U-4369 Oct 13, 2029
US 8889671 ↗ Drug substance U-4369 Jan 21, 2034
US 8658641 ↗ Drug substance — Jun 20, 2030
FDA exclusivity
CodeWhat it grantsExpires
NCENew Chemical Entity (5-year)Dec 12, 2030
GAINQualified Infectious Disease Product (+5-year)Dec 12, 2035
Common questions
Is there a generic version of this drug?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for this drug. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until Dec 2035 — 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68547-0915-10 You're viewing this 1 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET 2026-04-01 Active

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68547-915-10, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68547-0915-10, written without dashes as 68547091510. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68547-0915-10, the first segment (68547) is the labeler code FDA assigned to La Jolla Pharmaceutical Company; the middle segment (0915) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (10) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by La Jolla Pharmaceutical Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
La Jolla Pharmaceutical Company is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🎯 Indications and Usage 214 words ▾

1 INDICATIONS AND USAGE NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.2 )

1.1Uncomplicated Urogenital Gonorrhea NUZOLVENCE is indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg [see Clinical Studies (14) ].

1.2Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent 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 ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Pregnancy Testing: Obtain a pregnancy test in females of reproductive potential prior to initiating NUZOLVENCE. ( 2.1 ) NUZOLVENCE must be mixed with water before administering. ( 2.2 ) Do not mix NUZOLVENCE with other liquids or sprinkle on food.

( 2.2 ) Administer the entire dose within 15 minutes of mixing. If the dose is not administered within 15 minutes of mixing, a new dose of NUZOLVENCE must be prepared. ( 2.2 , 2.4 ) Adults and pediatric patients 12 years of age and older, weighing at least 35 kg: Recommended dose is 3 g (one packet) administered as a single dose orally.

( 2.3 ) Patients weighing 35 kg to less than 50 kg: Administer NUZOLVENCE on an empty stomach, 1 hour before or 2 hours after food. ( 2.3 ) Patients weighing greater than or equal to 50 kg: Administer NUZOLVENCE with food. ( 2.3 ) See full prescribing information for complete details on preparation and administration of NUZOLVENCE.

( 2.4 )

2.1Pregnancy Testing in Females of Reproductive Potential Obtain a pregnancy test in females of reproductive potential prior to initiating treatment with NUZOLVENCE [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ].

2.2Important Administration Instructions NUZOLVENCE must be mixed with water before administering. Do not mix NUZOLVENCE with other liquids or sprinkle on food. Do not take NUZOLVENCE in the dry form. Administer the entire dose within 15 minutes of mixing. If the dose is not administered within 15 minutes of mixing, a new dose of NUZOLVENCE must be prepared [see Dosage and Administration (2.4) ] .

2.3Recommended Dosage in Adults and Pediatric Patients 12 Years of Age and Older Weighing at Least 35 Kg The recommended dose of NUZOLVENCE in adults and pediatric patients 12 years of age and older weighing at least 35 kg is 3 grams (g) (one packet) administered as a single dose orally. See Table 1 for instructions on whether to administer NUZOLVENCE with or without food based on body weight [see Clinical Pharmacology (12.3) ] . Table 1: Administration of NUZOLVENCE With or Without Food Based on Weight Dose of NUZOLVENCE Body Weight (kg) Administration of NUZOLVENCE Relative to the Ingestion of Food 3 g administered as a single, oral dose 35 kg to less than 50 kg Take on an empty stomach, 1 hour before or 2 hours after food Greater than or equal to 50 kg Take with food

2.4Preparation and Administration Instructions for NUZOLVENCE for Oral Suspension NUZOLVENCE must be mixed with water before administering. Do not mix NUZOLVENCE with other liquids or sprinkle on food. Accurately measure 60 mL of water into the provided mixing container.

Add the entire contents of one unit-dose packet of NUZOLVENCE to the mixing container and immediately secure the provided lid onto the mixing container. Shake vigorously for at least 60 seconds. Continue to shake until all granules are suspended and there is a uniform suspension.

Once NUZOLVENCE is mixed to achieve a uniform suspension, administer the entire contents of the mixing container immediately. To ensure the full dose of NUZOLVENCE is consumed, add an additional 60 mL of water to the same mixing container, shake, and administer the entire additional 60 mL of water. Administer the entire dose within 15 minutes of mixing.

If the dose is not administered within 15 minutes of mixing, a new dose of NUZOLVENCE must be prepared. See the Instructions for Use for additional details on the preparation and administration of NUZOLVENCE for oral suspension.

💊 Dosage Forms and Strengths 39 words ▾

3 DOSAGE FORMS AND STRENGTHS For Oral Suspension: 3 g of zoliflodacin as white to off-white granules in each unit-dose packet of NUZOLVENCE. For oral suspension: 3 g of zoliflodacin in each unit-dose packet of NUZOLVENCE. ( 3 )

⛔ Contraindications 99 words ▾

4 CONTRAINDICATIONS NUZOLVENCE is contraindicated in: patients with a known history of hypersensitivity to NUZOLVENCE [see Warnings and Precautions (5.4) ] . patients who use concomitant moderate or strong CYP3A4 inducers because concomitant use is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce the efficacy of NUZOLVENCE [see Drug Interactions (7.1) and Clinical Pharmacology (12.3) ]. Known history of hypersensitivity to NUZOLVENCE. ( 4 ) Concomitant use with moderate or strong CYP3A4 inducers because this is predicted to result in decreased plasma concentrations of zoliflodacin and may reduce NUZOLVENCE efficacy.

( 4 , 7.1 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: Potential Risk for Pregnant Females: May cause fetal harm when administered during pregnancy based on data from animal studies. Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Avoid use of NUZOLVENCE during pregnancy.

( 5.1 , 8.1 , 8.3 ) Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential: Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after administration of NUZOLVENCE. ( 5.2 , 8.3 , 13.1 ) Testicular Toxicity and Risks to Male Fertility: May cause testicular toxicity and impair male fertility based on data from animal studies. An assessment of spermatogenesis has not been conducted in humans.

Advise males of the potential risk. ( 5.3 , 8.3 , 13.1 ) Hypersensitivity Reactions: Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE. Discontinue NUZOLVENCE and institute appropriate supportive measures, if an allergic reaction occurs.

( 5.4 ) Clostridioides difficile Infection: Evaluate if diarrhea occurs. ( 5.5 )

5.1Embryo-Fetal Toxicity: Potential Risk for Pregnant Females Based on data from animal studies, NUZOLVENCE may cause fetal harm when administered to a pregnant female at clinically relevant doses. Reproductive and developmental toxicity studies at AUC exposures 1.6-fold (mice) and 8.5-fold (rats) the maximum recommended human dose (MRHD) of zoliflodacin administered to pregnant rodents during organogenesis resulted in fetal malformations (exencephaly) and increased embryo-fetal loss [see Use in Specific Populations (8.1) ] .

Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE. Avoid use of NUZOLVENCE during pregnancy. Obtain a pregnancy test prior to initiation of treatment with NUZOLVENCE in females of reproductive potential [see Dosage and Administration (2.1) and Use in Specific Populations (8.1 , 8.3) ] .

5.2Embryo-Fetal Toxicity: Potential Risk Related to Males with Female Partners of Reproductive Potential Based on data from an animal toxicity study, the risk of early pregnancy loss may be increased in female partners of males treated with NUZOLVENCE. A reduced number of live embryos and increased number of embryonic losses were observed in untreated female rats mated with male rats administered zoliflodacin at exposures approximately 3.9-times the clinical exposure at the MRHD for 4 weeks . Advise males with female partners of reproductive potential to use effective contraception for at least 3 months after administration of NUZOLVENCE. [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ].

5.3Testicular Toxicity and Risks to Male Fertility Based on findings from animal studies, NUZOLVENCE may cause testicular toxicity and impair male fertility. In repeat-dose toxicity studies, rats and dogs administered zoliflodacin for durations of 2 days to 4 weeks at AUC exposures 3- to 11-times the MRHD experienced minimal to moderate decreased spermatogenesis and testicular histopathological changes. In rats, loss of male rat fertility was no longer observed 4 weeks after the last dose; however, testicular histopathological changes in rats and dogs were only partially reversible after 2 to 3 months [see Nonclinical Toxicology (13.1) ] .

An evaluation of spermatogenesis has not been conducted in humans. Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility [see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ] .

5.4Hypersensitivity Reactions Hypersensitivity reactions, including rash and pruritus, have been reported in patients receiving NUZOLVENCE [see Adverse Reactions (6.1) ]. NUZOLVENCE is contraindicated in patients with a known history of hypersensitivity to NUZOLVENCE [see Contraindications (4) ] . Before therapy with NUZOLVENCE…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in the Warnings and Precautions section of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] The most common adverse reactions including laboratory abnormalities (incidence ≥2%) with NUZOLVENCE are neutropenia, headache, leukopenia, dizziness, nausea, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Entasis Therapeutics, Inc. at 1-800-651-3861 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. A total of 782 patients received a 3 g dose of zoliflodacin across all phases of clinical trials. The safety of NUZOLVENCE was evaluated in a phase 3, randomized, open-label, active-controlled, multicenter, multinational trial (NCT03959527) (Trial 1).

In total, 927 patients with suspected uncomplicated gonorrhea due to N. gonorrhoeae were randomized (2:1) and treated with either a single oral 3 g dose of NUZOLVENCE (N=619) or a combination of a single 500 mg intramuscular dose of ceftriaxone and a single 1 g oral dose of azithromycin (N=308) [see Clinical Studies (14) ] . Patients were eligible for enrollment if they were ≥12 years old and ≥35 kg. The majority (98%) of patients were adults (≥18 years); 14 patients were 15 to 18 years old: 12/619 (1.9%) in the NUZOLVENCE arm and 2/308 (0.6%) in the ceftriaxone and azithromycin arm.

South Africa had the highest proportion of enrolled patients (46%), followed by Thailand (29%), the United States (17%), and the European Union (8%). The majority of patients treated with NUZOLVENCE were male (88%). Patients identified as Black or African American (56%), Asian (31%), White (11%), American Indian or Alaska Native (1%), or Other (1%).

A total of 3% of patients treated with NUZOLVENCE identified as Hispanic or Latino and 22% were living with Human Immunodeficiency Virus (HIV). Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation: There were no serious adverse reactions or adverse reactions leading to treatment discontinuation or death. Common Adverse Reactions: Table 2 lists adverse reactions occurring in ≥2% of patients receiving NUZOLVENCE in Trial 1.

Table 2: Adverse Reactions in ≥2% of Patients with Suspected Uncomplicated Gonorrhea Infection Treated with NUZOLVENCE in Trial 1 Trial 1 was not designed to evaluate meaningful comparisons of the incidence of adverse reactions in the NUZOLVENCE and the ceftriaxone and azithromycin treatment groups. The safety population includes patients with urogenital gonorrhea as well as those with uncomplicated gonorrhea infections at other body sites not covered under the approved indication. (Safety Population) Adverse Reaction NUZOLVENCE N = 619 n (%) Ceftriaxone and Azithromycin N = 308 n (%) N, total number of patients in treatment arm; n, number of patients meeting criteria.

Headache Headache includes tension headache and headache. 61 (10) 15 (5) Dizziness 21 (3) 5 (2) Nausea 16 (3) 12 (4) Diarrhea 15 (2) 22 (7) Headache : In Trial 1, headache was reported in 61/619 (10%) of patients receiving NUZOLVENCE; headache severity was mild in 8% of patients and moderate in 2%. Laboratory Abnormalities Laboratory abnormalities that occurred at a frequency of 2% or greater in Trial 1 are provided in Table 3.

Table 3: Laboratory Abnormalities in ≥2% of Patients with Suspected Uncomplicated Gonorrhea Infection Treated with NUZOLVENCE, with Normal Baseline Values in Trial 1 Trial 1 was not designed to evaluate meaningful comparisons of the incidence of laboratory changes in the NUZOLVENCE and the ceftriaxone and azithromycin treatment groups. The safety population includes patients with urogenital gonorrhea as well as tho…

🔄 Drug Interactions 64 words ▾

7 DRUG INTERACTIONS

7.1Effect of Other Drugs on NUZOLVENCE Moderate and Strong CYP3A4 Inducers Concomitant use of moderate or strong inducers of CYP3A4 with NUZOLVENCE is contraindicated [see Contraindications (4) ] . Zoliflodacin is a CYP3A4 substrate. Moderate and strong CYP3A4 inducers are predicted to result in decreased plasma concentrations of zoliflodacin and may reduce NUZOLVENCE efficacy [see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. In pregnant mice, repeat oral administration of zoliflodacin during organogenesis was associated with fetal malformations (exencephaly) and increased embryo-fetal loss at AUC exposures 1.6-fold the MRHD and decreased fetal weights at 2.9-fold the MRHD. In pregnant rats, zoliflodacin administration resulting in AUC exposures 8.5-fold the MRHD increased embryo-fetal loss, and exposures 3.2-fold the MRHD decreased fetal weights.

There was no effect on embryo-fetal survival at exposures 5.5-fold the MRHD to zoliflodacin in pregnant rats. When zoliflodacin was administered to rats throughout pregnancy, parturition, and lactation, no effects on pup survival, birth weight, or growth were observed at maternal exposures up to 2.4-fold the MRHD (see Data ). There are no human data on NUZOLVENCE use in pregnancy to evaluate the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.

The background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defects, 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 In pregnant mice, repeat oral administration of zoliflodacin at 250, 500, and 1000 mg/kg/day during organogenesis (gestation days [GD] 5-16) was associated with fetal exencephaly at and above doses of 500 mg/kg/day (AUC exposures equal to or greater than 1.6-fold the MRHD). Increased implant losses occurred at 500 mg/kg/day, and decreased fetal weights occurred at 1000 mg/kg/day (AUC exposures 2.9-fold the MRHD). No adverse embryo-fetal effects were observed at 250 mg/kg/day (AUC exposure 0.6-fold the MRHD).

In female rats, repeat oral administration of zoliflodacin at 200, 500, or 1000 mg/kg/day from at least 2 weeks prior to mating through organogenesis (GD 16), decreased pregnancy rates and reduced embryo-fetal survival occurred at 1000 mg/kg/day (AUC exposures 8.5-fold the MRHD), without fetal malformations. No effect on embryo-fetal survival occurred at 500 mg/kg/day (AUC exposures 5.5-fold the MRHD). Across all dose levels, decreased fetal weights and delayed skeletal ossification were observed.

In pregnant rats, repeat oral administration of zoliflodacin from GD 6 through lactation Day 20 at doses up to 200 mg/kg/day (maternal AUC exposures 2.4-fold the MRHD at the end of gestation), resulted in no maternal toxicity or adverse effects on prenatal or postnatal offspring survival or growth. In offspring evaluated at 8-9 weeks, increased motor activity occurred in males and females at 200 mg/kg/day and in females at 100 mg/kg/day (maternal AUC exposures 1.4-fold MRHD at the end of gestation). At both dose levels, maternal AUC exposures were below clinical exposures at the end of lactation.

Results of learning and memory assessments were indeterminate due to limitations of the study design.

8.2Lactation Risk Summary There are no data on the presence of zoliflodacin in either human or animal milk, effects on the breastfed infant, or effects on milk production. If NUZOLVENCE is present in breast milk, intestinal flora alteration in the breastfed infant could occur. The developmental and health benefits of breastfeeding should…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary Based on findings from animal studies, NUZOLVENCE may cause fetal malformations or increased embryo-fetal loss when administered to a pregnant female. In pregnant mice, repeat oral administration of zoliflodacin during organogenesis was associated with fetal malformations (exencephaly) and increased embryo-fetal loss at AUC exposures 1.6-fold the MRHD and decreased fetal weights at 2.9-fold the MRHD. In pregnant rats, zoliflodacin administration resulting in AUC exposures 8.5-fold the MRHD increased embryo-fetal loss, and exposures 3.2-fold the MRHD decreased fetal weights.

There was no effect on embryo-fetal survival at exposures 5.5-fold the MRHD to zoliflodacin in pregnant rats. When zoliflodacin was administered to rats throughout pregnancy, parturition, and lactation, no effects on pup survival, birth weight, or growth were observed at maternal exposures up to 2.4-fold the MRHD (see Data ). There are no human data on NUZOLVENCE use in pregnancy to evaluate the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.

Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . A postmarketing descriptive pregnancy safety study is available for NUZOLVENCE. If exposure occurs during pregnancy, pregnant females or their healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.

The background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defects, 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 In pregnant mice, repeat oral administration of zoliflodacin at 250, 500, and 1000 mg/kg/day during organogenesis (gestation days [GD] 5-16) was associated with fetal exencephaly at and above doses of 500 mg/kg/day (AUC exposures equal to or greater than 1.6-fold the MRHD). Increased implant losses occurred at 500 mg/kg/day, and decreased fetal weights occurred at 1000 mg/kg/day (AUC exposures 2.9-fold the MRHD). No adverse embryo-fetal effects were observed at 250 mg/kg/day (AUC exposure 0.6-fold the MRHD).

In female rats, repeat oral administration of zoliflodacin at 200, 500, or 1000 mg/kg/day from at least 2 weeks prior to mating through organogenesis (GD 16), decreased pregnancy rates and reduced embryo-fetal survival occurred at 1000 mg/kg/day (AUC exposures 8.5-fold the MRHD), without fetal malformations. No effect on embryo-fetal survival occurred at 500 mg/kg/day (AUC exposures 5.5-fold the MRHD). Across all dose levels, decreased fetal weights and delayed skeletal ossification were observed.

In pregnant rats, repeat oral administration of zoliflodacin from GD 6 through lactation Day 20 at doses up to 200 mg/kg/day (maternal AUC exposures 2.4-fold the MRHD at the end of gestation), resulted in no maternal toxicity or adverse effects on prenatal or postnatal offspring survival or growth. In offspring evaluated at 8-9 weeks, increased motor activity occurred in males and females at 200 mg/kg/day and in females at 100 mg/kg/day (maternal AUC exposures 1.4-fold MRHD at the end of gestation). At both dose levels, maternal AUC exposures were below clinical exposures at the end of lactation.

Results of learning and memory assessments were indeterminate due to limitations of the study design.

🧒 Pediatric Use 142 words ▾

8.4Pediatric Use The safety and effectiveness of NUZOLVENCE for the treatment of uncomplicated urogenital gonorrhea have been established in pediatric patients 12 years of age and older, weighing at least 35 kg [see Indications and Usage (1.1 ] . Use of NUZOLVENCE in this pediatric population is supported by clinical, microbiological and safety data from an adequate and well-controlled trial (Trial 1) in adults and pediatric patients with uncomplicated urogenital gonorrhea and additional pharmacokinetic data in adult patients.

In Trial 1, 12 patients aged 16 to <18 years, weighing 46 to 76.2 kg, received a single 3 g dose of NUZOLVENCE [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] . The safety and effectiveness of NUZOLVENCE in pediatric patients younger than 12 years of age or weighing less than 35 kg have not been established.

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Clinical studies of NUZOLVENCE did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

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

12.2Pharmacodynamics The ratio of the unbound plasma zoliflodacin area under the concentration-time curve from time of dosing extrapolated to infinity to the zoliflodacin MIC ( f AUC 0-inf /MIC) is the best predictor of efficacy based on in vitro models of infection. Cardiac Electrophysiology A thorough QTc study of single oral doses of zoliflodacin 2 g and 4 g (not approved doses of NUZOLVENCE) was conducted in 72 healthy subjects aged 18 to 45 years. A concentration-dependent increase in QTc interval was observed in the thorough QTc study.

Based on the observed relationship, clinically significant QTc interval prolongation is not expected at the maximum recommended single dose of NUZOLVENCE.

12.3Pharmacokinetics Zoliflodacin, as single doses, generally displayed dose-proportional increases in exposure up to 800 mg (0.27 times the recommended dosage). Increases above 800 mg led to slightly less than dose-proportional increases in exposure up to 4 g (1.3 times the recommended dosage). The pharmacokinetic properties of zoliflodacin in healthy subjects are displayed in Table 4.

Table 4: Pharmacokinetic Properties of Zoliflodacin in Healthy Subjects Abbreviations: AUC = area under the concentration-time curve; CL/F=apparent total body clearance; C max = maximum drug concentration; CYP = Cytochrome P450; %GCV = % geometric coefficient of variation; T ½ =elimination half-life; T max =the time to C max ; Vz/F=apparent volume of distribution. Absorption T max (h), median (minimum to maximum) Fasted: 2.5 (1.0 to 4.0); Fed: 4.0 (3.0 to 5.5) Food effect Based on studies with a moderate-fat, moderate-calorie meal consisting of approximately 462 kcal (39% fat, 51% carbohydrates, and 10% protein) or a high-fat, high-calorie meal consisting of approximately 884 kcal (estimated to contain approximately 55% fat, 29% carbohydrates, 16% protein).

At the 3 g dose, C max was increased by approximately 1.5-fold and AUC was increased by approximately 1.5 to 2-fold when given with a moderate or high fat meal vs fasted conditions. Distribution % bound to human plasma proteins 83% Blood-to-plasma ratio

0.69Vz/F (L), geometric mean (%GCV) Fasted: 177 (26.6); Fed: 98.7 (24.1) Metabolism Metabolic pathways The primary clearance mechanism is metabolism through both CYP-mediated and non-CYP-mediated pathways. Non-CYP-mediated clearance has not been fully characterized. CYP-mediated metabolism is predominantly via CYP 3A4/5 enzymes, with lesser contributions from CYP1A2, CYP2C9, CYP2C8, and CYP2C19.

Elimination Major route of elimination Fecal T 1/2 (h), geometric mean (%GCV) Fasted: 6.4 (20.4); Fed 5.5 (14.0) CL/F (L/h), geometric mean (%GCV) Fasted: 19.1 (28.8); Fed: 12.5 (27.8) Excretion % drug-related material in feces 79.6% % of dose excreted unchanged in feces 1.5% % drug-related material in urine 18.2% % of dose excreted unchanged in urine 2.5% The predicted zoliflodacin exposure parameters in adult patients with uncomplicated urogenital gonorrhea are presented in Table 5. Table 5: Zoliflodacin Exposures in Patients with Uncomplicated Urogenital Gonorrhea Pharmacokinetic Parameter Data presented as geometric mean (%CV) based on post hoc parameters from 24 patients enrolled in the Trial 1 (weight range 48.2 to 112.3 kg) who received zoliflodacin 3 g after a low/moderate fat meal.

Geometric Mean (%GCV) Abbreviations: AUC 0-inf = area under the concentration-time curve from time zero to infinity; C max = maximum drug concentration. C max (mcg/mL) 28.5 (21.6%) AUC 0-inf (h*mcg/mL) 353 (24.1%) Effect of Food Following administration of the 3 g dose of NUZOLVENCE with a moderate-to-high-fat meal, zoliflodacin C max was increased by approximately 1.5-fold and the AUC 0-inf was increased by approximately 1.5- to 2-fold. With a high-fat, high-calorie meal (consisting of approximately 884 kcal, 55% fat, 29% carbohydrates, 16% protein), the fed…

🧬 Mechanism of Action 14 words ▾

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

📦 How Supplied / Storage and Handling 101 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied NUZOLVENCE (zoliflodacin) for oral suspension is supplied as a kit. Table 7: NUZOLVENCE Kit Configuration Kit Configuration Strength NDC Code Carton containing: 1 unit-dose packet of white to off-white granules containing zoliflodacin One 120 mL mixing container with lid Instructions for Use Medication Guide 3 g 68547-915-10

16.2Storage and Handling NUZOLVENCE should be stored in the original packaging at room temperature 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room Temperature]. Do not freeze.

📦 Storage and Handling 46 words ▾

16.2Storage and Handling NUZOLVENCE should be stored in the original packaging at room temperature 20 °C to 25 °C (68 °F to 77 °F); excursions permitted to 15 °C to 30 °C (59 °F to 86 °F). [See USP Controlled Room Temperature]. Do not freeze.

📋 Description 82 words ▾

11 DESCRIPTION NUZOLVENCE for oral suspension contains zoliflodacin, an oral spiropyrimidinetrione bacterial type II topoisomerase inhibitor. The chemical name of zoliflodacin is (2R,4S,4aS)-11-Fluoro-1,2,4,4a-tetrahydro-2,4-dimethyl-8-[(4S)-4-methyl-2-oxo-3-oxazolidinyl]spiro[isoxazolo[4,5-g][1,4]oxazino[4,3-a]quinoline-5(6H),5'(2'H)-pyrimidine]-2',4',6'(1'H,3'H)-trione. Its molecular formula is C 22 H 22 FN 5 O 7 and molecular mass is 487.4 g/mol.

Its chemical structure is depicted below. Each unit dose packet of NUZOLVENCE for oral suspension contains 3 g of zoliflodacin and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, talc, and xanthan gum. Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved labeling (Medication Guide and Instructions for Use). Embryo-Fetal Toxicity: Potential Risk for Pregnant Females Advise pregnant females about the potential risk to the fetus with maternal exposure to NUZOLVENCE [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1 , 8.3) ]. Advise females who take NUZOLVENCE during pregnancy that a pregnancy safety study is available to monitor pregnancy outcomes and encourage them to report their pregnancy to Entasis Therapeutics at 1-800-651-3861 [see Use in Specific Populations (8.1) ].

Embryo-Fetal Toxicity Related to Males with Female Partners of Reproductive Potential Advise males who receive NUZOLVENCE and have female partners of reproductive potential to use effective contraception for at least 3 months after receiving NUZOLVENCE [see Warnings and Precautions (5.2) , Use in Specific Populations (8.3) , and Nonclinical Toxicology (13.1) ]. Testicular Toxicity and Risks to Male Fertility Advise males that NUZOLVENCE may cause testicular toxicity and impair male fertility [see Warnings and Precautions (5.3) , Use in Specific Populations (8.3) , and Nonclinical Toxicology (13.1) ] .

Important Preparation Instructions Prior to Administration Advise patients that NUZOLVENCE are granules for oral suspension and must be mixed with water before administration. Instruct patients not to take the granules in the dry form [see Dosage and Administration (2.2) ] . Important Administration Instructions Regarding the Ingestion of Food Advise patients weighing 35 kg (77 pounds) to less than 50 kg (110 pounds) to take NUZOLVENCE on an empty stomach, 1 hour before or 2 hours after food [see Dosage and Administration (2.3) ] .

Advise patients weighing 50 kg (110 pounds) or more to take NUZOLVENCE with food [see Dosage and Administration (2.3) ] . Diarrhea Advise the patient, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs, including NUZOLVENCE. Sometimes, 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, tell them to contact their healthcare provider [see Warnings and Precautions (5.5) ]. Antibacterial Resistance Patients should be counseled that antibacterial drugs including NUZOLVENCE should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).

When NUZOLVENCE 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 NUZOLVENCE or other antibacterial drugs in the future [see Warnings and Precautions (5.6) ].

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE NUZOLVENCE ® (nu-ZOL-vence) (zoliflodacin) for oral suspension This Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 12/2025 Read this Medication Guide and Instructions for Use before you take NUZOLVENCE. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about NUZOLVENCE? NUZOLVENCE may cause serious side effects, including: fetal harm. It is not known if NUZOLVENCE can harm your unborn baby.

Females: Your healthcare provider should have you take a pregnancy test before you receive NUZOLVENCE. If you take NUZOLVENCE while you are pregnant, your baby may be at risk for serious birth defects. Males: Males with female partners who can become pregnant should use effective contraception for at least 90 days (3 months) after treatment with NUZOLVENCE. harm to testicles.

NUZOLVENCE may be harmful to testicles and lower sperm count in males and cause fertility problems. NUZOLVENCE may harm your sperm. allergic reactions. Allergic reactions, including rash and itching, have been reported in people receiving NUZOLVENCE. diarrhea caused by Clostridioides difficile infection.

Antibiotics can sometimes cause a type of severe diarrhea called Clostridioides difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can be serious or life-threatening. CDI can happen up to 2 months after finishing treatment with NUZOLVENCE.

Call your healthcare provider right away if you develop frequent, watery, or bloody stools, or stomach cramps that are severe, do not go away, or come back, after taking NUZOLVENCE. What is NUZOLVENCE? NUZOLVENCE is a prescription antibacterial medicine used to treat uncomplicated urogenital gonorrhea in adults and children 12 years of age and older, who weigh at least 77 pounds (35 kg).

It is not known if NUZOLVENCE is safe and effective in children younger than 12 years of age or who weigh less than 77 pounds (35 kg). Do not take NUZOLVENCE if you: have a history of being allergic to NUZOLVENCE. See the end of this Medication Guide for a complete list of ingredients in NUZOLVENCE. are taking certain medicines called CYP3A4 inducers which increase the enzyme CYP3A4 in your liver.

These medicines can make NUZOLVENCE less effective. Ask your healthcare provider or pharmacist if you are not sure if any of your medicines are CYP3A4 inducers. Before taking NUZOLVENCE, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant.

It is not known if NUZOLVENCE can harm your unborn baby. See " What is the most important information I should know about NUZOLVENCE? " Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with NUZOLVENCE. Pregnancy Safety Study: There is a pregnancy safety study for women who are exposed to NUZOLVENCE during pregnancy.

The purpose of this registry is to check the health of you and your baby. If you are pregnant while being treated, you or your healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861. are breastfeeding or plan to breastfeed. It is not known if NUZOLVENCE passes into your breast milk.

Talk to your healthcare provider about the best way to feed your baby after taking NUZOLVENCE. Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should I take NUZOLVENCE?

Read the Instructions for Use leaflet for information about the right way to take NUZOLVENCE. Always mix NUZOLVENCE with water before taking. Do not mix NUZOLVENCE with other liquids or sprinkle on food.

Drink NUZOLVENCE within 15 minutes after mixing. If NUZOLVENCE is not taken within 15 minutes, do not take and call your healthcare provider for a new dose of NUZOLVENCE. Take NUZOLVENCE…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68547-0578-10 · La 68554-0001-01 · Hetero →
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.