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Fexinidazole 600 mg Tablet, 14-count

by Sanofi-Aventis U.S. LLC · 14 TABLET in 1 DOSE PACK (0024-4512-14)

NDC 00024-4512-14

🏷️ FDA NDC (as labeled) 0024-4512-14 billing pads the labeler segment with a zero

This package

Contains14-count Pack sizes2 compare ↓

Also comes in: 24 tablets 00024-4512-24

Rx only Brand On market Non-controlled

🗂️ Data synced Sep 17, 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 Dr. Brian Staiger, PharmD

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

🆔 Identity & classification

FDA NDC (as labeled) 0024-4512-14

Product NDC 0024-4512

11-digit billing NDC 00024451214

NCPDP billing unit EA — each (per item)

RxCUI 2564151, 2564152, 2564153

UNII 306ERL82IR

Application # NDA214429

SPL Set ID 74a611bc-9977-46bb-b626-0370b3031628

Established class (EPC) Nitroimidazole Antimicrobial

Mechanism of action Cytochrome P450 1A2 Inhibitors; Cytochrome P450 2B6 Inhibitors; Cytochrome P450 2C19 Inhibitors; Cytochrome P450 2D6 Inhibitors; Cytochrome P450 3A4 Inhibitors; Cytochrome P450 3A5 Inhibitors; Cytochrome P450 1A2 Inducers; Cytochrome P450 2B6 Inducers; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; Organic Cation Transporter 2 Inhibitors; Organic Anion Transporter 1 Inhibitors; Organic Anion Transporter 3 Inhibitors; Multidrug and Toxin Extrusion Transporter 1 Inhibitors; Multidrug and Toxin Extrusion Transporter 2 K Inhibitors

Chemical class Nitroimidazoles

DEA schedule Non-controlled

Marketing category NDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-07-16

Route ORAL

Dosage form TABLET

Substance FEXINIDAZOLE

Why two NDCs? The FDA registers this code as 0024-4512-14 — 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 → 00024-4512-14. 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 Nitroimidazole Antimicrobial class.

Pharmacologic class Nitroimidazole Antimicrobial

Drug family (ATC) Nitroimidazole derivatives

How it works Cytochrome P450 2D6 Inhibitors, Cytochrome P450 1A2 Inhibitors, Cytochrome P450 2B6 Inhibitors, Cytochrome P450 2C19 Inhibitors

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSanofi-Aventis U.S. LLC

Application holderSANOFI AVENTIS US LLC

FDA applicationNDA214429 (NDA)

Labeler code00024

First marketedJul 2021

Product typeHuman Prescription Drug

Portfolio84 products on file

🔎 All NDCs from Sanofi-Aventis U.S. LLC

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

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.

6 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 system	Per each	Per 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.

Try another pack size: 24 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Fexinidazole 600 mgthis 00024-4512-14	Sanofi-Aventis	14 tablets	—	—	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

🏛️

2021

First FDA approval

Jul 2021

📍

2026

Currently FDA-listed

5 years listed

🛡️

2028

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 Jul 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.

📅 FDA approved Jul 16, 2021 RLD RS ⏳ ~1.8 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

Exclusivity NCE

Exclusivity ODE-359

2021 2023 2025 2027

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.

FDA exclusivity

Code	What it grants	Expires
NCE	New Chemical Entity (5-year)	Jul 16, 2026
ODE-359	Orphan Drug Exclusivity (7-year)	Jul 16, 2028

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 Jul 2028 — 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 NDC	Description	Marketing start	Status
00024-4512-14 You're viewing this	14 TABLET in 1 DOSE PACK (0024-4512-14)	2021-07-16	Active
00024-4512-24	24 TABLET in 1 DOSE PACK (0024-4512-24)	2021-07-16	Active

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

Pack size FAQ

What quantity is in NDC 00024-4512-14?

NDC 00024-4512-14 is a 14-count package — 14 tablet in 1 dose pack.

What is the difference between NDC 00024-4512-14 and NDC 00024-4512-24?

Both are Fexinidazole 600 mg Tablet — the drug itself is identical. NDC 00024-4512-14 is the 14-count package, while NDC 00024-4512-24 is the 24 tablets package.

What NDC number is used to bill for this package of Fexinidazole 600 mg Tablet?

Bill NDC 00024-4512-14 — the 11-digit billing format is 00024451214. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	✓ Available
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 0024-4512-14, 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: 00024-4512-14, written without dashes as 00024451214. 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 00024-4512-14, the first segment (00024) is the labeler code FDA assigned to Sanofi-Aventis U.S. LLC; the middle segment (4512) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (14) 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 Sanofi-Aventis U.S. LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 24 tablets (00024-4512-24). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Sanofi-Aventis U.S. LLC 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients

🎯 Indications and Usage 193 words ▾

1 INDICATIONS AND USAGE Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Fexinidazole Tablets is a nitroimidazole antimicrobial, indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.

( 1 ) Limitations of Use Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/µL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options. ( 1 , 5.1 ) Limitations of Use Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/µL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1) ] .

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer Fexinidazole Tablets once daily with food each day at about the same time of the day. Do not break or crush tablets. ( 2.1 , 2.2 ) Recommended Dosage of Fexinidazole Tablets in Patients 6 years of age and older and weighing at least 20 kg ( 2.2 ) Body Weight Type of Dose Daily Dose Number of Tablets Duration of Treatment Greater than or equal to 35 kg Loading dose 1,800 mg 3 4 days Maintenance dose 1,200 mg 2 6 days Greater than or equal to 20 kg to less than 35 kg Loading dose 1,200 mg 2 4 days Maintenance dose 600 mg 1 6 days

2.1Important Administration Instructions Patients should be closely followed by their healthcare provider during treatment with Fexinidazole Tablets. Fexinidazole Tablets must be administered with food [see Dosage and Administration (2.2) ] . Avoid consumption of alcoholic beverages during treatment with Fexinidazole Tablets and for at least 48 hours after completing therapy [see Warnings and Precautions (5.6) ] .

If a first event of vomiting occurs after receiving Fexinidazole Tablets, do not re-dose . Administer the next dose the following day using the recommended treatment schedule [see Adverse Reactions (6.1) ] . If a scheduled dose is missed (not taken on the assigned day), normal dosing should resume the following day until the full course (10 days) of treatment has been completed .

The clinical consequences of multiple missed doses of Fexinidazole Tablets are not known .

2.2Recommended Dosage Administer Fexinidazole Tablets, orally, once daily for a total of 10 days (loading dose plus maintenance dose) with food each day at about the same time of the day. Do not break or crush Fexinidazole Tablets. The recommended dosage of Fexinidazole Tablets for patients 6 years of age and older is according to body weight as described in Table 1 below.

Table 1: Recommended Dosage of Fexinidazole Tablets in Patients 6 Years of Age and Older and Weighing at Least 20 kg Body weight Type of Dose Recommended Administer Fexinidazole Tablets once daily with food each day at about the same time of the day Daily Dose Number of 600 mg Fexinidazole Tablets Daily Duration of Treatment Greater than or equal to 35 kg Loading dose 1,800 mg 3 4 days Maintenance dose 1,200 mg 2 6 days Greater than or equal to 20 kg to less than 35 kg Loading dose 1,200 mg 2 4 days Maintenance dose 600 mg 1 6 days

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 600 mg of fexinidazole per tablet as pale-yellow, round, biconvex tablets debossed with "4512" on one side. Tablets: 600 mg ( 3 )

⛔ Contraindications 106 words ▾

4 CONTRAINDICATIONS Fexinidazole Tablets are contraindicated in: Patients with known hypersensitivity to Fexinidazole Tablets and/or any nitroimidazole-class drugs (e.g., metronidazole, tinidazole). Patients with severe hepatic impairment [see Warnings and Precautions (5.5) , Adverse Reactions (6.1) , and Use in Specific Populations (8.7) ] . Patients with Cockayne syndrome.

Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole, another nitroimidazole drug, structurally related to fexinidazole, in patients with Cockayne syndrome [see Adverse Reactions (6.2) ] . Known hypersensitivity to fexinidazole, and/or nitroimidazole drugs ( 4 ) Patients with severe hepatic impairment ( 4 ) Patients with Cockayne syndrome ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Decreased Efficacy in Severe Human African Trypanosomiasis caused by Trypanosoma brucei gambiense. ( 1 , 5.1 ) QT Interval Prolongation: Prolongation of the QT interval due to Fexinidazole Tablets occurs in a concentration-dependent manner. Avoid use in patients with known prolongation, proarrhythmic conditions, and concomitant use with drugs that prolong the QT interval, those that block cardiac potassium channels, and/or those that induce bradycardia, or are inducers of hepatic CYP450.

( 5.2 , 7.1 , 7.2 , 12.2 ) Neuropsychiatric Adverse Reactions: Adverse reactions such as agitation, anxiety, abnormal behavior, depression, suicidal ideation, nightmares, hallucination, and personality change have been observed during therapy. Inform patients and their caregivers of the risk. Consider alternative therapy or increased monitoring of the patient, including hospitalization in patients with psychiatric disorders, or if these adverse reactions occur.

( 5.3 ) Neutropenia: Avoid concomitant use of drugs which may cause neutropenia and monitor leukocyte count periodically. Monitor patients with neutropenia for symptoms or signs of infection. ( 5.4 , 6.1 ) Potential for Hepatotoxicity: Evaluate liver-related laboratory tests at the start and during treatment.

( 4 , 5.5 ) Risk of Disulfiram-like Reactions Due to Concomitant Use with Alcohol: Nitroimidazole-class drugs may cause a disulfiram-like reaction in patients who concurrently consume alcohol. Advise patients to avoid consumption of alcohol during treatment with and for at least 48 hours after completing therapy. ( 2.1 , 5.6 ) Risk of Psychotic Reactions Due to Concomitant Use with Disulfiram: Psychotic reactions have been reported in patients concurrently taking disulfiram and nitroimidazole-class drugs.

Avoid use in patients who have taken disulfiram within the last two weeks. ( 5.7 ).

5.1Decreased Efficacy in Severe Human African Trypanosomiasis Caused by Trypanosoma brucei gambiense Decreased efficacy was observed in patients treated with Fexinidazole Tablets as compared to nifurtimox-eflornithine combination therapy (NECT)-treated patients in a randomized, comparative open-label study in the subgroup of patients with severe second stage disease, as defined by cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/µL at baseline [see Clinical Studies (14) ] . The 18-month success rate in this subgroup of patients with severe second stage disease was 86.9% with Fexinidazole Tablets compared to 98.7% with NECT with a difference of -11.8%, 95% confidence interval (CI) (-18.3%, -2.1%).

All-cause mortality was higher in patients with severe disease treated with Fexinidazole Tablets than in patients treated with NECT through 24 months (7/160 [4.4%] vs 0/78 [0%], treatment difference 4.4%, 95% CI [-0.9%, 8.9%]). Patients with severe second stage HAT (CSF-WBC >100 cells/µL) due to T. brucei gambiense disease should only be treated with Fexinidazole Tablets if there are no other available treatment options.

5.2QT Interval Prolongation Fexinidazole Tablets have been shown to prolong the QT interval in a concentration-dependent manner [see Clinical Pharmacology (12.2) ] . Treatment with Fexinidazole Tablets caused an average increase of 19 msec in the QTcF interval. In clinical trials in HAT patients, three (<1%) patients in the fexinidazole group had a QTcF value of >500 ms versus none in the nifurtimox-eflornithine combination therapy (NECT) group.

Avoid use of Fexinidazole Tablets in patients who have: QTcF interval greater than 470 msec A history of torsade de pointes, congenital long QT syndrome, cardiac arrhythmias, uncompensated heart failure, or family history of sudden death Uncorrected hypokalemia Avoid concomitant administration of Fexinidazole Tablets with other drugs that are known to prolong the QT interval, those that block cardiac potassium channels, and/or those that induce bradycardia [see Drug Interactions (7.1) ] . Avoid concomitan…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Decreased Efficacy in Severe Human African Trypanosomiasis Caused by Trypanosoma brucei gambiense [see Warnings and Precautions (5.1) ] QT Interval Prolongation [see Warnings and Precautions (5.2) ] Neuropsychiatric Adverse Reactions [see Warnings and Precautions (5.3) ] Neutropenia [see Warnings and Precautions (5.4) ] Potential for Hepatotoxicity [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence >10%) are headache, vomiting, insomnia, nausea, asthenia, tremor, decreased appetite, dizziness, hypocalcemia, dyspepsia, back pain, upper abdominal pain, and hyperkalemia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 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. Fexinidazole Tablets were evaluated for the treatment of HAT due to T. brucei gambiense in three clinical trials, of which one was comparative and two were noncomparative. Trial 1 compared the safety of Fexinidazole Tablets to nifurtimox-eflornithine combination therapy (NECT) in second stage, meningoencephalitic HAT (N=394).

Trial 2 enrolled patients with stage 1 hemolymphatic and early stage 2 HAT (N=230), and Trial 3 assessed the safety of fexinidazole in pediatric patients aged 6 years or older with any stage HAT (N=125). The three trials were primarily conducted in the Democratic Republic of Congo (DRC) and a total of 749 patients received at least one dose of study medication. The patients ranged from 6 to 73 years of age, and 11 were more than 65 years old.

Trials 1 and 3 enrolled more males than females (61% and 54% were males, respectively), while the gender distribution was equally balanced in Trial 2. The mean BMI ranged from 16.1 to 19.3 kg/m 2 across trials which was consistent with the nutritional status of the study population. Patients with AST/ALT >2 times the upper limit of normal or total bilirubin >1.5 the upper limit of normal were excluded from the trials.

Trial 1 included 264 patients in the fexinidazole treatment arm and 130 patients in the NECT treatment arm. The patients were followed for up to 24 months from the completion of treatment. Common Adverse Reactions The most common adverse reactions occurring in >10% of HAT patients (15 years of age and older) receiving Fexinidazole Tablets in Trial 1 were headache, vomiting, insomnia, nausea, asthenia, tremor, decreased appetite, dizziness, hypocalcemia, dyspepsia, back pain, upper abdominal pain, and hyperkalemia.

Selected adverse reactions occurring in ≥2% of HAT patients 15 years of age and older receiving Fexinidazole Tablets in Trial 1 are provided in Table 2. Table 2: Selected Adverse Reactions Occurring in ≥2% of HAT Patients 15 Years of Age and Older Receiving Fexinidazole Tablets in Trial 1 Adverse Reaction Fexinidazole Tablets N=264 N (%) NECT N=130 N (%) Blood and lymphatic system disorders Neutropenia Defined as an absolute neutrophil count of less than 1,000 cells/mm 3 occurring at any time following the first dose of study drug to the end of the study.

15 (5.7%) 4 (3.1%) Cardiac disorders Palpitations 13 (4.9%) 5 (3.8%) Eye disorders Photophobia 6 (2.3%) 0 Gastrointestinal disorders Vomiting 75 (28.4%) 37 (28.4%) Nausea 68 (25.8%) 20 (15.4%) Dyspepsia 34 (12.9%) 10 (7.7%) Abdominal pain upper 27 (10.2%) 6 (4.6%) Salivary hypersecretion 16 (6.1%) 3 (2.3%) Constipation 13 (4.9%) 2 (1.5%) Abdominal distension 8 (3.0%) 0 Gastritis 8 (3.0%) 2 (1.5%) General disorders and administration site conditions Asthenia 60 (22.7%) 19 (14.6%) Feeling hot 25 (9.5%) 3 (2.3%) Chest pain 23…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Avoid use of herbal medicines and supplements. ( 7.1 ) See full prescribing information for complete list of clinically significant drug interactions. ( 7.2 )

7.1Pharmacodynamic Interactions Herbal Medicines and Supplements There is a potential for pharmacodynamic interactions and/or toxicities between fexinidazole and herbal medicines and supplements. Avoid concomitant use of herbal medicines and supplements during treatment with Fexinidazole Tablets. Drugs that May Prolong the QT Interval and/or Induce Bradycardia Coadministration of Fexinidazole Tablets with drugs known to block potassium channels (e.g., antiarrhythmics, neuroleptics, fluoroquinolones, imidazole and triazole antifungals, pentamidine) prolong the QT interval (e.g., antimalarials, phenothiazines, tricyclic antidepressants, terfenadine and astemizole, IV erythromycin, and quinolone antibacterial drugs) and/or induce bradycardia (such as β-blockers) should be avoided [see Warnings and Precautions (5.2) ] .

7.2Pharmacokinetic Drug Interactions Table 3: Effect of Fexinidazole on other Drugs Drugs Metabolized by Cytochrome P450 (CYP) 3A4/5 Examples (not fully inclusive): Lovastatin, simvastatin, nisoldipine, saquinavir, midazolam, certain hormonal contraceptives (e.g., birth control pills, skin patches, implant) Clinical Impact Fexinidazole is considered a moderate CYP3A4/5 inducer [see Clinical Pharmacology (12.3) ] . Co-administration of Fexinidazole Tablets and CYP3A4/5 substrates may reduce the systemic exposures of CYP3A4/5 substrate drug(s), which may lead to reduced efficacy [see Clinical Pharmacology (12.3) ] .

Prevention or Management Avoid concomitant use with Fexinidazole Tablets . If coadministration cannot be avoided, monitor for lack of efficacy of sensitive substrate drugs. If concomitant use of oral contraceptives cannot be avoided, an alternative contraceptive that is not affected by enzyme inducers (e.g., intrauterine system) or additional nonhormonal contraception (e.g., condoms) is recommended during treatment with Fexinidazole Tablets and for at least 5 days after the last dose.

Drugs Metabolized by CYP1A2 or CYP2C19 Examples (not fully inclusive): CYP1A2: duloxetine, tacrine, tizanidine, theophylline CYP2C19: lansoprazole, mephenytoin, diazepam Clinical Impact Increased risk for adverse reactions associated with increased concentrations of the drug due to inhibition of either CYP1A2 or CYP2C19 by fexinidazole [see Clinical Pharmacology (12.3) ] . Prevention or Management Monitor for adverse reactions associated with these drugs when used concomitantly with Fexinidazole Tablets. Drugs Metabolized by CYP2B6 Examples (not fully inclusive): Bupropion, efavirenz Clinical Impact Increased risk for the lack of efficacy associated with decreased plasma concentrations of the drug due to induction of CYP2B6 by fexinidazole and Metabolite M1 [see Clinical Pharmacology (12.3) ] .

Prevention or Management Avoid concomitant use with Fexinidazole Tablets. If coadministration cannot be avoided, monitor for lack of efficacy of these drugs. Drugs Metabolized by uridine 5'-diphospho--glucuronosyl transferase (UGT) Examples (not fully inclusive): Zidovudine, bictegravir, cabotegravir, dolutegravir, bexagliflozin, canagliflozin, sotagliflozin, deferasirox, lamotrigine, selexipag Clinical Impact Fexinidazole metabolites have the potential to be UGT inducers [see Clinical Pharmacology (12.3) ] .

Co-administration of Fexinidazole Tablets and UGT substrates may reduce the systemic exposures of UGT substrate drug(s), which may lead to reduced efficacy. Prevention or Management When fexinidazole is concomitantly administered with UGT substrates, monitor for lack of efficacy of UGT substrate drugs. Drugs Substrates of OCT2, OAT1, OAT3, MATE1, and MATE2-K Transporters Examples (not fully inclusive): Metformin, dofetilide, adefovir, cefaclor, furosemide Clinical Impact Increased risk for adverse reactions associated with increased concentrations of t…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Avoid use in patients with severe renal impairment. ( 8.6 )

8.1Pregnancy Risk Summary There are risks to the mother and fetus associated with untreated HAT due to T. brucei gambiense during pregnancy (see Clinical Considerations ) . Available data from clinical trials with fexinidazole use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects or miscarriage. There were no effects on prenatal development in embryo-fetal studies where pregnant rats were administered oral fexinidazole during organogenesis at a dose similar to the clinical dose based on AUC comparisons.

Effects of fexinidazole on embryo-fetal development were observed in the rat and in the rabbit at doses harmful to the dams only. Exposure of fexinidazole and its metabolites at those maternal toxic doses in rats and rabbits were 2 times and less than 0.02 times the clinical exposure, respectively. In the prenatal and postnatal development study, administration of oral fexinidazole to pregnant rats during organogenesis and through lactation resulted in lower body weights in first generation offspring from dams treated at approximately 1.03 times the clinical exposure based on AUC comparisons.

The estimated 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.

Clinical Considerations Disease-associated maternal and/or embryo/fetal Risk There are adverse effects on maternal and fetal outcomes associated with untreated HAT due to T. brucei gambiense in pregnancy. Disease progression may occur during pregnancy. Pregnant women should be treated for HAT due to T. brucei gambiense during pregnancy to prevent vertical transmission.

For timing of treatment during pregnancy, consider the benefits of Fexinidazole Tablets to the mother and the potential risks to the fetus. Data Animal data In the embryo-fetal toxicity studies, pregnant rats were exposed from gestation day (GD) 6 through GD 17. There was no effect on prenatal development in the rat up to the daily dose of 200 mg/kg, similar to the clinical dose based on AUC comparisons.

Maternal toxicity was evidenced by the significantly reduced body weight gain observed at 800 mg/kg. Delayed ossification (sternebrae, metacarpals and caudal vertebrae) and reduced fetal and placental weights were observed in the presence of maternal toxicity. In the rabbit embryo-fetal development study, pregnant rabbits were exposed from GD 6 to GD 20.

Fexinidazole resulted in abortions in the presence of maternal toxicity (reduced food consumption and reduced body weight gain) at doses of 20 mg/kg/day and above, less than 0.02 times the clinical exposures, based on pharmacokinetics comparisons. In the prenatal and postnatal development study, female rats were exposed from GD 6 to lactation day 21. Lower body weights were reported in F1 pups from dams treated (approximately 1.03 times the clinical exposure based on AUC comparisons) throughout lactation.

Sexual maturity showed a minimal delay for both males and females. Postweaning development for behavior and reproductive performance did not indicate any late adverse effect on the progeny.

8.2Lactation Risk Summary There are no data on the presence of fexinidazole in human milk or the effect on milk production. There are no reports of adverse effects to the breastfed child associated with fexinidazole exposure through breastmilk based on a limited number of reported cases. Fexinidazole is present in rat 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…

🤰 Pregnancy ~2 min read ▾

Sexual maturity showed a minimal delay for both males and females. Postweaning development for behavior and reproductive performance did not indicate any late adverse effect on the progeny.

🧒 Pediatric Use 174 words ▾

8.4Pediatric Use The safety and effectiveness of Fexinidazole Tablets for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) HAT due to Trypanosoma brucei gambiense have been established in pediatric patients aged 6 years and older and weighing at least 20 kg. Use of Fexinidazole Tablets for this indication is supported by evidence from an adequate and well-controlled trial in adults with additional efficacy, pharmacokinetic and safety data in pediatric patients aged 6 years and older [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ] .

Pediatric patients may be more sensitive to vomiting. The safety profile for Fexinidazole Tablets in pediatric patients was generally similar to that of adult patients with the exception of more frequent vomiting within 2 hours of administration of Fexinidazole Tablets. Vomiting did not result in permanent treatment discontinuation [see Adverse Reactions (6.1) ] .

The safety and efficacy of Fexinidazole Tablets have not been established in pediatric patients younger than 6 years old and/or less than 20 kg in body weight.

🧓 Geriatric Use 60 words ▾

8.5Geriatric Use Of the 619 subjects in the three clinical trials treated with Fexinidazole Tablets for HAT, there were 11 subjects who were 65 years of age or older, and no subjects greater than 75 years of age. There were an insufficient number of elderly subjects to detect differences in safety and/or effectiveness between elderly and younger adult patients.

🆘 Overdosage 112 words ▾

10 OVERDOSAGE Randomized, controlled clinical studies were conducted in normal adult male subjects who were administered single or multiple oral doses of fexinidazole of up to 3,600 mg daily for 14 days (not an approved dose). The subjects experienced adverse reactions of increased transaminases, vomiting and panic attack [see Adverse Reactions (6.1) ] . Reported symptoms of overdosage in a pediatric HAT patient following ingestion of a higher than recommended dosing regimen in Trial 3 included vomiting over the first 5 days of treatment and increased potassium and decreased calcium levels from Day 11 to Week 9.

There is no specific antidote for Fexinidazole Tablets. Treatment should be supportive with appropriate monitoring.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fexinidazole is an antiprotozoal drug [see Microbiology (12.4) ] .

12.2Pharmacodynamics Cardiac Electrophysiology Concentration-dependent QTcF prolongation was observed with administration of Fexinidazole Tablets. Based on the exposure-response relationship, the mean (upper 90% confidence interval) increase in QTcF is predicted to be 19.0 msec (23.3 msec) at the recommended dosing regimen. The observed increase in QTcF appears to be associated with the M2 (sulfone) metabolite of fexinidazole [see Warning and Precautions (5.2) ] .

12.3Pharmacokinetics The pharmacokinetics (PK) of fexinidazole and its two pharmacologically active M1 (sulfoxide) and M2 (sulfone) metabolites following administration of the recommended adult dosage regimen of Fexinidazole Tablets in 12 healthy adult male subjects under fed conditions are presented in Table 5. Table 5: Pharmacokinetics of Fexinidazole and its Active M1 and M2 Metabolites following Administration of Fexinidazole Tablets 1,800 mg Once Daily for 4 Days, Then 1,200 mg Once Daily for 6 Days to Healthy Adult Subjects Under Fed Conditions (N=12) Fexinidazole M1 M2 C max = maximum plasma concentration; T max = time to maximum concentration; CSF = cerebrospinal fluid; CYP = cytochrome P450 enzymes; AUC 0–24 hours = area under the plasma concentration-time curve from time zero to 24 hours, AUC 0–t = area under the plasma concentration-time curve from time zero to the last timepoint with measurable analyte concentrations; DBS = dried blood spot NA: Not available or not applicable Mean (±SD) C max mcg/mL Day 1 1.6 (±0.4) 8.1 (±2.2) 7.5 (±3.3) Day 4 0.8 (±0.3) 8.0 (±2.3) 19.6 (±5.4) Day 10 0.5 (±0.2) 5.9 (±2.1) 12.5 (±3.5) Mean (±SD) AUC (0–24 hours) mcg∙h/mL Day 1 14.3 (±2.6) 102.3 (±28.5) 110.1 (±41.1) Day 4 11.6 (±2.2) 127.9 (±49.2) 391.5 (±126.7) Day 10 7.0 (±2.5) 84.2 (±36.3) 252.4 (±73.6) Absorption Median T max (Range) on Day 4 , hours 4 (0–9) 4 (0–6) 6 (0–24) Effect of Food The effect of food following administration of a single 1,200 mg dose with a meal containing approximately 963 Kcal with 62% of total calories from fat, 17% from protein, and 21% from carbohydrate (n=12).

The AUC of fexinidazole, M1, and M2 were approximately 4 to 5-fold higher following administration with food compared to the fasted state. Distribution Apparent Volume of Distribution on Day 4, L 3222 (±1199) NA NA Plasma Protein Binding 98% 41% 57% Mean (Range) CSF concentrations at 24 hours after the last fexinidazole dose on Day 10, mcg/mL From study in patient with HAT. NA 1.39 (0–4.5) 6.45 (0.3–14.9) Mean (Range) CSF to DBS Ratios NA 0.53 (0.1–2.2) 0.36 (0.1–0.8) Elimination Mean (±SD) Day 10 Half-life, hours 15 (±6) 16 (±6) 23 (±4) Mean (±SD) Apparent Clearance on Day 4, L/hour 161 (±37) NA NA Metabolism Fexinidazole Fexinidazole is metabolized to M1 by several CYP450 enzymes, including CYP3A4 and flavin monooxygenases.

Active Metabolites Several CYP450 enzymes including, CYP3A4 and flavin monooxygenases, are involved in the metabolism of M1 to M2. M2 is not further metabolized. The AUC 0–24 of M1 and M2 are 11 and 34-fold higher, respectively, than that of fexinidazole.

Excretion Urine Less than 3.2% of a given dose of Fexinidazole Tablets, primarily as M1 and M2 metabolites Specific Populations Elderly patients No specific pharmacokinetic studies have been performed in patients older than 65 years of age. In a population PK analysis of patients with HAT over a range of ages from 6 to 71 years, age was not a significant covariate affecting the PK of fexinidazole and the M1 and M2 metabolites and no differences in the PK of any of these three moieties were observed. Pediatric patients The ranges of plasma AUC values of fexinidazole, M1, and M2 in pediatric and adult HAT patients with body weights greater than or equal to 20 kg were overlapping following administration of Fexinidazole Tablets at the recommended pediatric and adult dosage regimens, indicating si…

🧬 Mechanism of Action 14 words ▾

12.1Mechanism of Action Fexinidazole is an antiprotozoal drug [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 91 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Fexinidazole 600 mg tablets are pale-yellow, round, biconvex tablets debossed with "4512" on one side. Fexinidazole 600 mg tablets are supplied as: NDC 0024-4512-24, child-resistant blister pack of 24 tablets (10-day dose pack) for adults and pediatric patients weighing 35 kg or more. NDC 0024-4512-14, child-resistant blister pack of 14 tablets (10-day dose pack) for pediatric patients older than 6 years weighing 20 kg to less than 35 kg.

Store below 30°C (86°F). Store in the original package in order to protect from light and moisture.

📦 Storage and Handling 17 words ▾

Store below 30°C (86°F). Store in the original package in order to protect from light and moisture.

📋 Description 100 words ▾

11 DESCRIPTION Fexinidazole Tablets contain fexinidazole, a nitroimidazole antimicrobial drug for oral use. The chemical name of fexinidazole is 1-methyl-2-{[4-(methylthio)phenoxy]methyl}-5-nitro-1H-imidazole. Its molecular formula is C 12 H 13 N 3 O 3 S and the molecular weight is 279.3 g/mol.

The structural formula is: Fexinidazole is a yellow powder. It is practically insoluble in water, sparingly soluble in acetone and acetonitrile, very slightly soluble in ethanol and slightly soluble in methanol. Fexinidazole 600 mg Tablets contain the active ingredient fexinidazole and the following inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate.

Chemical Structure

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Administration with Food Advise the patient that Fexinidazole Tablets must be taken with food each day at about the same time of the day (e.g., during or immediately after the main meal of the day), to make sure it is adequately absorbed [see Dosage and Administration (2.1 , 2.2) ] . Alcohol Consumption Advise patients not to consume alcoholic beverages during treatment with Fexinidazole Tablets and for at least 48 hours after completing Fexinidazole Tablets therapy [see Dosage and Administration (2.1) and Warnings and Precautions (5.6) ] .

Vomiting Advise the patient not to administer an additional dose if vomiting occurs after the administration of Fexinidazole Tablets but continue with the next scheduled dose the following day. If a second event of vomiting occurs after administration of any other dose of Fexinidazole Tablets, counsel the patient on the importance of contacting the healthcare provider immediately [see Dosage and Administration (2.1) ] . Missed Doses Advise patients that if a scheduled dose is missed (not taken on the assigned day), normal dosing should resume the following day until the full course (10 days) of treatment has been completed.

Counsel the patient on the importance of contacting the health care practitioner immediately if a second scheduled dose is missed [see Dosage and Administration (2.1) ] . Neuropsychiatric Adverse Reactions Counsel patients and their caregivers of the risk for neuropsychiatric adverse reactions, such as insomnia, headache, tremor, mood changes, psychiatric disorders (such as agitation, anxiety, abnormal behavior, depression, nightmares, hallucination, and personality change) and suicidal ideation [see Warnings and Precautions (5.3) and Adverse Reactions (6.1) ] .

If such adverse reactions occur, advise the patients and their caregivers to contact their healthcare provider immediately. Dizziness Counsel the patient that they should not drive or use machines if they feel tired or dizzy. Dizziness, fatigue, asthenia, and somnolence have been reported following treatment with Fexinidazole Tablets [see Adverse Reactions (6.1) ] .

Drug Interactions Advise patients to disclose to their healthcare provider all other medications, including herbal medicines, the patient is currently taking while being treated with fexinidazole tablets [see Drug Interactions (7) ] .

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

abdominal distension: A swollen or stretched feeling in the belly, often from gas or fluid.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

absolute neutrophil count: A blood test number showing how many infection-fighting neutrophil white blood cells you have.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agitation: A state of feeling restless and upset and being unable to relax, sometimes with pacing or fidgeting.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

anxiety: A feeling of worry, nervousness, or unease, sometimes along with a racing heart or restlessness.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

asthenia: Unusual weakness or lack of physical strength and energy.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

contraception: Methods used to prevent pregnancy, such as birth control pills, condoms, or an intrauterine device.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP1A2: A liver enzyme that breaks down certain medicines and whose activity can be changed by cigarette smoke.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

Distribution: How a medicine spreads from the blood into the body's tissues and organs after it is absorbed.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

embryo-fetal toxicity: Harm to a developing baby in the womb, such as birth defects, slowed growth, or loss of the pregnancy.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

Excretion: How the body removes a medicine or its leftover pieces, mainly through the urine or stool.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

gastritis: Swelling or irritation of the lining of the stomach.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

hallucination: Seeing, hearing, feeling, or smelling something that is not actually there.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperkalemia: A higher-than-normal level of potassium, an important mineral, in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inducer: A substance that speeds up an enzyme, which can lower the levels of drugs that enzyme breaks down.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

lactation: The making and release of milk from a mother's breasts after giving birth.

loading dose: A larger dose given at the start to quickly build the medicine up to an effective level in the body.

maintenance dose: The regular ongoing dose taken to keep a steady, effective amount of medicine in the body over time.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

neutrophil: A type of white blood cell that is one of the body's main defenders against infection.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

palpitations: The feeling that your heart is racing, pounding, fluttering, or skipping beats.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

photophobia: Discomfort or pain in the eyes when exposed to light.

plasma concentration: The amount of medicine measured in the liquid part of the blood at a given time.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

protein binding: How much of a medicine sticks to proteins in the blood instead of moving freely through the body.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

substrate: A drug or other substance that a particular enzyme or transporter acts on.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

transaminases: Liver enzymes measured in a blood test; higher-than-normal levels can be a sign that the liver is irritated or damaged.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

UGT: A family of enzymes that attach a sugar-like molecule to a drug, making it easier for the body to remove.

upper limit of normal: The highest value considered normal for a lab test; results above it are flagged as elevated.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

volume of distribution: A calculated value showing how widely a medicine spreads into body tissues versus staying in the blood.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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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.

Fexinidazole 600 mg Tablet, 14-count

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