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Xeomin incobotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution, 1 vial — NDC 46783-0160-10 package photo

Xeomin incobotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution, 1 vial

by Merz North America, Inc. · 1 VIAL, SINGLE-USE in 1 CARTON (46783-160-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE
NDC 46783-0160-10
🏷️ FDA NDC (as labeled) 46783-160-10 billing pads the product segment with a zero
This package
Contains1 vial Pack sizes2 compare ↓
Also comes in: 1 vial 46783-0160-01
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) 46783-160-10
Product NDC 46783-160
11-digit billing NDC 46783016010
RxCUI 1009456, 1009459, 1732157, 1732161
UNII E211KPY694
UPC 0346783165018, 0346783160013
Application # BLA125360
SPL Set ID 3f35d6e0-3450-4abc-a0da-cc7b277e7c6e
Established class (EPC) Acetylcholine Release Inhibitor; Neuromuscular Blocker
Mechanism of action Acetylcholine Release Inhibitors
Physiologic effect Neuromuscular Blockade
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2011-08-01
Route INTRAMUSCULAR
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Substance BOTULINUM TOXIN TYPE A
GCN Seq No 065731
GCN 27767
HICL code 036687
Ingredient (HICL) Incobotulinumtoxina
HIC1 code S
Therapeutic class — broad (HIC1) Locomotor System
HIC2 code S7
Therapeutic class — intermediate (HIC2) Affect Primarily Skeletal Muscle
HIC3 code S7A
Therapeutic class — specific (HIC3) Neuromuscular Blocking Agents
AHFS code 12:20.20.24
AHFS class Botulinum Toxins
FDB label name XEOMIN 100 UNIT VIAL
FDB brand name Xeomin
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 46783-160-10 — 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 → 46783-0160-10. 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.

🏷️ RxNorm drug class

This medicine belongs to the Acetylcholine Release Inhibitor class.

Pharmacologic class Acetylcholine Release Inhibitor, Neuromuscular Blocker
How it works Acetylcholine Release 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

LabelerMerz North America, Inc.
FDA applicationBLA125360 (BLA)
Labeler code46783
First marketedAug 2011
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

Label name XEOMIN 100 UNIT VIAL Ingredient Incobotulinumtoxina
📗 Our plain-language guide HelloPharmacist
  • Xeomin is a purified form of botulinum toxin type A — the same general family as Botox and Dysport, but formulated differently. One key difference is that Xeomin doesn't contain ce...
  • What exactly is Xeomin and how is it different from other botulinum toxin shots?
  • The timing and duration depend on what you're being treated for. For most conditions, the effects aren't immediate — it can take days to weeks to feel the full benefit. The effects...
  • How soon will I notice it working, and how long does it last?
📖 Read our full IncobotulinumtoxinA Injection guide →

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 ZIF514RVZR
    A protein derived from human blood plasma. In medicines, it acts as a stabilizer and binder, helping maintain drug potency and form, and may improve how the medication disperses or dissolves in the body.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

2 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.
Try another pack size: 1 vial
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
Xeomin 100 [USP'U] 00259-4110-01 Merz 1 vial — — FDA listed —
Xeomin 100 [USP'U] 00259-1610-01 Merz 1 vial — — FDA listed —
Xeomin 100 [USP'U]this 46783-0160-10 Merz 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
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 & biosimilar status

🏛️
2010
First FDA approval
Jul 2010
📍
2026
Currently FDA-listed
16 years listed
🔓
·
Biosimilar pathway open
listed protections lapsed 2022
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: The latest listed FDA patent/protection lapsed Jul 2022 — those protections no longer apply, though a biosimilar still needs FDA licensure and a manufacturer to market it.
📅 FDA approved Jul 30, 2010

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
XeominincobotulinumtoxinA
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2010 2012 2014 2016 2018 2020 2022
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJul 30, 2022
Common questions
Is there a biosimilar for XEOMIN 100 UNIT VIAL?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, 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 Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

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

Medicare Part D (outpatient prescription) spending for Xeomin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Xeomin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.23M
Claims incl. refills
1.1K
Beneficiaries
1K
Spend / beneficiary
$1,172.99
Spend / claim
$1,092.71
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46783-0160-01 1 VIAL, SINGLE-USE in 1 CARTON (46783-160-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2011-08-01 Active
46783-0160-10 You're viewing this 1 VIAL, SINGLE-USE in 1 CARTON (46783-160-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE 2011-08-01 Active

Pack size FAQ

What quantity is in NDC 46783-0160-10?
NDC 46783-0160-10 contains 1 vial — 1 vial, single-use in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-use.
What is the difference between NDC 46783-0160-10 and NDC 46783-0160-01?
Both are Xeomin incobotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution — the drug itself is identical. NDC 46783-0160-10 is the 1 vial package, while NDC 46783-0160-01 is the 1 vial package.
What NDC number is used to bill for this package of Xeomin incobotulinumtoxinA 100 [USP'U]/1 Injection, Powder, Lyophilized, For Solution?
Bill NDC 46783-0160-10 — the 11-digit billing format is 46783016010. 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 ✓ 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 46783-160-10, 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: 46783-0160-10, written without dashes as 46783016010. 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 46783-0160-10, the first segment (46783) is the labeler code FDA assigned to Merz North America, Inc.; the middle segment (0160) 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 Merz North America, Inc.. 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 1 vial (46783-0160-01). 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?
Merz North America, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection.

Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1) ] .

WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection.

Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. ( 5.1 )

🎯 Indications and Usage ~1 min read ▾

1 INDICATIONS AND USAGE XEOMIN is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the treatment or improvement of: Chronic sialorrhea in patients 2 years of age and older ( 1.1 ) Upper limb spasticity in patients 2 years of age and older ( 1.2 ) Cervical dystonia in adults ( 1.3 ) Blepharospasm in adults ( 1.4 ) the appearance of upper facial lines in adults: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity ( 1.5 ) moderate to severe horizontal forehead lines associated with frontalis muscle activity ( 1.5 ) moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity ( 1.5 )

1.1Chronic Sialorrhea XEOMIN is indicated for the treatment of chronic sialorrhea in patients 2 years of age and older.

1.2Upper Limb Spasticity XEOMIN is indicated for the treatment of upper limb spasticity in patients 2 years of age and older.

1.3Cervical Dystonia XEOMIN is indicated for the treatment of cervical dystonia in adult patients.

1.4Blepharospasm XEOMIN is indicated for the treatment of blepharospasm in adult patients.

1.5Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) XEOMIN is indicated in adult patients for the temporary improvement in the appearance of upper facial lines: moderate to severe glabellar lines (GL) associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines (HFL) associated with frontalis muscle activity moderate to severe lateral canthal lines (LCL) associated with orbicularis oculi muscle activity.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Chronic Sialorrhea : Chronic Sialorrhea in Adults: the recommended total dose is 100 Units per treatment session consisting of 30 Units per parotid gland and 20 Units per submandibular gland, no sooner than every 16 weeks ( 2.2 ) Chronic Sialorrhea in Pediatric Patients: the recommended dose is based on body weight administered in a 3:2 dose ratio into the parotid and submandibular glands, respectively, no sooner than every 16 weeks; ultrasound guidance recommended ( 2.2 ) Upper limb spasticity, cervical dystonia, and blepharospasm: the optimum dose, frequency, and number of injection sites in the treated muscle(s) should be based on severity and prior treatment response in patients previously treated with botulinum toxin; individualize dosing for each patient: Upper Limb Spasticity in Adults: the recommended total dose is up to 400 Units, divided among affected muscles ( 2.3 ) Upper Limb Spasticity in Pediatric Patients: the recommended total dose is 8 Units/kg (maximum 200 Units) per single upper limb or 16 Units/kg (maximum 400 U) in both upper limbs, divided among affected muscles ( 2.3 ) Cervical Dystonia: the recommended initial dose is 120 Units per treatment session ( 2.4 ) Blepharospasm: the recommended initial dose is 50 Units (25 Units per eye) ( 2.5 ) Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines): When treating all three areas simultaneously (glabellar lines, horizontal forehead lines, and lateral canthal lines), the maximum recommended dose is 64 Units ( 2.6 ).

When not treating simultaneously: Glabellar Lines: four Units into each of five sites, for a maximum dose of 20 Units Horizontal Forehead Lines treated simultaneously with Glabellar Lines: for HFL four Units into each of five sites (20 Units) and four Units into each of five GL sites (20 Units), for a maximum dose of 40 Units Lateral Canthal Lines: four Units into each of three sites per side (six injection sites in total), for a maximum dose of 12 Units per side (24 Units in total) Administer retreatment with XEOMIN no more frequently than every three months.

Reconstituted XEOMIN: Is intended for intramuscular or intraglandular injection in the parotid and submandibular glands only ( 2.7 ) Use for only one injection session and for only one patient ( 2.7 ) Instructions are specific for 50 Unit, 100 Unit, and 200 Unit vials ( 2.7 ) Store in a refrigerator (2°C to 8°C) and use within 24 hours ( 2.7 )

2.1Instructions for Safe Use The potency Units of XEOMIN for injection are specific to the preparation and assay method utilized. Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method [see Warnings and Precautions (5.2) and Description (11) ] . Reconstituted XEOMIN is intended for intramuscular or intra-salivary gland injection only.

Do not exceed the recommended maximum cumulative dose in a treatment session for any indication.

2.2Recommended Dose for Chronic Sialorrhea Chronic Sialorrhea in Adult Patients The recommended total dose per treatment session is 100 Units. XEOMIN is injected into the parotid and submandibular glands on both sides (i.e., 4 injection sites per treatment session). The recommended total dose per treatment session is 100 Units.

The dose is divided with a ratio of 3:2 between the parotid and submandibular glands (Table 1). Figure 1: Glands for Injection in Chronic Sialorrhea in Adult Patients Use the following guidelines if locating salivary glands using anatomic landmarks: 1) To inject the parotid gland, find the midpoint on the line connecting the tragus and mandible angle (Site A and B, respectively, Figure 1), approximately at the height of the ear lobe. Deliver the injection one finger breadth anterior to this site (Star 1, Figure 1).

2) To inject the submandibular gland, find the midpoint between the angle of the mandible and the tip of the chin…

💊 Dosage Forms and Strengths 48 words ▾

3 DOSAGE FORMS AND STRENGTHS For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial for reconstitution only with preservative-free 0.9% Sodium Chloride Injection, USP. For injection: 50 Units, 100 Units, or 200 Units lyophilized powder in a single-dose vial ( 3 )

⛔ Contraindications 80 words ▾

4 CONTRAINDICATIONS XEOMIN is contraindicated in patients with: Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation [see Warnings and Precautions (5.3) and Description (11) ] . Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection. Known hypersensitivity to the active substance botulinum neurotoxin type A or to any of the excipients ( 4 , 5.3 ) Infection at the proposed injection sites ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Respiratory, speech, or swallowing difficulties: increased risk if bilateral neck muscle injections are needed, or with pre-existing muscular disorders; immediate medical attention may be required ( 5.1 , 5.4 ) The potency Units of XEOMIN cannot be compared to or converted into Units of any other preparations of botulinum toxin products ( 5.2 ) Corneal exposure and ulceration: protective measures may be required ( 5.5 )

5.1Spread of Toxin Effect Postmarketing safety data from XEOMIN and other approved botulinum toxins suggest that botulinum toxin effects may, in some cases, be observed beyond the site of local injection. The symptoms are consistent with the mechanism of action of botulinum toxin and may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection.

Swallowing and breathing difficulties can be life threatening and there have been reports of death related to the spread of toxin effects. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can occur in adults treated for spasticity and other conditions, and particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including lower limb spasticity in children, and in approved indications, symptoms consistent with spread of toxin effect have been reported at doses comparable to or lower than doses used to treat cervical dystonia.

Patients or caregivers should be advised to seek immediate medical care if swallowing, speech, or respiratory disorders occur.

5.2Lack of Unit Equivalency Between Botulinum Toxin Products The potency Units of XEOMIN are specific to the preparation and assay method utilized. Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method [see Description (11) ] .

5.3Hypersensitivity Reactions Serious hypersensitivity reactions have been reported with botulinum toxin products. Hypersensitivity reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately.

The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction [see Contraindications (4) ].

5.4Dysphagia and Breathing Difficulties Treatment with XEOMIN and other botulinum toxin products can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing.

When distant effects occur, additional respiratory muscles may be involved [see Warnings and Precautions (5.4) ] . Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months, and require use of a feeding tube to maintain adequate nutrition and hydration.

Aspiration may result from severe dysphagia, and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised. Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles.

There have been post-marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions to XEOMIN are discussed in greater detail in other sections of the labeling: Spread of Effects from Toxin [see Warnings and Precautions (5.1) ] Lack of Unit Equivalency between Botulinum Toxin Products [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Dysphagia and Breathing Difficulties [see Warnings and Precautions (5.4) ] Corneal Exposure, Corneal Ulceration, and Ectropion in Patients Treated with XEOMIN for Blepharospasm [see Warnings and Precautions (5.5) ] Risk of Ptosis in Patients Treated for Glabellar Lines [see Warnings and Precautions (5.6) ] Human Albumin and Transmission of Viral Diseases [see Warnings and Precautions (5.7) ] The most commonly observed adverse reactions at rates specified below and greater than placebo are: Chronic Sialorrhea: Chronic Sialorrhea in Adults (≥4% of patients) : tooth extraction, dry mouth, diarrhea, and hypertension ( 6.1 ) Chronic Sialorrhea in Pediatric Patients (≥1% of patients): bronchitis, headache, and nausea/vomiting ( 6.1 ) Spasticity: Upper Limb Spasticity in Adults (≥2% of patients) : seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection ( 6.1 ) Upper Limb Spasticity in Pediatric Patients (≥3% of patients) : nasopharyngitis and bronchitis ( 6.1 ) Cervical Dystonia (≥5% of patients) : dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain ( 6.1 ) Blepharospasm (≥10% of patients) : eyelid ptosis, dry eye, visual impairment, and dry mouth ( 6.1 ) Upper facial lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines): (>1% of patients) : injection site bruising ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Merz Pharmaceuticals, LLC at 888-493-6646 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. Chronic Sialorrhea Chronic Sialorrhea in Adult Patients Table 6 lists the adverse reactions that occurred in ≥3% of XEOMIN-treated patients in the double-blind, placebo-controlled phase of the study in adult patients with chronic sialorrhea [see Clinical Studies (14.1) ] .

The most common adverse reactions (≥4%) were tooth extraction, dry mouth, diarrhea, and hypertension. In the controlled portion of this study, 74 patients received 100 Units of XEOMIN, and 36 patients received placebo. XEOMIN-treated patients were 21-80 years old (mean 65 years), and were predominantly male (71%) and White (99.5%).

Table 6: Adverse Reactions (≥3%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Adult Chronic Sialorrhea Study Adverse Reaction XEOMIN 100 Units (N = 74) % Placebo (N = 36) % Tooth extraction 5 0 Dry mouth 4 0 Diarrhea 4 3 Hypertension 4 3 Fall 3 0 Bronchitis 3 0 Dysphonia 3 0 Back pain 3 0 Dry eye 3 0 Chronic Sialorrhea in Pediatric Patients Table 7 lists the adverse reactions that occurred in ≥1% of XEOMIN-treated patients 6-17 years of age in the double-blind, placebo-controlled portion of the study in pediatric patients with chronic sialorrhea [see Clinical Studies (14.1) ] .

Of the patients 6-17 years of age, 148 patients received a dose of XEOMIN according to body weight, and 72 patients received placebo. Thirty-five patients 2-5 years of age received an open-label dose of XEOMIN according to body weight. XEOMIN-treated patients were 2-17 years of age (mean 10 years), predominately male (63%) and White (100%).

Table 7: Adverse Reactions (≥1%) and Greater for XEOMIN than Placebo: Double-Blind Phase of the Placebo-Controlled Pediatric Chronic Sialorrhea Study Adverse Reaction XEOMIN (6-17 years) (N = 148) % Placebo (6-17 years) (N = 72) % Bronchitis 1 0 Headache 1 0 Nausea/Vomitin…

🔄 Drug Interactions 157 words ▾

7 DRUG INTERACTIONS Aminoglycosides or other agents that interfere with neuromuscular transmission may potentiate the effect of XEOMIN; co-administer only with caution and close observation ( 7 )

7.1Aminoglycosides and Other Agents Interfering with Neuromuscular Transmission Co-administration of XEOMIN and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., tubocurarine-type muscle relaxants) should only be performed with caution as these agents may potentiate the effect of the toxin.

7.2Anticholinergic Drugs Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.

7.3Other Botulinum Neurotoxin Products The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

7.4Muscle Relaxants Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of XEOMIN.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy: based on animal data, may cause fetal harm ( 8.1 )

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. XEOMIN was embryotoxic in rats and increased abortions in rabbits when given at doses higher than the maximum recommended human dose (MRHD) for cervical dystonia (120 Units), on a body weight basis.

In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When XEOMIN was administered intramuscularly to pregnant rats during organogenesis (3 Units/kg, 10 Units/kg, or 30 Units/kg on gestational days [GDs] 6, 12, and 19; or 7 Units/kg on GDs 6 to 19; or 2 Units/kg, 6 Units/kg, or 18 Units/kg on GDs 6, 9, 12, 16, and 19), decreases in fetal body weight and skeletal ossification were observed at doses that were also maternally toxic.

The no-effect level for embryotoxicity in rats was 6 Units/kg (3 times the MRHD for cervical dystonia on a body weight basis). Intramuscular administration to pregnant rabbits during organogenesis (1.25 Units/kg,

2.5 Units/kg, or

5.0Units/kg on GDs 6, 18, and 28) resulted in an increased rate of abortion at the highest dose, which was also maternally toxic. In rabbits, the no-effect level for increased abortion was

2.5Units/kg (similar to the MRHD for cervical dystonia on a body weight basis).

8.2Lactation Risk Summary There are no data on the presence of XEOMIN in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XEOMIN and any potential adverse effects on the breastfed infant from XEOMIN or from the underlying maternal conditions.

8.4Pediatric Use The safety and effectiveness of XEOMIN have not been established in pediatric patients for the treatment of lower limb spasticity, cervical dystonia, and blepharospasm, or the temporary improvement in the appearance of upper facial lines: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines associated with frontalis muscle activity moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity [see Warnings and Precautions (5.1) ] .

Chronic Sialorrhea in Pediatric Patients The safety and effectiveness of XEOMIN have been established by evidence from an adequate and well-controlled study of XEOMIN in patients 6 to 17 years of age with chronic sialorrhea [see Clinical Studies (14.1) ] . Use of XEOMIN in patients 2 to 5 years of age is supported by the findings of efficacy and safety in patients 6 years and older with chronic sialorrhea, and by safety data in patients 2 to 5 years of age. Safety and effectiveness in pediatric patients below the age of 2 years have not been established [see Warnings and Precautions (5.1) ].

Upper Limb Spasticity in Pediatric Patients The safety and effectiveness of XEOMIN for the treatment of upper limb spasticity have been established by evidence from an adequate and well-controlled study of XEOMIN in pediatric patients 2 to 17 years of age [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) , and Clinical Studies (14.2) ]. Safety and effectiveness in pediatric patients below the age of 2 years have not been established [see Warnings and Precautions (5.1) ]. Juvenile Animal Toxicity Data In a study in which juvenile rats received intramuscular injections of Xeomin (0, 5, 10, or 30 Units/kg) every other week from postnatal day 21 for 10 weeks, decreased limb use, decreased body weight gain, skel…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. XEOMIN was embryotoxic in rats and increased abortions in rabbits when given at doses higher than the maximum recommended human dose (MRHD) for cervical dystonia (120 Units), on a body weight basis.

In the U.S. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal Data When XEOMIN was administered intramuscularly to pregnant rats during organogenesis (3 Units/kg, 10 Units/kg, or 30 Units/kg on gestational days [GDs] 6, 12, and 19; or 7 Units/kg on GDs 6 to 19; or 2 Units/kg, 6 Units/kg, or 18 Units/kg on GDs 6, 9, 12, 16, and 19), decreases in fetal body weight and skeletal ossification were observed at doses that were also maternally toxic.

The no-effect level for embryotoxicity in rats was 6 Units/kg (3 times the MRHD for cervical dystonia on a body weight basis). Intramuscular administration to pregnant rabbits during organogenesis (1.25 Units/kg,

2.5 Units/kg, or

5.0Units/kg on GDs 6, 18, and 28) resulted in an increased rate of abortion at the highest dose, which was also maternally toxic. In rabbits, the no-effect level for increased abortion was

2.5Units/kg (similar to the MRHD for cervical dystonia on a body weight basis).

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of XEOMIN have not been established in pediatric patients for the treatment of lower limb spasticity, cervical dystonia, and blepharospasm, or the temporary improvement in the appearance of upper facial lines: moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity moderate to severe horizontal forehead lines associated with frontalis muscle activity moderate to severe lateral canthal lines associated with orbicularis oculi muscle activity [see Warnings and Precautions (5.1) ] .

Chronic Sialorrhea in Pediatric Patients The safety and effectiveness of XEOMIN have been established by evidence from an adequate and well-controlled study of XEOMIN in patients 6 to 17 years of age with chronic sialorrhea [see Clinical Studies (14.1) ] . Use of XEOMIN in patients 2 to 5 years of age is supported by the findings of efficacy and safety in patients 6 years and older with chronic sialorrhea, and by safety data in patients 2 to 5 years of age. Safety and effectiveness in pediatric patients below the age of 2 years have not been established [see Warnings and Precautions (5.1) ].

Upper Limb Spasticity in Pediatric Patients The safety and effectiveness of XEOMIN for the treatment of upper limb spasticity have been established by evidence from an adequate and well-controlled study of XEOMIN in pediatric patients 2 to 17 years of age [see Warnings and Precautions (5.1) , Adverse Reactions (6.1) , and Clinical Studies (14.2) ]. Safety and effectiveness in pediatric patients below the age of 2 years have not been established [see Warnings and Precautions (5.1) ]. Juvenile Animal Toxicity Data In a study in which juvenile rats received intramuscular injections of Xeomin (0, 5, 10, or 30 Units/kg) every other week from postnatal day 21 for 10 weeks, decreased limb use, decreased body weight gain, skeletal muscle atrophy, and decreased bone growth and density were observed at all doses.

Male reproductive organ histopathology (atrophy of the germinal epithelium of the testis, associated with hypospermia) was observed at the mid and high doses, and mating behavior was impaired at the high dose. A no-effect dose for adverse effects on development in juvenile animals was not established. The lowest dose tested (5 Units/kg) is less than the human dose of 400 Units on a body weight (kg) basis.

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Chronic Sialorrhea Of the total number of 184 patients in the placebo-controlled study in chronic sialorrhea in adult patients [see Clinical Studies (14.1) ] , 107 were 65 years of age and over (46 treated with XEOMIN 100 Units, 44 treated with XEOMIN 75 Units, and 17 received placebo). No differences in safety or effectiveness were observed between older and younger patients. Other clinical studies have not identified differences in responses between older and younger patients, but increased sensitivity in older patients cannot be ruled out.

Upper Limb Spasticity Of the total number of 283 patients in the placebo-controlled studies in upper limb spasticity in adult patients [see Clinical Studies (14.2) ], 118 were 65 years of age and over (70 treated with XEOMIN and 48 received placebo), which included 12 patients 75 years of age and over (7 treated with XEOMIN and 5 received placebo). No overall differences in safety or effectiveness were observed between older and younger adult patients. Other clinical studies have not identified differences in responses between older and younger adult patients, but increased sensitivity in older patients cannot be ruled out.

Cervical Dystonia Of the total number of 233 patients in the placebo-controlled study in cervical dystonia [see Clinical Studies (14.3) ] , 29 were 65 years of age and over (19 treated with XEOMIN and 10 received placebo). Of these, ten XEOMIN-treated patients and four placebo-treated patients experienced an adverse event. For patients 65 years of age and over treated with XEOMIN, the most common adverse events were dysphagia (21%) and asthenia (11%).

Blepharospasm Of the total number of 169 patients in the placebo-controlled studies in blepharospasm [see Clinical Studies (14.4) ] , 61 were 65 years of age and over (45 treated with XEOMIN and 16 received placebo). No overall difference in effectiveness was observed between older and younger patients. Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) Of the total number of 547 subjects in the placebo-controlled clinical studies for glabellar lines [see Clinical Studies (14.5) ] , 21 subjects were 65 years of age and over.

Of the total number of 730 subjects in the placebo-controlled clinical studies for upper facial lines GL, HFL, and LCL [see Clinical Studies (14.5) ] , 46 subjects were 65 years of age and over. Clinical trials of XEOMIN showed no increase in the incidence of adverse events related to treatment with XEOMIN in patients 65 years of age and over but the trials did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

🆘 Overdosage 215 words ▾

10 OVERDOSAGE Excessive doses of XEOMIN may be expected to produce neuromuscular weakness with a variety of symptoms, particularly when treated intramuscularly. Respiratory support may be required where excessive doses cause paralysis of the respiratory muscles. In the event of overdose, the patient should be medically monitored for symptoms of excessive muscle weakness or muscle paralysis [see Warnings and Precautions (5.1 , 5.4) ].

Symptomatic treatment may be necessary. Symptoms of overdose are not likely to be present immediately following injection. Should accidental injection or oral ingestion occur, the person should be medically supervised for several weeks for signs and symptoms of excessive muscle weakness or paralysis.

There is no significant information regarding overdose from clinical studies of XEOMIN. In the event of overdose, antitoxin raised against botulinum toxin is available from the Centers for Disease Control and Prevention (CDC) in Atlanta, GA. However, the antitoxin will not reverse any botulinum toxin-induced effects already apparent by the time of antitoxin administration.

In the event of suspected or actual cases of botulinum toxin poisoning, please contact your local or state Health Department to process a request for antitoxin through the CDC. If you do not receive a response within 30 minutes, please contact the CDC directly at 770-488-7100. More information can be obtained at http://www.cdc.gov/ncidod/srp/drugs/formulary.html#1a .

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action XEOMIN blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine.

In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.

12.3Pharmacokinetics Using currently available analytical technology, it is not possible to detect XEOMIN in the peripheral blood following intramuscular or intraglandular injection at the recommended doses.

12.6Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of XEOMIN.

Of the 2649 patients treated with XEOMIN in clinical trials [see Clinical Studies (14) ] , 9 (0.3%) patients were positive for neutralizing antibodies after treatment whose antibody status at baseline was unknown and 4 (0.2%) additional patients developed neutralizing antibodies after treatment. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies. Chronic Sialorrhea Chronic Sialorrhea in Adult Patients Of the 180 patients treated with XEOMIN in the main phase and extension period of the adult chronic sialorrhea clinical trial [see Clinical Studies (14.1) ] , 1 (0.6%) patient was positive for neutralizing antibodies after treatment.

The patient had an antibody status unknown at baseline, and had not received a botulinum toxin treatment in the 12 months prior to enrollment in the study. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies. Chronic Sialorrhea in Pediatric Patients Of the 252 patients treated with XEOMIN in the main phase and open-label extension period of the pediatric chronic sialorrhea clinical trial [see Clinical Studies (14.1) ] , antibody measurements were only performed in patients with body weight of 30 kg or more, resulting in 80 patients tested for antibodies at baseline.

Three patients tested positive for neutralizing antibodies at baseline and remained positive at the end of the study. No additional patients developed neutralizing antibodies, and none of the patients demonstrated a secondary lack of treatment response. Upper Limb Spasticity Upper Limb Spasticity in Adult Patients Of the 456 patients treated with XEOMIN in the main phase and open-label extension period of the adult upper limb spasticity clinical trials (Study 1 and Study 2) [see Clinical Studies (14.2) ], 4 patients were positive for neutralizing antibodies at baseline, and 2 (0.4%) additional patients (with unknown antibody status at baseline) were positive after treatment.

Both patients had not received a botulinum toxin treatment in the 12 months prior to enrollment in the studies. No patients demonstrated a secondary lack of treatment response due to neutralizing antibodies. Upper Limb Spasticity in Pediatric Patients Of the 907 patients treated with XEOMIN in clinical trials for treatment of pediatric spasticity [see Clinical Studies (14.2) ] , 7 patients were positive for neutralizing antibodies at baseline, and 4 (0.4%) additional patients (with unknown antibody status at baseline) were positive after treatment.

All of these patients were treated with onabotulinumtoxinA and/or abobotulinumtoxinA prior to enrollment in the…

🧬 Mechanism of Action 94 words ▾

12.1Mechanism of Action XEOMIN blocks cholinergic transmission at the neuromuscular and salivary neuroglandular junction by inhibiting the release of acetylcholine from peripheral cholinergic nerve endings. This inhibition occurs according to the following sequence: neurotoxin binding to cholinergic nerve terminals, internalization of the neurotoxin into the nerve terminal, translocation of the light-chain part of the molecule into the cytosol of the nerve terminal, and enzymatic cleavage of SNAP25, a presynaptic target protein essential for the release of acetylcholine.

In both muscles and glands, impulse transmission is re-established by the formation of new nerve endings.

📦 How Supplied / Storage and Handling ~1 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied XEOMIN for injection is a sterile white to off-white lyophilized powder supplied in Type 1 borosilicate glass single-dose vials with tamper-proof aluminum seals and bromobutyl rubber closures that are not made with natural rubber latex in the following pack sizes: Upper Limb Spasticity and Cervical Dystonia Package XEOMIN 50 Units XEOMIN 100 Units XEOMIN 200 Units Carton with one single-dose vial NDC 0259-1605-01 NDC 0259-1610-01 NDC 0259-1620-01 Chronic Sialorrhea and Blepharospasm Package XEOMIN 50 Units XEOMIN 100 Units Carton with one single-dose vial NDC 0259-1605-01 NDC 0259-1610-01 Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) Package XEOMIN 50 Units XEOMIN 100 Units Carton with one single-dose vial NDC 46783-161-01 NDC 46783-160-01 Storage and Handling Store unopened vials of XEOMIN at or below 25°C (77°F).

Refrigeration of unopened vials is not required. Do not use after the expiration date on the vial. Reconstituted XEOMIN may be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours until time of use [see Dosage and Administration (2.7) ].

How Supplied XEOMIN for injection is a sterile white to off-white lyophilized powder supplied in Type 1 borosilicate glass single-dose vials with tamper-proof aluminum seals and bromobutyl rubber closures that are not made with natural rubber latex in the following pack sizes: Upper Limb Spasticity and Cervical Dystonia Package XEOMIN 50 Units XEOMIN 100 Units XEOMIN 200 Units Carton with one single-dose vial NDC 0259-1605-01 NDC 0259-1610-01 NDC 0259-1620-01 Chronic Sialorrhea and Blepharospasm Package XEOMIN 50 Units XEOMIN 100 Units Carton with one single-dose vial NDC 0259-1605-01 NDC 0259-1610-01 Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines) Package XEOMIN 50 Units XEOMIN 100 Units Carton with one single-dose vial NDC 46783-161-01 NDC 46783-160-01

📦 Storage and Handling 60 words ▾

Storage and Handling Store unopened vials of XEOMIN at or below 25°C (77°F). Refrigeration of unopened vials is not required. Do not use after the expiration date on the vial. Reconstituted XEOMIN may be stored in a refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours until time of use [see Dosage and Administration (2.7) ].

📋 Description 184 words ▾

11 DESCRIPTION The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A. The botulinum toxin complex is purified from the culture supernatant and then the active ingredient is separated from the proteins (hemagglutinins and non-hemagglutinins) through a series of steps yielding the active neurotoxin with molecular weight of 150 kDa, without accessory proteins. XEOMIN is a sterile white to off-white lyophilized powder intended for intramuscular or intra-salivary gland injection after reconstitution with preservative-free 0.9% Sodium Chloride Injection, USP [see Dosage Forms and Strengths (3) ] .

One vial of XEOMIN contains 50 Units, 100 Units, or 200 Units of incobotulinumtoxinA, human albumin (1 mg), and sucrose (4.7 mg). The primary release procedure for XEOMIN uses a cell-based potency assay to determine the potency relative to a reference standard. One Unit corresponds to the median intraperitoneal lethal dose (LD 50 ) in mice.

As the method for conducting the assay is specific to XEOMIN, Units of biological activity of XEOMIN cannot be converted into Units of any other botulinum toxin assessed with other specific assays.

💬 Information for Patients 149 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Swallowing, Speaking, or Breathing Difficulties or Other Unusual Symptoms Advise patients to inform their healthcare provider if they develop any unusual symptoms, including difficulty with swallowing, speaking, or breathing, or if any existing symptom worsens [see Boxed Warning and Warnings and Precautions (5.1 , 5.4) ]. Inform patients of the risk of aspiration.

Ability to Operate Machinery or Vehicles Counsel patients that if loss of strength, muscle weakness, blurred vision, or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities. Corneal Exposure, Corneal Ulceration, and Ectropion in Patients Treated for Blepharospasm Inform patients that injections of XEOMIN may cause reduced blinking or effectiveness of blinking, and that they should seek immediate medical attention if eye pain or irritation occurs following treatment [see Warnings and Precautions (5.5) ].

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE XEOMIN ® (Zeo-min) (incobotulinumtoxinA) for injection, for intramuscular or intraglandular use What is the most important information I should know about XEOMIN? XEOMIN may cause serious side effects that can be life-threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with XEOMIN: Problems with swallowing, speaking, or breathing.

These problems can happen hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN. People with certain breathing problems may need to use muscles in their neck to help them breathe.

These people may be at greater risk for serious breathing problems with XEOMIN. Swallowing problems may last for several months. People who cannot swallow well may need a feeding tube to receive food and water.

If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems. Spread of toxin effects.

In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body double vision blurred vision and drooping eyelids hoarseness or change or loss of voice trouble saying words clearly loss of bladder control trouble breathing trouble swallowing These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

See " What should I avoid while receiving XEOMIN? " What is XEOMIN? XEOMIN is a prescription medicine: that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea) in adults and children 2 years of age and older. that is injected into muscles and used to: treat increased muscle stiffness in the arm because of upper limb spasticity in adults and children 2 years of age and older. treat the abnormal head position and neck pain with cervical dystonia (CD) in adults. treat abnormal spasm of the eyelids (blepharospasm) in adults. improve the appearance of upper facial lines (glabellar lines, horizontal forehead lines, and lateral canthal lines) (treated at the same time or individually) for a short period of time (temporary) in adults.

It is not known if XEOMIN is safe and effective in children younger than: 2 years of age for the treatment of chronic sialorrhea 2 years of age for the treatment of upper limb spasticity 18 years of age for the treatment of upper facial lines (glabellar lines, horizontal forehead lines, and lateral canthal lines), cervical dystonia, or blepharospasm Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN. See the end of this Medication Guide for a complete list of ingredients in XEOMIN. had an allergic reaction to any other botulinum toxin products. have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your healthcare provider about all of your medical conditions, including if you: have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome). See " What is the most important information I should know about XEOMIN? " have had any side effects from any other botulinum toxin in the past. have a breathing problem, such as asthma or emphysema. have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration). have drooping eyelids. have had eye surgery. have had surgery on your face. are pregnant or plan to become pregnant.

It is not known if XEOMIN can harm yo…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 46783-0110-06 · Merz 46783-0161-01 · Merz →
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