Full Prescribing Information including Medication Guide | Patients

Clinical Evidence for XEOMIN®

Effectiveness Without Excess

In pivotal trials with over 2,600 patients, XEOMIN delivered results with 0% treatment resistance due to neutralizing antibodies.1

Actual patient. Individual results may vary.

Proven Performance for Upper Facial Lines

Treating the full upper facial complex—frown lines, forehead lines, and crow’s feet—can mean using up to 64 units in one session. This higher-unit approach increases patients’ cumulative exposure to neurotoxin, making product purity more important than ever.1

Backed by 15 years of clinical and global experience, XEOMIN is a double-filtered neurotoxin studied in 2 pivotal trials for simultaneous treatment of these 3 key areas of the upper face.2,3

Response Rate at Day 30*: 92.0%3
Dosing: 20 units3

Woman raising her eyebrows to show forehead lines with a pink circle around them
See Results

Response Rate at Day 30*: 92.0%3
Dosing: 20 units3

Woman scowling to show frown lines with a pink circle around them
See Results

Response Rate at Day 30*: 81.3%3
Dosing: 24 units (12 per side)3

Woman smiling to show crow's feet with a pink circle around them
See Before & After

*Based on the investigator-assessed score of none or mild on Merz Aesthetics Scale (MAS) at maximum contraction (secondary endpoint).

Woman raising her eyebrows to show forehead lines with a pink circle around them
Woman scowling to show frown lines with a pink circle around them
Woman smiling to show crow's feet with a pink circle around them

Actual patient pictured before treatment with XEOMIN. Individual results may vary.

Results With XEOMIN Lasted Up to 4 Months

Data from 2 upper facial lines trials can help you set patient expectations and plan for return visits to maintain results.

Graph showing Xeomin vs placebo and subject-assessed GAIS improvement in upper facial lines

GAIS=Global Aesthetic Improvement Scale.

Line graph titled “Subject-Assessed GAIS Improvement in Upper Facial Lines” showing the responder rate percentage over 120 days. XEOMIN (64 U) peaks at ~100% responder rate on day 30 and maintains approximately ~60% on day 120. The placebo responder rate remains at or below 10% throughout the 120-day period.

XEOMIN’s efficacy and safety for simultaneous treatment of upper facial lines was established in a robust clinical trial program. Over 700 patients were enrolled in two phase 3, randomized, double-blind, multicenter, placebo-controlled studies. Patients were followed for up to a year: Both studies followed patients for up to 120 days and included an open-label extension phase consisting of 2 additional 120-day treatment cycles.

Primary Endpoint: XEOMIN met the primary endpoint of treatment success at Day 30 (composite endpoint of investigator and subject assessment of none or mild and at least a 2-grade improvement on MAS at maximum contraction).

Woman wearing a hair cap being injected by gloved hands

Turn Clinical Evidence Into Clinical Practice

You’ve seen the data—now it’s time to put it to work. Join the thousands of injectors who trust the science behind XEOMIN to deliver consistent, natural-looking results.

Bring XEOMIN to Your Practice

Performance in Head-to-Head Clinical Trials

Compared to BOTOX® and DYSPORT® in a study of glabellar lines, XEOMIN® delivered comparable time to onset and duration of effect.*

Chart showing median time to onset of effect through day 8 of Xeomin vs Dysport vs Botox

Line graph titled “Median Time to Onset of Effect Through Day 8” measuring the percentage of patients who have not yet experienced onset over an 8-day period. The data show XEOMIN® (magenta) reaching 0% by day 4, while BOTOX® (black) and DYSPORT® (gray) reach 0% by day 8.

Chart showing median duration of treatment effect of Xeomin vs Dysport vs Botox

Bar chart titled “Median Duration of Treatment Effect” showing duration in days for female and male patients. Female duration: XEOMIN® (approx. 150), BOTOX® (approx. 140), and DYSPORT® (approx. 140). Male duration: XEOMIN® (approx. 120), BOTOX® (approx. 115), and DYSPORT® (approx. 115).

*Units of biological activity of XEOMIN cannot be compared with or converted into units of any other botulinum toxin products.
†Represents female patients only.

Glabellar Frown Lines Head-to-Head Study Design4

A total of 180 subjects were enrolled (60 per group) in this randomized, controlled study, which directly compared the time to onset and duration of effect for incobotulinumtoxinA (XEOMIN®), onabotulinumtoxinA (BOTOX®), and abobotulinumtoxinA (DYSPORT®) for the treatment of glabellar frown lines.

Subjects received a single treatment of either 21 U incobotulinumtoxinA, 21 U onabotulinumtoxinA, or 63 U abobotulinumtoxinA and were followed for up to 180 days.

Primary Endpoints: Time to onset was defined as the day the investigator noted a decrease in glabellar muscle activity. Duration of treatment effect was defined as the time until muscle action returned to the baseline level.

Head-to-Head Glabellar Frown Lines Trial Design5

In a prospective, multicenter, randomized, double-blind, parallel trial, XEOMIN was randomized 1:1 vs another neurotoxin. The study enrolled 250 healthy female patients (≥18 years old) with glabellar lines of at least moderate severity at maximum frown. XEOMIN demonstrated comparable efficacy and duration up to four months. Patients were classified as responders only if they had a ≥1 point improvement from the baseline on the Facial Wrinkle Scale (FWS) at maximum frown, as assessed by the independent review panel using subject photographs at one month post treatment.

Lasting Effects and Sustained Patient Satisfaction vs BOTOX®

In a head-to-head equivalency study, 250 patients received either 20 units of XEOMIN or 20 units of BOTOX® to treat their glabellar lines.

Chart showing greater than or equal to 1 point improvement on FWS over 4 months

Bar chart titled “≥1-Point Improvement on FWS as Assessed by Independent Blind Evaluators” showing percentage of patients by month. XEOMIN® vs BOTOX®: Month 1 (95.7% vs 99.2%), Month 2 (89.7% vs 95.0%), Month 3 (80.2% vs 80.7%), and Month 4 (62.1% vs 67.2%).

Chart showing patient satisfaction over 4 months

Bar chart titled “Patient Satisfaction Remained High Throughout the 4-Month Study” showing percentage of satisfied XEOMIN® vs BOTOX® patients: Month 1 (97.4% vs 97.5%), Month 2 (95.7% vs 95.0%), Month 3 (93.9% vs 91.5%), and Month 4 (93.0% vs 90.4%).

*Patients responding as “slightly satisfied,” “satisfied,” or “extremely satisfied.”

From Clinical Results to Practical Application

Learn more about reconstituting, dosing, storing, and other practical considerations for using XEOMIN.

Using XEOMIN

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.

INDICATIONS AND USAGE

XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe upper facial lines in adults (glabellar lines with corrugator and/or procerus muscle activity [GL], horizontal forehead lines associated with frontalis muscle activity [HFL], and lateral canthal lines associated with orbicularis oculi activity [LCL].)

IMPORTANT SAFETY INFORMATION

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.

CONTRAINDICATIONS

Hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur further injection of XEOMIN should be discontinued and appropriate medical therapy immediately instituted. XEOMIN is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation.

Use in patients with an infection at the injection site could lead to severe local or disseminated infection. XEOMIN is contraindicated in the presence of infection at the proposed injection site(s).

WARNINGS AND PRECAUTIONS

  • 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. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
  • The potency Units and Units of biological activity of XEOMIN are specific to their respective preparation and assay method utilized, and thus cannot be compared or converted into Units of any other botulinum toxin products.
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Upper Facial Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN.
    • GL: To reduce the complication of ptosis avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes. Corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
    • HFL: Treat HFL in conjunction with GL to minimize the potential for brow ptosis.
    • LCL: Avoid injections too close to the zygomaticus major muscle to prevent lip ptosis.
  • Use caution when XEOMIN is used in patients who have marked facial asymmetry, with surgical alterations to the facial anatomy, pre-existing eyelid or eyebrow ptosis, when excessive weakness or atrophy is present in the target muscles, excessive dermatochalasis, deep dermal scarring, thick sebaceous skin (e.g., the inability to substantially lessen glabellar lines even by physically spreading them apart).
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD have ever been reported for albumin.

ADVERSE REACTIONS

Upper Facial Lines (Glabellar Lines, Horizontal Forehead Lines, and Lateral Canthal Lines): The most commonly observed adverse reaction (incidence ≥ 1% of patients and greater than placebo) for XEOMIN was injection site bruising (2%).

DRUG INTERACTIONS

Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.

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

USE IN PREGNANCY

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.

PEDIATRIC USE

Safety and effectiveness of XEOMIN for upper facial lines in patients less than 18 years of age have not been established.

Copyright ©2024 Merz North America, Inc. All rights reserved.

References: 1. Xeomin [Prescribing Information]. Franksville, WI: Merz North America, Inc; 2023. 2. Data on file. Merz North America, Inc. 2019. 3. Joseph J, et al. Aesthet Surg J. 2025;45(3):293-304. 4. Rappl T, et al. Clin Cosmet Investig Dermatol. 2013;6:211-219. 5. Kane MA, et al. Dermatol Surg. 2015;41(11):1310-1319.