Full Prescribing Information including Medication Guide | Patients

Why Choose XEOMIN®?

Ingredients Matter—Let’s Talk Tox

By eliminating complexing proteins that can compromise treatment’s effectiveness over time, XEOMIN helps you deliver consistent, repeatable outcomes for upper facial lines.1,2*

Actual patient. Individual results may vary.

*In pivotal trials, no patients demonstrated a secondary lack of treatment response due to neutralizing antibodies.

Woman smiling and scrunching her face, with smooth forehead, frown lines, and crow's feet.

Real Talk: Is Your Toxin Ready for a Long-Term Relationship?

Fast forward 10 years. Will your toxin require more effort (and dose) to get the same results?

All therapeutic proteins—like those in neurotoxins—have the potential to trigger an immune response. And higher protein loads have been shown to amplify that response by triggering the formation of neutralizing antibodies against the toxin.3,4

Actual patient. Individual results may vary.

Two Ways Neutralizing Antibodies Are Sabotaging Your Relationship

Toxin resistance doesn’t happen overnight. These are the subtle, expensive ways neutralizing antibodies dismantle efficacy—and undermine patient loyalty—over time.

Need for Repeat Injections

36%

of patients who have ever received aesthetic toxin treatment report needing shorter intervals between treatments.5

Increasing Dosage Over Time

66%

of healthcare professionals report needing higher doses or treating more frequently to achieve the same effect.6

Actual patient. Individual results may vary.

Blonde woman smiling.
90% of patients think a toxin's purity is very important.

In a survey of patients asked about the importance of product purity and consistency5:

57%

of users have experienced diminished effect after 3+ treatments.

74%

of users would switch brands if results started to be less effective.

60%

of users would consider changing providers if decreased effect persists.

Actual patient. Individual results may vary.

A 2023 survey recruited 2,955 toxin users globally to respond to a 25-minute online survey about toxin efficacy. Inclusion criteria were: age 18+ years, history of 3+ treatments, and toxin treatment within the past 12 months. Recruitment was initiated with GenPop sampling to align to census data for age and gender (and in US: region, household income, and ethnicity) to analyze prevalence of toxin users experiencing lack of effect.5

It’s Time to Double Filter Your Standards

XTRACT technology showing complexing proteins being removed

How XEOMIN Works

Only XEOMIN is double filtered with XTRACT TECHNOLOGY®, removing the complexing proteins that can trigger neutralizing antibody formation and reduce efficacy over time.1,2,8,9

Your patients want a long term relationship with their toxin. You want consistent results year after year.

That’s why XEOMIN® is designed for performance dose after dose. It’s the first and only double-purified toxin with XTRACT TECHNOLOGY™ that eliminates complexing proteins and bacterial remnants for consistent results treatment after treatment, and a 96% patient satisfaction rate.

XEOMIN® — Pure. Proven. Performance.

XEOMIN® (incobotulinumtoxinA) is an FDA approved treatment to temporarily improve the look of moderate to severe upper facial lines treated simultaneously or individually.

Effects of XEOMIN may spread hours to weeks after injection, causing serious symptoms. Alert your doctor as difficulty swallowing, speaking, breathing, eye problems, or muscle weakness can be signs of life-threatening conditions.

Side effects may include headache, bruising, injection site reactions, eyelid drooping, brow drooping, and allergic reactions.

Tell your doctor about your medical history, muscle and nerve conditions, and all medicines, especially botulinum toxins, muscle relaxants, and blood thinners, as these may increase the risk serious side effects.

Doses of XEOMIN are not the same as other botulinum toxins.

Reduced Total Protein, Reduced Risk of Antibody Formation

In pivotal trials with over 2,600 patients, XEOMIN delivered results with 0% treatment resistance due to neutralizing antibodies.8

With over 2,000 patients across 30+ real-world studies, evidence continues to show that neutralizing antibodies can impact long-term results.4,10-24

Your choice of toxin matters.

Graph showing Xeomin vs. competitors in total clostridial protein load.

Bar chart titled “Total Clostridial Protein Load” comparing nanograms (ng) of clostridial protein per 100U vial: Xeomin (0.44), Botox® (5.0), Jeuveau® (4.6), and Dysport® (4.35).*

*Total clostridial protein per 100 U (ng) in a 500 U DYSPORT® vial.

These data do not imply differences in clinical performance, safety, or treatment response among products.

Proven to Smooth, Backed by Science

XEOMIN has 15 years of clinical success and global experience.

15 years of real-world aesthetic use27

Approved in 80 countries

20+ million aesthetic treatments globally28

Bring XEOMIN to Your Practice

Your choice of toxin matters. Use XEOMIN to help you stand out and build a practice based on reliable results.

Get Started
Woman with light on her face consulting with injector. With text 'not actual patient'

The Proof Behind the Experience

Beautiful results are built on solid science. Explore trial data and peer-reviewed research that supports the XEOMIN experience.

Explore the Evidence

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. Prager W. Clin Pharmacol. 2013;5:39-52. 2. Rzany B, et al. Dermatol Surg. 2013;39(1 pt 1):95-103. 3. Kerscher M, et al. J Drugs Dermatol. 2019;18(1):52-57. 4. Carr WW, et al. Adv Ther. 2021;38(10):5046-5064. 5. Data on file. Merz North America, Inc. 2023. 6. Data on file. Merz North America, Inc. 2022. 7. Data on file. Merz North America, Inc. 2020. 8. Xeomin [Prescribing Information]. Franksville, WI: Merz North America, Inc; 2023. 9. Frevert J. Drugs RD. 2015;15(1):1-9. 10. Naumann M, et al. J Neural Transm (Vienna). 2013;120(2):275-290. 11. Callaway JE. Clin Dermatol. 2004;22(1):23-28. 12. Jankovic J, et al. Neurology. 2006;67(12):2233-2235. 13. Bellows S, et al. Toxins (Basel). 2019;11(9):491. 14. Fabbri M, et al. Neurotox Res. 2016;29(1):105-117. 15. Chinnapongse RB, et al. Clin Neuropharmacol. 2012;35(5):215-223. 16. Hefter H, et al. BMJ Open. 2012;2(4):e000646. 17. Hefter H, et al. Int Park & Mov Dis Soc. 2016;3(5):500-506. 18. Albrecht P, et al. Neurology. 2019;92(1):e48-e54. 19. Lee JI, et al. Ann Clin Transl Neurol. 2021;8(1):15-28. 20. Samadzadeh S, et al. Toxins (Basel). 2020;12(8):499. 21. Hefter H, et al. Front Neurol. 2021;12:636590. 22. Hefter H, et al. Toxins (Basel). 2022;14(1):44. 23. Hefter H, et al. J Neurol. 2023;270(2):788-796. 24. Martin MU, et al. Toxins (Basel). 2024;16(2):101. 25. Park JY, et al. Plast Reconstr Surg Glob Open. 2020;8(1):e2627. 26. Frevert J. Drugs RD. 2010;10(2):67-73. 27. Data on file. Merz North America, Inc. 2019. 28. Data on file. Merz North America, Inc. 2024.