pectations
delivered

With nearly 15 years of clinical and global experience, Xeomin® has a well-established efficacy and safety profile

In 2 randomized, double-blind, multicenter clinical trials, Xeomin was proven to temporarily improve the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients.1-3 The most commonly observed adverse reaction incidence ≥2% of patients and greater than placebo) for Xeomin was headache (5.4%).

graphic details clinical trial of 547 patients given 20 units of Xeomin on 5 injection points in the glabellar
Significantly superior efficacy over placebo
bar chart shows physician and patient response rates were higher than the placebo in clinical trials
Efficacy assessed by independent review panel
bar chart compares efficacy of Xeomin to another neurotoxin on frown lines assessed by independent panel
Efficacy assessed by treating physician
bar chart compares efficacy of Xeomin to another neurotoxin on frown lines assessed by treating physician
Patient satisfaction
bar chart compares patient satisfaction for Xeomin and another neurotoxin for treating frown lines

Up to 4 months of Xeomin efficacy and patient satisfaction in a majority of patients4,5

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.

  1. Xeomin® (incobotulinumtoxinA) for injection, for intramuscular use. Prescribing Information. Merz Pharmaceuticals, LLC, 2020.
  2. Carruthers A, Carruthers J, Heinz M, et al. Multicentre, randomized phase III study of a single dose of incobotulinumtoxinA, free from complexing proteins, in the treatment of glabellar frown lines. Dermatol Surg. 2013;39:551-558.
  3. Hanke CW, Narins RS, Brandt F, et al. A randomized, placebo-controlled, double-blind phase III trial investigating the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using a stringent composite endpoint. Dermatol Surg. 2013;39(6):891-899.
  4. Data on File, Merz North America.
  5. Kane MA, Gold MH, Coleman WP, et al. A randomized, double-blind trial to investigate the equivalence of incobotulinumtoxinA and onabotulinumtoxinA for glabellar frown lines. Dermatol Surg. 2015;41(11):1319.

INDICATIONS AND USAGE

XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines with corrugator and/or procerus muscle activity in adult patients.

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

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

Glabellar Lines: The most commonly observed adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN® was Headache (5.4%).

DRUG INTERACTIONS

Co-administration of XEOMIN® and aminoglycoside antibiotics 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.
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 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® in patients less than 18 years of age have not been established.

XEOMIN® is available only through licensed physicians.

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