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.

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.

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

• The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
• 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].
• 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.
• Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN. In order to reduce the complication of ptosis the following steps should be taken: avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes; and corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.
• 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.
• Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.

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 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 in patients less than 18 years of age have not been established.

Copyright © 2023 Merz North America, Inc. All rights reserved. Merz Aesthetics, the Merz Aesthetics logo, and Xeomin are registered trademarks of Merz Pharma GmbH & Co. KGaA. All others belong to their respective owners.

For full prescribing information including Medication Guide, please click here.

Not all neurotoxins are the same, despite what your patients may think.

Xeomin® is unique. It was the first clinically proven anti-wrinkle injection uniquely purified to remove proteins unnecessary for treatment.*

Xeomin is indicated for temporary improvement in the appearance of moderate to severe glabellar lines in adult patients. Xeomin can help differentiate your practice.5 Xeomin is different in ways that matter to you and to your patients.

• Xeomin® is a Botulinum Toxin Type A that blocks transmission of acetylcholine (ACh) from neuron to muscle
• This inhibits muscle contraction and causes muscle paresis (weakness) or paralysis
• Botulinum Toxin Type A only affects “cholinergic neurons” (neurons which use acetylcholine as a neurotransmitter)
• Botulinum Toxin Type A effects dissipate after ~ 3 months because new SNAP-25 proteins take 3 months to be synthesized1

Our precise manufacturing process

Xeomin is uniquely purified and precisely manufactured in a German facility using using our advanced XTRACT technology™ to isolate the therapeutic component.

Exacting standards

The active ingredient of Xeomin is botulinum serotype A. Merz takes the toxin complex and employs a precise manufacturing process that isolates the therapeutic component and removes the complexing/unnecessary proteins to produce Xeomin. Complexing/unnecessary proteins accompany the active neurotoxin but do not play an active role in treatment. Studies have not been performed to determine whether the presence or absence of complexing/unnecessary proteins has a long-term effect on safety or efficacy.

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. The most commonly observed adverse reaction incidence ≥2% of patients and greater than placebo) for Xeomin was headache (5.4%).

Up to 4 months of Xeomin efficacy and patient satisfaction in a majority of patients

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.

Xeomin®(incobotulinumtoxinA) is a prescription medication injected into muscles and used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. Xeomin®contains botulinum toxin type A, a protein purified from the bacterium Clostridium botulinum.

When you squint or frown, the muscles between your eyebrows contract, causing the skin to furrow and fold. Over time, as your skin ages and loses some of its elasticity, these repeated contractions can cause persistent frown lines. Botulinum toxin type A – the active ingredient in Xeomin®– acts on nerve endings in muscles to prevent muscle fibers from contracting. By reducing these contractions, Xeomin®can temporarily reduce the lines between your eyebrows.

Xeomin®was proven effective in two randomized, double-blind, multicenter, placebo-controlled clinical trials of 547 healthy, adult patients. The average age of patients in the study was 46 years. Patients received 20 Units of Xeomin®and were classified as responders if they had a 2-grade improvement on a 4-point scale as assessed by the physician and patient. Using these criteria, treatment success was higher with Xeomin®than placebo on Day 30 in both studies (60% and 48% vs. 0% for placebo in both studies). Based on these trials, Xeomin®received FDA approval for use in glabellar lines in 2011.

You may begin to see visible smoothing as early as 3-4 days after injection. The median first onset of effect was less than a week. The maximum effect occurred at 30 days. The typical duration of effect was up to 3 months in clinical trials but may last significantly longer or shorter in individual patients.

Xeomin®may cause serious side effects, including allergic reactions. Symptoms of an allergic reaction to Xeomin®may include: itching, rash, redness, swelling, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or seek medical help right away if you have wheezing, experience other asthma symptoms, or if you become dizzy or faint. In clinical trials of Xeomin®for the treatment of frown lines between the eyebrows, headache was the most common side effect. Xeomin®may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking Xeomin®. If this happens, do not drive a car, operate machinery, or do other dangerous activities. Tell your doctor if you have any side effect that bothers you or that does not subside. These are not all of the possible side effects of Xeomin®. For more information, see accompanying Full Prescribing Information including Medication Guide, or ask your doctor.