XEOMIN® (incobotulinumtoxinA) for injection, for intramuscular use, available at Hall Plastic Surgery & Rejuvenation Center.

XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, is indicated for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients. XEOMIN should be administered no more frequently than every three months.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT

Postmarketing reports indicate that the effects of XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, 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 spasticity in children and adults, 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.

Please see Full Prescribing Information, including Medication Guide for more information.

CONTRAINDICATIONS

XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, is contraindicated in patients with a known hypersensitivity to the active substance botulinum toxin type A or to any of the components in the formulation and in the presence of infection at the proposed injection site(s). Use in patients with an infection at the injection site could lead to severe local or disseminated infection.

WARNINGS AND PRECAUTIONS

• The potency units of XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, 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.
• 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 (incobotulinumtoxinA) for injection, for intramuscular use, should be discontinued and appropriate medical therapy immediately instituted. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders.
• Treatment with XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, 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 Boxed Warning]. 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. These reactions can occur within hours to weeks after injection with botulinum toxin.
• Glabellar Lines: Do not exceed the recommended dosage and frequency of administration of XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use. In order to reduce the complication of ptosis the following steps should be taken:

  1. Avoid injection near the levator palpebrae superioris, particularly in patients with larger brow depressor complexes.

  2. Corrugator injections should be placed at least 1 cm above the bony supraorbital ridge.

• 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 (incobotulinumtoxinA) for injection, for intramuscular use.
• XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, contains albumin, a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) is also considered extremely remote. No cases of transmission of viral diseases or CJD have ever been reported for albumin.

ADVERSE REACTIONS

Glabellar Lines: The most common adverse reaction (incidence ≥ 2% of patients and greater than placebo) for XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, was Headache (5.4%).

DRUG INTERACTIONS

Concomitant treatment of XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, and aminoglycoside antibiotics, spectinomycin, or other agents that interfere with neuromuscular transmission (e.g., tubocurarine-like agents), or muscle relaxants, should be observed closely because the effect of XEOMIN may be potentiated.

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

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

The safety and effectiveness of XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, in patients less than 18 years of age have not been established.

Please see Full Prescribing Information for more information on XEOMIN (incobotulinumtoxinA) for injection, for intramuscular use, including complete Boxed WARNING.

Copyright © 2012 Merz Aesthetics, Inc. All rights reserved. XEOMIN is a registered trademark and Merz Aesthetics and the Merz Aesthetics logo are trademarks of Merz Pharma GmbH & Co. KGaA EM00490-00