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Xeomin (Botulinum Toxin Type A) - Summary



Postmarketing reports indicate that 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 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 [see Warnings and Precautions] .



The active ingredient of XEOMIN is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A. The botulinum toxin complex is purified from the culture supernatant and then the active ingredient is separated from the proteins (hemaglutinins and non-hemaglutinins) through a series of steps yielding the active neurotoxin with molecular weight of 150 kDa, without accessory proteins. XEOMIN is a sterile white to off-white lyophilized powder intended for intramuscular injection after reconstitution with 0.9% Saline for Injection, USP (without preservative). One vial of XEOMIN contains 50 or 100 Units of incobotulinumtoxinA, 1 mg of human albumin, and 4.7 mg sucrose. One Unit corresponds to the mouse median lethal dose (LD50) when the reconstituted product is injected intraperitoneally into mice under defined conditions. The method for conducting the assay is specific to XEOMIN, units of biological activity of XEOMIN cannot be converted into units of any other botulinum toxin assessed with other specific assays.

Cervical Dystonia

XEOMIN (incobotulinumtoxinA) is indicated for the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-na¯ve and previously treated patients.


XEOMIN (incobotulinumtoxinA) is indicated for the treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA (Botox).

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Published Studies Related to Xeomin (Botulinum Toxin Type A)

A Prospective, Split-Face, Randomized, Double-Blind Study Comparing OnabotulinumtoxinA to IncobotulinumtoxinA for Upper Face Wrinkles. [2015]
wrinkles using a 1:1 dose ratio... CONCLUSIONS: For identical dosage, both onabotulinumtoxinA and

The efficacy and safety of liquid-type botulinum toxin type A for the management of moderate to severe glabellar frown lines. [2015]
lines... CONCLUSIONS: The efficacy and safety of MT10109L were comparable to those of

The early use of botulinum toxin in post-stroke spasticity: study protocol for a randomised controlled trial. [2014]
BACKGROUND: Patients surviving stroke but who have significant impairment of function in the affected arm are at more risk of developing pain, stiffness and contractures. The abnormal muscle activity, associated with post-stroke spasticity, is thought to be causally associated with the development of these complications...

Correlation of botulinum toxin dose with neurophysiological parameters of efficacy and safety in the glabellar muscles: a double-blind, placebo-controlled, randomized study. [2014]
Despite the extensive use of botulinum toxin type A (BoNT-A) in treatments for glabellar frown lines, the dose-response effect in the glabellar muscles remains unknown. The aim of this randomized, double-blind, placebo-controlled prospective study was to characterize the neurophysiological parameters that correlate with the effect of BoNT-A in the glabellar muscles and its diffusion to surrounding ocular muscles...

Botulinum toxin type A potentiates the effect of neuromotor rehabilitation of Pisa syndrome in Parkinson disease: a placebo controlled study. [2014]
group of PD patients with PS... CONCLUSIONS: Our preliminary data suggest that BT may be considered an important

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Clinical Trials Related to Xeomin (Botulinum Toxin Type A)

Treatment of Plantar Fasciitis With Xeomin [Recruiting]
The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of the foot. Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain. The current standard orthopaedic management of plantar fasciitis begins with nonsurgical treatment modalities. Surgical treatment of plantar fasciitis is indicated only if nonsurgical means fail. A newer method of treating plantar fasciitis before resorting to surgery is the use of Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the subject to date. The purpose of this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in one physician's (J. A.) practice at Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded study.

Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin�) in the Treatment of Glabellar Rhytids [Recruiting]
The objective of the study is to compare the efficacy and duration of escalating doses of IncobotulinumtoxinA (Xeomin) in the treatment of glabellar rhytids (frown lines between the eyes). Fifteen subjects will be enrolled in the study; specifically 60 male or female patients 18 years of age or older with moderate to severe glabellar rhytids at maximum contracture. Each patient will be randomized to receive one of 5 doses of Xeomin, in a one-time dose to the treatment area. The efficacy endpoints will be determined by investigator and subject live assessment of the glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 4 point photographic scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles [3]) used in previous studies. A written description of each photograph will be included to help standardize the application of the Photographic Scale.

Incobotulinum Toxin A (Xeomin�) for Troublesome Sialorrhea in Parkinson's Disease (PD)/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) [Withdrawn]
The purpose of this study is to evaluate the safety and efficacy of Incobotulinum Toxin A (Xeomin) injections into the parotid and submandibular glands in patients with Parkinson's Disease/Parkinsonism and Amyotrophic Lateral Sclerosis (ALS) with troublesome sialorrhea.

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia [Completed]
At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all patients who entered the extension period were treated with up to five injection sessions of incobotulinumtoxinA (Xeomin) during the extension period.

Treatment of Notalgia Paresthetica With Xeomin [Completed]
Patients will be randomized (1: 1) to receive either injections of Xeomin in 0. 9% NaCl or NaCl alone. Xeomin will be reconstituted with 2 mL of NaCl 0. 9 which will give a final concentration of 5 U of botulinum toxin A per 0. 1 mL. The area affected will be injected with 0. 1 mL at each 1-2 cm2 for a maximum total dose of 200 units. Patients will be evaluated at Weeks 8, 12, 18 and 24. An unblinded pharmacist or designee will prepare placebo and Xeomin injections. Patients will be unblinded at the end of the week 12 visit. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin while patients initially randomized to Xeomin will not be injected. All patients will be seen for follow-up visits at Weeks 18 and 24. Efficacy in reducing pruritus will be measured with a 10 cm visual analogue score. This will be performed at Day 0, Week 8, Week 12, Week 18 and Week 24. Efficacy will also be measured by measuring the area of the hyperpigmented zone on the back. Safety will be evaluated with adverse events.

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Reports of Suspected Xeomin (Botulinum Toxin Type A) Side Effects

Drug Ineffective (3)Neck Pain (2)Dysphagia (2)Injection Site Pain (2)Hypersensitivity (1)Headache (1)Application Site Pruritus (1)Gastritis (1)Injection Site Necrosis (1)Leukocytoclastic Vasculitis (1)more >>

Page last updated: 2015-08-10

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