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Xeomin (Botulinum Toxin Type A) - Summary

 
 



Distant Spread of Toxin Effect


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.

 

XEOMIN SUMMARY

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-naive and previously treated patients.

Blepharospasm

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


See all Xeomin indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Xeomin (Botulinum Toxin Type A)

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...

Upper extremity spasticity in children with cerebral palsy: a randomized, double-blind, placebo-controlled study of the short-term outcomes of treatment with botulinum A toxin. [2013]
varying levels of function... CONCLUSIONS: Children receiving BoNT-A injections demonstrated clinically

Combined use of botulinum toxin type A and B for forehead rhytides: a randomized, double-blind, split-face study. [2013]
rhytides... CONCLUSION: We observed the equivalent efficacy in the mixture of both toxins and

Safety and efficacy of botulinum toxin in primary orthostatic tremor. [2013]
Primary orthostatic tremor (POT) is a rapid 13-18 Hertz tremor that produces a subjective feeling of unsteadiness when standing, and is absent when seated or supine. It predominantly affects the legs during isometric contraction though a similar tremor can be seen in the arms and jaw...

more studies >>

Clinical Trials Related to Xeomin (Botulinum Toxin Type A)

Treatment of Notalgia Paresthetica With Xeomin [Recruiting]
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.

Trial Evaluating Xeomin� (incobotulinumtoxinA) for Cervical Dystonia or Blepharospasm in the United States [Recruiting]
This is a prospective, observational trial evaluating the "real world" use of Xeomin®(incobotulinumtoxinA). Physicians may enroll patients who are eligible to be treated with a botulinum toxin for cervical dystonia or blepharospasm based upon their clinical experience. The physician must have chosen to treat the patient with Xeomin® (incobotulinumtoxinA) prior to and independent of enrollment in this study. Physicians may choose to treat their subjects with up to 2 treatment cycles (approximately 6 months/subject) of Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin. According and dependent on clinical practice, the investigators expect that subjects will be seen by the investigator for an average of 3 visits (two treatment cycles).

Open-Label Non-Inferiority Study Evaluating the Efficacy and Safety of Xeomin� in Subjects With Cervical Dystonia Flex [Recruiting]
This study will compare Xeomin®, a botulinum toxin medication, in shorter treatment intervals (Short Flex dosing) to the standard interval dosing (Long Flex dosing) to determine if the response to treatment is comparable in both how it works and any side effects. Xeomin® is approved by the United States Food and Drug Administration (FDA) for the treatment of cervical dystonia (CD). The use of Xeomin® is investigational in regards to shorter treatment intervals. An investigational use is one that is not approved by the FDA.

Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face [Recruiting]
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old in the treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the face after a 4-week and a 3-month period of product application.

A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea [Recruiting]
This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea.

The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both Physician Investigator (PI) and subject will remain blinded for the duration of the study. At the 16 week visit, control subjects will enter the rescue arm portion of the study and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.

more trials >>

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: 2014-11-30

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