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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.
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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).
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NEWS HIGHLIGHTS
Published Studies Related to Xeomin (Botulinum Toxin Type A)
Effectiveness of type A botulinum toxins for aesthetic indications and their
relative economic impact. [2012]
BoNT-A formulations licensed for aesthetic indications in the UK... CONCLUSION: In most scenarios, BoNT-A treatment with abobotulinumtoxinA will
Anticholinergic therapy vs. onabotulinumtoxina for urgency urinary incontinence. [2012]
therapy are needed... CONCLUSIONS: Oral anticholinergic therapy and onabotulinumtoxinA by injection
Botulinum toxin effects on gasatrocnemius strength and plantar pressure in
diabetics with peripheral neuropathy and forefoot ulceration. [2012]
gastrocnemius-soleus muscles to reduce muscle strength and plantar pressure... CONCLUSION: There were no adverse events associated with the Botox® injections.
Modification of altered ankle motor control after stroke using focal application
of botulinum toxin type A. [2012]
SUBJECTS: 15 post-stroke and 10 matched neurologically intact subjects... CONCLUSIONS: BTX-A is effective in reducing antagonistic and distant muscle
Vandetanib: in medullary thyroid cancer. [2012]
Vandetanib, an orally active, small-molecule, multitargeted tyrosine kinase
inhibitor, demonstrates potent inhibitory activity against vascular endothelial
growth factor receptor (VEGFR)-2 and -3, epidermal growth factor receptor (EGFR)
and the rearranged during transfection (RET) tyrosine kinase receptor...
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).
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 15 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®, either
20-, 40-, 60-, 80-, or 100 units, 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) [Recruiting]
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.
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 >>
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Page last updated: 2013-02-10
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