Causes2,3

  • Cerebral palsy (CP)
  • Traumatic brain injury or spinal cord injury
  • Stroke (ischemic or hemorrhagic)
  • Brain damage caused by oxygen deficiency
  • Multiple sclerosis
  • Encephalitis or meningitis
  • Brain tumor sequelae
Black wrist wrap

Symptoms4

  • Muscle stiffness (known as hypertonia)
  • Limited range of movement
  • Reduced ability to relax muscles
  • Muscle spasms
  • Changes in limb position
  • Pain

Common Occurrence after TBI5

  • Spasticity may be one of the many possible consequences after a traumatic brain injury (TBI)
  • An estimated 475,000 children between 0-14 years of age sustain a TBI annually
  • In pediatric spasticity, MRI imaging shows damage to or development differences in the motor cortex

Clinical Patterns4

Flexed elbow
Flexed elbow
Flexed wrist
Flexed wrist
Pronated forearm
Pronated forearm
Clenched fist
Clenched fist
Thumb-in-palm
Thumb-in-palm

Elijah Is a 9-year-old Soccer Player Who STAYS POSITIVE On and Off the Field

The life he's fighting for

From the time he was young, Elijah has loved being a leader. He inspires his soccer teammates with confidence and optimism—scoring goals and starting cheers. When his younger siblings or parents need help, he always leads the charge.

Elijah, a patient with pediatric upper limb spasticity, talking about XEOMIN

The weigh-in

  • When Elijah was 6 years old, he developed upper limb spasticity following a traumatic brain injury
  • Sometimes he experiences difficulty writing, changing clothes, and playing with friends
  • Socially, symptoms of upper limb spasticity can often get in the way and make it more difficult to connect with classmates or teammates

Sparring with upper limb spasticity

  • For a few years after the accident, Elijah adjusted his life to live with the symptoms of upper limb spasticity, receiving physical therapy
Elijah standing next to a heavy bag

Never defeated, Elijah and his mom looked at options

The Pediatric Portfolio

Watch a pediatric physiatrist discuss the safety and efficacy of XEOMIN for approved pediatric indications

Explore XEOMIN for the treatment of pediatric upper limb spasticity†

See the Data
Worried about waning efficacy?
See the XEOMIN Difference
Learn More Back to Indications

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. A pediatric assessment for XEOMIN demonstrates that XEOMIN is safe and effective in cerebral palsy patients. XEOMIN is not approved for this specific patient population due to marketing exclusivity for another botulinum toxin.

TBI, traumatic brain injury.

Clinically meaningful improvements in muscle tone as measured by the Ashworth Scale1,6,7

  • Significant difference observed in mean change on the Ashworth Scale with XEOMlN high-dose vs low-dose treatment
  • 86% of patients treated at 8 Units/kg and 71% of patients treated with 2 Units/kg responded to treatment with a 1-point or greater change on the Ashworth Scale
Ashworth Scale Scores at Week 4 for Each Treated Clinical Pattern†
A chart showing the change in Ashworth scale scores, across each clinical pattern, for patients who used XEOMIN to treat pediatric upper limb spasticity
The Ashworth Scale is a clinical measure of the severity of spasticity by judging the resistance to passive movement
Ashworth Scale Mean Change at 4th Injection From Baseline
A chart showing the change in Ashworth scale scores, across each clinical pattern at 4th injection from baseline, for patients who used XEOMIN to treat pediatric upper limb spasticity

Improvement in overall spasticity as measured by the Global Impression of Change Scale (GICS)

  • The investigators' GICS scores at Week 4 demonstrated clinically meaningful improvement
  • The difference in GICS scores between the low-dose and high-dose groups was not statistically significant1,7‡

Consistent meaningful improvement from baseline to week 41

Investigator GICS at Week 4 (main period injection)
Investigator GICS XEOMIN results for pediatric upper limb spasticity patients at week 4. The chart shows 1.7 for high dose and 1.6 for low dose
Mean GICS Scores at 4th Injection From Baseline
Mean GICS XEOMIN results for pediatric upper limb spasticity patients at 4th injection from baseline. The chart shows 2.0 for GICS investigator, 2.1 for GICS-child/teen, and 1.9 for GICS-parent
See Xeomin Safety
Worried about waning efficacy?
See the XEOMIN Difference
Learn More Back to Indications

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. A pediatric assessment for XEOMIN demonstrates that XEOMIN is safe and effective in cerebral palsy patients. XEOMIN is not approved for this specific patient population due to marketing exclusivity for another botulinum toxin.

GICS, Global Impression of Change Scale.

Common Adverse Reactions
Most common adverse reactions affecting ≥2% of patients treated with XEOMIN 2 Units/kg or 8 Units/kg1
Adverse Reactions
Percentage of patients
XEOMIN 2 Units/kg
n=87
XEOMIN 8 Units/kg
n=176
Infections and infestations
Nasopharyngitis
6
3
Bronchitis
2
3
Pharyngotonsillitis
2
2
Upper respiratory tract infection
2
2
Respiratory tract infection viral
1
2
Injury, poisoning, and procedural complications
Fall
0
2
Musculoskeletal and connective tissue disorders
Pain in extremity
0
2
Learn About XEOMIN Dosing
Worried about waning efficacy?
See the XEOMIN Difference
Learn More Back to Indications

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023.
  2. Ward AB. A literature review of the pathophysiology and onset of post-stroke spasticity. Eur J Neurol. 2012;19(1):21-27.
  3. Ozcakir S, Sivrioglu K. Botulinum toxin in poststroke spasticity. Clin Med Res. 2007;5(2):132-138.
  4. Spasticity. American Association of Neurological Surgeons website. Accessed June 18, 2021. https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity
  5. Araki T, Yokota H, Morita A. Pediatric traumatic brain injury: characteristic features, diagnosis, and management. Neurol Med Chir (Tokyo). 2017;57(2):82-93.
  6. Heinen F, Desloovere K, Schroeder AS, et al. The updated European Consensus 2009 on the use of botulinum toxin for children with cerebral palsy. Eur J Paediatr Neurol. 2010;14(1):45-66.
  7. Dabrowski E, Chambers HG, Gaebler-Spira D, et al. IncobotulinumtoxinA efficacy/safety in upper-limb spasticity in pediatric cerebral palsy: randomized controlled trial. Pediatr Neurol. 2021;123:10-20.
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IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
  • Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
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.
  • Serious 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, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • 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) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post- marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
  • 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.
ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

  • Chronic Sialorrhea:
    • in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
    • in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
  • Upper Limb Spasticity
    • in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
    • in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
  • Cervical Dystonia in adults (≥5% of patients): dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
  • Blepharospasm in adults (≥10% of patients): eyelid ptosis, dry eye, visual impairment, and dry mouth.
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 for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
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.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
  • Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
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.
  • Serious 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, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • 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) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post- marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
  • 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.
ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

  • Chronic Sialorrhea:
    • in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
    • in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
  • Upper Limb Spasticity
    • in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
    • in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
  • Cervical Dystonia in adults (≥5% of patients): dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
  • Blepharospasm in adults (≥10% of patients): eyelid ptosis, dry eye, visual impairment, and dry mouth.
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 for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.