Not an actual patient.

Pediatric Upper Limb Spasticity


(excluding spasticity caused by cerebral palsy)
Not an actual patient.
Not an actual patient.

Designed For Purity, XEOMIN Has Only The Ingredients
It Needs To Deliver Results

Designed For Purity,
XEOMIN Has Only
The Ingredients
It
Needs To Deliver
Results

Upper Limb Spasticity in Pediatrics

(excluding spasticity caused by cerebral palsy)

XEOMIN for Upper Limb Spasticity

XEOMIN for Upper Limb Spasticity, Excluding Spasticity Caused by Cerebral Palsy, in Pediatrics

In children with upper limb spasticity, there is an imbalance of signals from the brain to the muscles, which causes stiffness and spasms. This can lead to abnormal arm or hand positions, uncomfortable movement, and pain.1

XEOMIN is injected into muscles to help interfere with these signals. This helps decrease muscle stiffness and improve your child’s ability to function using the affected muscles.2

clenched fist 3

Some stiffness and spasms may still occur, but in most patients less severely.

Images are for illustration purposes only. Individual results may vary.

XEOMIN Helps Improve
Upper Limb Spasticity
Symptoms

In clinical studies, XEOMIN improved muscle tone and resulted in functional
improvements 4 weeks after initiation of treatment2*

86%

Of patients treated at 8 Units/kg experienced a 1-point change or greater on the Ashworth Scale2

71%

Of patients treated at 2 Units/kg experienced a 1-point change or greater on the Ashworth Scale2

1.7

Mean improvement at Week 4 in GICS score for patients treated at 8 Units/kg2

XEOMIN provided sustained, long-term improvements in muscle tone for all upper limb muscle groups over 56 weeks (4 injection cycles)2†

*Functional improvement was measured using the Global Impression of Change Scale (GICS), a global measure of a patient’s functional improvement.

Clinical patterns treated were flexed elbow, flexed wrist, forearm pronators, clenched fist, and thumb-in-palm over 4 injection cycles.

What is Upper Limb Spasticity?

What is Upper Limb Spasticity in Pediatrics?

upper limb spasticity

Affecting the arms, specifically the elbow, forearm, wrist, and hand muscles

Increase in muscle tension causing tightness, stiffness, or uncontrollable pull of muscles

Symptoms3,4
  • Muscle stiffness (known as hypertonia)
    • Muscles become overactive and tense
  • Limited range of movement
    • Difficulty moving
    • Limitations in performing daily activities
  • Reduced ability to relax muscles
  • Muscle spasms
  • Changes in limb position
  • Pain
5 Common Patterns4

Flexed elbow

Bent wrist

Pronated forearm

Clenched fist

Thumb-in-palm

Upper Limb Spasticity in Pediatrics

(excluding spasticity caused by cerebral palsy)

XEOMIN for Upper Limb Spasticity, Excluding Spasticity Caused by
Cerebral Palsy, in Pediatrics

clenched fist 1

In children with upper limb spasticity, there is an imbalance of signals from the brain to the muscles, which causes stiffness and spasms. This can lead to abnormal arm or hand positions, uncomfortable movement, and pain.1

clenched fist 2

XEOMIN is injected into muscles to help interfere with these signals. This helps decrease muscle stiffness and improve your child’s ability to function using the affected muscles.2

clenched fist 3

Some stiffness and spasms may still occur, but in most patients less severely.

Images are for illustration purposes only. Individual results may vary.

XEOMIN Helps Improve Upper Limb Spasticity Symptoms

In clinical studies, XEOMIN improved muscle tone and resulted in functional
improvements 4 weeks after initiation of treatment2*

86%

Of patients treated at 8 Units/kg experienced a 1-point change or greater on the Ashworth Scale2

71%

Of patients treated at 2 Units/kg experienced a 1-point change or greater on the Ashworth Scale2

1.7

Mean improvement at Week 4 in GICS score for patients treated at 8 Units/kg2

XEOMIN provided sustained, long-term improvements in muscle tone for all upper limb muscle groups over 56 weeks (4 injection cycles)2†

*Functional improvement was measured using the Global Impression of Change Scale (GICS), a global measure of a patient’s functional improvement.

Clinical patterns treated were flexed elbow, flexed wrist, forearm pronators, clenched fist, and thumb-in-palm over 4 injection cycles.

What is Upper Limb Spasticity in Pediatrics?

Affecting the arms, specifically the elbow, forearm, wrist, and hand muscles

Increase in muscle tension causing tightness, stiffness, or uncontrollable pull of muscles

Symptoms1,2
  • Muscle stiffness (know as hypertonia)
    • Muscles become overactive and tense
  • Limited range of movement
    • Difficulty moving
    • Limitations in performing daily activities
  • Reduced ability to relax muscles
  • Muscle spasms
  • Changes in limb position
  • Pain
5 Common Patterns2

Flexed elbow

Bent wrist

Pronated forearm

Clenched fist

Thumb-in-palm

References

  1. Ozcakir S, Sivrioglu K. Botulinum toxin in poststroke spasticity. Clin Med Res. 2007;5(2):132-138
  2. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2021.
  3. Differential diagnosis for spasticity. NeuroRehab Resource website. http://www.neurorehabresource.org/Files/NRR_Differential_Diagnosis.pdf. Accessed June 18, 2021.
  4. Spasticity. American Association of Neurological Surgeons website. https://www.aans.org/en/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed June 18, 2021.
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.