Causes2-4

  • Stroke (most common cause)
  • Traumatic brain injury
  • Multiple sclerosis
  • Spinal cord problems (such as lesions)
  • Cerebral palsy in adults
A black punching bag

Symptoms4

  • Muscle stiffness (known as hypertonia)
  • Limited range of movement
  • Reduced ability to relax muscles
  • Muscle spasms
  • Changes in limb position
  • Pain
In clinical trials, most patients treated for upper limb spasticity with XEOMIN were adults with post-stroke spasticity5-7

Common Occurrence after Stroke

  • Spasticity may be one of many possible consequences after a stroke2
  • There is a wide range of prevalence data in post-stroke spasticity, from as little as 19% to as much as 98% of patients8,9
  • The onset of spasticity after stroke is also highly variable. It may occur shortly after the stroke or more than 1 year later10
A line graph showing the increase in spasticity signs 4 weeks after a stroke, 1 to 3 months post-stroke, and more than 3 months post-stroke

Clinical Patterns

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

Russell Is a 61-Year-Old Retired Dentist Who Never Backs Down

The life he's fighting for

After a fulfilling career in dentistry, Russell applied his steady hands to his first love: gardening. His wife, Gabby, an incredible cook, loves his new hobby too, and enjoys incorporating his vegetables into her latest dishes and his flowers into all the rooms of their home.

The weigh-in

  • 6 months ago, Russell suffered a stroke; 3 months after that, he began experiencing spasticity in his right arm, which is his dominant arm for performing most of his everyday tasks
  • Russell's spasticity is predominantly manifesting in the clinical patterns of flexed wrist, clenched fist, and flexed elbow, which makes it painful and challenging to perform activities like gardening, writing, and cooking in the kitchen with his family

Sparring with upper limb spasticity

  • Russell embraced physical therapy, which has helped; however, his range of motion remains limited due to spasticity
  • He tried oral medications with limited effect
  • Up to this point he has had no prior treatment with neurotoxins
Russell standing next to a punching bag

Never defeated, Russell got into the game

Explore XEOMIN for the treatment of upper limb spasticity

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

*Excluding spasticity caused by cerebral palsy.

Duration of Effect11

  • Long duration of effect is possible with XEOMIN for adult upper limb spasticity
    • In a clinical study, XEOMIN efficacy lasted between 20 and 28 weeks in some adult patients with upper limb spasticity
Mean Change at Week 4 on the Ashworth Scale for Primary Target Clinical Pattern1,5*
A chart showing the results of a clinical study of XEOMIN

The Ashworth Scale is a clinical measure of the severity of spasticity by judging the resistance to passive movement

Improvement in overall spasticity as measured by global impression of change scale (GICS)

GICS is a global measure of a patient's functional improvement.11

  • 3 out of 4 patients showed at least minimal improvement in spasticity with XEOMIN1,5
  • 43% (73/171) of patients were rated as much improved [40% (68/171)] or very much improved [3% (5/171)] with XEOMIN, compared with only 23% (20/88) in the placebo group1,5
A chart showing the GICS scores of XEOMIN at week 4

The investigators' GICS scores at Week 4 demonstrated that XEOMIN was superior to placebo1

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

GICS, Global Impression of Change Scale

Common Adverse Reactions
Most common adverse reactions affecting ≥2% of patients and greater than placebo in 2 randomized, double-blind, placebo-controlled studies1,5,6*
Adverse Reactions
Percentage of patients
XEOMIN
n=217
Placebo
n=182
Seizure
3
0
Nasopharyngitis
2
0
Dry mouth
2
1
Upper respiratory tract infection
2
1
Learn About XEOMIN Dosing
Worried about waning efficacy?
See the XEOMIN Difference
Learn More Back to Indications

The 2 randomized, double-blind, placebo-controlled studies include the PURE study, which was conducted in the United States, and a separate clinical study used for European approval of XEOMIN for adult upper limb spasticity.

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023.
  2. Spasticity, what is it? American Stroke Association website. Accessed June 18, 2021. https://www.stroke.org/en/about-stroke/effects-of-stroke/physical-effects-of-stroke/physical-impact/spasticity
  3. Differential diagnosis for spasticity. NeuroRehab Resource website. Accessed June 18, 2021. http://www.neurorehabresource.org/Files/NRR_Differential_Diagnosis.pdf
  4. Spasticity. American Association of Neurological Surgeons website. Accessed June 18, 2021. https://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity
  5. Elovic EP, Munin MC, Kaňovský P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxinA for upper-limb post-stroke spasticity. Muscle Nerve. 2016;53(3):415-421.
  6. Kaňovský P, Slawek J, Denes Z, et al. Efficacy and safety of botulinum neurotoxin NT 201 in poststroke upper limb spasticity. Clin Neuropharmacol. 2009;32(5):259-265.
  7. Barnes M, Schnitzler A, Medeiros L, Aguilar M, Lehnert-Batar A, Minnasch P. Efficacy and safety of NT 201 for upper limb spasticity of various etiologies—a randomized parallel-group study. Acta Neurol Scand. 2010;122(4):295-302.
  8. Wissel J, Schelosky LD, Scott J, Christe W, Faiss JH, Mueller J. Early development of spasticity following stroke: a prospective, observational trial. J Neurol. 2010;257(7):1067-1072.
  9. Ward AB. A literature review of the pathophysiology and onset of post-stroke spasticity. Eur J Neurol. 2012;19(1):21-27.
  10. Wissel J, Manack A, Brainin M. Toward an epidemiology of poststroke spasticity. Neurology. 2013;80(3 Suppl 2):S13-19.
  11. Kaňovský P, Elovic EP, Hanschmann A, et al. Duration of treatment effect using incobotulinumtoxinA for upper-limb spasticity: a post-hoc analysis. Front Neurol. 2021;11:615706.
  12. Carr WW, Jain N, Sublett JW. Immunogenicity of botulinum toxin formulations: potential therapeutic implications. Adv Ther. 2021;38(10):5046-5064.
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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.