Characteristics

  • Most common form of focal dystonia3
  • Estimated to affect more than 90,000 people in the United States in 20073
  • Misdiagnoses may include tremor, Parkinson’s disease, tics, chorea, psychogenic movement disorder, headache, and scoliosis4
A black speed bag used in boxing

Symptoms5

  • Head and neck turning, tilting, or jerking
  • Head and neck shaking (spasms)
  • Neck and shoulder pain
  • Neck and shoulder stiffness

Unlike other forms of focal dystonia, pain is often a prominent symptom with cervical dystonia3

Types of Head Movement

  • Torticollis and laterocollis, or a combination of these two, are the most common manifestations5
  • Head tremor5
Anterocollis
Retrocollis
Rotational torticollis
Laterocollis

Symptom Stabilization

  • Stabilization of symptoms is common but can take several years6
  • Remission has been reported in 10% to 23% of patients6
  • Progression to segmental dystonia occurs in up to 20% of patients6

Melissa is a 45-Year-Old ICU Nurse Who Never Backs Down from a Challenge

The life she's fighting for

When she's not running a tight ship at home, Melissa is on the floor of a busy ICU as charge nurse. A leader at heart, Melissa has a passion for life and a personality to match. But nothing makes her prouder than cheering her kids on at their weekly soccer and baseball games.

Melissa, a patient with adult cervical dystonia, sitting on a stool talking about XEOMIN

The weigh-in

  • Melissa was diagnosed with cervical dystonia 4 and a half years ago with a posture that includes both torticollis and retrocollis
  • She experienced depression and a significant impact in pain
  • The pain from cervical dystonia created a challenge in her role as an ICU nurse, which prompted her to seek treatment

Sparring with cervical dystonia

  • After years of struggling with pain, Melissa was ready to take control
  • She was prescribed a botulinum toxin formulation that contains complexing proteins and received treatment for 3 years
  • However, after a period of treatment success, Melissa began to suffer a progressive worsening of her cervical dystonia despite increases in dosage
Melissa standing in front of a gym locker

Never defeated, Melissa and her doctor made a change

Real Patient testimonials

Jan
Michelle

Explore XEOMIN for the treatment of adult cervical dystonia

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TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale; ICU, Intensive Care Unit.

Duration of Effect7-9

  • Some patients can experience long duration of effect with XEOMIN for cervical dystonia
    • In clinical studies, some patients with cervical dystonia were re-treated with XEOMIN every 20 weeks

Demonstrated Improvement in Cervical Dystonia As Measured by the Primary Endpoint1,2*

Both doses of XEOMIN demonstrated significant improvement in the TWSTRS total scores from baseline to Week 4 when compared with placebo.1

  • Efficacy of XEOMIN was similar in patients who were botulinum toxin-naïve and those who were not2
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Baseline was determined at visit 2 (day 0); visit 1 was initial screening visit. At Week 4, there was no reduction in the TWSTRS total score for placebo.

TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale; U, Units.

Common Adverse Reactions
Pivotal study: most common adverse reactions affecting ≥5% of patients and greater than placebo1
Adverse Reactions
Percentage of patients
XEOMIN
120 U (n=77)
XEOMIN
240 U (n=82)
Placebo
(n=74)
Subjects with adverse reactions
57
55
42
Musculoskeletal and connective tissue disorders
23
32
11
Neck pain
7
15
4
Muscular weakness
7
11
1
Musculoskeletal pain
7
4
1
Gastrointestinal disorders
18
24
4
Dysphagia
13
18
3
Nervous system disorders
16
17
7
General disorders and administration site conditions
16
11
11
Injection site pain
9
4
7
Infections and infestations
14
13
11
Respiratory, thoracic, and mediastinal disorders
13
10
3

There were no new or unexpected safety findings with XEOMIN.2

Learn About XEOMIN Dosing
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U, Units.

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2023.
  2. Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; US XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN®, botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011;308(1-2):103-109.
  3. Dashtipour K, Lew M. Cervical dystonia. In: Stacy MA, ed. Handbook of Dystonia. 1st ed. New York, NY: Informa Healthcare; 2007:137-154.
  4. Tarsy D. Dystonia. In: Adler CH, Ahlskog JE, eds. Parkinson’s Disease and Movement Disorders: Diagnosis and Treatment Guidelines for the Practicing Physician. Totowa, NJ: Humana Press; 2000:297-311.
  5. Lalli S, Albanese A. The diagnostic challenge of primary dystonia: evidence from misdiagnosis. Mov Disord. 2010;25(11):1619-1626.
  6. Jankovic J. Treatment of cervical dystonia. In: Brin MF, Comella C, Jankovic J, eds. Dystonia: Etiology, Clinical Features, and Treatment. Philadelphia, PA: Lippincott Williams & Wilkins; 2004:159-166.
  7. Data on file. Raleigh, NC: Merz Pharmaceuticals, LLC; 2021.
  8. Evidente VG, Fernandez HH, LeDoux MS, et al. A randomized, double-blind study of repeated incobotulinumtoxinA (Xeomin®) in cervical dystonia. J Neural Transm (Vienna). 2013;120(12):1699-1707.
  9. Evidente VG, Truong D, Jankovic J, Comella CL, Grafe S, Hanschmann A. IncobotulinumtoxinA (Xeomin®) injected for blepharospasm or cervical dystonia according to patient needs is well tolerated. J Neurol Sci. 2014;346(1-2):116-120.
  10. Benecke R, Jost WH, Kaňovský P, Ruzicka E, Comes G, Grafe S. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology. 2005;64(11):1949-1951.
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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.