MY GOAL:
Help my patients understand their condition.

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DIAGNOSING CERVICAL DYSTONIA CAN BE DIFFICULT

Cervical dystonia (CD), also known as spasmodic torticollis, is characterized by abnormal movements or postures of the neck and head. Spasms may affect any combination of the neck muscles.1


PREVALENCE OF CD

89 Cases Per Million

There is an estimated US prevalence of 89 cases of CD per million persons2


2:1 Female predominance3

Icons showing a 2:1 ratio of women to men

UNDERRECOGNIZED

Graph showing 43%

In one survey, 43% of people with CD had visited 4 or more physicians before a diagnosis of CD was made2

  • Patients with mild symptoms may not seek medical advice4
  • Wide-range spectrum of dystonia leads to difficult diagnosis4
  • More common conditions are often suspected or diagnosed instead of CD, at least initially4

MOST COMMON POSTURES ASSOCIATED WITH CD

Patients may present with a combination of postures, as well as sustained or jerky movements5,6

Illustration of a woman looking to the right

TORTICOLLIS
(rotation)

Illustration of a woman looking up

RETROCOLLIS
(extension)

Illustration of a woman tilting her head to the left

LATEROCOLLIS
(lateral tilt)

Illustration of a woman looking down

ANTEROCOLLIS
(flexion)


PHYSICAL CONCERNS*

Graph showing 75%

Up to 75% of CD patients suffer from neck pain7


Icons of people with 7 of 10 colored blue

Nearly 7 of 10 patients say the pain is moderate to severe6


CERVICAL DYSTONIA CAN CAUSE A DRAMATIC IMPACT ON A PATIENT'S LIFE

CD can cause functional and occupational disability, social isolation, and depression.1,8

PATIENT CONCERNS*

  • In a study evaluating the impact of CD on work productivity, 38.5% of those employed when symptoms began stopped work due to CD (107 out of 278 patients)9
  • Quality of life scores for patients with CD were as low as other neurological conditions, such as Parkinson's disease and stroke1
  • Energy and vitality scores for patients with CD were comparable to those of stroke patients1

Neck pain is significantly associated with negative employment outcomes, including job changes, reduced productivity, likelihood of a patient seeking disability benefits, and complete job loss in some patients10

Illustration of a man walking a dog

FUNCTIONAL

DISABILITY8

Illustration of a woman frowning with a group of people behind her in the distance

SOCIAL
ISOLATION1,8

Illustration of a man working on a computer

OCCUPATIONAL
DISABILITY8

Illustration of a woman frowning

DEPRESSION1,8

*There are no studies showing that treating CD affects the specific outcomes on this page.

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MYOBLOC logo

MYOBLOC is the only type B botulinum toxin therapy approved for treatment of CD. Learn more about MYOBLOC for Cervical Dystonia.

IMPORTANT SAFETY INFORMATION

INDICATIONS

MYOBLOC® injection is indicated for:

  • the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults
  • the treatment of chronic sialorrhea in adults

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed WARNING.

The effects of MYOBLOC® 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 an underlying condition that would predispose them to these symptoms.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

  • A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation
  • Infection at the proposed injection site(s)

WARNING AND PRECAUTIONS

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
  • Hypersensitivity Reactions
    Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC 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.
  • Dysphagia and Breathing Difficulties
    Treatment with MYOBLOC 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. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
    • Cervical Dystonia: Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
    • Pre-Existing Neuromuscular Disorders: Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.
  • Human Albumin and Transmission of Viral Diseases
    This product contains albumin, a derivative of human blood. 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 be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

MOST COMMON ADVERSE REACTIONS (>5% of patients and >5% more than placebo)

Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache

Chronic Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of MYOBLOC 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. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.

References:

1. Camfield L, Ben-Shlomo Y, Warner TT; Epidemiological Study of Dystonia in Europe Collaborative Group. Impact of cervical dystonia on quality of life. Mov Disord 2002;17:838-841. 2. Jankovic J. Tsui J, Bergeron C. Prevalence of cervical dystonia and spasmodic torticollis in the United States general population Parkinsonism Relat Disord. 2007;13(7):411-416. 3. Defazio G. Jankovic J, Giel JL. Papapetropoulos S. Descriptive epidemiology of cervical dystonia Tremor Other Hyperkinet Mov (NY). 2013;3:tre-03-193-4374-2. doi:10.7916/0BOC4 TGJ 4. Lalli S, Albanese A. The diagnostic challenge of primary dystonia: evidence from misdiagnosis. Mov Disord. 2010;25(11): 1619-1626. 5. Cervical dystonia. Dystonia Medical Research Foundation. www.dystonia-foundation.org. Accessed October 22, 2018. 6. Chan J, Brin MF, fahn S. Idiopathic cervical dystonia: clinical character ist,cs. Mov Disord. 1991;6(2):119-126. 7. Lew MF. Botulinum toxin type B: an effective treatment for alleviating pain associated with cervical dystonia J Back Musculoskel Rehab. 2002; 16( ):3-9. 8. Van Zandijcke M. Cervical dystonia (spasmodic torticollis): some aspects of the natural history. Acta Neurol Belg. 1995:95:210-215 9. Molho ES, Stacy M. et al. Impact of cervical dystonia on work productivity: an analysis from a patient registry. Mov Disord. 2015; 3(2):130-138. 10. Molho ES, Agarwal N, Regan K, Higgins DS. Factor SA. Effect of cervical dystonia on emplyment a retrospective analysis of the ability of treatment to restore premorbid employment status. Mov Disord. 2009:24:1384-1387.

IMPORTANT SAFETY INFORMATION

INDICATIONS

MYOBLOC® injection is indicated for:

  • the treatment of cervical dystonia (CD) to reduce the severity of abnormal head position and neck pain associated with CD in adults
  • the treatment of chronic sialorrhea in adults

IMPORTANT SAFETY INFORMATION

WARNING: DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete boxed WARNING.

The effects of MYOBLOC® 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 an underlying condition that would predispose them to these symptoms.

CONTRAINDICATIONS

MYOBLOC is contraindicated in patients with:

  • A known hypersensitivity to any botulinum toxin product or to any of the components in the formulation
  • Infection at the proposed injection site(s)

WARNING AND PRECAUTIONS

  • Lack of Interchangeability Between Botulinum Toxin Products
    The potency units of MYOBLOC are specific to the preparation and biological activity assay method utilized. Due to differences in the aspects of this assay such as the vehicle, dilution scheme, and laboratory protocols for various potency assays, potency units are not interchangeable with other preparations of botulinum toxin products and, therefore, units of biological activity of MYOBLOC cannot be compared to or converted into units of any other botulinum toxin products assessed with any other specific assay method.
  • Hypersensitivity Reactions
    Serious hypersensitivity reactions have been reported with botulinum toxin products. Angioedema, urticaria, and rash have occurred with MYOBLOC treatment. Hypersensitivity reactions can also include anaphylaxis, serum sickness, soft tissue edema, and dyspnea. If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of MYOBLOC and institute appropriate medical therapy immediately. The use of MYOBLOC 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.
  • Dysphagia and Breathing Difficulties
    Treatment with MYOBLOC 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. In most cases, this is a consequence of weakening of muscles in the area of injection that are involved in breathing or swallowing. When distant effects occur, additional respiratory muscles may be involved. Deaths as a complication of severe dysphagia have been reported after treatment with botulinum toxin. Dysphagia may persist for several months and require use of a feeding tube to maintain adequate nutrition and hydration. Aspiration may result from severe dysphagia and is a particular risk when treating patients in whom swallowing or respiratory function is already compromised.
    • Cervical Dystonia: Treatment of cervical dystonia with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in a critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been postmarketing reports of serious breathing difficulties, including respiratory failure, in cervical dystonia patients. Patients treated with botulinum toxin may require immediate medical attention should they develop problems with swallowing, speech or respiratory disorders. These reactions can occur within hours to weeks after injection with botulinum toxin.
    • Pre-Existing Neuromuscular Disorders: Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) should be monitored particularly closely when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including severe dysphagia and respiratory compromise from typical doses of MYOBLOC.
  • Human Albumin and Transmission of Viral Diseases
    This product contains albumin, a derivative of human blood. 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 be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been identified for licensed albumin or albumin contained in other licensed products.

MOST COMMON ADVERSE REACTIONS (>5% of patients and >5% more than placebo)

Cervical Dystonia: dry mouth, dysphagia, injection site pain, headache

Chronic Sialorrhea: dry mouth, dysphagia

DRUG INTERACTIONS

Co-administration of MYOBLOC and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like compounds) should only be performed with caution as the effect of the toxin may be potentiated. Use of anticholinergic drugs after administration of MYOBLOC 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. Excessive weakness may also be exaggerated by administration of a muscle relaxant before or after administration of MYOBLOC.

Please see the full Prescribing Information, including Boxed WARNING and Medication Guide.