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ABOUT CERVICAL DYSTONIA


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

COMMON SYMPTOMS OF CD
Neck pain4
Involuntary contraction of neck muscles1
Muscle hypertrophy1
Tremor involving head and neck1
Limited range of motion1

FOUR MOST COMMON POSTURES ASSOCIATED WITH CD

CERVICAL DYSTONIA CAN CAUSE

A DRAMATIC IMPACT ON A PATIENT'S LIFE


CD can cause functional and occupational disability, social isolation and depression.5-8

Pain is a predominant complaint of most patients with CD

CD had a significantly negative impact on quality of life (QoL) when compared with the general population.5

STUDY RESULTS

In a study conducted by Camfield et al., results showed5*:

  • Patients with CD scored much worse in all 8 physical and mental domains on the SF-36
  • When patients with CD were compared with patients with other neurological conditions (eg, Parkinson’s disease [PD], stroke), QoL scores were similarly low for select domains
  • CD pain scored similar to PD pain

*289 patients were evaluated on QoL using a generic health status measurement scale (SF-36).

MYOBLOC

is an effective first-line treatment for CD and offers a range of supporting data in treating painful cervical dystonia.

References:

  1. 1. Jankovic J. Dystonias, choreas, athetosis, and ballism. In: Goldman L, Ausiello D, eds. Cecil Textbook of Medicine. 22nd ed. Philadelphia, PA: Saunders; 2004:2312–2314.
  2. 2. Nutt JG, Muenter MD, Aronson A, Kurland LT, Melton LJ III. Epidemiology of focal and generalized dystonia in Rochester, MN. Mov Disord. 1988;3:188–194.
  3. 3. Claypool W, Duane DD, Ilstrup DM, Melton LJ III. Epidemiology and outcome of cervical dystonia (spasmodic torticollis) in Rochester, MN. Mov Disord. 1995;10:608–614.
  4. 4. Costa J, Espirito-Santo C, Borges A, et al. Botulinum toxin type B for cervical dystonia. Cochrane Database Syst Rev. 2005;1:CD004315.
  5. 5. Camfield L, Ben-Shlomo Y, Warner TT, and the Epidemiological Study of Dystonia in Europe Collaborative Group. Impact of cervical dystonia on quality of life. Mov Disord. 2002;17:838–841.
  6. 6. Lew MF. Botulinum toxin type B: an effective treatment for alleviating pain associated with cervical dystonia. J Back Musculoskel Rehab. 2002;16:3–9.
  7. 7. Van Zandijcke M. Cervical dystonia (spasmodic torticollis). Some aspects of natural history. Acta Neurol Belg. 1995;95:210–215.
  8. 8. Ben-Shlomo Y, Camfield L, Warner T. What are the determinants of quality of life in people with cervical dystonia? J Neurol Neurosurg Psychiatry. 2002;72:608–614.
  9. 9. Chan J, Brin MF, Fahn S. Idiopathic cervical dystonia: clinical characteristics. Mov Disord. 1991;6:119–126.

INDICATIONS

MYOBLOC® (rimabotulinumtoxinB) 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 FOR MYOBLOC

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)

WARNINGS 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
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.

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact US WorldMeds at 1-888-461-2255, Option 2. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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