There are several organizations that provide valuable support and information about cervical dystonia for you and your patients.
Disclaimer: This section provides links to relevant websites that will help you expand your knowledge about cervical dystonia and gain access to additional information that you may find useful in your practice. Unless otherwise indicated, Ipsen is neither affiliated with nor endorses any of the following organizations. These associations, societies, and medical databases are not intended to be all-inclusive, but are a representative sampling of information sources.
- American Academy of Neurology (AAN): www.aan.com
AAN is a professional association committed to providing the best possible care for patients with neurological disorders. - American Academy of Physical Medicine and Rehabilitation (AAPM&R): www.aapmr.org
AAPM&R is a society of rehabilitation physicians who are nerve, muscle, bone, and brain experts. They treat injury or illness non-surgically to decrease pain and restore function. - The Dystonia Medical Research Foundation (DMRF): www.dystonia-foundation.org
DMRF is an organization dedicated to advancing research for treatments of dystonia and ultimately a cure, promoting awareness and education, and supporting the needs and well-being of individuals with dystonia and their families. - The Dystonia Society: www.dystonia.org.uk
The Dystonia Society is a charity that strives to provide support to people affected by dystonia and raise awareness about the disorder through education and research. - Medscape: www.medscape.com
Medscape provides healthcare professionals with medical information and educational tools. - The Movement Disorder Society: www.movementdisorders.org
The Movement Disorder Society is an international professional society committed to advancing the research and treatment of patients with movement disorders. - National Institute of Neurological Disorders and Stroke (NINDS): www.ninds.nih.gov
NINDS is a division of the National Institute of Health (NIH) that strives to reduce the burden of neurological disease by conducting and supporting research and spreading information on the causes and treatment of neurological disorders. - National Institutes of Health: www.nih.gov
The National Institutes of Health, a part of the US Department of Health and Human Services, is the main government agency for conducting and supporting medical research. - National Spasmodic Torticollis Association (NSTA): www.torticollis.org
NSTA strives to support the needs of people with cervical dystonia and their loved ones, increase awareness, and further research about treatments for this condition. - PubMed: www.pubmed.gov
PubMed is a service of the US National Library of Medicine and the National Institutes of Health. The database of over 18 million journal articles dating back to 1948 provides links to complete articles. - ST/Dystonia: www.spasmodictorticollis.org
ST/Dystonia is a non-profit organization committed to helping people with spasmodic torticollis (ST). This group provides helpful information for patients, including a booklet with tips for living with ST and more than 100 pages of information about ST and treatment options, as well as patient and doctor interviews. - WE MOVE (Worldwide Education and Awareness for Movement Disorders): www.wemove.org
WE MOVE is a not-for-profit organization dedicated to improving awareness, diagnosis, and management of movement disorders.
Indication
Dysport is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for the treatment of adults with cervical dystonia to reduce the severity of abnormal head position and neck pain in both toxin-naïve and previously treated patients.
Important Safety Information
Distant Spread of Toxin Effect: Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. 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 treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.
Dysport is contraindicated in patients with hypersensitivity to any botulinum toxin product or its excipients, including human albumin, lactose, and cow's milk protein, or who have an infection at the proposed injection site.
The potency Units of Dysport are not interchangeable with other preparations of botulinum toxin products and, therefore, Units of biological activity of Dysport cannot be compared to or converted into Units of any other botulinum toxin products. Recommended dose and frequency of administration should not be exceeded.
Immediate medical attention may be required in cases of respiratory, speech, or swallowing difficulties. Dysphagia may persist for several weeks, 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. Concomitant neuromuscular disorder may exacerbate clinical effects of treatment.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders 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 Dysport.
Dysport contains human albumin. Based on effective donor screening and product manufacturing processes, Dysport carries an extremely remote risk for transmission of viral diseases. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin.
The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established.
Patients receiving concomitant treatment of Dysport and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of botulinum toxin may be potentiated. Use of anticholinergic drugs may potentiate systemic anticholinergic effects. The effect of administering different botulinum neurotoxins during the course of treatment with Dysport is unknown.
There are no adequate and well-controlled studies in pregnant women. Dysport should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The most commonly observed adverse reactions (>5% of patients) with Dysport for the treatment of cervical dystonia are muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, neck pain, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.
To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-877-397-7671 (877- DYSPOR1). You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning, and Medication Guide.
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