About the Dysport Risk Evaluation and Mitigation Strategy (REMS)
Dysport is differentiated from other marketed botulinum toxin products by the unique non-proprietary name abobotulinumtoxinA. Based on FDA direction to all manufacturers of botulinum neurotoxins available in the US, Ipsen has implemented a REMS program in order to ensure that the potential benefits of treating cervical dystonia with Dysport outweigh the potential risks of:
- Medication errors related to the lack of interchangeability of Dysport Units with those of toxins of other manufacturers; and
- The potential for the occurrence of spread of toxin effect beyond the injection site
Here are some useful guidelines to help incorporate the REMS program into your practice:
- Inform staff members about the purpose of REMS and ensure that each one has a copy of the
Dysport Medication Guide. - Make sure that any existing patient consent documentation for Dysport therapy is consistent with the Dysport Medication Guide.
- Remember to provide a copy of the Medication Guide to patients and caregivers and to review it with them at every injection, as it may include new information.
A key element of the Dysport REMS is the FDA-approved patient Medication Guide, which will be provided with each carton of Dysport. By promoting an informed discussion between the physician and patient, the Medication Guide will help ensure that patients are fully aware of and understand the risks of Dysport treatment in relation to the potential benefits. Make sure that you always have a supply of Medication Guides in your office. For additional copies, contact your Ipsen representative.
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.
All trademarks used herein belong to their respective owners.
