Do you expect symptom relief to last between injection sessions?

In the treatment of pediatric patients (2 years & older) with spasticity start Dysport first-line for lasting symptom relief1:
• Dysport is FDA-approved for the treatment of spasticity in children aged 2 years and older
• The majority of patient in the clinical study were retreated between 16 and 22 weeks

Results from a clinical trial specifically for pediatric patients with upper limb spasticity (2 years & older)

Dysport was evaluated with meaningful clinical endpoints.

Primary and secondary efficacy endpoints1,2

Primary Efficacy Endpoint

Mean change from baseline in muscle tone by Modified Ashworth Scale (MAS) in the primary targeted muscle group (PTMG) at Week 6

Secondary Efficacy Endpoint

Mean Physician Global Assessment (PGA) score of response to treatment at Week 6. Although PGA scores numerically favored Dysport treatment over low-dose control, the difference was not statistically significant.


Study Design1,2

The efficacy and safety of Dysport were evaluated in a randomized, prospective, double-blind, multicenter, Phase III, controlled, multiple treatment study with pediatric patients aged 2 to 17 years.




Study design: Patients were randomized to received Dysport 2 Units/kg (n=70), 8 Units/kg (n=70), or 16 Units/kg (n=70) for the first treatment cycle. The completion of 1 cycle occurred when the patient received their next injection. The primary efficacy endpoint was mean change from baseline in muscle tone at Week 6, assessed by MAS in the PTMG. Secondary efficacy endpoints were mean change in the PGA at Week 6, and mean GAS score at Week 6. Patient were assessed for retreatment eligibility at Week 16. if ineligible for retreatment, they were evaluated every 6 weeks (plus or minus 2 weeks) until eligible. There had to be a minimum of 16 weeks between each injection session, and patients could receive a maximum of 4 sessions over the course of the study. After completing their first treatment cycle, patients receiving Dysport 2 Units/kg were re-randomized to receive Dysport 8 Units/kg or 16 Units/kg. Patient receiving the higher doses remained at their dose unless an adjustment up (not exceeding 16 Units/kg) or down was mandated by the investigator. The study remained double blind for the remaining 3 cycles, or until patients exited the study at 1 year and 9 months.

GAS=Goal Attainment Score; MAS= Modified Ashworth Score; PGA=Physican’s Global Assessment; PTMG=primary target muscle group.

Study Design

The effect of Dysport lasted beyond the minimum 16-week retreatment period in some patients2*



  • Out of the patients receiving Dysport 8 Units/kg, 15.8% were retreated between Weeks 34 and 52. Of that number, 3 patients were withdrawn, while 6 did not need a reinjection, or data was missing2
  • Out of the patients receiving Dysport 16 Units/kg, 20% were retreated between Weeks 34 and 52. Of that number, 3 patients were withdrawn, while 7 did not need a reinjection, or data was missing2
  • The optimal dose of Dysport, muscles to be injected, and retreatment eligibility should be selected based on the patient’s progress and response to treatment1,2
  • Retreatment for upper limb spasticity should occur no sooner than 16 weeks after the first injection1
  • Eligibility for retreatment was assessed by the investigator at every visit onward from Week 16 for lower limb spasticity or Week 16 for upper limb spastcity2

*Patients who remained in the upper limb study after Week 16 were permitted additional discretionary follow-up visits at Week 22, Week 28, Week 34, or beyond3
†Patients who remained in the upper limb study after Week 12 were permitted additional discretionary follow-up visits at Week 16, Week 22, and Week 28 to access eligibility for retreatment

Time to Retreatment

View safety results for Dysport-treated pediatric patients (2 years & older) with upper limb spasticity


Sign up for comprehensive injection training to ensure patients get the most out of Dysport

Enhance your level of Dysport expertise with comprehensive injection training:

• Opportunity to be added to the Dysport Doctor Locator, where patients can easily find your practice if you are eligible*

• 1:1 injection training in your office (hands-on mentorship training) or at another facility (observe experienced faculty)

• Live group training programs with a simulator demonstration or live WebEx

• Educational videos, brochures, and information on purchasing and reimbursement

*See eligibility criteria at


Injection Training


Warning: Distant Spread of Toxin Effect

Postmarketing reports indicate that the effects of Dysport® (abobotulinumtoxinA) 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 and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose.


Dysport is contraindicated in patients with known hypersensitivity to any botulinum toxin products, cow’s milk protein, components in the formulation or infection at the injection site(s). Serious hypersensitivity reactions including anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea have been reported. If such a reaction occurs, discontinue Dysport and institute appropriate medical therapy immediately.

Warnings and Precautions

Lack of Interchangeability Between Botulinum Toxin Products

The potency Units of Dysport are specific to the preparation and assay method utilized. They 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 assessed with any other specific assay method.

Dysphagia and Breathing Difficulties

Treatment with Dysport 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 side 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 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. 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 junction 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 Dysport.

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 also 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.

Intradermal Immune Reaction

The possibility of an immune reaction when injected intradermally is unknown. The safety of Dysport for the treatment of hyperhidrosis has not been established. Dysport is approved only for intramuscular injection.

Most Common Adverse Reactions

Adults with lower limb spasticity (≥5%): falls, muscular weakness, and pain in extremity and with upper limb spasticity (≥4%): muscular weakness.

Pediatric patients with lower limb spasticity (≥10%): nasopharyngitis, cough and pyrexia and with upper limb spasticity (≥10%): upper respiratory tract infection and pharyngitis.

Adults with cervical dystonia (≥5%): muscular weakness, dysphagia, dry mouth, injection site discomfort, fatigue, headache, musculoskeletal pain, dysphonia, injection site pain, and eye disorders.

Drug Interactions

Co-administration 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 after administration of Dysport may potentiate systemic anticholinergic effects, such as blurred vision. The effect of administering different botulinum neurotoxins at the same time or within several months of each other is unknown. Excessive weakness may be exacerbated by another administration of 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 Dysport.

Special Populations

Use in Pregnancy

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. Based on animal data, Dysport may cause fetal harm.

Pediatric Use

The safety and effectiveness of Dysport injected into proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established. Based on animal data Dysport may cause atrophy of injected and adjacent muscles; decreased bone growth, length, and mineral content; delayed sexual maturation; and decreased fertility.

Geriatric Use

In general, elderly patients should be observed to evaluate their tolerability of Dysport, due to the greater frequency of concomitant disease and other drug therapy. Subjects aged 65 years and over who were treated with Dysport for lower limb spasticity reported a greater percentage of fall and asthenia as compared to those younger (10% vs. 6% and 4% vs. 2%, respectively).

To report SUSPECTED ADVERSE REACTIONS or product complaints, contact Ipsen at 1-855-463-5127. You may also report SUSPECTED ADVERSE REACTIONS to the FDA at 1-800-FDA-1088 or


Dysport for injection is indicated for the treatment of:

  • Lower and upper limb spasticity in adults
  • Lower limb spasticity in pediatric patients 2 years of age and older
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults


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


  1. Dysport® (abobotulinumtoxinA) [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; January 2019.
  2. Data on file. Basking Ridge, NJ; Ipsen Biopharmaceuticals, Inc.
  3. Esquenazi A, Alfaro A, Ayyoub Z, et al. PM R. 2017. pii: S1934-1482(16)31113-3. doi: 10.1016/j.pmrj.2017.02.014. [Epub ahead of print]. Accessed August 30, 2017.
  4. Web site. Accessed August 30, 2017.
  5. Delgado MR, Tilton A, Russman B, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: a randomized controlled trial. Pediatrics. 2016:137(2):e20152830. doi: 10.1542/peds.2015-2830.
  6. Rehabilitation Measures Database. Rehab measures: Ashworth Scale/Modified Ashworth Scale. Accessed June 15, 2016.
  7. Palisano R, Rosenbaum P, Bartlett D, Livingston M. Gross Motor Function Classification System: Expanded and Revised. Accessed June 15, 2016.
  8. Truong D, Brodsky M, Lew M, et al; Global Dysport Cervical Dystonia Study Group. Long-term efficacy and safety of botulinum toxin type A (Dysport®) in cervical dystonia. Parkinsonism Relat Disord. 2010;16:316-323.
  9. Truong D, Duane DD, Jankovic J, et al. Efficacy and safety of botulinum type A toxin (Dysport®) in cervical dystonia: results of the first US randomized, double-blind, placebo-controlled study. Mov Disord. 2005;20:783-791.
  10. Blitzer E, Benson BE, Guss J. Botulinum Neurotoxin for Head and Neck Disorders. New York, NY. Thieme Medical Publishers, Inc. 2012.
© 2019 Ipsen Biopharmaceuticals Inc. All rights reserved. March 2019 DYS-US-003337


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