Full Prescribing Information |This site is intended for U.S. Healthcare Professionals.
The FIRST and
ONLY FDA-APPROVED
botulinum toxin for
the treatment of
LOWER LIMB SPASTICITY in pediatric patients
2 years of age
and older1

Loosen the hold of lower limb spasticity for 4 to 5½ months* in most patients1

Results from a clinical trial specifically for pediatric patients with lower limb spasticity 2 years of age and older

Dysport® (abobotulinumtoxinA) was evaluated with meaningful clinical endpoints
Co-primary efficacy endpoints1,2
Modified Ashworth Scale

Reduction in ankle plantar flexor muscle tone at Week 4, as measured by the mean change from baseline in Modified Ashworth Scale (MAS)

Physician’s Global Assessment

Improvement in response to treatment at Week 4, as measured by mean Physician’s Global Assessment (PGA) of response to treatment score

Study Design1,2

This chart shows the end points of a Dysport clinical study design for pediatric patients with lower limb spasticity
*The ITT population (N=235) included all randomized subjects who received at least one injection of study treatment and who had a MAS score in the gastroc-soleus muscle complex assessed both at baseline and at Week 4.
  • A multicenter, prospective, double-blind, randomized, placebo-controlled study assessing Dysport® in pediatric patients 2 to 17 years of age with lower limb spasticity because of cerebral palsy causing dynamic equinus foot deformity
  • In the pivotal clinical trial, doses of Dysport® 10 Units/kg/leg or Dysport® 15 Units/kg/leg or placebo were injected intramuscularly into the gastrocnemius and soleus muscles1
  • The 12-week follow-up visit included assessment for retreatment eligibility
  • Pediatric patients who remained in the study after Week 12 were permitted additional discretionary follow-up visits at Week 16, Week 22, and Week 28 to assess eligibility for retreatment3
Endpoints evaluated using validated scales
Modified Ashworth Scale

The MAS is an updated version of the Ashworth Scale used to measure muscle tone and includes an additional scoring component to measure resistance during movement4

Physician’s Global Assessment

The PGA is a global assessment of a physician’s impression of a patient’s response to treatment2

Patient characteristics (ITT population)2
Disease or treatment characteristic Placebo (n=77) Total Dysport® (both doses) (n=158)
Aged 2-9 years 84% (65) 85% (134)
Aged 10-17 years 16% (12) 15% (24)
Prior treatment with a botulinum toxin 47% (36) 49% (77)
GMFCS level I or II 91% (70) 88% (139)
GMFCS level III 9% (7) 12% (19)
Baseline MAS score 2 or 3 99% (76) 100% (158)
Unilateral 61% (47) 58% (92)
Bilateral 39% (30) 42% (66)
GMFCS (Gross Motor Function Classification System) levels studied5: I - Walks without limitations II - Walks with limitations III - Walks using a hand-held mobility device
For pediatric patients with lower limb spasticity 2 years of age and older

Dysport® significantly reduced muscle tone at Week 41

Reduction in ankle plantar flexor muscle tone vs placebo as assessed by the mean change in Modified Ashworth Scale (MAS) at Week 41
Modified Ashworth Scale
A placebo-controlled clinical study showed Dysport (abobotulinumtoxinA) significantly reduced muscle tone for pediatric patients with lower limb spasticity at Week 4
  • MAS score at baseline (mean [SD]): placebo, 3.2 (0.4); Dysport® (abobotulinumtoxinA) 10 Units/kg/leg, 3.1 (0.3); Dysport® 15 Units/kg/leg, 3.1 (0.3)1,2
  • The most frequently reported adverse reactions (≥10%) were: upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough, and pyrexia
For pediatric patients with lower limb spasticity 2 years of age and older

Physicians noted a significant response to treatment in patients receiving Dysport® (abobotulinumtoxinA) at Week 41

Response to treatment vs placebo as assessed by the mean Physician’s Global Assessment (PGA) at Week 41
Physician’s Global Assessment
This chart shows Physician’s Global Assessment (PGA) of Dysport for treatment of pediatric patients with lower limb spasticity at week 4
  • PGA and MAS were assessed by separate investigators2
  • The most frequently reported adverse reactions (≥10%) were: upper respiratory tract infection, nasopharyngitis, influenza, pharyngitis, cough, and pyrexia
For pediatric patients with lower limb spasticity 2 years of age and older

Discover time between treatment visits

Majority of the pediatric patients with lower limb spasticity were retreated between 16-22 weeks by Dysport injectionin a clinical study

However, some patients had a longer duration of response1

*Patients who remained in the study after Week 12 were permitted additional discretionary follow-up visits at Week 16, Week 22, and Week 28 to assess eligibility for retreatment.3
  • The degree and pattern of muscle spasticity and the overall clinical benefit at the time of reinjection may necessitate alterations in the dose of Dysport® (abobotulinumtoxinA) and muscles to be injected1
  • Repeat Dysport® treatment should be administered when the effect of a previous injection has diminished but no sooner than 12 weeks after the previous injection1
  • Eligibility for retreatment was assessed by the investigator at every visit from Week 12 onwards

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Important Safety Information

Warning: 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 upper limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to lower than the maximum recommended total dose.

Contraindications

Dysport® is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow’s milk protein.

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 (see Boxed Warning). 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 (eg, 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

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. 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 reported for albumin.

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.

Adverse Reactions

Most common adverse reactions (≥2% and greater than placebo in either Dysport® group) in adults with upper limb spasticity for Dysport® 500 Units, Dysport® 1,000 Units, and Placebo, respectively, were: nasopharyngitis (4%, 1%, 1%), urinary tract infection (3%, 1%, 2%), muscular weakness (2%, 4%, 1%), musculoskeletal pain (3%, 2%, 2%), dizziness (3%, 1%, 1%), fall (2%, 3%, 2%), and depression (2%, 3%, 1%).

Most common adverse reactions (≥5% and greater than placebo) in adults with cervical dystonia for Dysport® 500 Units and Placebo, respectively, were: muscular weakness (16%, 4%), dysphagia (15%, 4%), dry mouth (13%, 7%), injection site discomfort (13%, 8%), fatigue (12%, 10%), headache (11%, 9%), musculoskeletal pain (7%, 3%), dysphonia (6%, 2%), injection site pain (5%, 4%), and eye disorders (7%, 2%).

Most common adverse reactions (≥10% in any group and greater than placebo) in pediatric patients with lower limb spasticity for Dysport® 10 Units/kg, 15 Units/kg, 20 Units/kg, or 30 Units/kg; and Placebo, respectively, were: upper respiratory tract infection (9%, 20%, 5%, 10%, 13%), nasopharyngitis (9%, 12%, 16%, 10%, 5%), influenza (0%, 10%, 14%, 3%, 8%), pharyngitis (5%, 0%, 11%, 3%, 8%), cough (7%, 6%, 14%, 10%, 6%), and pyrexia (7%, 12%, 8%, 7%, 5%).

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®.

Use in Pregnancy

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

Pediatric Use

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.

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 www.fda.gov/medwatch.

Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:

  • Adults with upper limb spasticity, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors
  • Adults with cervical dystonia
  • Lower limb spasticity in pediatric patients 2 years of age and older

The safety and effectiveness of Dysport® injected into upper limb muscles or proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established.

Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated.

Safety and effectiveness in pediatric patients with cervical dystonia or upper limb spasticity have not been established.

The safety and effectiveness of Dysport® in the treatment of lower limb spasticity in adult patients has not been demonstrated.


Click here to view Dysport® Full Prescribing Information including Boxed Warning and Medication Guide.



Botox®, Xeomin®, and Myobloc® are registered trademarks of their respective owners.

References
  1. Dysport® (abobotulinumtoxinA) [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; July 2016.
  2. Data on file. Basking Ridge, NJ; Ipsen Biopharmaceuticals, Inc.
  3. 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.
  4. Rehabilitation Measures Database. Rehab measures: Ashworth Scale/Modified Ashworth Scale. http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902. Accessed June 15, 2016.
  5. Palisano R, Rosenbaum P, Bartlett D, Livingston M. Gross Motor Function Classification System: Expanded and Revised. https://canchild.ca/system/tenon/assets/attachments/000/000/058/original/GMFCS-ER_English.pdf. Accessed June 15, 2016.

Indications

Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:

The safety and effectiveness of Dysport® injected into upper limb muscles or proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established.

Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated.

Safety and effectiveness in pediatric patients with cervical dystonia or upper limb spasticity have not been established.

The safety and effectiveness of Dysport® in the treatment of lower limb spasticity in adult patients has not been demonstrated.

Click here for Full Prescribing Information and Medication Guide

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If in a private practice or clinic, please select the applicable coverage benefit to acquire Dysport® (abobotulinumtoxinA):

If Dysport® (abobotulinumtoxinA) is covered under the medical benefit, choose the best option for your office:

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