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Efficacy in adults with upper limb spasticity (ULS)

Dysport® (abobotulinumtoxinA) significantly reduced muscle tone at Week 41

Reduction in muscle tone as measured by the MAS at Week 41

This chart shows a Dysport clinical study design for adult patients with upper limb spasticity
Study design: An international, multicenter, double-blind, randomized, placebo-controlled study of 238 adult patients with ULS due to stroke or traumatic brain injury. About half of patients were botulinum toxin naïve, while the other half had received prior treatment with a botulinum toxin. Patients were randomized (1:1:1) to receive either Dysport® 500 U, Dysport® 1,000 U, or placebo. The co-primary efficacy endpoints were the mean change between baseline and Week 4 in Modified Ashworth Scale (MAS) scores for the primary target muscle group (elbow, wrist, and finger flexors) and the Physician's Global Assessment (PGA) of response to treatment. At baseline, the mean MAS score [SD] was 3.9 [0.4] for the placebo group, 3.9 [0.5] for the Dysport® 500-U group, and 3.9 [0.4] for the Dysport® 1,000-U group.1,2
  • At Week 4, adults receiving either dose of Dysport® had significantly reduced muscle tone in the primary target muscle group vs placebo, as assessed by the mean change from baseline in the Modified Ashworth Scale (MAS)1
  • Clinical improvement may be expected 1 week after administration of Dysport®1
    • At Week 1: LS mean change from baseline in MAS was -0.2 for placebo, -0.8 for Dysport® 500 U, and -0.9 for Dysport® 1,000 U (P≤0.05 vs placebo)2
  • The most common adverse reactions (>2% and greater than placebo in either Dysport® group) in adults with ULS for Dysport® 500 U, Dysport® 1,000 U, and placebo were: nasopharyngitis, urinary tract infection, muscular weakness, musculoskeletal pain, dizziness, fall, and depression1
Adults with Upper Limb Spasticity

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

Overall response to treatment as measured by the Physician's Global Assessment (PGA) at Week 41

Treatment response for a Dysport (abobotulinumtoxinA) clinical study for adult patients with upper limb spasticity
See study design above. The co-primary efficacy endpoints were the mean change in MAS score in the primary target muscle group and the PGA of treatment response between baseline and Week 4.
  • At Week 4, adults receiving Dysport® had significant response to treatment vs placebo, as assessed by the PGA1
  • The most common adverse reactions (>2% and greater than placebo in either Dysport® group) in adults with ULS for Dysport® 500 U, Dysport® 1,000 U, and placebo were: nasopharyngitis, urinary tract infection, muscular weakness, musculoskeletal pain, dizziness, fall, and depression1
Adults with Upper Limb Spasticity

Approximately 3 out of 4 patients had a response to treatment* with Dysport® (abobotulinumtoxinA) at Week 42

See study design above. The co-primary efficacy endpoints were the mean change from baseline in the MAS score in the primary target muscle group and the mean PGA of response to treatment at Week 4.

Percentage of patients responding* to treatment as measured by MAS2

This data shows 3 out of 4 patients with upper limb spasticity had a treatment response for Dysport injection at week 4
  • Clinical improvement may be expected 1 week after administration of Dysport®
    • At Week 1: 53% (n=42) of patients receiving Dysport® 500 U and 67% (n=53) receiving Dysport® 1,000 U had a treatment response (vs 15% [n=12] receiving placebo, P≤0.05 vs placebo)2
  • Some patients had a longer duration of response1
    • At Week 12: 43% (n=34) of patients receiving Dysport® 500 U and 48% (n=38) receiving Dysport® 1,000 U still had a treatment response (vs 14% [n=11] receiving placebo, P≤0.05)2
    • At Week 16: 19% (n=15) of patients receiving Dysport® 500 U and 27% (n=21) of patients receiving Dysport® 1,000 U still had a treatment response (vs 4% [n=3] for placebo)2
    • At Week 20: 10% (n=16) of patients in both Dysport® arms still had a treatment response (vs 0% for placebo)2
*Response defined as at least 1 grade improvement in muscle tone from baseline on the MAS in the primary muscle target group. Calculations were based on the number of patients responding at each week divided by the total number of patients at Week 4.
Adults with Upper Limb Spasticity

Dysport® (abobotulinumtoxinA) offers the flexibility to retreat based on the return of clinical symptoms

Time to retreatment for adults with ULS

Majority of the patients with upper limb spasticity were retreated between 12-16 weeks by Dysport (abobotulinumtoxinA) in a clinical study
  • Repeat Dysport® treatment should be administered when symptoms return, but no sooner than 12 weeks after the previous injection1
  • A majority of patients in clinical studies were retreated between 12 and 16 weeks; however, some patients had a longer duration of response; ie, 20 weeks
  • The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Dysport® and muscles to be injected. Clinical improvement may be expected one week after administration of Dysport®

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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.

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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