Recommended Dysport dosage and administration for pediatric patients with upper limb spasticity1

Obtain your patient’s weight

Dosing is based on Dysport Units per kilogram of body weight.1

  • Convert from pounds to kilograms (1 kg is equal to 2.2 lb)

 

Choose unilateral or bilateral upper or lower limb injection

Botulinum toxins (BoNTs) are not interchangeable, and the potency units are not the same.Units of biological activity of Dysport cannot be compared to, or converted into, units of any other BoNT.1

Recommended total upper limb spasticity Dysport dose per treatment session1:

Unilateral

  • Dysport 8 to 16 Units/kg/limb with a total dose not to exceed Dysport 16 Units/kg/limb or Dysport 640 Units, whichever is lower

Bilateral

  • Dysport 8 to 16 Units/kg/limb with a total dose not to exceed Dysport 21 Units/kg/limb or Dysport 840 Units, whichever is lower

Recommended total lower limb spasticity Dysport dose per treatment session1:

Unilateral

  • Dysport 10 to 15 Units/kg/leg with a total dose not to exceed Dysport 15 Units/kg/leg or Dysport 1,000 Units, whichever is lower

Bilateral

  • Dysport 20 to 30 Units/kg/leg with a total dose not to exceed Dysport 30 Units/kg/leg or Dysport 1,000 Units, whichever is lower

Select muscles

The total dose administered should be divided between the affected spastic muscles of the lower limb(s).1

  • When possible, the dose should be divided across more than 1 injection site in any single muscle
  • No more than 0.5 mL should generally be administered at any single injection site; the maximum recommended total dose of Dysport in a single treatment session is 30 Units/kg or 1,000 Units in a 3-month interval
  • Although actual location of the injection sites can be determined by palpation, the use of injection guiding technique, eg, electromyography or electrical stimulation, is recommended to target the injection sites

 

Determine Dysport dose

Dosing in initial and subsequent treatment sessions should be tailored to the individual based on1

  • Size, number, and location of muscles involved
  • Severity of spasticity
  • Presence of local muscle weakness
  • Patient’s response to previous treatment and/or adverse event history with botulinum toxins

Retreatment

  • Most patients in the upper and lower limb studies did not need retreatment until Week 16-22; however, some had a longer duration of response1
  • The degree and pattern of muscle spasticity and overall clinical benefit at the time of reinjection may necessitate alterations in the dose of Dysport and the muscles to be injected1
  • Retreatment should occur no sooner than 12 weeks after the previous injection

FDA-Approved Dysport dose range per muscle

 

Achieve desired concentration

  • Considerations for achieving desired concentration include: the patient’s weight, limit of 0.5mL per injection site, the recommended number of injection sites per muscles in the GSC1
  • Total dose per treatment session1
    • Unilateral, Dysport 8 to 16 Units/kg/limb with a total dose not to exceed Dysport 16 Units/kg/limb or Dysport 640 Units, whichever is lower

Bilateral, Dysport 8 to 16 Units/kg/limb with a total dose not to exceed Dysport 21 Units/kg/limb or Dysport 840 Units, whichever is lower

Dosing Recommendations

Reconstitution and injection checklist

  • Using a sterile syringe, needle, and aseptic technique, draw up the appropriate amount of diluent.
  • Insert the needle into the vial. The partial vacuum will begin to pull the diluent into the Dysport vial. Do not use the Dysport vial if no vacuum is observed.
  • Swirl gently to dissolve. The reconstituted solution should be clear, colorless, and free of particulate matter.
  • Draw the required patient dose of Dysport into a sterile syringe and dilute with additional diluent, if required, to achieve the final volume for injection.
  • Expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach an appropriately sized new sterile needle to administer the injection.
  • Inject into target muscle(s) within 24 hours of reconstitution. Dysport should be used for only one injection session and for only one patient after reconstitution.

 

After reconstitution, Dysport should be used for only one injection session and for only one patient. Once reconstituted, Dysport should be stored in the original container, in a refrigerator at 2° C to 8° C (36° F to 46° F), protected from light for up to 24 hours. It must be discarded if not used within 24 hours. Do not freeze reconstituted Dysport. Discard the vial and needle in accordance with local regulations.

Injection checklist

Learn more on ordering, patient support, and downloadable resources intended to provide you and your practice with helpful information

Ordering & Support

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• 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

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Injection Training

IMPORTANT SAFETY INFORMATION

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.

Contraindications

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 www.fda.gov/medwatch.

INDICATIONS

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.

 

References
  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]. http://www.pmrjournal.org/article/S1934-1482(16)31113-3/fulltext. Accessed August 30, 2017.
  4. NeuroRehabResource.org Web site. http://www.neurorehabresource.org/Files/NRR_Differential_Diagnosis.pdf. 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. http://www.rehabmeasures.org/Lists/RehabMeasures/PrintView.aspx?ID=902. Accessed June 15, 2016.
  7. 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.
  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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