Full Prescribing Information |This site is intended for US healthcare professionals.

Dysport offers FDA-approved dosing recommendations in pediatric patients with lower limb spasticity 2 years of age and older

1

Obtain your patient’s weight

    Dosing is based on Dysport® (abobotulinumtoxinA) Units per kilogram of body weight. 1
  • Convert from pounds to kilograms (1 kg is equal to 2.2 lb)
2

Choose unilateral or bilateral lower limb injection

    Botulinum toxins (BoNTs) are not interchangeable and the potency units are not the same. 1 Units of biological activity of Dysport® cannot be compared to, or converted into, units of any other BoNT. 1 Recommended total Dysport® dose per treatment session 1: Unilateral
  • Dysport® 10 to 15 Units/kg with a total dose not to exceed Dysport® 15 Units/kg or Dysport® 1,000 Units, whichever is lower
  • Bilateral
  • Dysport® 20 to 30 Units/kg with a total dose not to exceed Dysport® 30 Units/kg or Dysport® 1,000 Units, whichever is lower
3

Select muscles (gastrocnemius/soleus)

    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
  • 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
4

Determine Dysport dose

    Dosing in initial and subsequent treatment sessions should be tailored to the individual based on 1
  • 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
  • The majority of patients in the clinical study were retreated between 16-22 weeks; however, some had a longer duration of response 1
  • The degree and pattern of muscle spasticity and overall clinical benefit at the time of re-injection may necessitate alterations in the dose of Dysport® and the muscles to be injected 1
  • Retreatment should occur no sooner than 12 weeks after the previous injection
Recommended Dysport dose range per muscle, per leg, of the GSC 1*
Total dose per treatment session must not exceed Dysport® 15 Units/kg for unilateral lower limb injections, Dysport® 30 Units/kg for bilateral injections, or Dysport® 1,000 units, whichever is lower.
FDA-approved dosing recommendations for Dysport® (abobotulinumtoxinA) injection for pediatric patients with lower limb spasticity

No more than 0.5 mL should generally be administered at any single injection site. *Gastroc-soleus complex.

For pediatric patient with lower limb spasticity 2 years of age and older

Dysport Unit Dosing Range - by Weight

Select Patient Weight (kg)
Unilateral Lower Limb: Total Dysport® dose per treatment session
(10 to 15 Units/kg/leg)*
Gastrocnemius
(6 to 9 Units/kg/leg)
 
Soleus
(4 to 6 Units/kg/leg)
*Total dose per treatment session must not exceed Dysport® 15 Units/kg for unilateral lower limb injections, Dysport® 30 Units/kg for bilateral injections, or Dysport® 1,000 units, whichever is lower.
For pediatric patient with lower limb spasticity 2 years of age and older
5

Achieve desired concentration

  • Considerations for achieving desired concentration include: the patient’s weight, limit of 0.5 mL per injection site, the recommended number of injection sites per muscle in the GSC 1
  • Total dose per treatment session 1
    • Lower limb: unilateral, not to exceed Dysport® (abobotulinumtoxinA) 15 Units/kg; bilateral, not to exceed Dysport® 30 Units/kg, or Dysport® 1,000 Units, whichever is lower
Image of Dysport® (abobotulinumtoxinA) injection 300 unit vial
Image of Dysport® (abobotulinumtoxinA) injection 500 unit vial

Adapted from Section 2.1, Table 1 of the Full Prescribing Information.

*Sterile preservative-free 0.9% Sodium Chloride Injection, USP. Reconstituted Dysport® is for intramuscular injection only.

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.

For pediatric patients with lower limb spasticity 2 years of age and older

Dysport dosing scenarios*

Eric, age 2 John, age 10
Step 1: Obtain weight 10 kg (22 lb) 32 kg (71 lb)
Step 2: Choose unilateral or bilateral lower limb injection Bilateral (Dysport® 20 to 30 Units/kg) Unilateral (Dysport® 10 to 15 Units/kg)
Step 3: Select muscles Gastrocnemius Recommended dose range Dysport® 12 to 18 Units/kg Gastrocnemius Recommended dose range Dysport® 6 to 9 Units/kg
Soleus Recommended dose range Dysport® 8 to 12 Units/kg Soleus Recommended dose range Dysport® 4 to 6 Units/kg
Step 4: Determine Dysport® dose (kg x [Dysport® Units/kg]) Total Dysport® Dose per Treatment Session Dysport® 200 to 300 Units divided between affected spastic muscles Total Dysport® Dose per Treatment Session Dysport® 320 to 480 Units divided between affected spastic muscles
Dose Range for Gastrocnemius Dysport® 120 to 180 Units Dose Range for Gastrocnemius Dysport® 192 to 288 Units
Dose Range for Soleus Dysport® 80 to 120 Units Dose Range for Soleus Dysport® 128 to 192 Units
Step 5: Achieve desired concentration Vial Dysport® 300 Units Vial Dysport® 500 Units
Diluent 1.5 mL Diluent 2.5 mL
Resulting Dose Dysport® 20 Units/0.1 mL Resulting Dose Dysport® 20 Units/0.1 mL
*Hypothetical patient examples. Sterile preservative-free 0.9% Sodium Chloride Injection, USP. Reconstituted Dysport® for intramuscular injection only.

The C.L.I.M.B.® program includes comprehensive Dysport injection training:

  • Opportunity to be added to the Dysport Doctor Locator, where patients can easily find your practice if you are eligible*
  • 1:1 in-office training
  • Live group training or web conference (dosing, reconstitution, and injection simulator)
  • Educational videos, brochures, and information on purchasing and reimbursement
    *See eligibility criteria at www.CLIMB-training.com.
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Media time to retreatment of cervical dystonia patients was 14 weeks with Dysport® (abobotulinumtoxinA)

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, including upper limb spasticity in children, 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 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. Hypersensitivity reactions including anaphylaxis have been reported.

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 upper limb spasticity (≥2% and greater than placebo): nasopharyngitis, urinary tract infection, muscular weakness, musculoskeletal pain, dizziness, fall, and depression.

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

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

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

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. 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.

Dysport for injection is indicated for the treatment of:

  • Adults with cervical dystonia
  • Spasticity in adult patients
  • Lower limb spasticity in pediatric patients 2 years of age and older

Please see Full Prescribing Information including Boxed Warning and Medication Guide.



Reference
  1. Dysport® (abobotulinumtoxinA) [Prescribing Information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals, Inc; September 2017.

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.

Click here for Full Prescribing Information and Medication Guide

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Please acquire Dysport® (abobotulinumtoxinA) from your wholesalers

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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  • Requires upfront financial investment
  • Your office acquires Dysport® directly from a select group of Specialty Distributors
  • Your office collects copay/coinsurance directly from the patient
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To purchase from authorized specialty distributors of record, select from the distributors below:

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Call 1-800-543-2111

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McKesson Specialty Health

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If Dysport® (abobotulinumtoxinA) is covered under the pharmacy benefit, IPSEN CARES® can help you find a network specialty pharmacy:

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