Dysport offers FDA-approved dosing recommendations in pediatric patients with spasticity, aged 2 years and older
Dysport has clear dosing guidelines and a dosing app to help you inject approved muscles with appropriate doses1
Step 1: Obtain your patient’s weight
Dosing is based on Dysport Units per kilogram of body weight1
Convert from pounds to kilograms (1 kg is equal to 2.2 lb)
Step 2: Choose unilateral or bilateral lower and upper limb injection
Prioritization of muscles may be required to stay within the recommended dose range.
Recommended total UPPER LIMB SPASTICITY Dysport dose per treatment session:
- 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
- Retreatment for upper limb spasticity should occur no sooner than 16 weeks after the first injection
Recommended total LOWER LIMB SPASTICITY Dysport dose per treatment session:
- UNILATERAL: Dysport 10 to 15 Units/kg/leg with a total dose not to exceed Dysport 15 Units/kg/leg or Dysport 1000 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 1000 Units, whichever is lower
- Retreatment for lower limb spasticity should occur no sooner than 12 weeks after the first injection.
In pediatric patients treated for BOTH UPPER AND LOWER LIMB SPASTICITY:
- If more than one limb is injected, the maximum recommended total dose per treatment session is 30 Units/kg or 1000 Units, whichever is
- Retreatment, based on return of clinical symptoms, should not occur in intervals of less than 3 months.
Step 3: Select muscles
The total dose administered should be divided between the affected spastic muscles.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
Step 4: 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
- A majority of pediatric patients with upper limb spasticity did not need retreatment until weeks 16-28; however, some had a longer duration of response1,2,*
- A majority of pediatric patients with lower limb spasticity did not need retreatment until weeks 16-22; however, some had a longer duration of response1,2,†
- 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 16 weeks after the previous injection for upper limb spasticity, and no sooner than 12 weeks after the previous injection for lower limb spasticity1
*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 beyond.3
†Patients who remained in the lower limb 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
FDA-approved doses range and muscles for injection for pediatric patients with upper limb spasticity or lower limb spasticity
Muscles for injection for upper limb spasticity in pediatric patients with their respective FDA-approved Dysport dose range.
- Recommended dosing for upper limb spasticity: 8 Units/kg to 16 Units/kg per limb. The maximum recommended total dose administered per treatment session must not exceed 16 Units/kg or 640 Units, whichever is lower
Muscles for injection for lower limb spasticity in pediatric patients with their respective FDA-approved Dysport dose range.
- 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 1000 Units, whichever is lower
Step 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.
For pediatric patients
For other dilution options, refer to Table 1: Dilution Instructions for Dysport Vials (500 and 300 Units) in package insert Section 2.2: Preparation of Dysport Solution for Administration
Examples of dilutions with Dysport 300-Unit and 500-Unit vials
Other dilutions may be necessary to enable dosing flexibility; for example:
Adapted from Section 2.2, Table 1 of the Full Prescribing Information.
*Sterile, preservative-free 0.9% Sodium Chloride Injection, USP.
Reconstituted Dysport is for intramuscular injection only.
Dilution & Reconstitution
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.
*Sterile, preservative-free 0.9% Sodium Chloride Injection, USP
- Dysport should be used for only one injection session and for only one patient.
- 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.
Reconstitution instructions are specific for the 300-Unit and 500-Unit vials.
Reconstituted Dysport is for intramuscular injection only.
Whether you are new to pediatric spasticity management, thinking about trying Dysport, or looking for a refresher, take your injection expertise to the next level with the following resources:
Whether you are new to adult spasticity management, thinking about trying Dysport, or looking for a refresher on administration, take your injection expertise to the next level with the C.L.I.M.B.® educational learning platform.
C.L.I.M.B. is a multitier learning continuum designed to accommodate physicians new to and experienced with botulinum toxin therapy. This educational curriculum is designed to help physicians across all levels improve their clinical skills involving the appropriate use of Dysport through online e-learning modules discussing some of the latest advances in the field for diagnosis, treatment and outcomes, on-demand peer-to-peer programs, and other educational resources. Be sure to visit CLIMB-training.com often to check for new content and updates.
E-learning modules currently available for adult spasticity.