The first and only FDA-APPROVED botulinum toxin to treat children (2 & older) with lower limb spasticity
How Dysport works
- Dysport is a type of muscle injection therapy, a treatment in which a doctor injects medicine into the muscles that are stiff
- Dysport works by blocking overactive nerve signals from getting to the muscles
- Without receiving those signals, the muscles are weakened and symptoms reduced for up to 4 to 5½ months, or possibly longer
First FDA Approval for PLLS (2 & older)
In 2016, Dysport became the first and only botulinum toxin approved by the FDA to treat increased muscle stiffness in children 2 years of age and older with lower limb spasticity.
For the FDA to approve its use in children, Dysport was specifically studied in a clinical trial with 235 children aged 2 to 17 years who had lower leg spasticity because of cerebral palsy, causing dynamic equinus foot deformity. Dysport was given to 158 of the children; 77 received a placebo.
In the clinical trial, doctors assessed each child (2 & older) treated with Dysport at Week 4
They measured how well Dysport was working in 2 main ways
- Improvement in calf muscle stiffness (muscle tone)
- The doctor’s overall impression of how each patient responded to treatment
The children also had follow-up visits starting at 3 months to see if
- The effects of the previous injection had lessened
- It was time for another Dysport treatment session
The next Dysport treatment should not be given sooner than 12 weeks after the last Dysport treatment session. Your healthcare professional will assess your child’s lower limb spasticity at each treatment session and may adjust the dose and muscles injected.
Injected muscles were weakened up to 4 to 5½ months (16-22 weeks) or longer in some children
- This helped lessen symptoms of stiffness in the children’s calf muscles
- After treatment, children could continue with physical or occupational therapy
Treatment with Dysport can be repeated when the benefits from the previous treatment have decreased, but there should be at least 12 weeks between treatments.
Dysport safety and side effects
Recognize possible side effects—and know what to do about them.
The most common side effects of Dysport in children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, flu, cough, and fever.
It’s important to understand how any medicine may affect your child
While you and your child’s doctor are considering treatment with Dysport, talk about possible common and serious side effects. Tell the doctor about any side effect that bothers your child or that does not go away.
The most important information you should know about Dysport
Dysport may cause serious side effects that can be life threatening, including problems breathing or swallowing, or spread of toxin effects. These problems can happen within hours or days to weeks after an injection of Dysport. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Dysport.
Who Should Not Take Dysport
Do not take Dysport if you are allergic to Dysport or any of the ingredients in Dysport (See Medication Guide for ingredients), or are allergic to cow’s milk protein; had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®; or have a skin infection at the planned injection site.
These are not all the possible side effects of Dysport. For more information, ask your doctor or pharmacist or read the Full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Things to discuss with your child's doctor
Questions to ask about Dysport treatment
Remember, your child’s doctor is your best source of information about lower limb spasticity. Ask your doctor whether Dysport may be a treatment option for your child. If you need to find a physician who injects Dysport, use our convenient Dysport Doctor Locator to help find a physician near you!
- What should I expect from Dysport treatment?
- How will I know that Dysport therapy is working?
- When should I schedule another treatment session?
- What is the Important Safety Information I should know about Dysport?
- What are the possible side effects of Dysport?
- What can we do to make my child more comfortable during the treatment?
- How do I explain Dysport therapy to my child?
- Can I be in the room during the treatment?
- Who do I call if I have questions between appointments?
- How soon after treatment should physical or occupational therapy continue?
Doctor Discussion Guide
Your child’s medical history
Before starting treatment with Dysport, you should tell your doctor about all of your child’s medical conditions, especially any that may affect their muscles and nerves. You should also inform your doctor of all other medical conditions, including if your child has or has had:
- Any problems with breathing, swallowing, or bleeding
- A slow or irregular heartbeat or rhythm
- Any side effect or allergy to any botulinum toxin product
Also, let your doctor know if your child:
- Will be having surgery
- Is pregnant or plans to become pregnant; it is not known if Dysport can harm an unborn baby
- Is breastfeeding or planning to breastfeed; it is not known if Dysport can pass into breast milk
It is important to inform your child’s doctor if your child has ever received any other botulinum toxin products in the past or had an allergic reaction to Botox®, Xeomin®, or Myobloc®,* or had treatment with any of these products in the last 4 months.
Also, let your doctor know if your child has recently received an antibiotic by injection or is currently taking any prescription or nonprescription medications, muscle relaxants, sleep medicines, allergy/cold medicines, vitamins, or herbal supplements.
Before your child starts any new medicines, be sure to tell the doctor if your child has ever had treatment with Dysport.
Your child can receive treatment with Dysport even if your child has been treated with another botulinum toxin in the past, such as Botox®, Xeomin®, or Myobloc®.*
Tell your doctor if your child has received any botulinum toxin product in the last 4 months and also which product your child received. Your child should not take Dysport if he or she has had any allergic reaction to any of these other botulinum toxin products.
Dysport should be given at least 12 weeks after the last injection. Also inform your child’s doctor if your child is allergic to any of the inactive ingredients in Dysport, including human albumin or cow’s milk protein.
*Botox®, Xeomin®, and Myobloc® are registered trademarks of their respective owners.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Dysport?
Dysport may cause serious side effects, including problems breathing or swallowing and/or spread of toxin effects, that can be life threatening and death can happen as a complication. These problems can happen within hours, or days to weeks after an injection of Dysport.
- Problems swallowing, breathing, or speaking. Treatment with Dysport can result in swallowing or breathing problems. People with pre-existing swallowing or breathing problems may be at greater risk following treatment with Dysport. Swallowing problems may last for several weeks; you may need a feeding tube to receive food or water. If swallowing problems are severe, food or liquids may go into your lungs.
- Spread of toxin effects. The effects of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism which include: loss of strength and muscle weakness all over the body, double or blurred vision, and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, and trouble breathing or swallowing. The risk of these symptoms is probably greatest in children treated for spasticity. These problems could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.
Call your doctor or get medical help right away if you experience these problems after treatment with Dysport.
Do not receive a Dysport injection if: you are allergic to Dysport or any of its ingredients, or cow’s milk protein; you had an allergic reaction to any other botulinum toxin product, such as Myobloc®, Botox®, or Xeomin®; or you have a skin infection at the planned injection site.
Before you receive a Dysport injection tell your doctor:
- About all your medical conditions, including if you have a disease that affects your muscles and nerves (such as ALS or Lou Gehrig’s disease [amyotrophic lateral sclerosis], myasthenia gravis, or Lambert-Eaton syndrome). You may be at increased risk of serious side effects, including difficulty swallowing or breathing.
- If you have or have had any of the following: a side effect from any botulinum toxin in the past; problems with breathing such as asthma or emphysema; swallowing; bleeding; diabetes; and slow heartbeat, or problems with your heart rate or rhythm.
- If you have plans to have surgery, had surgery on your face, have weakness of your forehead muscles (trouble raising your eyebrows), drooping eyelids, or any other change in the way your face normally looks.
- If you are pregnant or breastfeeding or plan to become pregnant or breastfeed. It is not known if Dysport can harm your unborn baby or if it passes into breast milk.
- About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received Dysport in the past.
Especially tell your doctor if you have received any other injections of botulinum toxin in the last four months or ever; Myobloc®, Botox®, or Xeomin® (exactly which ones); an antibiotic recently by injection; or if you take muscle relaxants; allergy, cold or sleep medicine.
Most Common Side effects of Dysport in:
- adults with upper limb spasticity include: urinary tract infection, muscle weakness, musculoskeletal pain, fall, depression, stuffy or runny nose and sore throat, and dizziness.
- adults with lower limb spasticity include: muscle weakness, pain in your arms or legs, and fall.
- people with cervical dystonia include: muscle weakness, dry mouth, feeling of tiredness, muscle pain, problems speaking, eye problems, difficulty swallowing, injection site pain, and headache.
- children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, flu, cough, and fever.
Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Dysport. For more information, ask your doctor or pharmacist. You may report side effects to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.
What is Dysport?
Dysport is a prescription medicine that is injected into muscles and used to treat:
- cervical dystonia (CD) in adults
- increased muscle stiffness in adults with spasticity
- increased muscle stiffness in children 2 years of age and older with lower limb spasticity
It is not known whether Dysport is safe or effective in children under 2 years old for the treatment of lower limb spasticity; for treating other types of muscle spasms; or for treating cervical dystonia or upper limb spasticity in children under 18 years of age.
Please visit www.ipsencares.com for full patient eligibility & terms and conditions.