Why Dysport?

Dysport is a type of muscle injection therapy called a botulinum toxin. It is a medicine that a doctor injects into muscles that are stiff. The goal is to reduce stiffness and improve your child’s ability to move the affected limb(s).

Whether your child is trying a botulinum toxin for the first time or is trying a different one, the following information can help you and the healthcare team decide if Dysport could be an appropriate option for your child.

Dysport is approved by the FDA. It was the first botulinum toxin approved to treat children 2 years of age or older with increased muscle stiffness in their arms or legs (upper or lower limb spasticity). Dysport is not approved to treat upper limb spasticity in children that is caused by cerebral palsy.

How Dysport works

Dysport helps to temporarily block signals from the brain from reaching the affected muscles. By blocking these signals, Dysport prevents the brain from telling the muscles to become too tight or stiff.

Without receiving those signals, the muscles are weakened and symptoms reduced for up to 4 to 5½ months (possibly longer).

Longer relief from symptoms of spasticity could mean fewer injection sessions for your child.

 

Dysport was studied in 2 separate studies for children

The upper limb study (2014-2018)

A total of 208 children with upper limb spasticity participated in this study. All of them received Dysport, and they were divided evenly into 3 groups of 70. The first group was given a high dose of Dysport, the second group was given a medium dose, and the third group was given a low dose. After the first injection, doctors measured the reduction in upper limb stiffness at 1½ months and recorded their overall impression of how each child responded to treatment. They recorded their overall impression again after 4 months.

The lower limb study (2011-2014)

A total of 235 children with lower limb spasticity participated in this study. Dysport was given to 158 children, and 77 were given a placebo. After the first injection, doctors measured the reduction in lower limb stiffness at 1 month and recorded their overall impression of how each child responded to treatment. They recorded their overall impression again after 3 months.

Clinical study results

Dysport was found to be effective for the majority of children in the studies.

 

In the upper limb study
In the upper limb study, the patients with the longest-lasting results were those who received the high dose of Dysport. Most patients got another injection around 4 to 7 months after their first injection, but some patients’ results lasted for up to a year.

 

In the lower limb study
In the lower limb study, most patients’ results lasted for 4 to 5½ months after their first injection, but some patients’ lasted for as long as 6 to 7 months.

 

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 years & older) with upper limb spasticity include:

  • upper respiratory tract infection
  • sore throat

The most common side effects of DYSPORT in children (2 years & older) with lower limb spasticity include:

  • stuffy or runny nose and sore throat
  • cough
  • 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 safety 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 severe problems with swallowing or breathing occur after treatment with Dysport.

Who should not take Dysport

Your child should not take Dysport if he or she is allergic to Dysport or any of the ingredients in Dysport (See Medication Guide for ingredients), or is allergic to cow’s milk protein; has had an allergic reaction to any other botulinum toxin products, such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA)*; or has 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 spasticity and treatment with Dysport. Whether your child has just been diagnosed or you are looking to start treatment, you probably have a lot of questions. Here is a list of things you may want to ask:

  • What results can I expect with Dysport injections?
  • How long do results typically last?
  • When do I schedule another treatment appointment?
  • What is the injection experience like?
  • What treatment goals should I set for my child?

Doctor Discussion Guide

Download Discussion Guide

 

See if Dysport could be right for your child.
Ask your child’s doctor about Dysport.

 

Your child’s medical history

Before your child starts treatment with Dysport, you should tell the doctor about all of your child’s medical conditions, especially any that may affect their muscles and nerves (such as amyotrophic lateral sclerosis [ALS], or Lou Gehrig’s disease; myasthenia gravis; or Lambert-Eaton syndrome). Your child may be at increased risk of serious side effects, including difficulty swallowing or breathing.

You should also inform your child’s doctor of all other medical conditions, including if your child has or has had:

  • A slow or irregular heartbeat or rhythm
  • Diabetes
  • Any side effect or allergy to any botulinum toxin product

Also, let the 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

Prior treatment

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® (onabotulinumtoxinA), Xeomin® (incobotulinumtoxinA), or Myobloc® (rimabotulinumtoxinB),*  or had treatment with any of these products in the last 4 months.

Also, let your child’s 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® (onabotulinumtoxinA), Xeomin® (incobotulinumtoxinA), or Myobloc® (rimabotulinumtoxinB).*

Tell your child’s 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.

Starting Dysport

Learn what to expect with Dysport treatment

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IMPORTANT SAFETY INFORMATION

What is the most important safety 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 lower limb spasticity include: fall, muscle weakness, pain in your arms or legs.
  • adults with upper limb spasticity include: muscle weakness.
  • children (2 to 17 years of age) with upper limb spasticity include: upper respiratory infection and sore throat.
  • children (2 to 17 years of age) with lower limb spasticity include: upper respiratory infection, stuffy or runny nose and sore throat, cough, and fever.
  • adults with cervical dystonia include: muscle weakness, difficulty swallowing, dry mouth, injection site discomfort, tiredness, headache, muscle pain, problems speaking, injection site pain and eye problems.

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:

  • increased muscle stiffness in adults with lower and upper limb spasticity
  • increased muscle stiffness in children 2 years of age and older with lower limb spasticity
  • increased muscle stiffness in children 2 years of age and older with upper limb spasticity, excluding spasticity caused by cerebral palsy
  • cervical dystonia (CD) in adults

 

Please see full Prescribing Information including Medication Guide with Important Warning.
Botox, Xeomin, and Myobloc are registered trademarks of their respective owners.

 

© 2019 Ipsen Biopharmaceuticals Inc. All rights reserved. March 2019 DYS-US-003338