How Dysport works
- Dysport is a type of prescription medicine called botulinum toxin type Athat is injected into the muscles affected by upper limb spasticity, temporarily blocking the signals that cause muscles to tighten (contract)
- Study results showed that most patients needed treatment again between 3 and 4 months
- Some had a longer response and were treated again at 5 months
- It is an injection you receive right in your doctor’s office
The next Dysport treatment should not be given sooner than 12 weeks after the last Dysport treatment session. Your healthcare professional will assess your spasticity at each treatment session and may adjust the dose and muscles injected.
A history of approval
In 2009, Dysport initially was approved by the FDA for use in adults with cervical dystonia. In 2015, Dysport received approval for use in adults with upper limb spasticity, and in 2017, it received an expanded indication for adult spasticity that added lower limb. In 2016, Dysport was approved for use in children (2 & older) with lower limb spasticity.
How Dysport worked in clinical trials
For adults with upper limb spasticity, approximately 3 out of 4 patients had a response to treatment at Week 4, as measured by a reduction in stiffness in the elbow, wrist, or finger muscles
- For some patients, improvement was seen 1 week after treatment
Study design: A placebo-controlled study of 238 adult patients with ULS due to stroke or traumatic brain injury. About half of patients had never been treated with botulinum toxins, while the other half had received prior treatment with a botulinum toxin. At Week 4, doctors assessed how well Dysport was working by the improvement in muscle tone, showing a reduction in stiffness in elbow, wrist, and finger muscles, and the doctor’s overall impression of how each patient responded to treatment.
For adults with lower limb spasticity, nearly half of patients treatedwith Dysport had a response to treatment at Week 4, as measured by a reduction in muscle stiffness at the ankle joint.
- For some patients, improvement was seen 1 week after treatment
Study design: A study of 381 adults with lower limb spasticity after stroke or traumatic brain injury; about 2 out of 3 were new to treatment, while the rest had received treatment before. Patients received Dysport or placebo for 4 weeks. At Week 4, doctors checked the ankle for improvement in muscle tone.
Dysport safety and side effects
Recognize possible side effects—and know what to do about them
The 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.
The most common side effects of Dysport in adults with lower limb spasticity include: muscle weakness, pain in your arms or legs, and fall.
When you take any medicine, it’s important to understand how it may affect your body.
While you and your doctor are considering treatment with Dysport, talk about possible common and serious side effects. Tell your doctor if you have any side effect that bothers you 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 Botox®, Xeomin®, or Myobloc®; 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 doctor
Questions to ask
Your doctor is your best source of information about adult spasticity. Ask your doctor whether Dysport may be a treatment option for you. If you need to find a physician who injects Dysport, use our convenient Dysport Doctor Locator to help find a physician near you!Whether you have just been diagnosed with spasticity 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 during your visit:
- 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?
Doctor Discussion Guide
Your medical history
Before starting treatment with Dysport, you should tell your doctor about all of your medical conditions, especially any that may affect your muscles and nerves. You should also inform your doctor of all other medical conditions, including if you have or have 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 you are:
- Planning to have surgery
- Pregnant or plan to become pregnant; it is not known if Dysport can harm your unborn baby
- Breastfeeding or planning to breastfeed; it is not known if Dysport can pass into breast milk
It is important to inform your doctor if you have 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 you have recently received an antibiotic by injection or are currently taking any prescription or nonprescription medications, muscle relaxants, sleep medicines, allergy/cold medicines, vitamins, or herbal supplements.
Before starting any new medicines, be sure to tell your doctor if you have ever had treatment with Dysport.
You can receive treatment with Dysport even if you have been treated with another botulinum toxin in the past, such as Botox®, Xeomin®, or Myobloc®.*
Dysport was studied in adults with ULS, including those who had:
- Already used another botulinum toxin
- Never used any botulinum toxin
Tell your doctor if you have received any botulinum toxin product in the last 4 months and also which product you received. Do not take Dysport if you 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 doctor if you are 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 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