What to expect with Dysport treatment
In the clinical trial, doctors assessed each child (2 & older) treated with Dysport at 1 month (Week 4).
The children also had follow-up visits starting at 3 months (Week 12).
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.
How is Dysport given?
Dysport is a prescription medicine that is given by your child’s doctor
The injection day with Dysport
Getting injections during a treatment session is no fun for anyone, especially kids. As a parent, it can be difficult to see your child in distress. Your treatment team will likely know what you’re going through and may be able to help.
First day tip
The office visit could last several hours or even the whole day. If your child goes to school, he or she will probably miss school or any other activities usually planned for that day. Come prepared with books, soft toys, crayons, and other comforts from home or diversions to help the day go as smoothly as possible.
The days ahead
For the first few days or weeks, you may not really see a difference in the stiffness in your child’s leg(s). In the study, results were typically seen in children (ages 2 & older) by 4 weeks after their treatment session. However, the time to see results can vary for each child.
After Dysport is injected into muscles, those muscles are weakened for up to 16 to 22 weeks or longer. This may help lessen your child’s symptoms. After the injection, your child can continue with physical or occupational therapy.
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 your child has severe problems with swallowing or breathing after treatment with Dysport.
Common side effects
The most common side effects of Dysport are upper respiratory infection, stuffy or runny nose, sore throat, flu, cough, and fever.
Talk to your doctor if your child has any side effects. For more information about the possible side effects, ask your doctor.
Planning for retreatment
Dysport injection therapy is not a cure. The effects of each Dysport treatment session will lessen over time, and another treatment session will be needed to reduce the calf muscle stiffness again.
Your child’s doctor will look at your child’s level of spasticity and spasms to figure out when to schedule another Dysport treatment session, after at least 3 months or longer. In the Dysport clinical study, many children were retreated between 4 and 5½ months (16-22 weeks). Some children may have a longer (or shorter) time to retreatment. The next Dysport treatment should not be given sooner than 12 weeks after the last Dysport treatment sessions.
Work with your child’s healthcare team to evaluate your child’s progress, and ask them to teach you how to know when it’s time for the next treatment session.
Approximately 6 out of 10 children
were retreated between…
Remember, you may need time to schedule your next appointment, take time off from work or school, and arrange travel to and from the doctor’s office or clinic. Keep your child’s healthcare team informed about how he or she is doing and your plans.
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.