What is Dysport?
Dysport is a prescription medicine that is injected into muscles and used:
- to treat cervical dystonia (CD) in adults
- to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults younger than 65 years of age for a short period of time (temporary)
- to treat increased muscle stiffness in people 2 years of age and older with spasticity
It is not known whether Dysport is safe or effective in people younger than:
- 18 years of age for the treatment of cervical dystonia
- 18 years of age for the treatment of glabellar lines
- 2 years of age for the treatment of spasticity
What is the most important information I should know about Dysport?
Dysport may cause serious side effects that can be life threatening including:
- Problems breathing or swallowing
- Spread of toxin effects
These problems can happen within hours, or days to weeks after an injection of Dysport. Call your doctor or get medical help right away if you have any of these problems after treatment with Dysport:
1. Problems swallowing, speaking, or breathing. These problems can happen within hours, or days to weeks after an injection of Dysport usually because the muscles that you use to breathe and swallow can become weak after the injection. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Dysport.
- People with certain breathing problems may need to use muscles in their neck to help them breathe. These patients may be at greater risk for serious breathing problems with Dysport.
- Swallowing problems may last for several weeks. People who cannot swallow well may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving Dysport have the highest risk of getting these problems.
2. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include:
- loss of strength and muscle weakness all over the body
- blurred vision and drooping eyelids
- trouble saying words clearly (dysarthria)
- trouble breathing
- double vision
- hoarseness or change or loss of voice (dysphonia)
- loss of bladder control
- trouble swallowing
These symptoms can happen within hours, or days to weeks after you receive an injection of Dysport. These problems could make it unsafe for you to drive a car or do other dangerous activities. See "What should I avoid while receiving Dysport?"
Who should not use Dysport?
Do not take Dysport if you:
- are allergic to Dysport or any of the ingredients in Dysport. See the end of this Medication Guide for a list of ingredients in Dysport
- are allergic to cow's milk protein
- had an allergic reaction to any other botulinum toxin product such as Myobloc (rimabotulinumtoxinB), Botox (onabotulinumtoxinA), or Xeomin (incobotulinumtoxinA)
- have a skin infection at the planned injection site
What should I tell my healthcare provider before using Dysport?
Tell your healthcare provider about all your medical conditions, including if you:
- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome). See "What is the most important information I should know about Dysport?"
- have allergies to any botulinum toxin product
- had any side effect from botulinum toxin product in the past
- have or have had a breathing problem, such as asthma or emphysema
- have or have had swallowing problems
- have or have had bleeding problems
- have diabetes
- have or have had a slow heart beat or other problem with your heart rate or rhythm
- have plans to have surgery
- had surgery on your face
- have weakness of your forehead muscles (such as trouble raising your eyebrows)
- have drooping eyelids
- experienced dry eye with previous use of botulinum toxin products
- have any other change in the way your face normally looks
- are pregnant or plan to become pregnant. It is not known if Dysport can harm your unborn baby
- are breast-feeding or planning to breast-feed. It is not known if Dysport passes into breast milk
Tell your healthcare provider 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 healthcare provider that you have received Dysport in the past.
Especially tell your healthcare provider if you:
- have received any other botulinum toxin product in the last four months
- have received injections of botulinum toxin, such as Myobloc (rimabotulinumtoxinB), Botox (onabotulinumtoxinA) or Xeomin incobotulinumtoxinA) in the past be sure your healthcare provider knows exactly which product you received
- have recently received an antibiotic by injection
- take muscle relaxants
- take an allergy or cold medicine
- take a sleep medicine
Ask your healthcare provider if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.
How should I use Dysport?
- Dysport is an injection that your healthcare provider will give you
- Dysport is injected into the affected muscles
- If you are an adult, your healthcare provider may give you another dose of Dysport after 12 weeks or longer, if it is needed
- If you are an adult being treated for CD or spasticity or you are a child (2 to 17 years of age) being treated for spasticity, your healthcare provider may change your dose of Dysport until you and your healthcare provider find the best dose for you. Children should not be retreated sooner than every 12-16 weeks
- The dose of Dysport is not the same as the dose of any other botulinum toxin product
What should I avoid while taking Dysport?
Dysport may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking Dysport. If this happens, do not drive a car, operate machinery, or do other dangerous activities. See "What is the most important information I should know about Dysport?"
What are the possible side effects of Dysport?
Dysport can cause serious side effects. See "What is the most important information I should know about Dysport?"
The most common side effects of Dysport in people with cervical dystonia include:
- muscle weakness
- dry mouth
- feeling of tiredness
- muscle pain
- problems speaking
- eye problems
- difficulty swallowing
- injection site pain or discomfort
- headache
The most common side effects of Dysport in people with glabellar lines include:
- stuffy or runny nose and sore throat
- injection site pain
- upper respiratory infection
- blood in urine
- headache
- injection site reaction
- swelling of eyelids
- drooping eyelids
- sinus infection
- nausea
The most common side effect of Dysport in adults with upper limb spasticity include:
- muscle weakness
The most common side effects of Dysport in adults with lower limb spasticity include:
- muscle weakness
- pain in your arms or legs
- fall
The most common side effects of Dysport in children (2 to 17 years of age) with upper limb spasticity include:
- upper respiratory tract infection
- sore throat
The most common side effects of Dysport in children (2 to 17 years of age) with lower limb spasticity include:
- stuffy or runny nose and sore throat
- cough
- fever
Tell your healthcare provider 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 healthcare provider or pharmacist.
Tell your healthcare provider if you have dry eye or changes in vision following use of Dysport.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Dysport
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about Dysport. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Dysport that is written for healthcare professionals.
What are the ingredients in Dysport?
Active ingredient: (botulinum toxin Type A)
Inactive ingredients: human albumin and lactose. Dysport may contain cow's milk protein.
For more information about Dysport, call 855-463-5127 or go to www.dysport.com or www.DysportUSA.com.
