What is Dysport®?
Prescription Dysport is an injection used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.
Dysport is a purified formulation that has been shown to deliver temporary improvements in moderate to severe frown lines, even with repeat treatments. So, the effect of repeat treatment with Dysport may be comparable to your first use.
In clinical trials, the efficacy of Dysport was studied in a total of 376 patients and was demonstrated with up to 4 repeated treatments. The safety of Dysport has been studied in up to 12 repeated treatments.
How does Dysport® work?
With just 1 injection into each of 5 points between and above the eyebrows, Dysport blocks the signal from the nerve to the muscles, ultimately resulting in a reduction of muscle activity and temporarily preventing contraction of the muscles that cause frown lines.
Injection sites for Dysport
The untreated facial muscles still contract normally, allowing you to freely show facial expressions, such as smiling, in untreated areas.
You should not be treated with Dysport more frequently than every 90 days.
Dysport® dimensions
Treatment Time: With Dysport, often it's only a 10-20 minute treatment. Ask your doctor about any precautions you should take after your treatment. Call your doctor or get medical help right away if you have any problems swallowing, speaking, or breathing. If this happens, do not drive a car, operate machinery, or do other dangerous activities.
Repeatable results: In clinical trials, the efficacy of Dysport was demonstrated with up to 4 repeated treatments. You should wait at least 90 days between treatments. The safety of Dysport has been studied in up to 12 repeated treatments.
Worldwide experience: Dysport is used for aesthetic purposes in 36 countries. In U.S. clinical trials, Dysport was studied for safety in more than 2400 aesthetic patients. Of those, 769 participated in pivotal studies, with a subset of 376 evaluated for efficacy of Dysport.
Dysport® Safety
For a printer-friendly version of the Medication Guide, click here.
MEDICATION GUIDE |
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Read the Medication Guide that comes with Dysport before you start using it and each time Dysport is given to you. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. You should share this information with your family members and caregivers.
What is the most important information I should know about Dysport?
Dysport may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems after treatment with Dysport.
Problems swallowing, speaking, or breathing. These problems can happen hours 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 can not 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.
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
- double vision
- blurred vision and drooping eyelids
- hoarseness or change or loss of voice (dysphonia)
- trouble saying words clearly (dysarthria)
- loss of bladder control
- trouble breathing
- trouble swallowing
These symptoms can happen hours 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?”.
What is Dysport?
Dysport is a prescription medicine that is injected into muscles and used:
- to treat the abnormal head position and neck pain that happens with 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)
CD is caused by muscle spasms in the neck. These spasms cause abnormal position of the head and often neck pain. After Dysport is injected into muscles, those muscles are weakened for up to 12 to 16 weeks or longer. This may help lessen your symptoms
Frown lines (wrinkles) happen because the muscles that control facial expression are used often (muscle tightening over and over). After Dysport is injected into the muscles that control facial expression, the medicine stops the tightening of these muscles for up to 4 months.
It is not known whether Dysport is safe or effective in children under 18 years of age.
It is not known whether Dysport is safe or effective for the treatment of other types of muscle spasms. It is not known whether Dysport is safe or effective for the treatment of other wrinkles.
Who should not take 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®* or Botox®*
- have a skin infection at the planned injection site
What should I tell my doctor before taking Dysport?
Tell your doctor 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?”
- allergies to any botulinum toxin product
- had any side effect from any botulinum toxin product in the past
- a breathing problem, such as asthma or emphysema
- swallowing problems
- bleeding problems
- diabetes
- a slow heart beat or other problem with your heart rate or rhythm
- plans to have surgery
- had surgery on your
- weakness of your forehead muscles (such as trouble raising your eyebrows
- drooping eyelids
- any other change in the way your face normally
Tell your doctor if you:
- 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 doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal and other natural products. Using Dysport with certain other medicines may cause serious side effects. Do not start any new medicines while taking Dysport without talking to your doctor first.
Especially tell your doctor if you:
- have received any other botulinum toxin product in the last four months
- have received injections of botulinum toxin, such as Myobloc® (Botulinum Toxin Type B)* or Botox® (Botulinum Toxin Type A)* in the past; be sure your doctor 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 doctor 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 doctor and pharmacist each time you get a new medicine.
How should I take Dysport?
- Dysport is an injection that your doctor will give you
- Dysport is injected into the affected muscles
- Your doctor may give you another dose of Dysport after 12 weeks or longer, if it is needed
- If you are being treated for CD, your doctor may change your dose of Dysport, until you and your doctor find the best dose for you
- 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?”
Other side effects of Dysport include:
- dry mouth
- injection site discomfort or pain
- tiredness
- headache
- neck pain
- muscle pain
- eye problems: double vision, blurred vision, decreased eyesight, problems with focusing the eyes (accommodation), drooping eyelids, swelling of the eyelids
- allergic reactions. Symptoms of an allergic reaction to Dysport may include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or asthma symptoms, or if you get dizzy or faint
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.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about 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. For more information about Dysport call 877-397-7671 or go to www.dysport.com or www.DysportUSA.com.
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.
History
Though approved in the United States in April 2009, Dysport® has steadily gained in popularity around the world. Today Dysport is marketed and sold for aesthetic use in 36 countries (as of October 2009). With its approval by the U.S. Food and Drug Administration, you, too, may join others worldwide who have been treated with Dysport.
In U.S. clinical studies the most common side effects were nose and throat irritation, headache, injection site skin reaction, upper respiratory tract infection, eyelid swelling, eyelid drooping, sinus inflammation, and nausea. In some cases, Dysport may cause serious side effects, such as swallowing or breathing problems, that may be life threatening. For more information on possible side effects of Dysport, please see the Important Safety Information including Boxed Warning below and the Medication Guide, or talk to your healthcare professional.
