Important Safety Information

Dysport® (abobotulinumtoxinA) may cause serious side effects that can be life threatening, including problems breathing or swallowing and spread of toxin effects. These problems can happen within hours, or days to weeks, after an injection of Dysport. Deaths due to these problems have occurred. 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. This is usually because the muscles used to breathe and swallow can become weak after the injection. Death can happen if you have severe problems with swallowing or breathing after treatment with Dysport. People who already have problems with swallowing or breathing before receiving Dysport have the highest risk of getting these problems.

Spread of toxin effects. In some cases, 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. 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 speaking (dysarthria), loss of bladder control, trouble breathing, or trouble swallowing. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Dysport contains albumin, which is naturally found in human blood. An extremely remote risk for spreading viral diseases or Creutzfeldt-Jakob disease (CJD) does exist. No cases of transmission of viral diseases or CJD have ever been identified for albumin.

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.

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.

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 Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA), or have a skin infection at the planned injection site.

Tell your doctor all about your medical conditions, such as diseases that affect your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease], myasthenia gravis, or Lambert-Eaton syndrome), as you may be at increased risk of serious side effects, including severe dysphagia (difficulty swallowing) and respiratory problems (difficulty breathing) from normal doses of Dysport.

Tell your doctor if you have or have had any of the following: allergies to any botulinum toxin product, side effect(s) from any botulinum toxin product in the past, breathing problems (such as asthma or emphysema), swallowing problems, bleeding problems, diabetes, slow heartbeat, or other problems with your heart rate or rhythm.

Tell your doctor if you 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, or have any other change in the way your face normally looks.

Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding or planning to breast-feed. It is not known if Dysport can harm your unborn baby. 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 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 injections of botulinum toxin, such as Myobloc®, Botox®, or Xeomin®, in the past; have recently received an antibiotic by injection, take muscle relaxants, take an allergy or cold medicine, or take a sleep medicine. Be sure your doctor knows exactly which product you received.

The dose of Dysport is not the same as the dose of any other botulinum toxin product.

Other side effects of Dysport include dry mouth, injection site discomfort or pain, tiredness, headache, neck pain, muscle pain, and eye problems, such as double vision, blurred vision, decreased eyesight, problems with focusing the eyes (accommodation), drooping eyelids, and swelling of the eyelids.

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 the FDA at 1-800-FDA-1088.

The Medication Guide summarizes the most important information about Dysport. If you would like more information, talk with your doctor. Full Product Information, including Boxed Warning, and Medication Guide, has been provided to your doctor.

For more information about Dysport, call 1-855-463-5127.

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Dysport is a registered trademark of Ipsen Biopharm Limited.
All trademarks used herein belong to their respective owners.