Announcing the FDA approval of Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in adults!
What is Dysport®?

Dysport® is a prescription medicine that is injected into muscles and used to treat:

  • increased muscle stiffness in adults with spasticity
  • cervical dystonia (CD) in adults
  • 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.

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 cervical dystonia or upper limb spasticity in children under 18 years of age.

Can I use Dysport® if I have already had treatment with another botulinum toxin?

You can receive treatment with Dysport® (abobotulinumtoxinA) even if you have used another botulinum toxin in the past, such as Botox® (onabotulinumtoxinA), Xeomin®(incobotulinumtoxinA), or Myobloc® (rimabotulinumtoxinB). Dysport® has been studied in people who have previously received treatment with another botulinum toxin.

Tell your doctor if you have received any botulinum toxin product in the last 4 months and also which product you received. Dysport® should not be given until at least 3 months after your last treatment. Do not take Dysport® if you have had an allergic reaction to another botulinum toxin treatment in the past or if you are allergic to any of the inactive ingredients in Dysport®, including human albumin, or cow’s milk protein.

How long can I expect my Dysport® to last?

Unfortunately, Dysport® results are not permanent. Initial treatments for wrinkles typically last 3 to 6 months. Subsequent treatments may prove to have more lasting results, up to one year in duration. Treatment of hyperhidrosis (excessive sweating) may last up to one year (average 5.2 months).

What do I need to do after my treatment?

There is no downtime with this treatment. Swelling at injection site may occur and is normal and will subside throughout the day. After your session is completed, you are free to head home or carry on with your day’s activities.  We advise you to remain upright for the next four hours and refrain from exercise or excessive massaging of the injection sites, as doing so may displace the Dysport® beyond where it is intended. Following your Dysport® treatment, smoother skin will gradually appear within the next five to ten days.

Important Safety Information for Dysport®

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®. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with Dysport®. 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 after an injection of Dysport® if the muscles that you use to breathe or swallow become weak. If these problems are severe, death can happen as a complication. People with certain breathing problems may need to use muscles in their necks to help them breathe and may be at greater risk for serious breathing problems 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. 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 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, trouble saying words clearly, loss of bladder control, trouble breathing, or trouble swallowing. These problems could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

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.

Before you take 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), as you may be at increased risk of serious side effects, including difficulty swallowing or breathing.

Before you take Dysport®, tell your doctor if you have or have had any of the following: a side effect from any botulinum toxin in the past; breathing problems such as asthma or emphysema; swallowing problems; bleeding problems; diabetes; and 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 in the last four months or in the past. Be sure your doctor knows exactly which product you received such as Myobloc® (rimabotulinumtoxinB), Botox® (onabotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have recently received an antibiotic by injection; take muscle relaxants; take an allergy or cold medicine; or take a 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.

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, and headache.

Most common side effects of Dysport® in 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch  or call 1-800-FDA-1088.