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Announcing the first and only FDA-approved botulinum toxin treatment

for pediatric patients 2 years of age and older with lower limb spasticity

Pediatric patients with lower limb spasticity (2 and older)
Adults with upper limb spasticity

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®. 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 people 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.

Click here to view Dysport® Full Prescribing Information including Boxed Warning and Medication Guide.

Botox®, Xeomin®, and Myobloc® are registered trademarks of their respective owners.

Indications

What is Dysport®?

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

  • increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb spasticity
  • cervical dystonia (CD) in adults
  • increased muscle stiffness in calf muscles 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.

Please see Important Safety Information and Full Prescribing Information

Indications

Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:

  • Adults with upper limb spasticity, to decrease the severity of increased muscle tone in elbow flexors, wrist flexors, and finger flexors
  • Adults with cervical dystonia
  • Lower limb spasticity in pediatric patients 2 years of age and older

The safety and effectiveness of Dysport® injected into upper limb muscles or proximal muscles of the lower limb for the treatment of spasticity in pediatric patients has not been established.

Safety and effectiveness in pediatric patients with lower limb spasticity below 2 years of age have not been evaluated.

Safety and effectiveness in pediatric patients with cervical dystonia or upper limb spasticity have not been established.

The safety and effectiveness of Dysport® in the treatment of lower limb spasticity in adult patients has not been demonstrated.

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