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This site is intended for US residents only

What is Adult Spasticity – Dysport® (abobotulinumtoxinA)

What is adult spasticity?

Spasticity is a condition that causes spasms and stiffness in your arms, legs, or both, interfering with movement and your ability to perform simple tasks, such as walking or dressing. The pain due to extreme stiffness and loss of mobility can become a turning point in your life.

What is Adult Spasticity – Dysport® (abobotulinumtoxinA)

What is adult spasticity?

Spasticity is a condition that causes spasms and stiffness in your arms, legs, or both, interfering with movement and your ability to perform simple tasks, such as walking or dressing. The pain due to extreme stiffness and loss of mobility can become a turning point in your life.

Signs & Symptoms

Are you experiencing the signs and symptoms of spasticity?

It can take many forms. These are some of the most common:

Are you experiencing the signs and symptoms of spasticity?

Don’t wait to talk to your doctor.
Your condition could worsen over time, so see your doctor as soon as you start having symptoms.

Causes of spasticity

What causes spasticity?

What causes spasticity?

Spasticity can occur when the nerve cells that carry messages from your brain to different parts of your body are damaged. When this happens, the affected muscles in your limbs may receive the wrong signals. This can cause your muscles to contract or tense up, leading to stiffness and tightness.

Spasticity can occur because of different medical conditions or events that can damage nerve cells, including:

  • A stroke
  • A serious injury to the brain or spinal cord
  • Diseases like cerebral palsy or multiple sclerosis

 

Developing spasticity can be a turning point in your life, because the extreme stiffness can be painful. It can also interfere with movement and your ability to perform simple tasks.

Be sure to tell your doctor about any and all symptoms you’ve been having, including:

  • Muscle stiffness
  • Pain
  • Difficulty doing activities you were able to do before

If you think you might have adult spasticity, it’s important to identify it and discuss treating it with your doctor right away. Together, you and your healthcare team can create a plan that’s right for you.

In the United States, it is estimated that over 2.4 million adults experience some form of limb spasticity related to various medical conditions, including:

Stroke—1,495,000

Cerebral palsy—649,400

Multiple sclerosis—268,000

Managing Spasticity

Management of Spasticity

Treatment With Dysport®

  • Dysport is injected into affected muscles to help lessen your symptoms.
  • Dysport is a type of medicine that is injected directly into affected arm or leg muscles by a specialist. It helps to temporarily block signals from the brain that tell the affected muscles to contract or tighten, usually for months at a time.
  • Response to treatment may be different for each patient, so be sure to talk to your doctor regularly during treatment.
  • Talk to your doctor about your condition and whether Dysport may be an option.

 

How Dysport worked in clinical trials

For adults with upper limb spasticity, approximately 3 out of 4 patients had a response to treatment at week 4 as measured by a reduction in stiffness in the elbow, wrist, or finger muscles

For most patients, improvement was seen 1 week after treatment

For adults with lower limb spasticity, nearly half of patients had a response to treatment at week 4 as measured by a reduction in muscle stiffness at the ankle joint:

For most patients, improvement was seen 1 week after treatment

In these clinical studies, a majority of patients needed treatment again between 12 and 16 weeks.
The next Dysport treatment should not be given sooner than 12 weeks after the last Dysport treatment session. Your doctor will assess your spasticity at each treatment session and may adjust the dose and muscles injected.

What is DYSPORT?            
DYSPORT is a prescription medicine that is injected into muscles and used to treat:

  • increased muscle stiffness in people 2 years of age and older with spasticity
  • cervical dystonia in adults

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about DYSPORT?            
DYSPORT may cause serious side effects that can be life threatening. 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: 

  • Problems swallowing, speaking, or breathing. These problems can happen within hours to weeks after an injection of DYSPORT due to weakening of associated muscles. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with DYSPORT. Swallowing problems may last for several weeks. People with certain pre-existing swallowing or breathing problems 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 including loss of strength and muscle weakness all over the body, double or blurred vision, drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, and trouble breathing or swallowing.

These symptoms can happen within hours to weeks after you receive an injection of DYSPORT. These problems could make it unsafe for you to drive a car, operate machinery, or do other dangerous activities.

Who should not receive DYSPORT?

Do not receive DYSPORT if you: are allergic to DYSPORT or any of its ingredients, or to cow’s milk protein; had an allergic reaction to any other botulinum toxin product such as Myobloc®, Botox®, or Xeomin®; have a skin infection at the planned injection site.

What should I tell my doctor before receiving 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
  • have allergies to any botulinum toxin product or had any side effect from any botulinum toxin product in the past
  • have or have had problems with breathing (such as asthma or emphysema), swallowing, or bleeding
  • have diabetes
  • have or have had a slow heartbeat, or other problem with your heart rate or rhythm
  • have plans to have surgery or had surgery on your face
  • have weakness in or near your muscles being treated, drooping eyelids, experienced dry eye with previous use of botulinum toxin products, or any other change in the way your face normally looks
  • are pregnant (or plan to be) or breast-feeding (or planning to)

Tell your doctor 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 doctor that you have received DYSPORT in the past. Especially tell your doctor if you: have received any other botulinum toxin product in the last four months or any time in the past (be sure your doctor knows exactly which product you received); have recently received an antibiotic by injection; take muscle relaxants, an allergy or cold medicine, or a sleep medicine.

What are the possible side effects of DYSPORT?

  • The most common side effects in adults with upper limb spasticity include muscle weakness; in adults with lower limb spasticity include muscle weakness, pain in arms or legs, and falls
  • The most common side effects in children (2 to 17 years of age) with upper limb spasticity include upper respiratory tract infection and sore throat; in children with lower limb spasticity include stuffy or runny nose, sore throat, cough, and fever
  • The most common side effects in people with cervical dystonia include muscle weakness, muscle pain, difficulty swallowing, dry mouth, problems speaking, injection site pain or discomfort, feeling of tiredness, eye problems, and headache

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.

Please see full , including with IMPORTANT WARNING.