About Cervical Dystonia

Co-Pay Assistance Program What to Expect With Treatment Questions for Your Doctor Resources

What is cervical dystonia?

Cervical dystonia is a condition that falls under a broader category called dystonia. Dystonia is a neurological disorder in which sustained, involuntary muscle contractions, or spasms, lead to involuntary movements and abnormal postures. Dystonia can be generalized (throughout the body), or focal (affecting a certain muscle or muscle group).

Cervical dystonia, also called spasmodic torticollis, is a common type of focal dystonia. In this condition, uncontrolled spasms of the neck muscles cause the head to turn, pull in one direction, or shake. Cervical dystonia often causes significant pain and discomfort. There are different kinds of cervical dystonia.

Abnormal head position and neck pain associated with cervical dystonia can make daily activities difficult. While there is no cure, treatments are available to help you relieve the symptoms of cervical dystonia. Learn more about symptom relief with Dysport therapy.

Who is affected by cervical dystonia?

Cervical dystonia can affect men and women of all ages. However, it is almost twice as common in women as men, and symptoms most often begin between 25 and 55 years of age.

How common is cervical dystonia?

An estimated 125,000 people in the United States suffer from cervical dystonia. However, studies suggest that even more individuals may have this condition, but remain undiagnosed or misdiagnosed. Sometimes people suffer with this movement disorder for over a year before being correctly diagnosed and treated. It is important for patients to take a proactive approach with their doctors.

Learn about a treatment option for cervical dystonia symptoms.

How do symptoms change over time?

The severity of symptoms can vary from day to day. However, cervical dystonia is considered a progressive disease, because symptoms are usually mild at the beginning and can grow more severe over time. Most often, symptoms get worse over the course of 2 to 5 years, and then “plateau,” or stop getting worse. In rare cases, symptoms may get better or go away altogether (known as remission). Even in these cases, though, there is a chance that symptoms may return.

Can cervical dystonia be treated?

Yes. Fortunately, there are treatment options that can help relieve symptoms of cervical dystonia. The current treatment of choice is botulinum toxins. This type of medication is injected directly into the affected muscles, and successfully reduces symptoms for most patients.

Your doctor may recommend physical therapy or exercise to help reduce pain and improve range of motion. A number of oral medications such as pain relievers and muscle relaxants are available as well, but are not specifically approved for the treatment of cervical dystonia.

Learn more about cervical dystonia.

References:

Dystonia Medical Research Foundation Web site. Cervical dystonia (spasmodic torticollis). http://www.dystonia-foundation.org/pages/cervical_dystonia_more_info/46.php. Accessed Feb. 11, 2011.

National Spasmodic Torticollis Association Web site. Signs and symptoms. http://www.torticollis.org/spasmodic-toricollis-symptoms.html. Accessed Feb. 11, 2011.

ST/Dystonia Web site. FAQs. http://www.spasmodictorticollis.org/media/doc/DystoniaFAQSheet.doc. Accessed Feb. 11, 2011.

ST/Dystonia Web site. What is ST? http://www.spasmodictorticollis.org/info/index.cfm. Accessed Feb. 11, 2011.

WE MOVE Web site. Diagnosis. http://wemove.org/dys/cdys_dia.html. Accessed Feb. 11, 2011.

WE MOVE Web site. Symptoms. http://wemove.org/dys/cdys_sym.html. Accessed Feb. 11, 2011.

Important Safety Information: MEDICATION GUIDE
DYSPORT® (DIS-port) (abobotulinumtoxinA) Injection

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 cannot 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 heartbeat or other problem with your heart rate or rhythm
  • plans to have surgery
  • had surgery on your face
  • weakness of your forehead muscles (such as trouble raising your eyebrows)
  • drooping eyelids
  • any other change in the way your face normally looks

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.

Issued March 2012

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Ipsen Biopharmaceuticals, Inc.
106 Allen Road
Basking Ridge, NJ 07059

and

Medicis Aesthetics, Inc.
a wholly owned subsidiary of Medicis Pharmaceutical Corporation
Scottsdale, AZ 85256

Please see Important Safety Information and Prescribing Information, including Boxed Warning, and Medication Guide.

All trademarks used herein belong to their respective owners.