Skin Treatments

Dysport

The Timing's Just Right

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Receive treatment with Dysport by September 30, 2010

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What is Dysport?

Prescription Dysport is an injection used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults less than 65 years of age.

Dysport is a purified formulation that has been shown to deliver temporary improvements in moderate to severe frown lines, even with repeat treatments. So, the effect of repeat treatment with Dysport may be comparable to your first use.*

*In clinical trials, the efficacy of Dysport was studied in a total of 376 patients and was demonstrated with up to 4 repeated treatments. The safety of Dysport has been studied in up to 12 repeated treatments.

Frown lines 101: What causes them?

Over time, repeated movement of the facial skin by the muscles forms frown lines between the eyebrows.

Wrinkles are not only age related. Frown lines are “dynamic”—they happen because of the way a person’s face moves. Because frown lines are created by facial movements such as frowning or squinting, they may develop even in younger adults. Dysport is used to treat moderate to severe frown lines in adult patients less than 65 years of age.

The muscles above and between the eyebrows contract and tighten, and can cause wrinkles. Dysport blocks the nerve signal that causes these facial muscles to contract. This ultimately results in a localized reduction of muscle activity in the treated area and temporarily stops the contraction of these muscles.

Dysport Safety

MEDICATION GUIDE
DYSPORTâ„¢ (DIS-port)
(abobotulinumtoxinA)
Injection

Read the Medication Guide that comes with DYSPORTâ„¢ before you start using it and each time DYSPORTâ„¢ 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 DYSPORTâ„¢?

DYSPORTâ„¢ 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 DYSPORTâ„¢:

• Problems swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of DYSPORTâ„¢ 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 DYSPORTâ„¢.
• 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 DYSPORTâ„¢.
• Swallowing problems may last for several weeks. People who can not 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 DYSPORTâ„¢ 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 DYSPORTâ„¢?

DYSPORTâ„¢ 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 DYSPORTâ„¢ 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 DYSPORTâ„¢ 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 DYSPORTâ„¢ is safe or effective in children under 18 years of age.

It is not known whether DYSPORTâ„¢ is safe or effective for the treatment of other types of muscle spasms. It is not known whether DYSPORTâ„¢ is safe or effective for the treatment of other wrinkles.

Who should not take DYSPORTâ„¢?

Do not take DYSPORTâ„¢ if you:

• are allergic to DYSPORTâ„¢ or any of the ingredients in DYSPORTâ„¢. See the end of this Medication Guide for a list of ingredients in DYSPORTâ„¢
• 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 DYSPORTâ„¢?

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 DYSPORTâ„¢?”
• 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 heart beat 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

Tell your doctor if you:

• are pregnant or plan to become pregnant. It is not known if DYSPORTâ„¢ can harm your unborn baby
• are breast-feeding or planning to breast-feed. It is not known if DYSPORTâ„¢ 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 DYSPORTâ„¢ with certain other medicines may cause serious side effects. Do not start any new medicines while taking DYSPORTâ„¢ 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 ?

• DYSPORTâ„¢ is an injection that your doctor will give you
• DYSPORTâ„¢ is injected into the affected muscles
• Your doctor may give you another dose of DYSPORTâ„¢ after 12 weeks or longer, if it is needed
• If you are being treated for CD, your doctor may change your dose of DYSPORTâ„¢, until you and your doctor find the best dose for you
• The dose of DYSPORTâ„¢ is not the same as the dose of any other botulinum toxin product

What should I avoid while taking DYSPORT ?

DYSPORTâ„¢ may cause loss of strength or general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of taking DYSPORTâ„¢. 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 DYSPORTâ„¢?”

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 DYSPORTâ„¢ 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 DYSPORTâ„¢ 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 DYSPORTâ„¢. 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 DYSPORTâ„¢:

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

This Medication Guide summarizes the most important information about DYSPORTâ„¢. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DYSPORTâ„¢ that is written for healthcare professionals. For more information about DYSPORTâ„¢ call 877-397-7671 or go to www.dysport.com or www.DysportUSA.com.

What are the ingredients in DYSPORTâ„¢?

Active ingredient: (botulinum toxin Type A)

Inactive ingredients: human albumin, and lactose. DYSPORT™ may contain cow’s milk protein.

Issued May 2009

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

Distributed by:
Tercica, Inc.
a subsidiary of the Ipsen Group
Brisbane, CA 94005

and

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

* All trademarks are the property of their respective owners

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