Treatment for Your Cervical Dystonia

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Dysport® for Injection (abobotulinumtoxinA) is a first-line treatment for the symptoms of cervical dystonia in patients with and without a history of botulinum toxin use. Dysport helps stop the uncontrolled muscle spasms that can cause abnormal head position and neck pain in cervical dystonia. In clinical trials, treatments with Dysport were generally 3 to 4 months apart or longer, depending on the return of symptoms. Retreatment should not be less than 12 weeks after the last injections.

Please see the Patient Medication Guide below, or visit www.dysport.com for the full Prescribing Information, including Boxed Warning, and to see if Dysport could be right for you.

Distant Spread of Toxin Effect: Postmarketing reports indicate that the effects of Dysport and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening, and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity, but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses, including spasticity in children and adults, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses.

About Dysport

What is Dysport?

Dysport (pronounced DIS-port) is a prescription medicine that is used to treat the abnormal head position and neck pain in adults with cervical dystonia. The active ingredient in Dysport is botulinum toxin type A.

How does Dysport work?

Dysport reduces the amount of a chemical called acetylcholine in the injected muscles. This action helps block the signals that cause these muscles to spasm. This effect can last for 3 to 4 months or longer after injection, and can help significantly reduce the severity of your symptoms.

Can I use Dysport if I have already been treated with another botulinum toxin therapy?

Yes. Dysport can be given to you whether you have received therapy with another botulinum toxin, such as Botox® (botulinum toxin type A) or Myobloc® (botulinum toxin type B) in the past, or you have never received this type of therapy. However, you should not receive Dysport if you experienced an allergic reaction while receiving treatment with any other botulinum toxin therapy. Tell your doctor if you have received another botulinum toxin therapy in the past, how recently you received it, and if you had any side effects. You should not receive Dysport any sooner than12 weeks after your last injection.

Are all botulinum toxin type A products the same?

These products all contain type A botulinum toxin and work in the same way. However, the products are not interchangeable. Dosing for the products is not the same. Your healthcare professional will determine the right dose of Dysport for you.

What to expect with treatment

What should I expect when I receive Dysport?

Dysport is a treatment that you receive right in your doctor’s office. When injected into the affected muscles, Dysport helps stop the uncontrolled muscle spasms. As a result, it treats symptoms of cervical dystonia, including abnormal head position and neck muscle pain.

Treatments with Dysport may be 3 to 4 months apart or longer, based on when your symptoms return. Retreatment should not be less than 12 weeks after the last injection. Depending on your response, your doctor may adjust your total dose of Dysport or inject different muscles on your next visit. In this way, your treatment is customized until it is best suited to you. The recommended starting dose with Dysport is500 Units, divided among the affected muscles.

How often will I need retreatment with Dysport?

Treatments with Dysport are typically 3 to 4 months apart or longer, depending on when your symptoms return. In clinical studies, half of all patients receiving Dysport went 14 weeks or longer between treatments. Retreatment should not be less than 12 weeks after the last injection. Your doctor will work with you to decide how often you need to be treated.

Dysport Co-Pay Assistance Program

What is the Dysport Co-Pay Assistance Program?

This is a program for patients with cervical dystonia that helps cover most or all of your out-of-pocket costs related to Dysport, the injection, and injection guidance, such as EMG.

How much can I save?

You can save most or even all of the amount of your co-pays for one year of treatment. You will receive a card that can be used to help with up to $2000 of your out-of-pocket costs for Dysport treatment ($500 per treatment). The card may be used to help with up to 4 treatments from October 1, 2011 to December 31, 2012.

Am I eligible for this Program? (see Program Rules below)

You qualify if:

·         You are receiving Dysport for cervical dystonia

and

·         Your Dysport therapy is covered by a commercial insurance company

How do I get started?

When your doctor decides that Dysport is right for you, he or she will fill out the Patient Access, Care, and Education (PACESM) enrollment form, and you will sign the Patient Authorization section. Your doctor then sends this form to our PACE team. A Program Specialist will contact you regarding your eligibility and enroll you in the Program.

How do I participate?

It’s as easy as 1, 2, 3.

1.      Your physician will enroll you in the Program by submitting a PACE enrollment form and a Patient Authorization form that requires your signature. Once you are enrolled in this Program, you will receive the Dysport® Co-Pay Assistance Program Prepaid MasterCard® loaded with your estimated out-of-pocket amount for Dysport, the injection, and injection guidance. This card can only be used at your doctor’s office or at your specialty pharmacy to pay for your Dysport-related out-of-pocket costs. You must use the card within 60 days or it will be automatically deactivated.

2.      After each treatment with Dysport, you will receive an Explanation of Benefits (EOB) form from your health insurance company showing the actual out-of-pocket costs you paid during your visit. You have up to 60 days after your treatment to send us your EOB form and your corresponding pharmacy receipt for Dysport (if applicable). Send this form to:

Dysport Co-Pay Assistance Program

c/o The Macaluso Group

271 Rt 46 West

Building B, Second floor

Fairfield, NJ 07004

Or fax it to 1-800-260-0066

3.      Each time you submit your EOB form and pharmacy receipt, your card will be reloaded with your estimated out-of-pocket costs so it’s ready for your next Dysport treatment.

What if I need more information?

For more information about the Dysport Co-Pay Assistance Program, contact PACE at:

·         1-888-525-2423 from 8:00 a.m. to 8:00 p.m. EST, Monday through Friday, and ask to speak with a Program Specialist. For more information about Dysport, visit www.dysport.com

Note: Ipsen reserves the right to discontinue or amend the Dysport Co-Pay Assistance Program at any time.

PROGRAM RULES

By participating in the Dysport Co-Pay Assistance Program (the “Program”) and attesting on the PACE enrollment form, I acknowledge and accept the following conditions:

·         The Program assists with out-of-pocket costs related to the cost of Dysport and authorized medical expenses, including the injection and injection guidance (some restrictions apply†). No other expenses are covered by this program;

·         I would otherwise be responsible for making the full co-pay or the co-insurance amount due to my physician or pharmacy;

·         I understand that a failure, by me or my physician, to follow the Program Rules may void my participation in the Program and I may be responsible for making full payment for undocumented or unauthorized charges applied to the card;

·         I am responsible for submitting the EOB form that I receive from my insurance company and pharmacy receipt (if applicable) to the Program administrator to document my authorized expenses within 60 days of my Dysport injection. Undocumented or unauthorized expenses will be reversed and my physician and/or pharmacy may require me to pay these expenses;

·         I will disclose my participation in the Program if required by my insurance company;

·         I understand I am not eligible to participate in this Program if I am covered by a federal- or state-funded insurance program or if I live in the state of Massachusetts;

·         †If I live in Minnesota, Michigan, or Rhode Island, I can only receive assistance with the cost of Dysport but not the cost of related medical services (injection and injection guidance).

The Dysport® Co-Pay Assistance Program Prepaid MasterCard® is issued by The Bancorp Bank pursuant to license by MasterCard International and this card may not be used everywhere MasterCard is accepted. No cash or ATM access. MasterCard is a registered trademark of MasterCard International Incorporated. The Bancorp Bank; Member FDIC.

Dysport History

What is the history of Dysport?

Dysport was approved for the treatment of cervical dystonia in the United States in 2009. While requirements for drug approval vary from country to country, Dysport has been available outside the United States for more than 20 years. It was first approved for use in the United Kingdom in 1990. Standards for approval in other countries may differ from those used by the FDA.

What are the most serious possible side effects of Dysport?

Dysport, and all botulinum toxin products, may cause serious side effects that can be life threatening. Deaths have occurred with this type of treatment. Problems can happen hours to weeks after an injection with Dysport. Get medical help right away if you have any of these problems after treatment with Dysport:

·         Problems swallowing, speaking, or breathing. People who already have swallowing or breathing problems before receiving Dysport have the highest risk of these problems

·         Swallowing problems may last for several weeks. People who cannot swallow well may need a feeding tube to receive food and water

·         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; or trouble swallowing

If you experience any of these side effects, do not drive a car, operate machinery, or do other dangerous activities.

What are other possible side effects of Dysport?

The most common side effects observed in clinical trials were muscle weakness, dry mouth, injection site discomfort or pain, tiredness, headache, neck pain, muscle pain, difficulty swallowing or speaking, and eye problems (such as double vision, blurred vision, decreased eyesight, problems with focusing the eyes, drooping eyelids, or swelling of the eyelids). Most side effects were mild to moderate. Less than 1% of patients in clinical trials receiving Dysport decided to discontinue participation due to side effects of treatment.

Other possible side effects include allergic reactions. Symptoms of an allergic reaction to Dysport may include itching, rash, red itchy welts, wheezing, asthma symptoms, 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.

These are not all the possible side effects of Dysport. For more information, ask your doctor. Tell your doctor if you have any side effect that bothers you or that does not go away. You are encouraged to report side effects to Ipsen at 1-877-397-7671 (1-877-DYSPOR1). You may also report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What should I tell my doctor before taking Dysport?

Tell your doctor:

•         About all your medical conditions, including diseases that affect your muscles or nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig’s disease] or myasthenia gravis), breathing problems such as asthma or emphysema, swallowing problems, heart problems, bleeding problems, diabetes, or any plans to have surgery

•         If you are pregnant or plan to become pregnant, or if you are breast-feeding or planning to breast-feed. It is not known if Dysport can harm your unborn baby, and it is not known if Dysport passes into breast milk

•         About all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal and other natural products. Dysport may interact with other medicines to 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 4 months. No botulinum toxin product should be given within 12 weeks of the last botulinum toxin treatment

•         Have received injections of any other botulinum toxin product, such as Myobloc or Botox, in the past. Be sure your doctor knows exactly which product you received, how recently you received it, and if you had an allergic reaction or any side effect

•         Have any known allergies, especially to cow’s milk protein

•         Have recently received an antibiotic by injection

•         Have skin infections in the head or neck area at the site of injection

•         Take muscle relaxants, allergy or cold medicine, or sleep medicine

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:

o   loss of strength and muscle weakness all over the body

o   double vision

o   blurred vision and drooping eyelids

o   hoarseness or change or loss of voice (dysphonia)

o   trouble saying words clearly (dysarthria)

o   loss of bladder control

o   trouble breathing

o   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 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 used herein belong to their respective owners.

Please see full Prescribing Information, including Boxed Warning.

© 2011 Tercica, Inc., A Subsidiary of the Ipsen Group               DYS00284             10/11     Printed in USA

My mom and I wanted to thank you for hosting such a great symposium this year. This was our third year and we are looking forward to next years. E. Mathews