(BPT) – About 10,000 children born annually in the United States will develop cerebral palsy.1
The month of March is Cerebral Palsy (CP) Awareness Month, culminating in the celebration of National CP Awareness Day on March 25th every year.
CP is the most common motor disability in children in the United States, affecting an average of one in 323 children.2
CP affects the part of the brain that controls muscle movements and therefore may permanently affect body movement, muscle coordination and balance.3 Symptoms of CP vary greatly from person to person and although the condition does not get worse over time, its symptoms may change over a person’s lifetime.3
Children with CP typically experience difficulties with movement and posture due to abnormal muscle tone4, and many of them have the symptom of spasticity—stiff or tight muscles and exaggerated reflexes—which often involves rapid muscle contractions and spasms.4,5
Dr. Ann Tilton, Professor of Clinical Neurology and Pediatrics and Chief of the Section of Child Neurology at Louisiana State University School of Medicine, explains, “Lower limb spasticity commonly involves spasticity in a muscle complex located in the calf.”6,7
Last summer, the U.S. Food and Drug Administration (FDA) approved Dysport® (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients two years of age and older, making it the first and only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity.
Dysport® and all botulinum toxin products have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. Please see below for additional Important Safety Information.
“Since the FDA approval, physicians now have access to education and training programs related to approved Dysport® dosing and instructions for use. This is exciting because, in partnership with our patients’ parents and caregivers, these resources can help train healthcare professionals to determine the most appropriate course of treatment for children with CP, who suffer from lower limb spasticity. The families of these children also have access to support programs, such as IPSEN CARES®, to help eligible patients get access to the medication they need,” says Dr. Tilton.
To learn more about Dysport® for the treatment of lower limb spasticity in pediatric patients ages two and older, consult your doctor and visit www.dysport.com.
What is Dysport®?
Dysport® is a prescription medicine that is injected into muscles and used to treat:
- 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.
Important Safety Information for Dysport®
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 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.
Please see Dysport® Full Prescribing Information including Boxed Warning and Medication Guide.
Botox®, Xeomin®, and Myobloc® are registered trademarks of their respective owners.
Dysport and C.L.I.M.B. are registered trademarks of Ipsen Biopharm Limited.
IPSEN CARES is a registered trademark of Ipsen S.A.
References:
- Centers for Disease Control and Prevention: Gateway to Health Communication & Social Marketing Practice – Cerebral Palsy. http://www.cdc.gov/healthcommunication/toolstemplates/entertainmented/tips/cerebralpalsy.html. Accessed July 22, 2016.
- Centers for Disease Control and Prevention: Data & Statistics for Cerebral Palsy. http://www.cdc.gov/ncbddd/cp/data.html. Accessed July 12, 2016.
- National Institute of Neurological Disorders and Stroke. NINDS Cerebral Palsy Information Page. http://www.ninds.nih.gov/disorders/cerebral_palsy/cerebral_palsy.htm#What_is. Accessed May 4, 2016.
- National Institute of Neurological Disorders and Stroke. Cerebral Palsy: Hope Through Research. http://www.ninds.nih.gov/disorders/cerebral_palsy/detail_cerebral_palsy.htm#3104_2. Accessed June 14, 2016.
- National Institute of Neurological Disorders and Stroke. Spasticity Information Page. http://www.ninds.nih.gov/disorders/spasticity/spasticity.htm Accessed June 23, 2016.
- Delgado M, et al. AbobotulinumtoxinA for equinus foot deformity in cerebral palsy: A randomized clinical trial. Pediatrics. 2016;137(2).
- Gray H. Anatomy of the Human Body. “The Muscles and Fasciæ of the Leg.” http://www.bartleby.com/107/129.html. Accessed June 23, 2016.
©2017 Ipsen Biopharmaceuticals, Inc.
February 2017 DYS-US-001471
