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Cerebral Palsy

Spastic cerebral palsy is the most common type of cerebral palsy, with 70% to 91% of motor disorders associated with cerebral palsy due to spasticity.1-5 In the U.S., nearly ¾ of a million children have cerebral palsy—50% (382,000) of these children suffer from severe spasticity.6

Unfortunately, the impact of spasticity is more devastating on children than adults because of the effects of muscle tightness on the growing musculoskeletal system. Muscle tightness can prevent normal bone and muscle development, resulting in substantial shortening of muscles, limb deformities, joint dislocations, and poor motor function, which occur when longitudinal muscle growth is restricted and tension is increased. Therefore, recognizing and implementing early treatment of spasticity in children with severe spasticity can potentially reduce the need for orthopedic surgery for contracture or torsion deformity.7

Severe Spasticity in
Cerebral Palsy Patients

 
 
 
 
 
 

There are 3 times as many patients with severe spasticity as a result of cerebral palsy

AS THERE ARE GAS STATIONS IN THE U.S.8

Three Kinds of Spastic Cerebral Palsy

Each type of spastic cerebral palsy should incorporate a different treatment plan to address the core disabilities and maximize functioning.1

                       (Hemiplegia)

                   (Diplegia)

               (Quadriplegia)

 

Spasticity Can Cause Major Functional Limitations

Equinovarus positioning of the foot is common in children with spastic cerebral palsy and causes major limitations in functional transfers or gait as the child grows.11

Supportive therapies, medications, and surgery may help to maximize a child’s functioning and alleviate discomfort.1 In children at least 4 years of age, consider implementing ITB Therapy with Lioresal® Intrathecal (baclofen injection). Children who are being considered for ITB Therapy with Lioresal® Intrathecal should be of sufficient body size to accommodate the implantable pump. The safety and efficacy of Lioresal® Intrathecal in children younger than 4 years has not been established.9

Choosing a therapeutic option like ITB Therapy with Lioresal® Intrathecal has a well-established safety and efficacy profile and allows for a drug dosage and mode of delivery adjusted to the needs of each patient.2,9,10

Prior to implantation of a device for chronic intrathecal unfusion of Lioresal® Intrathecal Intrathecal (baclofen injection) patients must show a response to Lioresal® Intrathecal Intrathecal in a screening trial. It is mandatory that all patients, caregivers, and treating physicians receive adequate information regarding the risks of the mode of treatment. Instruction should be given on signs and symptoms of overdose, procedures to be followed in the event of an overdose, and proper home care of the pump and insertion site.

  1. Post-stroke rehabilitation. National Institute of Neurological Disorders and Stroke (NINDS) website. https://stroke.nih.gov/materials/rehabilitation.htm. September 2014. Accessed December 14, 2016.
  2. Hoving MA, van Raak EP, Spincemaille GH, et al. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. Eur J Paediatr Neurol. 2009;13(3):240-246.
  3. Surman G, Bonellie S, Chalmers J, et al. UKCP: a collaborative network of cerebral palsy registers in the United Kingdom. J Public Health (Oxf). 2006;28(2):148-156.
  4. Reid SM, Carlin JB, Reddihough DS. Distribution of motor types in cerebral palsy: how do registry data compare? Dev Med Child Neurol. 2011;53(3):233-238.
  5. Hagberg B, Hagberg G, Beckung E, Uvebrant P. Changing panorama of cerebral palsy in Sweden. VIII. Prevalence and origin in the birth year period 1991-94. Acta Paediatr. 2001;90(3):271-277.
  6. McGuire JR. Chapter 2: Epidemiology of spasticity in the adult and child. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016.
  7. Saulino M, Ivanhoe CB, McGuire JR, et al. Best practices for intrathecal baclofen therapy: patient selection. Neuromodulation. 2016;19(6):607-615.
  8. 2015 Retail Fuels Report. National Association of Convenience Stores (NACS) website. Available at: https://www.nacsonline.com/YourBusiness/FuelsReports/2015/Documents/2015-NACS-Fuels-Report_full.pdf. Accessed September 27, 2017.
  9. Lioresal® Intrathecal (baclofen injection) [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.
  10. Kolaski K, Koman LA. Chapter 29: Surgical management of spasticity in the child with cerebral palsy. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016.
  11. Agarwal A, Verma I. Cerebral palsy in children: An overview. J Clin Orthop Trauma. 2012;3(2):77-81

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.