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All candidates for ITB Therapy with Lioresal® Intrathecal (baclofen injection) must meet the patient selection criteria. In addition, clinicians should consider additional selection criteria related to the patient's underlying condition.
Spasticity is one of the most disabling aspects of brain injury.1 Spasticity occurs in about 25% of those living with traumatic brain injury;2 the incidence is up to 40% for those with mid-brain injuries.2
CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):
It is estimated that 70-80% of persons living with CP have spasticity,3 and at least 60% of those with spasticity have functional limitations.4 For children with severe movement disorders, oral medications or injection therapy are often inadequate, especially in children older than five or six.5
CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):
Seventeen percent of people with MS have spasticity that frequently affects their activities of daily living.7
CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):
Sixty-two percent of people with spinal cord injury (SCI) from cervical or thoracic injury reported having spasticity. Twelve percent reported having spasticity so severe that it interfered with activities of daily living.8
CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):
According to clinical evidence 38% of people experience spasticity within 1 year following a stroke.9
CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):
For additional information please refer to SynchroMed™ II Brief Statement and Lioresal® prescribing information.
No Medtronic-approved protocol exists for the discontinuation of anticoagulation medication during the screening test and surgical procedure. The decision to proceed should be based on an individual analysis of risks and benefits.
Meythaler J, et al. Long-term continuously infused intrathecal baclofen for spastic dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999; 80(1):13-19.
Wedekind C, Lippert-Gruner M. Long-term outcome in severe traumatic brain injury is significantly influenced by brainstem involvement. Brain Inj 2005;19:681-4.
Centers for Disease Control and Prevention, www.cdc.gov, web site accessed 3/19/2008.
Kennes J, Rosenbaum P, Hanna SE, et al. Health status of school-aged children with cerebral palsy: information from a population-based sample. Dev Med Child Neurol 2002; 44: 240–47.
Albright AL. Neurosurgical treatment of spasticity and other pediatric movement disorders. J Child Neurol. 2003;18(supplement 1):S67-S78.
Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent orthopedic surgery in patients with spastic cerebral palsy. J Neurosurg. 1998;88(6):1009-1013.
Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10(5):589-595.
Anson CA, Shepherd C. Incidence of secondary complications in spinal cord injury. Int J Rehabil Res. 1996;19(1):55-66.
Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002:16(5):515-522.
Meythaler JM, Guin-Refroe S, Brunner, RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.
Common Adverse Reactions
Serious Adverse Reactions
Postmarketing Experience
For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at lioresal.com/prescribinginformation.
Rev. 06/2019