Patient Selection Intrathecal Baclofen Therapy with Lioresal® Intrathecal (baclofen injection)
Choosing a treatment option for managing severe spasticity depends on the severity of symptoms and efficacy of the current therapy as determined during the patient assessment process. Treatment typically begins with noninvasive therapies and, if unsuccessful, moves to more interventional treatment options. Often, several therapies are used together for optimum benefit to the patient.
Severe spasticity can be treated separately from the patient's primary underlying condition. Effective treatment of spasticity may:
In many cases, severe spasticity may be adequately managed with oral medication, rehabilitative interventions, and/or injection therapy. For some patients, however, these treatments do not provide sufficient relief, or they result in intolerable side effects. For example, oral drugs at effective doses for managing spasticity may cause severe drowsiness, dizziness, weakness, and nausea, which can limit participation in family, social, academic, and/or work-related activities.
Patients who are unresponsive to oral baclofen or who experience intolerable central nervous system (CNS) side effects from oral baclofen may benefit from ITB Therapy with Lioresal® Intrathecal (baclofen injection). ITB Therapy can significantly decrease severe spasticity1-9 and spasms.2, 7-9
ITB Therapy with Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity should be considered for patients who first respond to a screening dose prior to consideration for long term infusion via an implantable pump.
Lioresal® intrathecal is not recommended for intravenous, intramuscular, subcutaneous, or epidural administration. Hypersensitivity to oral baclofen is a contraindication to the therapy.
Use ITB Therapy with care in patients who:
For important safety information, including BOX WARNING, please refer to Lioresal® Intrathecal (baclofen injection) full prescribing information at www.lioresal.com/prescribing information.
Francisco GC, Boake C. Improvement in walking speed in poststroke spastic hemiplegia after intrathecal baclofen therapy: a preliminary study. Arch Phys Med Rehabil. 2003;84(8):1194-1199.
Meythaler JM, Guin-Refroe S, Brunner RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.
Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP. Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil. 2006;87(11):1509–1515.
Gilmartin R. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.
Hoving MA, van Raak EP, Spincemaille GH, Palmans LJ, Becher JG, Vles JS; Dutch Study Group on Child Spasticity. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. Eur J Paediatr Neurol. 2009;13:240-246.
Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992;77(2):236-240.
Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003;98(2):291-295.
Coffey RJ, Cahill D, Steers W. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term multicenter study. J Neurosurg. 1993;78(6):226-232.
Ordia JI, Fischer E, Adamski E, Chagnon KG, Spatz EL. Continuous intrathecal baclofen infusion by a programmable pump in 131 consecutive patients with severe spasticity of spinal origin. Neuromodulation. 2002;5(1):16-24.
Saulino M., Ivanhoe CB., McGuire J.R., Ridley B., Shilt J.S., Boster A.L. 2016. Best Practices for Intrathecal Baclofen Therapy: Patient Selection. Neuromodulation 2016; 19:607-615.
Common Adverse Reactions
Serious Adverse Reactions
For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at www.lioresal.com/prescribinginformation