About the Therapy Intrathecal Baclofen Therapy with Lioresal Intrathecal (baclofen injection)
ITB TherapySM with Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity uses an implantable infusion system to deliver precise amounts of Lioresal Intrathecal (baclofen injection) directly to the intrathecal space via a surgically implanted infusion pump and catheter.
Spasticity is an abnormal increase in muscle tone caused by injury of upper motor neuron pathways regulating muscles. Injury or disease of the central nervous system may cause spasticity. Spasticity may be a result of multiple sclerosis (MS), cerebral palsy (CP), stroke, brain injury, or spinal cord injury.
The consensus opinion of one expert panel defined spasticity as disordered sensori-motor control, resulting from upper motor neuro lesion, presenting intermittent or sustained involuntary activation of muscles.1
Severe spasticity can have a distressing effect on function, comfort, and care giving. It may result in musculoskeletal complications, incoordination, loss of function, pain, and permanent muscle shortening or contracture.
Treating severe spasticity may:
For patients with severe spasticity, enhancing their mobility, self-care abilities, and independence are significant achievements. To reach these milestones, effective therapy is necessary. Spasticity can be treated separately from the patient's primary underlying condition.
It can be difficult to effectively control severe spasticity. While physical rehabilitation and oral pharmacologic treatments work for many patients, some patients may not experience enough relief using these treatments alone. In addition, some patients encounter intolerable side effects from systemic medications. Patients who are unresponsive to oral baclofen or who experience intolerable central nervous system (CNS) side effects from oral medications may benefit from ITB Therapy. ITB Therapy can significantly decrease severe spasticity2-10 and spasms.3, 8-10
A patient should not receive ITB Therapy if the patient has an active infection, is hypersensitive to baclofen, has a body too small for an implantable pump, requires a pump implant deeper than 2.5 cm, or in the presence of spinal anomalies.
The intrathecal baclofen therapy system consists of a programmable pump, an intrathecal catheter, and an external programmer. The pump is surgically implanted in the patient's abdominal area, the catheter tip is placed in the intrathecal space, and the catheter is connected to the pump. Once implanted, the pump and catheter deliver Lioresal Intrathecal (baclofen injection) directly to the patient's spinal fluid, where it can act directly in the spinal fluid. The Medtronic SynchroMed™ II infusion pump used for ITB Therapy can be noninvasively programmed to deliver a range of infusion rates, in a variety of dosing patterns.
ITB Therapy delivers baclofen directly into the intrathecal space, thereby bypassing the blood-brain barrier. As a result, only a fraction of the oral dose is needed to produce efficacy while minimizing systemic side effects.11
Three features of ITB Therapy are particularly desirable and important to most patients:
The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Pump system component failures leading to pump stall, or dosing/programming errors may result in clinically significant overdose or withdrawal. Acute massive overdose may result in coma and may be life-threatening.
Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and may exert its effects by stimulation of the GABABreceptor subtype. However, the precise mechanism of action of baclofen as a muscle relaxant and antispasticity agent is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect.11
In people, as well as in animals, baclofen has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression.11
Pandyan AD, Gregoric M, Barnes MP et al. Spasticity: clinical perceptions, neurological realities and meaningful measurement. Disabil Rehabil 2005;27:2–6.
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.
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.
Becker R, Alberti O, Bauer BL. Continuous intrathecal baclofen infusion in severe spasticity after traumatic or hypoxic brain injury. J Neurol 1997; 224(3): 160-166
Lioresal® Intrathecal (baclofen injection) Drug Prescribing Information.
Natale M, Mirone G, Rotondo M, Moraci A. Intrathecal baclofen therapy for severe spasticity: Analysis on a series of 112 consecutive patients and future prospectives. Clin Neurol Neurosurg. 2012;114:321-325.
Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G. A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Arch Phys Med Rehabil. 2005;86:2165-2171.
Hoving MA, van Raak EP, Spincemaille GH, Palmans LJ, Becher JG, Vles JS. Efficacy of intrathecal baclofen therapy in children with intractable spastic cerebral palsy: a randomised controlled trial. Eur J Paediatr Neurol. May 2009;13(3):240-246.
Shilt JS, Reeves S, Lai LP, et al. The outcome of intrathecal baclofen treatment on spastic diplegia: Preliminary results with a minimum of two year follow up. J Ped Rehab Med. 2008;255-61.
Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure.
US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling.
Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH ≤3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid-naïve patients or to administer ziconotide.
Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose. Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration, screening procedures and underdose and overdose symptoms and methods of management. Physicians must be familiar with the drug stability information in the product technical manuals and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation.
Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass. If it is suspected or known that all or part of the drug was injected into the pocket during the refill procedure, monitor the patient closely for signs and symptoms of overdose in an appropriate facility for a sufficient amount of time or until the symptoms have resolved. Failure to recognize signs and symptoms and seek appropriate medical intervention can result in serious injury or death. Instruct patients to notify their healthcare professionals of the implanted pump before medical tests/procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult with their clinician if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes. Strong sources of electromagnetic interference (EMI), such as short wave (RF) diathermy and MRI, can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. Avoid using shortwave (RF) diathermy within 30 cm of the pump or catheter. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. Drug infusion is suspended during MRI; for patients who can not safely tolerate suspension, use alternative drug delivery method during MRI. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events, as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. Confirm pump status before and after MRI. Reference product labeling for information on sources of EMI, effects on patient and system, and steps to reduce risks from EMI.
Monitor patients after device or catheter replacement for signs of underdose/overdose. Infuse preservative-free (intraspinal) saline or, for vascular applications, infuse heparinized solutions therapy at minimum flow rate if therapy is discontinued for an extended period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator).
Include, but are not limited to, spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of, or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system component, pump inversion, technical/programming errors, injection into the pocket or subcutaneous tissue or improper use, including use of non-indicated formulations and/or not using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection; anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious adverse effects from catheter placement in intravascular applications.
Lioresal® is a registered trademark of Saol
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Important Safety Information
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Common Adverse Reactions
Serious Adverse Reactions
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For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.