Intrathecal Baclofen Therapy

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General

Minimizing Complications

This retrospective literature and safety-file review suggests guidelines for preventing, recognizing, and managing a life-threatening syndrome in patients who experience the abrupt withdrawal of intrathecal baclofen therapy. Symptoms of the syndrome include high fever, altered mental status, and profound muscular rigidity that sometimes progressed to fatal rhabdomyolysis.

Coffey RJ, Edgar TS, Francisco GE, Graziani V, Meythaler JM, Ridgely PM, et al.
Arch Phys Med Rehabil, 2002

A group of physicians experienced in the intrathecal drug delivery systems management reviewed surgical practices and principles associated with low catheter-related complication rates. The authors pooled their experiences to reach a consensus on implant techniques associated with a low rate of postoperative complications.

Follett KA, Burchiel K, Deer T, DuPen S, Prager J, Turner M, Coffey, J.
Neuromod, 2003

The most common complications leading to explantation of the intrathecal baclofen pump in children are skin breakdown and infection at the pump implantation site. The authors report a technique of subfascial implantation that provides greater soft tissue coverage of the pump, thereby reducing the potential for skin breakdown and improving the cosmetic appearance of the implantation site.

Kopell BH, Sala D, Doyle WK, Feldman DS, Wisoff JH, Weiner HL.
Neurosurg, 2001

Lioresal Intrathecal and on Compounding

This information is provided as background and education on the process of, and quality concerns with, compounding intrathecal baclofen. The FDA specifically states that a compounded product must not copy a commercially available, FDA approved drug.1  Intrathecal baclofen is commercially available as Lioresal® Intrathecal (baclofen injection).

Since Lioresal Intrathecal is delivered through a programmable drug pump, a wide range of patient dosages may be accommodated with the commercially available product.

The objective of this analysis was to determine the concentration accuracy of compounded intrathecal baclofen.

Moberg-Wolff E. As presented at the 67th Annual Assembly of the American Academy of Physical Medicine and Rehabilitation, 2006

This national survey studies the compliance of hospitals' quality assurance practices for pharmacy compounded sterile preparations with the American Society of Health System Pharmacists (ASHP) Guidelines on Quality Assurance for Pharmacy-Prepared Sterile Products.

Morris AM, Schneider PJ, Pedersen CA, Mirtallo JM.
Am J of Heal Sys Pharm, 2003

This report focuses on the issues of contamination in compounded sterile preparations and maintains that state boards of pharmacy are in the best position to conduct random checks of compounded products and to initiate and maintain adequate inspections of state-licensed facilities.

Kinkade, Kevin, Executive Director, Missouri Board of Pharmacy

References

  1. About USP - An Overview. Available at: http://www.usp.org/aboutusp. Accessed 7/9/2008.

Condition-Specific

Brain Injury

The objective of this study was to determine the impact of intrathecal baclofen (ITB) therapy on outcomes of functional independence, pain, subjective improvement, performance, and standard measures of spasticity.

Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G.
Arch Phys Med Rehabil, 2005

The purpose of this study was to describe the perceptions of care providers about intrathecal baclofen for management of spasticity.

Gooch JL, Oberg WA, Grams B, Ward LA, Walker ML.
Dev Med Child Neurol, 2004

The aim of this study was to determine the efficacy, safety, and cost-effectiveness of intrathecal baclofen delivered by a programmable pump for the chronic treatment of severe spasticity.

Ordia JI, Fischer E, Adamski E, Spatz EL.
J Neurosurg, 1996

This study analyzes the use of CIBI on 18 patients with severe spasticity from traumatic or hypoxic brain injury.

Becker R, Alberti O, Bauer BL.
J of Neurol, 1997

Twelve consecutive patients with severe spasticity and hypertonia following acquired brain injury were treated with continuous intrathecal infusion of baclofen via an implanted, programmable infusion pump-catheter system for a minimum of 3 months.

Meythaler JM, McCary A, Hadley MN.
J Neurosurg, 1997

Cerebral Palsy

The purpose of this study was to describe the perceptions of care providers about intrathecal baclofen for management of spasticity in 80 individuals.

Gooch JL, Oberg WA, Grams B, Ward LA, Walker ML.
Dev Med Chi Neurol, 2004

The objective of this case series was to determine if the continuous intrathecal delivery of baclofen will control spastic hypertonia caused by long-standing cerebral palsy.

Meythaler JM, Guin-Renfroe S, Law C, Grabb P, Hadley MN.
Arch Phys Med Rehabil, 2001

This article assessed the cost-effectiveness of intrathecal baclofen among children with severe spasticity of cerebral origin. The children in question have not responded to less invasive treatments such as oral medications relative to alternative medical and surgical intervention.

de Lissovoy G, Matza LS, Green H, Werner M, Edgar T.
J Chi Neurol, 2007

The purpose of this article is to describe outcomes of intrathecal baclofen therapy for 29 patients with cerebral palsy, focusing on impairments, functional limitations, and disability. Patients received individualized rehabilitation and were followed up to 24 months.

Awaad Y, Tayem H, Munoz S, et al.
J of Chi Neurol, 2003

This study assesses whether there is an improvement in motor function in individuals with cerebral palsy who have had a reduction of muscle tone by continuous intrathecal baclofen infusion. The study is a prospective, open label, non-blinded case series without a control group, conducted at multiple centers.

Krach LE, Kriel RL, Gilmartin RC, et al.
Ped Rehabil, 2005

The purpose of this study was to assess whether reduction of muscle tone by continuous intrathecal baclofen infusion affects the progression of hip subluxation in persons with cerebral palsy.

Krach LE, Kriel RL, Gilmartin RC, et al.
Pediatr Neurol, 2004

The purpose of this study was to assess the need for orthopedic surgery of the lower extremities in such cases, the authors retrospectively reviewed the outcome in patients with spastic cerebral palsy who were treated with intrathecal baclofen infusion.

Gerszten PC, Albright AL, Johnstone GF.
Neurosurg, 1998

The goal of this prospective, multicenter study was to ascertain the long-term effectiveness and safety of intrathecal baclofen in the treatment of spasticity of cerebral origin in children and young adults.

Albright AL, Gilmartin R, Swift D, Krach LE, Ivanhoe CB, McLaughlin JF.
Neurosurg, 2003

This study analyzes placement of the tip of the intrathecal catheter at the T6-T7 level rather than at the traditional T11-T12 level in children with spastic quadriparesis.

Grabb PA, Guin-Renfroe S, Meythaler JM.
Neurosurg, 1999

This study investigates the perspective of the individual receiving intrathecal baclofen or his/her caregiver concerning its effects and to describe characteristics of those that were satisfied or not satisfied.

Krach, LE, Nettleton A, Klempka B.
Ped Rehabil, 2006

Multiple Sclerosis

The objective of this study was to determine the impact of intrathecal baclofen (ITB Therapy) on outcomes of functional independence, pain, subjective improvement, performance, and standard measures of spasticity.

Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G.
Arch Phys Med Rehabil, 2005

The aim of this study was to determine the efficacy, safety, and cost-effectiveness of intrathecal baclofen delivered by a programmable pump for the chronic treatment of severe spasticity.

Ordia JI, Fischer E, Adamski E, Spatz EL.
J Neurosurg, 1996

This study seeks to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the treatment of severe spasticity or spinal cord origin.

Ordia JI, Fischer E, Adamski E, Chagron KG, Spatz EL.
Neuromod, 2002

This retrospective study evaluated the efficacy and functional benefits of chronic intrathecal baclofen infusion in severe spinal spasticity.

Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni M.
Funct Neurol, 2001

Patients were followed to study whether long-term control of spinal spasticity by intrathecal baclofen can be achieved.

Penn RD.
J Neurosurg, 1992

This randomized double-blind placebo-controlled study was conducted to determine whether intrathecal baclofen infusion can be safe and effective for the long-term treatment of intractable spasticity in patients with spinal cord injury or multiple sclerosis.

Coffey JR, Cahill D, Steers W, et al.
J Neurosurg, 1993

This article assesses intrathecal baclofen therapy as well as evaluates patient outcomes and satisfaction.

Vender JR, Hughes M, Hughes BD, Hester S, Holsenback S, Rosson B.
Neurosurg, 2006

This retrospective study is designed to determine the long-term ambulatory function in those receiving ITB Therapy.

Sadiq SA, Wang GC.
Neurol, 2006

The objective of this cross-sectional, two-level study was to characterize the population of multiple sclerosis patients suffering from spasticity and to evaluate treatment patterns, including intrathecal baclofen delivery, related to patient quality of life.

Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL.
Multiple Sclerosis, 2004

Spinal Cord Injury and Disease

The objective of this study was to determine the impact of intrathecal baclofen (ITB Therapy) on outcomes of functional independence, pain, subjective improvement, performance, and standard measures of spasticity.

Guillaume D, Van Havenbergh A, Vloeberghs M, Vidal J, Roeste G.
Arch Phys Med Rehabil, 2005

The aim of this study was to determine the efficacy, safety, and cost-effectiveness of intrathecal baclofen delivered by a programmable pump for the chronic treatment of severe spasticity.

Ordia JI, Fischer E, Adamski E, Spatz EL.
J Neurosurg, 1996

This study seeks to determine the efficacy and safety of intrathecal baclofen (ITB) delivered by a programmable pump for the treatment of severe spasticity of spinal cord origin.

Ordia J, Fischer E, Adamski E, Chagron KG, Spatz EL.
Neuromod, 2002

This retrospective study evaluated the efficacy and functional benefits of chronic intrathecal baclofen infusion in severe spinal spasticity.

Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni M.
Funct Neurol, 2001

This randomized double-blind placebo-controlled study was conducted to determine whether intrathecal baclofen infusion can be safe and effective for the long-term treatment of intractable spasticity in patients with spinal cord injury or multiple sclerosis.

Coffey JR, Cahill D, Steers W, Park TS, Ordia J, Meythaler J, Herman R, Shetter AG, Levy R, Gill B, et al.
J Neurosurg, 1993

Patients were followed to study whether long-term control of spinal spasticity by intrathecal baclofen can be achieved.

Penn RD.
J Neurosurg, 1992

Stroke

The objective of this case series is to explore whether intrathecal baclofen therapy improves ambulation in stroke survivors.

Francisco GE, Boake C.
Arch Phys Med Rehabil, 2004.

This study seeks to determine whether continuous intrathecal delivery of baclofen can effectively decrease spastic hypertonia due to stroke.

Meythaler JM, Guin-Refroe S, Brunner RC, Hadley MN.
Stroke, 2001.

This prospective open-label multicenter evaluates the impact of intrathecal baclofen on function and quality of life. It also seeks to obtain efficacy and safety data in poststroke spastic hypertonia.

Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SP.
Arch Phys Med Rehabil, 2006.

White Papers

Medtronic has confirmed through returned product analysis that the use of nonindicated drug formulations can compromise the performance of the SynchroMed II and SynchroMed EL infusion systems. This paper discusses the mechanism by which nonindicated drug formations can cause corrosion to the pumps internal components, resulting in permanent motor stalls and therapy cessation.

Medtronic has confirmed through engineering analyses that the use of indicated and nonindicated drug formulations can result in collection of CSF protein in the catheter lumen, distal end. Although this may occur with any drug, nonindicated drug formulations can result in significantly increased collections of material in the catheter lumen resulting in complete occlusion of the catheter.

For more information on the indications, contraindications, warnings, and precautions for the SynchroMed programmable infusion systems, please review the device brief summaries for the SynchroMed II Drug Infusion System and the SynchroMed EL Infusion System.

ITB Therapy (Intrathecal Baclofen Therapy) is indicated for use in the management of severe spasticity. For spasticity of spinal cord origin, ITB Therapy via an implantable infusion system should be reserved for patients unresponsive to oral baclofen or those who experience intolerable CNS side effects at effective doses. Patients with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

Indications, Safety & Warnings for ITB Therapy: Intrathecal Baclofen Withdrawal: 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 risk (e.g., spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).

This therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.

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 underdose. Acute massive overdose may result in coma and may be life threatening.

The most frequent and serious adverse events related to device and implant procedures are catheter dislodgement from the intrathecal space, catheter break/cut, and implant site infection including meningitis. Electromagnetic interference (EMI) and Magnetic resonance imaging (MRI) may cause patient injury, system damage, operational changes to the pump, and changes in flow rate.

Please refer to the full prescribing information and system information for details or call Medtronic at 1-800-328-0810. Rx Only. Lioresal® is a registered trademark of Novartis Pharmaceuticals Corporation.

January 2008