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ITB TherapySM

Screening, Implant, & Management

Screening Test

A standard screening test may determine whether ITB TherapySM (Intrathecal Baclofen Therapy) may be suitable for patients with severe spasticity. In the test, patients receive an intrathecally administered test dose of baclofen injection via a lumbar puncture. Patients who respond favorably may go on to receive ITB Therapy long-term. Non-response to a low dose may require a trial with a higher dose to demonstrate patient benefit.

  • 97% of patients with spasticity of spinal origin demonstrate a positive response to the screening test1
  • 86% of patients with spasticity of cerebral origin demonstrate a positive response to the screening test2

In these studies, a positive test was defined as a one-point reduction in Ashworth score for spasticity of cerebral origin and a two-point reduction in spasticity of spinal origin. An acceptable response should be determined for each patient in advance of the screening test.

The screening test must be conducted in a medically supervised and adequately equipped environment with immediate access to resuscitative equipment. Prior to the screening test, be sure to do the following:

  • Educate patient and caregiver regarding the screening test procedure.
  • Consider titration or discontinuation of concomitant oral antispasmodic medications. Some physicians only hold the daily dose on the day of screening.
  • Prepare for the possibility of significant hypotonia during screening as a result of the bolus injection. Following implant, the dose will be continuously administered over a 24-hour period and titrated to meet individual needs for function and care.

Learn More About:

1. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg. 1992;77(2):236-240.
2. Gilmartin R, Bruce D, Storrs BB, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000;15(2):71-77.

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.

Important Safety Information 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.

Additional Information