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ITB TherapySM

Patient Selection

Joey C., living with spinal cord injury. Receiving ITB Therapy since 2001
Joey C., living with spinal cord injury. Receiving ITB Therapy since 2001.

Careful patient selection is the key to therapeutic success. Functional patients with severe spasticity can benefit from increased movement and abilities, while less functional patients can benefit from easier positioning and daily care. Receiving treatment early, before muscles atrophy, is a critical factor in achieving mobility, range of motion, and other short- and long-term successes.

ITB TherapySM (Intrathecal Baclofen Therapy) should be considered for patients who have one or more of the following:

  • Severe spasticity or spasms that interfere with function or daily activities
  • Severe spasticity or spasms that interfere with care or positioning
  • Ineffective results or side effects (such as fatigue or nausea) from oral medications
  • Spasticity-related pain

See also special considerations for the following patient populations:

In addition, candidates must demonstrate a positive response to a single bolus dose of Lioresal® Intrathecal (baclofen injection) during the screening test.

Lioresal® Intrathecal is contraindicated for intravenous, intramuscular, subcutaneous or epidural administration.1 Hypersensitivity to oral baclofen is a contraindication to therapy.

1. Lioresal® Intrathecal (baclofen injection) Drug Package Insert.

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.


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