Intrathecal Baclofen Therapy

The following information is meant to be used as a guide to assist you post-implant for patients with ITB TherapySM .

Patient Management

Long-Term Patient Management

Follow-up care for ITB Therapy is critical to ongoing patient management. Some patient management considerations continue throughout the course of the patient's treatment.

Patient management considerations include:

  • Refilling the pump and programming dose adjustments
  • Rehabilitation Therapy
  • Monitoring for adverse events
  • Managing system complications

Rehabilitation Therapy

ITB Therapy may address some of the positive signs of the upper motor neuron syndrome - specifically spasticity and spasms – thus potentially allowing rehabilitation therapy to manage the negative signs such as weakness, loss of motor control, and low endurance.

Early goals for most patients receiving ITB Therapy may include:

  • Strengthening weak muscles
  • Stretching shortened muscles
  • Motor learning/awareness of new movement patterns

Examples of other spasticity management goals include:

  • Improve self-care
  • Improve gait
  • Improve functional ability and independence
  • Decrease pain associated with spasticity
  • Improve transfers
  • Improve sleep

It will be important to coordinate ongoing patient management for those who will be receiving rehabilitation therapy.

Inpatient Rehabilitation

Where appropriate, inpatient rehabilitation is followed by outpatient rehabilitation. Inpatient rehabilitation may be appropriate if:

  • Travel distance from home to center is too far to allow frequent visits during the titration phase.
  • Patient and caregiver education is required for a safe transition to home care.
  • Patient has additional rehabilitation issues to be addressed (e.g., transfer training, equipment needs).

Initially, inpatient rehabilitation may involve gentle range of motion maneuvers, incision monitoring, positioning, and adaptive equipment as needed (e.g., addition of a chest harness to accommodate loss of hypertonia, different seat cushion to accommodate increased sitting time).

Individuals who have functional goals may benefit from comprehensive outpatient rehabilitation to achieve maximum benefits from ITB Therapy.

Refill Appointments

The refill procedure involves a specific set of steps that must be followed precisely to help ensure patient safety. Before clinicians perform refills, they must be trained in the correct procedures.

A refill appointment usually includes:

  • An assessment of the patient's general condition and response to the therapy
  • Identify the need for dose titration
  • Confirming system performance
  • Refilling the pump
  • Determining the interval to the next refill
  • Programming the pump
  • Documenting patient care and prescribing information
  • Conducting ongoing patient education
  • Scheduling the next refill appointment

Pump Refill and Refill Intervals

A typical refill appointment takes about 30 minutes. The pump is refilled by inserting a needle through the skin into the pump septum.

A refill template, included in the Lioresal® Intrathecal (baclofen injection) refill kit, can be used to assist in locating the refill septum.

SynchroMed Pump Alarms

Medtronic recommends that clinicians refrain from depending solely on the pump alarm to determine refill intervals or remaining battery life. Some hearing-impaired patients may not hear the alarm or the pump may be implanted too deep to adequately hear the alarm. Always use the programmer to verify the battery life of the pump and the reservoir alarm status.

For reference, here are the SynchroMed II pump alarms:

Dosage Adjustment

The goal of ITB Therapy for severe spasticity is to determine for each patient the drug dose that achieves optimal spasticity control without intolerable adverse effects. It is important to observe patients for symptoms of drug overdose, tolerance, and ineffective dosing.

Drug dosage will vary with each patient. Encourage patients to notify their clinicians of unusual symptoms, drug overdose, or loss of drug effect. If drug tolerance, disease progression, or psychosocial issues that may impact therapeutic effect are ruled out, evaluate the infusion system for malfunction.

Manuals

Technical Resources

  • Bridge Bolus Calculation Reference Card

    Whenever there is a change in drug concentration or solution, the remaining old drug in the pump tubing and catheter must be accounted for to prevent under- or overdosing the patient while the old drug concentration is being cleared from the fluid pathway. This reference card outlines how to calculate a bridge bolus.

  • Patient Emergency Reminder Refill Card

    These cards give patients a way to track their medications, concentrations, volumes, and alarm dates. Patients should receive a card following a refill, and should keep it on them at all times in case of an emergency.

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