Intrathecal Baclofen Therapy

Help your patients understand their condition and potential treatments with patient education materials that speak clearly and accurately about severe spasticity and ITB TherapySM.

Newsletters

Connecting Newsletters

This newsletter offers information, education, and support to the patients, families and caregivers receiving and/or considering ITB TherapySM (Intrathecal Baclofen Therapy). Each issue has a special, editorial focus, but contains content for all indications.

This issue focuses on persistence and dedication with ITB Therapy.

This issue explores the importance of making connections.

This issue focuses on caregivers and caregiving.

This issue focuses on advocacy.

This issue is a special tribute to U.S. veterans.

This issue focuses on pediatrics.

This issue focuses on multiple sclerosis.

Video

This video illustrates the effect of ITB Therapy on Kaleigh who is living with severe spasticity due to cerebral palsy.

This video illustrates the effect of ITB Therapy on Nick who is living with severe spasticity due to cerebral palsy.

This video shares Kaleigh's experience with ITB Therapy. Kaleigh is a girl who struggles with severe spasticity due to cerebral palsy.

This video provides patients with an overview of ITB Therapy (Intrathecal Baclofen Therapy) .

This video educates adult patients, families, and caregivers on the ITB Therapy screening test.

This video educates pediatrics and their caregivers on the ITB Therapy screening test.

This video shares Bob's experience with ITB Therapy. Bob struggles with severe spasticity due to multiple sclerosis.

This video shares Mary's experience with ITB Therapy. Mary struggles with severe spasticity due to stroke.

Brochures

This brochure educates patients, families, and caregivers on ITB TherapySM (Intrathecal Baclofen Therapy) and addresses frequently asked questions.

This document summarizes safety information on ITB Therapy in a patient-friendly Q&A format.

These programs are a source of last resort for patients whose health insurance resources do not cover the drug component cost of intrathecal baclofen therapy or for patients who are unable to afford their co-payments associated with intrathecal baclofen therapy.

This brochure provides your patients with a way to sign up to receive information from Medtronic that is appropriate for them by completing a survey about their current situation.

Designed for pediatric patients, this coloring book tells a story about one family's decision to begin receiving ITB Therapy.

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