Is ITB Therapy Right for You?

Since 1992, more than 50,000 Medtronic baclofen pumps have been used worldwide to manage severe spasticity related to a variety of conditions. Talk to your doctor about a 1-day screening test to see what it may do for you or your loved one.

Eligibility Requirements

Your doctor will consider many important factors to decide if ITB Therapy^SM (Intrathecal Baclofen Therapy) is right for you.

You may be a candidate for ITB Therapy if you:

Have severe spasticity that interferes with your function, care and comfort, or activities of daily living
Show a positive response to Lioresal^® Intrathecal (baclofen injection) in a standard screening test
Have sufficient body size to support the pump, which must be implanted 2.5 centimeters (1 inch) or less from the surface of the skin
Do not have any infection
Are not allergic to baclofen
Wait at least 1 year after your injury (traumatic brain injury only)
Have had ineffective results or intolerable side effects (such as fatigue or nausea) from oral baclofen (for severe spasticity of spinal origin)

In addition, healthcare professionals may use the following criteria to determine if you are a candidate for a baclofen pump:

You experience severe spasticity or spasms that interfere with function or daily activities
Your severe spasticity or spasms interfere with care or positioning

About the Screening Test

A standard screening test determines if ITB Therapy may work for you. During the test, you’ll be screened with a small dose of the drug called Lioresal Intrathecal injected into the intrathecal space (where fluid flows around the spinal cord).

In one clinical study, Lioresal Intrathecal reduced spasticity in 97% of people with severe spasticity due to multiple sclerosis or spinal cord injury during the screening test.¹ In a second clinical study, Lioresal Intrathecal reduced spasticity in 86% of individuals with spasticity of cerebral origin during the screening test.²

If You Are a Candidate

If your doctor determines you are a candidate for ITB Therapy, you will need to make the final decision about whether to pursue the treatment.

Here are some suggestions to help you decide if ITB Therapy is right for you:

Read personal stories or talk with people who have a baclofen pump
Learn about our Ambassador Program
Make sure you’re comfortable with your doctor. He or she should be helpful, supportive, and ready to answer any questions you may have.
Request more information from Medtronic
Carefully weigh the benefits and risks of ITB Therapy
Consider the Full Prescribing Information

Before you meet with your doctor, think about what you hope to learn. Prepare questions, and be ready to provide information about your medical history.

References

Penn RD, Intrathecal Baclofen for Spasticity of Spinal Origin: Seven Years of Experience. J Neurosurg, 1992, 77: 236-240.
Gilmartin R, Bruce D, et al. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol 2000; 71-77.

Next: Your Healthcare Team

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

Safety Information – ITB Therapy

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, traumatic brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait 1 year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, respiratory depression (difficulty breathing), seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy.

For more information, please read the Lioresal^® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

This therapy is not for everyone. Please contact your doctor. A prescription is required.

Lioresal^® is a registered trademark of Novartis Pharmaceuticals Corporation.

Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.

Last updated: 27 Apr 2009