Daily Living – ITB Therapy

While Medtronic ITB Therapy^SM (Intrathecal Baclofen Therapy) can help improve your severe spasticity through medication, you play an important role in your own treatment.

The following guidelines will help you maximize the benefit from your ITB Therapy:

Carry your patient ID card and emergency cards with you at all times
Always keep your follow-up and refill appointments
Tell your doctor if you don't feel well, or are having problems with the pump
Immediately notify your doctor if you hear a pump alarm
Learn the programmable pump name (SynchroMed^®) and model number and the name of the medication used in the pump (Lioresal^® Intrathecal)
Make sure your family and friends know about the pump, so they can help in an emergency

Exercise and Daily Activities

Your doctor may recommend that you restrict activity for 6 to 8 weeks after your surgery. As you become more active, discuss your level and type of activity with your doctor. Follow his or her suggestions about work, sexual activity, travel, recreation, hobbies, and exercise.

Talk with your doctor if you perform any excessive or repetitive activities that may damage your programmable pump and catheter. Certain activities that can increase or decrease the flow rate of your pump are also potentially dangerous.

Travel

Tell your doctor if you plan to travel. If necessary, he or she will adjust your pump refills to prevent serious injury or death from a travel-related change in your treatment.

People who live or travel at high altitudes are often exposed to lower air pressures for long periods of time. This continued exposure can increase the flow rate of the pump. If your doctor determines an increase in flow rate might pose a significant risk to you, he or she can adjust your infusion prescription accordingly.

Medical and Dental Procedures

Tell your other doctors and your dentist about your Medtronic ITB Therapy before you have any medical or dental procedures. Certain procedures could affect your safety or the performance of the pump.

Electromagnetic Compatibility

Electromagnetic interference from sources such as diagnostic ultrasound, cellular phones and microwave ovens is unlikely to affect your baclofen pump. There are exceptions, however. For more information consult the SynchroMed II pump patient manual.

Support Groups and Networks

Medtronic has created a community in which those who suffer from severe spasticity and their family caregivers can share experiences, offer support, and better understand the challenges of living with spasticity.

Helpful resources include:

Advocacy groups offer further information, support, and volunteer opportunities for those affected by cerebral palsy.

For more information, contact the following organizations:

Next: Product Support

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: 18 Sep 2009