Questions and Answers – Living With ITB Therapy

What if the pump runs out of medication?

Your programmable pump needs to be refilled with medication periodically using an external procedure performed in your doctor's office.
More: After Surgery

Can I stop taking other medications for severe spasticity once I have ITB Therapy?

Your doctor will determine if you still need to take other medications.

How will alcohol or other medications affect me?

The drowsy effect of Lioresal® Intrathecal may add to the effect of alcohol or other depressants. Drowsiness has been reported in people receiving Lioresal Intrathecal. You should be careful driving, operating dangerous machinery, or taking part in activities that may be dangerous if you are not alert.

Does ITB Therapy affect sexual function?

There have been reports of people who have been affected. This effect isn't usually permanent and may be helped by changing the dose of Lioresal Intrathecal.

Does ITB Therapy interact with metal detectors, theft detectors, and security devices?

Your pump may set off metal theft detectors, or security devices. Don't linger near or lean on security screening devices. If you set off a device, show your ID card to security personnel.

Can I have a diagnostic ultrasound?

Electromagnetic interference (EMI) from diagnostic ultrasound (for example, carotid scan, Doppler studies) is unlikely to affect your SynchroMed pump. Note: To minimize potential image distortion, the transducer must be kept 15 centimeters (6 inches) away from the infusion system.

Can I use a cell phone?

Your programmable pump is protected from the low-powered stray electromagnetic interference (EMI) present in a typical cellular phone. However, if your phone is near your programmable pump (1 meter), be sure to turn your phone off prior to any telemetry on your pump to help prevent EMI. Some cellular phones contain a tiny magnet.

Will a microwave oven affect my pump?

Under normal conditions, the household appliances you use in your daily activities will not affect the programmable pump. If you suspect interference with your programmable pump, move away from or turn off the electrical device. The programmable pump will not be permanently affected.

Can I undergo magnetic resonance imaging (MRI) testing?

Contact your doctor before having magnetic resonance imaging (MRI) performed. Programmable pump performance has not been established for Magnetic Resonance Imaging (MRI) scanners at fields greater than 1.5 T (Tesla) scanners. People with a pump should not have an MRI using these scanners.

The MRI will cause your pump to temporarily stop and suspend drug delivery during the MRI. The MRI may also cause your pump to temporarily sound an alarm. The pump should resume normal operation after the MRI is complete. Your doctor should check your pump after an MRI to confirm it is still working properly.

Do I need to take special precautions for long airline flights or high-altitude activities, such as skiing or hiking in the mountains?

Before engaging in activities at high altitudes (such as airline flights, skiing or hiking in the mountains), discuss the effects of low pressure with your doctor. Patients who live or travel at high altitudes are exposed to lower air pressures. With continued exposure to lower pressure, the flow rate of the pump may increase and then stay at the higher rate. If your doctor determines that such an increase in flow rate might pose an undue risk to you, your doctor can adjust your infusion prescription to offset this higher flow rate.

In rare cases, exposure to the lower pressures can cause the flow rate of the SynchroMed II pump to exceed the programmed flow rate by more than 14.5% while the patient is exposed to the lower pressure. The infusion prescription in SynchroMed pumps can be changed for patients who will be exposed to lower pressures.

Can I go SCUBA diving or use hyperbaric chambers?

Do not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water (or above 2.0 ATA) could damage the pump, requiring surgery to replace the pump. To minimize damage to the pump when hyperbaric treatment is required, your doctor should fill the pump to capacity using the appropriate refill kit and maintain the current infusion prescription prior to exposure to hyperbaric conditions. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor. As pressure increases, pump flow decreases. Continuing to increase the pressure will eventually lead to serious injury or death.

Can I use hot tubs, steam rooms, saunas, and tanning beds?

If the temperature of a hot tub, steam room, sauna, or tanning bed is greater than 39˚C (102˚F), you should not use it. The flow rate of the pump will vary with body temperature. The flow rate increases as the temperature increases. If the increase is significant, the pump can deliver too much medication. This may lead to serious injury or death.

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: 23 Apr 2009

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