Treatment Options:
Intrathecal Medications

The US Food and Drug Administration approved the use of ITB Therapy^SM (Intrathecal Baclofen Therapy) for the treatment of spasticity of spinal and cerebral origin in 1992 and 1996, respectively. Since that time, it has been successfully used in the treatment of spasticity caused by stroke, cerebral palsy, multiple sclerosis, and acquired brain and spinal cord injuries.

Depending on your specific condition, ITB Therapy may impact your severe spasticity in different ways. Treatment may be even more effective when used in combination with physical, occupational, or speech therapy.

How ITB Therapy Treats Severe Spasticity
ITB Therapy uses a surgically implanted programmable pump and catheter that delivers medication which helps relieve severe spasticity. This medication is a liquid form of baclofen, called Lioresal^® Intrathecal (baclofen injection), that goes directly into the intrathecal space where fluid flows around the spinal cord.

Because Lioresal Intrathecal is delivered directly to where it's needed most in the spinal fluid, it relieves spasticity with smaller amounts of medication than when baclofen is taken orally. This method of delivery may help minimize side effects that can result from oral baclofen.

Candidates for ITB Therapy
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

Therapy Components
The ITB Therapy system consists of:

• Pump – a surgically placed, battery-powered programmable pump with a reservoir infuses the drug at a programmed rate via the catheter
• Catheter – a flexible silicone tube delivers medication from the pump to your body
• Lioresal Intrathecal – a liquid form of the medication baclofen

The system delivers a liquid form of the drug baclofen (Lioresal Intrathecal) directly to the fluid around the spinal cord, where it's needed most.

Most people report that the programmable pump is not uncomfortable or restrictive, and does not interfere with their movement. Depending on your body type, it may not show at all under regular clothes.

Important Safety Information related to ITB Therapy and the SynchroMed II System

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

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.