What Is ITB Therapy? ITB Therapy for Severe Spasticity

WHY CONSIDER A BACLOFEN PUMP?

If treatments like pills or injections aren't giving you enough relief from severe spasticity, talk to a specialist about the FDA-approved treatment option called ITB TherapySM with Lioresal® Intrathecal (baclofen injection).


WHAT IS SEVERE SPASTICITY?

Severe spasticity is a condition in which tight, stiff muscles make it difficult to control your arms, legs, or body. Spasticity can cause spasms, pain, and disability. Spasticity is considered severe when it gets in the way of daily activities, sleep patterns, and caregiving.

Spasticity occurs when nerves in the brain or spinal cord that control movements are injured. Spasticity is often related to cerebral palsy, brain injury, stroke, multiple sclerosis, and spinal cord injury.


WHY IS TREATMENT IMPORTANT?

The right treatment may make work, school, activities, and caregiving easier. It may give you greater comfort and control, allowing you to rethink what's possible.


WHEN OTHER TREATMENTS AREN'T WORKING

Many people can control spasticity well enough with oral medication, physical and occupational therapy, or injection therapy, but some find that these treatments don't work well enough or have intolerable side effects. Consider a baclofen pump if:

  • You aren't getting enough relief from other spasticity treatments.
  • You're struggling with drug side effects like drowsiness, confusion, weakness, and nausea.
  • You suffered a traumatic brain injury at least one year ago.

Safety and efficacy in patients under the age of 4 has not been established.


WHY A PUMP IS DIFFERENT

A common medication for spasticity is a muscle relaxer called baclofen. Taken orally, baclofen works well for many people, but in some may cause debilitating side effects like weakness, drowsiness, or nausea.

When baclofen is taken orally as a pill, most of the drug stays in the bloodstream. Only a small amount reaches the fluid surrounding the spinal cord, even at very high doses. In contrast, the pump delivers baclofen directly into the spinal fluid. When medicine is delivered right where it is needed, you need less, which may help minimize some of the possible side effects that may accompany oral baclofen.1


HOW THE PUMP WORKS

A baclofen pump delivers a precise amount of Lioresal® Intrathecal (a liquid form of baclofen) directly into the fluid that surrounds the spinal cord. This area is called the intrathecal space. A surgeon places the pump just under the skin of the abdomen. The pump is programmed wirelessly to release the right amount of medicine at the right time for the individual. Most patients say the pump feels comfortable and does not interfere with their day-to-day movements.

Treatment with a baclofen pump is also called ITB Therapy with Lioresal® Intrathecal (baclofen injection). The drug used in the pump for treatment of severe spasticity is called Lioresal Intrathecal.

The pump and medication are covered by most private health insurance plans, Medicare, and most state Medicaid programs. The treatment is approved by the FDA.


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.


The Medtronic baclofen pump is part of the Synchromed® Infusion System, which delivers the drug called Lioresal® Intrathecal (baclofen injection) for ITB TherapySM, a treatment for severe spasticity. Please read the following important safety information about ITB Therapy.

IMPORTANT SAFETY INFORMATION FOR ITB THERAPY (Intrathecal Baclofen Therapy)

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious baclofen withdrawal symptoms such as high fever, changed mental status, muscle stiffness, and in rare cases may result in loss of function of many vital organs 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 know the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; speak with your doctor about this.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, brain injury, or spinal cord injury may be candidates for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis, you may be considered for ITB Therapy if oral baclofen has not controlled your spasticity or has resulted in serious side effects that you cannot accept. If you suffered a brain injury due to trauma you must wait until one year after the injury to be considered for ITB Therapy. A trial of ITB Therapy will help to show if ITB Therapy can help you. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small for the implantable pump.

The implanted pump and catheter (tube that delivers the drug from the pump to the fluid around the spinal cord) are placed under the skin during a surgery. Some complications that you may experience with the surgery include infection, meningitis (infection of the lining of the brain and central nervous system), 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. Failure of the pump placed under your skin may cause symptoms due to overdose (receiving too much) or underdose (receiving too little) of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, dizziness, respiratory depression (difficulty breathing), hypothermia (lower than normal body temperature), seizures, loss of consciousness, and coma. Once the infusion system (the pump and the catheter) is implanted, possible complications include unintended movement of the catheter or pump within the body or breakdown of the skin over the pump. The catheter could leak, tear, kink, or become disconnected from the pump, resulting in underdose or no baclofen infusion. Symptoms of underdose include an increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early signs of baclofen withdrawal. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. 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. You or your caregiver should 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 Medtronic, Inc.

USA Rx Only Rev 0913

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.


1

Penn RD, Savoy SM, Corcos D, et al. Intrathecal baclofen for severe spinal spasticity. N Engl J Med 1989; 320: 1517-1521