Benefits and Risks ITB Therapy for Severe Spasticity

EXPLORE BENEFITS

Explore the benefits and risks of treatment with a baclofen pump, and then talk with your doctor about what they may mean for you.

LESS MEDICATION NEEDED

At doses high enough to be effective for some patients, oral baclofen can cause side effects such as drowsiness, confusion, dizziness, weakness, or nausea. A baclofen pump delivers the Lioresal® Intrathecal (baclofen injection) directly to the fluid flowing around the spine. When medicine is placed right where it is needed, you need less, which may help minimize some of the possible side effects that may accompany oral baclofen.

TRY IT FIRST

A screening test provides you and your doctor with an opportunity to discover whether your body will respond to the treatment before you proceed with surgery.

Possible temporary side effects of the screening test include:

  • Loose muscles
  • Nausea/vomiting
  • Sleepiness
  • Headaches
  • Dizziness

PROGRAMMED FOR YOUR NEEDS

Your pump will be programmed to deliver the exact dose you need, and can even vary the amount of Lioresal Intrathecal at different times of day. Let’s say you need more medication at night to reduce spasticity so you can sleep better, and less in the morning when spasticity is making transfers easier. Your doctor could adjust the timing of your doses to meet your needs. Programming can also vary from day to day to match your scheduled activities. For example, you might need less or more medication on the day of a physical therapy appointment.

LONG-TERM SPASTICITY MANAGEMENT

Treatment with a baclofen pump won’t cure severe spasticity or the medical condition causing it, but it may help control your spasticity long term.1,2

CAN BE REVERSED

Therapy can be turned off by your doctor, or if desired, the pump can be surgically removed.

PROVEN HISTORY

Doctors have been prescribing ITB TherapySM since 1992, when it was approved by the FDA in the United States. The same Medtronic pump is also used to deliver pain medication for many patients worldwide. More than 400,0003 patients have been implanted with a Medtronic pump.


UNDERSTAND THE RISKS

It's important to learn not only about the benefits of ITB TherapySM, but also the risks.

IMPORTANT SAFETY INFORMATION ABOUT ITB THERAPY

When receiving ITB TherapySM with Lioresal Intrathecal (baclofen injection), make sure you follow your clinician's instructions closely. A sudden stop in therapy can result in serious baclofen withdrawal symptoms, such as high fever, changed mental status, muscle stiffness, and in rare cases, may result in the loss of function of many vital organs and death.

It's critical that your clinician be called right away if you experience any of these symptoms. Make sure you keep your scheduled refill visits so you don’t run out of medication (baclofen). You should also know the early symptoms of baclofen withdrawal. Some people are at more risk than others for baclofen withdrawal. Speak with your clinician about this.

Symptoms of an overdose include:

  • Drowsiness
  • Seizures
  • Lightheadedness
  • Difficulty breathing
  • Loss of consciousness or coma
  • Below-normal body temperature
  • Overly loose muscles

Symptoms of early withdrawal include:

  • Itching
  • Lightheadedness
  • Low blood pressure
  • Tingling sensation
  • Increase or return of spasticity

If not treated, early symptoms of withdrawal can progress to advanced symptoms of withdrawal. Symptoms of advanced withdrawal are high fever, changed mental status, and muscle stiffness. In rare cases withdrawal may result in loss function of many vital organs and death. Recognize early symptoms of withdrawal and take action. Rapid, accurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal.

An overdose (too much medication) or withdrawal (too little medication) of baclofen is serious and can be life threatening. Call your clinician right away if you experience symptoms.

Pump or catheter failure may lead to overdose, underdose, or withdrawal.

Side effects associated with ITB TherapySM are often temporary and can be managed by adjusting the dosage delivered by the pump.

The most common and/or serious drug-related side effects of ITB TherapySM include:

  • Loose muscles
  • Nausea/vomiting
  • Sleepiness
  • Headache
  • Upset stomach
  • Dizziness

Other complications are possible:

  • Catheter or pump could move inside the body
  • Skin over the pump could break down
  • Pump could stop because the battery has run out, or a problem has occurred with one or more of its inner parts
  • Catheter could leak, tear, kink, or become disconnected, resulting in an underdose, which may lead to withdrawal
  • Surgical complications are possible and include infection, spinal fluid leak, and headache

If you decide to receive ITB TherapySM, and you need a medical or dental diagnostic procedure (e.g., MRI, diathermy), you’ll need to inform the healthcare professional that you have ITB TherapySM.

Contact Your Physician
Please direct all medical, medication and therapy questions to your physician’s office. Your physician has access to your medical records and history and can best diagnose any change in symptoms. Ask you physician how to reach the on-call physician for any medical concerns that arise after hours or on the weekend. Please contact your physician as soon as possible if you have a medical emergency, are experiencing symptom change or hearing your pump alarm.

Medtronic Patient Services
Medtronic can offer technical assistance when you have questions about your pump. Medtronic is not able to comment on your medical condition. To reach Medtronic Patient Services, call toll-free 1-800-510-6735 Monday-Friday, 8:00 a.m. to 5:00 p.m. CST.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.accessdata.fda.gov/scripts/medwatch, or call 800-332-1088.

For more information, refer to the Lioresal® Intrathecal (baclofen injection) Patient Information, Lioresal® Intrathecal prescribing information, and the SynchroMed™ II Infusion System brief statement.


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

Coffey RJ, Cahill D, Steers W. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long-term study. J Neurosurg, 1993;78(6):226-232.

2

Vles GF, Soudant DL, Hoving MA, et al. Long-term follow-up on continuous intrathecal baclofen therapy in non-ambulant children with intractable cerebral palsy. Eur J Paediatr Neurol. 2013;17(6):639-644.

3

Medtronic Data on File.