Benefits and Risks

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 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 muscles loose

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 are 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.

If you have questions regarding your pump or any medical or diagnostic procedure, please call Medtronic Patient Services at 800-510-6735, Monday–Friday, 8:00 a.m. to 5:00 p.m. CT.

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 package insert, and the SynchroMed™ II Infusion System brief statement.

Important Safety Information

References
  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.

 

 

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

PATIENT IMPORTANT SAFETY INFORMATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (baclofen injection)

Q: What is Lioresal® Intrathecal (baclofen injection)?

A: Lioresal® Intrathecal (baclofen injection) is a muscle relaxant and antispastic medication that is used for treatment of severe spasticity caused by injury to or certain conditions of the brain or spinal cord.

Q: What is severe spasticity?

A: Severe spasticity is a condition that results from an injury to or disease of the brain or spinal cord. Spasticity may make your muscles feel tight, stiff and difficult to move. With severe spasticity, you can experience stiffening of the muscles that makes your muscles feel like they are locked, or even jerk uncontrollably when you try to use them.

Q: What is ITB Therapy?

A: Intrathecal Baclofen Therapy (ITB) is a treatment using Lioresal® Intrathecal (baclofen) that is delivered into the fluid around your spinal cord (intrathecal) to help manage severe spasticity. For long term treatment, the drug is placed into a pump that is surgically placed under the skin of your abdomen. The pump delivers Lioresal® Intrathecal through a small tube (catheter) into your spinal fluid. Your doctor can program the pump to deliver the appropriate daily dose for you. Before you can be considered for long term treatment, you must have a test dose to see how you respond to the drug when it is delivered in this way. After the test dose is done, your doctor will discuss the results with you and determine if you are an appropriate candidate for the therapy.

Q: Who is a candidate for ITB Therapy?

A: People who have severe spasticity resulting from conditions of the brain or spinal cord (such as multiple sclerosis, cerebral palsy, stroke, brain injury or spinal cord injury) may be candidates for ITB Therapy. If your spasticity is due to spinal cord injury or multiple sclerosis and is not controlled with baclofen taken by mouth or you have side effects that are not acceptable from oral baclofen taken to treat your spasticity, you may be a candidate. If you have had a brain injury due to trauma, you should wait for one year after your injury to be considered for ITB Therapy.

Q: Who is not a candidate for ITB Therapy or a screening test dose?

A: If you are hypersensitive to baclofen, you should not use Lioresal® Intrathecal. If you have an active infection, you should not have a screening test or implant until the infection has resolved. You should not receive ITB Therapy if you have a body size that is too small to hold the implantable pump.

Q: What are the most common side effects of Lioresal® Intrathecal?

A: The side effects of Lioresal® Intrathecal can include drowsiness, lightheadedness, dizziness, nausea and vomiting, low blood pressure, headache, seizures, and loose muscles. As with most medications, you can experience overdose (drug dose is too high) or withdrawal (drug dose is too low). Your doctor will discuss the possible effects of Lioresal® Intrathecal and what to do if you experience any of the symptoms or side effects. Sexual dysfunction in men and women including decreased libido and orgasm dysfunction have been reported.

Q: What do I need to know if I am using Lioresal® Intrathecal?

A: All patients and caregivers should receive information on the risks of the treatment. Your doctor should give you information of the signs and symptoms of receiving too much or too little medication (overdose or withdrawal) and what to do if you notice those symptoms.

Q: What are the signs of withdrawal from Lioresal® Intrathecal?

A: An increase in your spasticity, itching, low blood pressure, lightheadedness, and a tingling sensation are the most common signs with withdrawal from Lioresal® Intrathecal. In rare cases, severe withdrawal symptoms may occur including high fever, change in mental status, extreme spasticity that is worse than before starting Lioresal® Intrathecal and muscle rigidity. If you experience any of these signs, it is extremely important that you or your caregiver contact your doctor immediately. If the sudden withdrawal is not treated, in rare cases, more severe medical conditions can develop that can result in death.

Q: What can I do to prevent Lioresal® Intrathecal withdrawal or abrupt interruption of Lioresal® Intrathecal?

A: It is very important that you not miss refill appointments. If you plan to travel let your doctor know so that your refill can be scheduled so that you don’t run out of medication. If you are hospitalized for any reason near the time of your refill, you or your caregiver should let your doctor know before the refill date so that arrangements can be made to refill your pump. Not all hospitals have doctors that can refill pumps, so let your doctor know as soon as possible if it is near your refill date. You should be aware of what your pump alarms sound like. If you hear an alarm, contact your doctor immediately.

Q: What are the signs of Lioresal® Intrathecal overdose?

A: Signs of receiving too much medication (overdose) can appear suddenly or gradually over a few days. Signs may include muscles being too loose, drowsiness, lightheadedness, dizziness, sleepiness, slowed or shallow breathing, lower than normal body temperature, seizures, loss of consciousness, and coma. It is very important that you or your caregiver contact your doctor immediately if you experience any of these signs and that you be taken to a hospital for treatment.

Q: What are the potential pump and catheter implant procedure complications?

A: The implanted pump and catheter are placed under the skin of the abdomen during a surgery. Some complications that you may experience with the implant surgery include infection, meningitis (infection of the lining of the brain and central nervous system), spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

Q: What are the potential pump and catheter complications that can occur after implant?

A: Once the infusion system (the pump and the catheter) is implanted, device complications may occur that may require surgery to remove or replace the pump, catheter or catheter fragment. Some of these device complications may impact the flow of medication delivered, which may cause symptoms of overdose or withdrawal of Lioresal® Intrathecal.

Possible complications include an internal component failure which may result in a loss of therapy, or an inability to program the pump. The pump, catheter or catheter fragment could migrate within the body or erode through the skin. Tissue or an inflammatory mass may form at the tip of the catheter in the intrathecal space and may cause a loss of therapy or neurological impairment including paralysis. The catheter could leak, tear or become disconnected resulting in delivery of medication into the area under the skin where the pump is implanted and/or along the catheter path. The catheter could kink or become blocked resulting in no delivery of medication. The pump could stop because the battery has run out or because of a problem with one or more of its inner parts. Errors in locating the pump during the refill procedure can result in symptoms of overdose that may be serious or life-threatening.

Q: Can I undergo Magnetic Resonance Imaging (MRI) testing?

A: Under certain conditions, an MRI can be conducted with the pump. Always inform your doctor that you have an implanted infusion system before any medical or diagnostic procedure such as MRI or diathermy. Please ask your doctor to determine if the MRI scan can be used with the pump. The MRI will cause your pump to temporarily stop, which will suspend drug delivery during the MRI. The pump should resume normal operation and drug delivery after the MRI is complete. Your pump may also temporarily sound an alarm during the scan; the alarm should stop at the conclusion of the scan. Following your MRI, your doctor should check your pump to confirm that it is working properly.

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.

The risk information provided here is not comprehensive. To learn more, talk about ITB Therapy and Lioresal® Intrathecal with your doctor and refer to the FDA-approved product labeling.

Lioresal® is a registered trademark of Saol.

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For more information, please read the Lioresal® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.