This story recounts the experience of one individual who has a baclofen pump. Medtronic invited her to share her story candidly. Please bear in mind that the experience is specific to this particular person. Not everyone who receives the treatment will receive the same results as the patient in this story. Talk with your doctor to determine if ITB TherapySM with Lioresal® Intrathecal (baclofen injection) is right for you.
LIFE AFTER STROKE
A very early riser by habit, Kay Wolfe of Atlanta was already dressed and at her home office desk around 5 a.m. one morning in 2005 when the left side of her face began to “feel very weird.”
Kay knew she was at an increased risk for a stroke as she has an arteriovenous malformation (AVM), which tangles blood vessels in the brain and directly diverts blood from the arteries to the veins. Due to her condition, Kay was aware of the warning signs of stroke. When her left arm felt very heavy, she called her husband — who was already at work about an hour away — to tell him what was happening. At that point, she could no longer lift her left arm or feel the left side of her face. Kay’s husband called 9-1-1 and told her to lay down on the floor. When Kay attempted to stand up, she crumpled to the ground.
Lying on the floor of her home office, Kay heard the sirens of the fire fighter EMTs who arrived and rushed into her home to find her. Kay could respond to their questions although her speech was slightly slurred because half of her tongue wasn’t moving.
Kay was transported to nearby Northside Hospital, spending several days in the ICU where it was unclear if she would survive the stroke. The neurosurgeon described the bleed as catastrophic, more than a cup of blood was involved and putting pressure on her brain. Despite this prognosis, her condition continued to improve, but the outlook was still grim — her doctor felt that she would be bed bound with significant brain damage.
But that wasn’t the case. Kay experienced spontaneous recovery and was transferred to The Shepherd Center in midtown Atlanta for inpatient therapy. During her time at Shepherd, severe post-stroke spasticity (PSS) began to set in. Her therapists used splints and other “contraptions” to combat the PSS to no avail. Kay’s left foot was pointed “ballerina style,” making it nearly impossible to walk, and her left arm was contorted in such a way that her doctors called it a “server’s arm” — it looked like she should be carrying a tray, but her hand was balled in a fist and her fingernails often cut into the palm of her hand. Kay said that nearly everything was impossible without the use of her left hand and arm — noting that she could not hold the base of her mascara when applying cosmetics.
GETTING THE PUMP
Through the course of her inpatient, outpatient and post-outpatient therapy, Kay and her doctor talked about the possibility of treatment for her PSS. Beginning with a temporary injection of BOTOX® that was effective for a short period, she continued with her recovery. When Dr. Kaelin told Kay about the baclofen pump and that it would be implanted in her midsection, she immediately said no for cosmetic reasons. ITB TherapySM with Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity uses the SynchroMed™ II implantable infusion system to deliver precise amounts of Lioresal® Intrathecal (baclofen injection) directly to the intrathecal space.
Ultimately, after further conversations with her doctor and her husband, the desire to walk again won out over the desire to wear a two-piece bathing suit. Kay responded very well to the trial injection and had her first pump implanted in 2007. In fact, her arm responded very well to ITB and she can now straighten her left arm and uncurl her fingers — which wasn’t possible before.
Another part of Kay’s stroke recovery was an operation to have her Achilles lengthened so that her foot is now flat enough to walk. She continues to exercise daily, to continue recovering and to stay active. “I’m going to do what I have to do, to keep doing my thing and keep moving,” she said.
Please bear in mind that the experiences are specific to each particular person. ITB Therapy is not for everyone — your results may vary. Talk with your doctor for more information.
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.
PATIENT IMPORTANT SAFETY INFORMATION FOR ITB THERAPYSM WITH LIORESAL® INTRATHECAL (baclofen injection)
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 is 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.
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 TherapySM?
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 TherapySM?
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 TherapySM. 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 TherapySM. Safety and efficacy in patients under the age of 4 has not been established.
Q: Who is not a candidate for ITB TherapySM 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 TherapySM 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 http://www.fda.gov/medwatch, or call 1-800-FDA-1088.
The risk information provided here is not comprehensive. To learn more, talk about ITB TherapySM and Lioresal® Intrathecal with your doctor and refer to the FDA-approved product labeling.
Lioresal® is a registered trademark of Saol.
Rx Only
Rev 0418
ST-111-3009-02