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Treatment Options

The aim of treatment is to reduce the impact of severe spasticity, to prevent further complications, and improve function and tone. This involves a coordinated effort between surgeons, doctors, nurses, physical/occupational therapists, neurologists, physical medicine and rehabilitation specialists (also known as physiatrists), and you and your caregivers. Your spasticity care team should tailor treatment according to your care needs and goals.1,2

Treatments for severe spasticity can include:3

  • Physical exercise and stretching
  • Bracing
  • Oral medications
  • Injectable medications
  • Intrathecal baclofen therapy (ITB)

Each of these methods of treating spasticity can be effectively utilized when used in the right circumstance, for the right patient — and sometimes in combination with each other. Oral medications, such as baclofen and tizanadine, are often used early in treatment, but many people may experience adverse side effects such as sedation. Injections with botulinum toxin (commonly referred to by the brand names Dysport®, Xeomin® and Botox®) can be helpful in treating localized spasticity. ITB TherapySM with Lioresal® Intrathecal (baclofen injection) is a treatment option to manage severe spasticity for certain patients, or when other options have failed or caused intolerable side effects.2

Other possible therapies include bracing and physical therapy—these may be used in combination with medication to provide optimal outcomes for patients with severe spasticity.2

If ITB TherapySM with Lioresal® Intrathecal is an option for you, a screening test is required to see if you respond to the medication. Not everyone responds to ITB TherapySM in the same way. Talk with your doctor to understand the benefits and risks of ITB TherapySM and whether it may be an option for you.

If you have tried other medications in the past, but not found them helpful, or couldn't tolerate their side effects, other additional treatment options may be available to help manage your spasticity. Seek treatment and ask your doctor if you may benefit from ITB TherapySM with Lioresal® Intrathecal.

Physician - "Depending on the severity of a patient’s spasticity, it can be managed in many different ways. For some, oral medications and therapy allow them to lead a life they are happy with. There are certainly many who need additional therapies, or who can't tolerate side effects of oral medications. Some of the best outcomes I have seen is when using multiple therapies to appropriately address the spasticity."

  1. Nair KP, Marsden J. The management of spasticity in adults. BMJ. 2014;349:g4737.
  2. Saulino M, Ivanhoe CB, McGuire JR, et al. Best Practices for intrathecal baclofen therapy: patient selection. Neuromodulation. 2016;19(6):607-615.
  3. Spasticity. American Stroke Association (ASA) website. https://www.strokeassociation.org/STROKEORG/LifeAfterStroke/RegainingIndependence/PhysicalChallenges/Spasticity_UCM_309770_Article.jsp#.WEcdiXeZMp8. Updated November 22, 2016. Accessed December 7, 2016.

Important Safety Information

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.

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 sudden 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 https://www.fda.gov/medwatch, or call 1-800-FDA-1088.

To report adverse reactions or quality issues, contact Amneal at:

Phone: 1(877) 835-5472
Email:  Drugsafety@amneal.com
Mail: Amneal Pharmaceuticals, 50 Horseblock Road, Brookhaven, New York 11719

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 Amneal Pharmaceuticals.

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