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Unmet Needs in Severe Spasticity

  • Severe spasticity can take a physical, emotional, and social toll on patients and their caregivers1
  • The aim of treatment is to reduce the impact of severe spasticity, to prevent further complications, and improve quality of life1,2
    • This is accomplished by meeting the clinical goal of maintaining muscle tone as close to normal as possible while minimizing the frequency and severity of spasms to the extent possible without inducing intolerable side effects
  • Studies suggest that patients are inadequately treated for severe spasticity due to poor tolerance or undertreatment3
  • For patients with spasticity of spinal origin, if other medications provide inadequate control of severe spasticity, undesirable or intolerable CNS side effects, or fail to adequately meet quality of life goals, then consider ITB Therapy℠ with Lioresal® Intrathecal (baclofen injection)4. Labeling for Lioresal® Intrathecal requires failure of oral medication prior to initiating ITB Therapy in spasticity of spinal origin; there is no precise definition regarding the duration of oral medication trial required, and an expert consensus panel strongly recommended proceeding quickly to ITB therapy in appropriately selected patients1
  • Patients with spasticity due to traumatic brain injury should wait at least 1 year after injury before considering long-term ITB Therapy℠ with Lioresal® Intrathecal1,4
  • ITB Therapy℠ with Lioresal® Intrathecal does not have to be a “last resort” approach for the management of severe spasticity
  • ITB Therapy is contraindicated in patients who are hypersensitive to baclofen. Implantation of the infusion system is contraindicated if the patient is of insufficient body size, requires a pump implant deeper than 2.5 cm, or, in the presence of spinal anomalies or active infection.4
  • The safety and effectiveness in pediatric patients below the age of 4 have not been established. Lioresal® Intrathecal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lioresal® Intrathecal should be given with caution in patients with impaired renal function. Dose reduction may be necessary. Lioresal® Intrathecal should be used with caution in patients with a history of autonomic dysreflexia.4
  1. Saulino M, Ivanhoe CB, McGuire JR, et al. Best Practices for intrathecal baclofen therapy: patient selection. Neuromodulation. 2016;19(6):607-615.
  2. Nair KP, Marsden J. The management of spasticity in adults. BMJ. 2014;349:g4737.
  3. McGuire JR. Chapter 2: Epidemiology of spasticity in the adult and child. In: Brashear A, Elovic E, eds. Spasticity: Diagnosis and Management. 2nd ed. New York, NY: Demos Medical Publishing, LLC, 2016
  4. Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.

Important Safety Information for Lioresal® Intrathecal (baclofen injection)

Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.

Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional postimplant clinician and patient information (see WARNINGS).

Indications and Usage

Contraindications

Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information.