Who should be treated with ITB Therapy with Lioresal® Intrathecal (baclofen injection)?

ITB Therapy with Lioresal® Intrathecal has a well-established safety and efficacy profile for the treatment of severe spasticity. It is indicated for use in the management of severe spasticity of spinal or cerebral origin. For spasticity of spinal cord origin, chronic infusion of Lioresal® Intrathecal via an implantable pump should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable CNS side effects at effective doses. Patients should first respond to a screen dose of intrathecal baclofen prior to consideration for long-term infusion via an implantable pump. Patients with traumatic brain injury should wait at least 1 year after injury before considering Lioresal® Intrathecal.1

There are many factors that affect which patients are right for ITB therapy. Most importantly, patients should be considered if their spasticity is interfering with comfort, function, and/or caregiving, meaning it is considered severe spasticity. Other considerations include the degree of body involvement, progressive or static nature of disease, comorbidities, mobility, cause of spasticity, and the

patient’s psychological stability, ability to comply with therapy, and distance from the management team for pump use and maintenance. In addition, financial considerations and insurance coverage should be considered.2

Lioresal® Intrathecal 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. Lioresal® Intrathecal is not recommended for intravenous, intramuscular, subcutaneous or epidural administration. Lioresal® Intrathecal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness in pediatric patients below the age of 4 have not been established. 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.1

Patients should be assessed to determine their severity of spasticity and to see if their therapy is providing the relief they need.

ITB Therapy with Lioresal® Intrathecal may be right for patients with severe spasticity caused by3:

  • Brain injury
  • Cerebral palsy
  • Multiple sclerosis (MS)
  • Spinal cord injury (SCI)
  • Stroke

It may be appropriate for both patients who are ambulatory and those who are not. It can be used in both children and adults, though it has not been studied in children under the age of 4. Importantly, this cost-effective option can be tailored to the specific needs of patients with ineffective or inadequate treatment or patients who have experienced intolerable CNS effects with oral agents.

30% to 50% of your patients with spasticity due to cerebral palsy, multiple sclerosis, spinal cord injury, or stroke may be suffering from severe spasticity. In addition, it is estimated that more than 100,000 patients with traumatic brain injury (TBI) suffer from severe spasticity.4

If your current treatment protocol is not providing adequate management of severe spasticity, or your patient is experiencing intolerable side effects, consider Lioresal® Intrathecal today.

  1. Lioresal® Intrathecal (baclofen injection) for intrathecal injection [prescribing information]. Saol Therapeutics, Roswell, Georgia; January 2019.
  2. Saulino M, Ivanhoe CB, McGuire JR, et al. Best practices for intrathecal baclofen therapy: patient selection. Neuromodulation. 2016;19(6):607-615.
  3. Nair KP, Marsden J. The management of spasticity in adults. BMJ. 2014;349:g4737.
  4. 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

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


Select Warnings and Precautions

Adverse Reactions

Common Adverse Reactions

Serious Adverse Reactions

Postmarketing Experience

Use in Specific Populations

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