refill kit enhancements

Dosing and Administration of Lioresal® Intrathecal (baclofen injection)

  • Lioresal® Intrathecal provides targeted delivery for individual relief of severe spasticity
  • Dosing options are flexible and should be tailored to meet individual patient needs in order to maintain tone as near normal as appropriate
  • For long-term management of severe spasticity, the SynchroMed® II programmable pump system (Medtronic) is surgically implanted under the skin of the abdomen to deliver calculated doses of Lioresal® Intrathecal to meet individual patient needs, whether they be a “steady state” of baclofen delivered consistently throughout the day or doses timed to address spasticity when it most often occurs1
  • Medtronic’s SynchroMed® II infusion pump can be programmed to fine-tune dosing—something that is not feasible with oral baclofen1
  • Lioresal® Intrathecal is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only in implantable pumps approved by the FDA specifically for the administration of Lioresal® Intrathecal into the intrathecal space. Lioresal® Intrathecal is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.
  1. 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


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.