CONSIDERATIONS BY CONDITION Intrathecal Baclofen Therapy with Lioresal® Intrathecal (baclofen injection)

PATIENT SELECTION BASED ON THE PATIENT’S UNDERLYING CONDITION

All candidates for ITB Therapy with Lioresal® Intrathecal (baclofen injection) must meet the patient selection criteria. In addition, clinicians should consider additional selection criteria related to the patient's underlying condition.

BRAIN INJURY

Spasticity is one of the most disabling aspects of brain injury.1 Spasticity occurs in about 25% of those living with traumatic brain injury;2 the incidence is up to 40% for those with mid-brain injuries.2

CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):

  • Caregiver support system assessment is important in this population; particular attention should be paid to transportation for refills and family comprehension of overdose and withdrawal symptoms.
  • Intrathecal baclofen therapy may assist in the ability of patients to participate in rehabilitation therapy.
  • Those with severe spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long-term intrathecal baclofen therapy.

CEREBRAL PALSY

It is estimated that 70-80% of persons living with CP have spasticity,3 and at least 60% of those with spasticity have functional limitations.4 For children with severe movement disorders, oral medications or injection therapy are often inadequate, especially in children older than five or six.5

CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):

  • Caregiver support system assessment is important in this population; particular attention should be paid to transportation for refills and family comprehension of overdose and withdrawal symptoms.
  • Ensure pediatric patients have adequate body mass to accommodate the pump.
  • Consider use of severe spasticity management therapies such as ITB Therapy before, or in conjunction with, orthopedic surgeries; note that the need for (or extent of) orthopedic surgery may be reduced or eliminated if ITB Therapy is used first, according to one study examining lower extremity spasticity.6
  • Safety and efficacy of ITB Therapy has not been established in children under 4.

MULTIPLE SCLEROSIS

Seventeen percent of people with MS have spasticity that frequently affects their activities of daily living.7

CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):

  • Dose titration can optimize the necessary level of tone for independent and ambulatory patients.
  • Disease progression may affect dose requirements, which can be addressed by adjusting the programming of the drug pump.
  • Caregiver support system assessment is important in this population. Due to potential cognitive deficits, it's important that caregivers are able and willing to attend refill visits and understand symptoms of overdose and withdrawal.
  • Given the unpredictable, progressive nature of the disease, it may be important to regularly reassess goals.
  • Fatigue is not a contraindication to rehabilitation following intrathecal baclofen therapy, but should be dosed accordingly.

SPINAL CORD INJURY

Sixty-two percent of people with spinal cord injury (SCI) from cervical or thoracic injury reported having spasticity. Twelve percent reported having spasticity so severe that it interfered with activities of daily living.8

CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):

  • Caregiver support system assessment is important in this population; particular attention should be paid to transportation for refills and family comprehension of overdose and withdrawal symptoms.
  • Dose titration can optimize tone needed for transfers.
  • Patients with a high-level injury or history of autonomic dysreflexia may pose a greater risk for complications.

STROKE

According to clinical evidence 38% of people experience spasticity within 1 year following a stroke.9

CLINICIANS SHOULD CONSIDER THE FOLLOWING BEFORE MAKING A RECOMMENDATION FOR ITB THERAPY WITH LIORESAL® INTRATHECAL (BACLOFEN INJECTION):

  • Dose titration of independent and ambulatory patients can allow for retention of needed tone.
  • A balance between overall tone and localized spasticity can be addressed through a complementary intervention, such as injection therapy.
  • In a clinical trial of patients with stroke-related spasticity, Meythaler et al. noted no complications related to short-term discontinuation of anticoagulant therapy in the two patients on anticoagulant therapy.10
    • Lumbar punctures for the screening test were performed using a 25-gauge spinal needle (versus the usual 22-gauge) in these patients. Prothrombin times were monitored in these patients, who had their warfarin held for at least three days.10
  • A conversation about the risks and benefits of discontinuing anticoagulation medication should be conducted during the screening test and surgical procedure. Include patients and their caregivers in the conversation*.
  • Caregiver support system assessment is important in this population; particular attention should be paid to transportation for refills and family comprehension of overdose and withdrawal symptoms.

For additional information please refer to SynchroMed™ II Brief Statement and Lioresal® prescribing information.

*

No Medtronic-approved protocol exists for the discontinuation of anticoagulation medication during the screening test and surgical procedure. The decision to proceed should be based on an individual analysis of risks and benefits.

1

Meythaler J, et al. Long-term continuously infused intrathecal baclofen for spastic dystonic hypertonia in traumatic brain injury: 1-year experience. Arch Phys Med Rehabil 1999; 80(1):13-19.

2

Wedekind C, Lippert-Gruner M. Long-term outcome in severe traumatic brain injury is significantly influenced by brainstem involvement. Brain Inj 2005;19:681-4.

3

Centers for Disease Control and Prevention, www.cdc.gov, web site accessed 3/19/2008.

4

Kennes J, Rosenbaum P, Hanna SE, et al. Health status of school-aged children with cerebral palsy: information from a population-based sample. Dev Med Child Neurol 2002; 44: 240–47.

5

Albright AL. Neurosurgical treatment of spasticity and other pediatric movement disorders. J Child Neurol. 2003;18(supplement 1):S67-S78.

6

Gerszten PC, Albright AL, Johnstone GF. Intrathecal baclofen infusion and subsequent orthopedic surgery in patients with spastic cerebral palsy. J Neurosurg. 1998;88(6):1009-1013.

7

Rizzo MA, Hadjimichael OC, Preiningerova J, Vollmer TL. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler. 2004;10(5):589-595.

8

Anson CA, Shepherd C. Incidence of secondary complications in spinal cord injury. Int J Rehabil Res. 1996;19(1):55-66.

9

Watkins CL, Leathley MJ, Gregson JM, Moore AP, Smith TL, Sharma AK. Prevalence of spasticity post stroke. Clin Rehabil. 2002:16(5):515-522.

10

Meythaler JM, Guin-Refroe S, Brunner, RC, Hadley MN. Intrathecal baclofen for spastic hypertonia from stroke. Stroke. 2001;32(9):2099-2109.


Lioresal® Intrathecal
(baclofen injection)

Important Safety Information

Indications and Usage

  • Lioresal® Intrathecal (baclofen injection) is a muscle relaxant and antispastic that is indicated for use in the management of severe spasticity of cerebral or spinal origin.
  • 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.
  • For patients with spasticity of spinal origin, 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 with spasticity due to traumatic brain injury should wait at least one year after the injury before consideration of long term intrathecal baclofen therapy.
  • Prior to implantation of a device for chronic intrathecal infusion of Lioresal® Intrathecal, patients must show a response to Lioresal® Intrathecal in a screening trial. Please review the dosing and administration section of the Lioresal® Intrathecal prescribing information for further details.
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).

Contraindications

  • Hypersensitivity to baclofen
  • Lioresal® Intrathecal is not recommended for intravenous, intramuscular, subcutaneous or epidural administration.

Select Warnings and Precautions

  • It is mandatory that all patients, caregivers, and treating physicians receive adequate information regarding the risks of the mode of treatment. Instruction 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). should be given on signs and symptoms of overdose, procedures to be followed in the event of an overdose, and proper home care of the pump and insertion site.
  • Due to the possibility of life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy.
  • Patients should be infection-free prior to both a screening trial and a pump implantation. The presence of infection may interfere with an assessment of the patient’s response to bolus Lioresal® Intrathecal (baclofen injection), increase the risk of surgical complications and complicate dosing.
  • Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Extreme caution must be used when filling an FDA approved implantable pump, following strict aseptic technique and ensuring refill directly into the reservoir and not the catheter access port.
  • An attempt should be made to discontinue concomitant oral antispasticity medication to avoid possible overdose or adverse drug interactions, either prior to screening or following implant and initiation of chronic Lioresal® Intrathecal infusion.
  • Following pump implantation, and for each adjustment of the dosing rate of the pump and/or concentration of Lioresal® Intrathecal, the patient should be monitored closely until it is certain the patient’s response to the infusion is acceptable and reasonably stable.
  • Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension and paresthesias.
  • Priapism may develop or recur if treatment with intrathecal baclofen is interrupted.
  • Signs of overdose may appear suddenly or insidiously, and a massive overdose may present as coma. Less sudden and/or less severe forms of overdose may present
  • with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.
  • Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of pump reservoir.
  • Delivery of more drug volume than the programmed rate (overinfusion) can result in unexpected overdose, or withdrawal caused by early emptying of the pump reservoir. Refer to the manufacturer's pump manual and instructions for refilling the reservoir.
  • Except in overdose related emergencies, the dose of Lioresal® Intrathecal should ordinarily be reduced slowly if the drug is discontinued for any reason.

Adverse Reactions

Common Adverse Reactions

  • The most frequent drug adverse events vary by indication but include: hypotonia (34.7%), somnolence (20.9%), headache (10.7%), convulsion (10.0%), dizziness (8.0%), urinary retention (8.0%), nausea (7.3%), and paresthesia (6.7%). Dosing and programming errors may result in clinically significant overdose or withdrawal. Acute massive overdose may result in coma and may be life threatening.
  • Drowsiness has been reported in patients on Lioresal® Intrathecal. Patients should be cautioned regarding the operation of automobiles or other dangerous machinery and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system depressant effects of Lioresal® Intrathecal may be additive to those of alcohol and other CNS depressants.

Serious Adverse Reactions

  • Seizures have been reported during overdose and with withdrawal from Lioresal® Intrathecal (baclofen injection) as well as in patients maintained on therapeutic doses of Lioresal® Intrathecal.
  • Fatalities have been reported with Lioresal® Intrathecal use.

Postmarketing Experience

  • The following adverse events have been reported during post-approval use of Lioresal® Intrathecal.
    • Musculoskeletal – The onset of scoliosis or worsening of a pre-existing scoliosis has been reported.
    • Urogenital – Sexual dysfunction in men and women including decreased libido and orgasm dysfunction have been reported.

Use in Specific Populations

  • There are no adequate and well controlled studies in pregnant women. Lioresal® Intrathecal should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • Nursing mothers should exercise caution, as oral baclofen has been shown to pass into milk at therapeutic doses.
  • Safety and effectiveness in pediatric patients below the age of 4 have not been established.
  • Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Lioresal® Intrathecal and kept under careful surveillance.
  • 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.

For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at www.lioresal.com/prescribinginformation

Rev. 06/2019