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Lioresal (baclofen)

BOXED WARNING

Abrupt discontinuation resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity that may advance to (rare) rhabdomyolysis, multiple organ-system failure, and death. Prevention of abrupt discontinuation requires careful attention to programming and monitoring of infusion system, refill scheduling and procedures, and pump alarms. Advise about importance of keeping scheduled refill visits and educate on early symptoms of baclofen withdrawal. Give special attention to patients at apparent risk (eg, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral/intrathecal therapy).

THERAPEUTIC CLASS

GABA analogue

DEA CLASS

RX

INDICATIONS

Management of severe spasticity of spinal cord origin (eg, multiple sclerosis [MS], spinal cord trauma) and of cerebral origin (eg, cerebral palsy, brain injury). May be considered an alternative to destructive neurosurgical procedures.

ADULT DOSAGE

Spasticity

Management of severe spasticity of spinal cord or cerebral origin; may be considered an alternative to destructive neurosurgical procedures

Screening Phase:
Prior to pump implantation and initiation of chronic infusion, patients must demonstrate a positive clinical response to a bolus dose in a screening trial

Initial: 1mL (50mcg) bolus administered into intrathecal space by barbotage over ≥1 min

Observe for 4-8 hrs; if initial response is inadequate, administer 2nd bolus dose of 1.5mL (75mcg) 24 hrs after the 1st

Observe for another 4-8 hrs; if response is still inadequate, administer a final bolus screening dose of 2mL (100mcg) 24 hrs after last dose

Patients who fail to respond to 100mcg bolus should not receive implanted pump for chronic infusion

Post-Implant Dose Titration Period:
To determine the initial total daily dose following implant, double the screening dose that gave a positive effect and administer over 24 hrs, unless the efficacy of the bolus dose was maintained for >8 hrs, in which case the starting daily dose should be the screening dose delivered over 24 hrs

No dose increases should be given in the first 24 hrs

Spasticity of Spinal Cord Origin:
After the first 24 hrs, slowly increase daily dose by 10-30% only once q24h, until desired effect is achieved

Spasticity of Cerebral Origin:
After the first 24 hrs, slowly increase daily dose by 5-15% only once q24h, until desired effect is achieved

Maint Therapy:
Spasticity of Spinal Cord Origin:
During periodic refills of the pump, the daily dose may be increased by 10-40%, but no more than 40%; the daily dose may be reduced by 10-20% if patients experience side effects

Range: 12-2003mcg/day; most patients are adequately maintained on 300-800mcg/day

Spasticity of Cerebral Origin:
During periodic refills of the pump, the daily dose may be increased by 5-20%, but no more than 20%; the daily dose may be reduced by 10-20% if patients experience side effects

Range: 22-1400mcg/day; most patients are adequately maintained on 90-703mcg/day

PEDIATRIC DOSAGE

Spasticity

Management of severe spasticity of spinal cord or cerebral origin; may be considered an alternative to destructive neurosurgical procedures

≥4 Years:
Screening Phase:
Prior to pump implantation and initiation of chronic infusion, patients must demonstrate a positive clinical response to a bolus dose in a screening trial

Initial: 1mL (50mcg) bolus administered into intrathecal space by barbotage over ≥1 min; for very small patients, 25mcg may be tried 1st

Observe for 4-8 hrs; if initial response is inadequate, administer 2nd bolus dose of 1.5mL (75mcg) 24 hrs after the 1st

Observe for another 4-8 hrs; if response is still inadequate, administer a final bolus screening dose of 2mL (100mcg) 24 hrs after last dose

Patients who fail to respond to 100mcg bolus should not receive implanted pump for chronic infusion

Post-Implant Dose Titration Period:
To determine the initial total daily dose following implant, double the screening dose that gave a positive effect and administer over 24 hrs, unless the efficacy of the bolus dose was maintained for >8 hrs, in which case the starting daily dose should be the screening dose delivered over 24 hrs

No dose increases should be given in the first 24 hrs

After the first 24 hrs, slowly increase daily dose by 5-15% only once q24h, until desired effect is achieved

Maint Therapy:
During periodic refills of the pump, the daily dose may be increased by 5-20%, but no more than 20%; the daily dose may be reduced by 10-20% if patients experience side effects

Range: 22-1400mcg/day; most patients are adequately maintained on 90-703mcg/day

<12 Years:
Usual: 274mcg/day
Range: 24-1199mcg/day

DOSING CONSIDERATIONS

Renal Impairment
May need to reduce dose

Other Important Considerations
Dose Adjustments in Chronic Use:
Tolerance has been treated by a "drug holiday" consisting of the gradual reduction of baclofen inj over 2-4 weeks and switching to alternative methods of spasticity management; after the "drug holiday," baclofen inj may be restarted at the initial continuous infusion dose

ADMINISTRATION

Intrathecal route

Delivery Specifications
The specific concentration that should be used depends on the total daily dose required as well as the delivery rate of the pump; baclofen inj may require dilution when used w/ certain implantable pumps
Refer to the manufacturer's manual for specific recommendations

Preparation Instructions
Screening:
Use 1mL screening ampule only (50mcg/mL) for bolus inj into subarachnoid space
For a 50mcg Bolus Dose: Use 1mL of screening ampule
For a 75mcg Bolus Dose: Use 1.5mL of screening ampule
For Max Screening Dose of 100mcg: Use 2mL of screening ampule (2 ampules)

Maintenance:
For patients who require concentrations other than 500mcg/mL or 2000mcg/mL, baclofen inj must be diluted; dilute w/ sterile, preservative-free NaCl for inj

Delivery Regimen
Baclofen inj is most often administered in a continuous infusion mode immediately following implant
For patients implanted w/ programmable pumps who have achieved relatively satisfactory control on continuous infusion, further benefit may be attained using more complex schedules of baclofen inj delivery (eg, patients who have increased spasms at night may require a 20% increase in hourly infusion rate)
Changes in flow rate should be programmed to start 2 hrs before time of desired clinical effect

HOW SUPPLIED

Inj: 50mcg/mL [1mL], 500mcg/mL [20mL], 2000mcg/mL [5mL, 20mL]

CONTRAINDICATIONS

IV, IM, SQ, or epidural administration.

WARNINGS/PRECAUTIONS

Potentially life threatening CNS depression, cardiovascular (CV) collapse, and/or respiratory failure may occur; physicians must be adequately trained and educated in chronic intrathecal infusion therapy. Do not implant pump until response to bolus inj is evaluated. Resuscitative equipment should be available. Monitor closely during initial phases of pump use and when dosing rate or concentration is adjusted until response is acceptable. Monitor for signs of overdose (eg, drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia, loss of consciousness, coma). Use extreme caution when filling implantable pump; direct inj into catheter access port or inadvertent inj into SQ tissue may cause life-threatening overdose. Potential risk for withdrawal syndrome; avoid abrupt discontinuation. Seizures reported. Children should be of sufficient body mass to accommodate implantable pump for chronic infusion. Patients should be infection-free prior to screening trial and pump implantation. A sudden need for substantial dose escalation may indicate catheter complication. Titrate dose to maintain some degree of muscle tone and allow occasional spasms to help support circulatory function, prevent deep vein thrombosis formation, and optimize daily living activities. May impair mental/physical abilities. Cases of intrathecal mass at the tip of the implanted catheter reported. Monitor for patients on intraspinal therapy for any new neurological signs or symptoms. Caution with dose titration when spasticity is needed to sustain upright posture and balance in locomotion. Caution with psychotic disorders, schizophrenia, or confusional states; exacerbation of these conditions may occur. Caution with renal impairment and history of autonomic dysreflexia. Ovarian cysts reported with oral therapy.

ADVERSE REACTIONS

Somnolence, dizziness, N/V, headache, convulsions, hypotonia, hypotension, pain, speech disorder, dry mouth, agitation, constipation, leukocytosis, chills, urinary retention.

DRUG INTERACTIONS

D/C oral antispasticity medication to avoid possible overdose or adverse drug interactions; avoid abrupt reduction or discontinuation of concomitant antispastics. Additive CNS depressant effect with alcohol and other CNS depressants. Hypotension and dyspnea reported with epidural morphine.

PREGNANCY AND LACTATION

Category C, caution in nursing.

MECHANISM OF ACTION

Gamma-aminobutyric acid (GABA) analogue; not fully established. Inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals. May exert effects by stimulating GABAB receptor subtype.

PHARMACOKINETICS

Distribution: (PO) Found in breast milk. Elimination: T1/2(CSF)=1.51 hrs over the first 4 hrs.

ASSESSMENT

Assess for drug hypersensitivity, spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral/intrathecal therapy, history of traumatic brain injury, body mass of children, presence of infection, psychotic disorders, schizophrenia, confusional states, history of autonomic dysreflexia, renal impairment, pregnancy/nursing status, and possible drug interactions.

MONITORING

Monitor response to therapy, for signs of overdose, withdrawal symptoms, drowsiness, exacerbations of psychotic disorders, schizophrenia, or confusional states, CNS depression, CV collapse, respiratory failure, intrathecal mass formation, new neurological signs/symptoms, catheter complications, and other adverse reactions.

PATIENT COUNSELING

Inform patients and caregivers on the risks of mode of treatment. Educate patients and caregivers of the signs/symptoms of overdose and withdrawal, procedures to follow in the event of overdose or withdrawal, and on proper home care of pump and insertion site. Advise on the importance of keeping scheduled refill visits. Caution patients on additive CNS depressant effects with alcohol and other CNS depressants. Inform that therapy may impair physical/mental abilities; caution when operating automobiles or other dangerous machinery.

STORAGE

≤30°C (≤86°F). Refrigeration not required. Do not freeze. Do not heat sterilize.

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