Gablofen

What is Gablofen?

• Gablofen (baclofen injection) is a gamma-aminobutyric acid (GABA) ergic agonist used in the management of severe spasticity.

Baclofen skeletal

Baclofen ball-and-stick model

What are the uses of this medicine?

• GABLOFEN is indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above.
• GABLOFEN should be reserved for patients unresponsive to oral baclofen therapy, or those who experience intolerable central nervous system side effects at effective doses.
• Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump.
• Spasticity due to traumatic brain injury: wait at least one year after injury before considering GABLOFEN therapy.

How does this medicine work?

• Baclofen (bak' loe fen) is a gamma-amino butyric acid (GABA) derivative that acts as an agonist of the GABA B receptor, thereby activating potassium channels and reducing calcium conductance leading to hypotonia and muscle relaxation.
• Baclofen acts primarily at the level of the spinal cord, inhibiting synaptic reflexes.
• Baclofen reduces the number and severity of muscle spasms and relieves pain, clonus and muscle rigidity due to spasticity.
• Baclofen is indicated primarily for treatment of spasticity from spinal cord injuries and multiple sclerosis.
• It has been used off label as adjunctive therapy to help with alcohol abstinence and withdrawal.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• with a hypersensitivity to baclofen

What drug interactions can this medicine cause?

• Combined use of GABLOFEN with morphine may cause hypotension and dyspnea.

Is this medicine FDA approved?

• Initial U.S. Approval: 1992

How should this medicine be used?

Recommended dosage:

• Maintenance Therapy: Titrate patients individually; Lowest dose with an optimal response should be used, generally 300 mcg/day to 800 mcg/day for spasticity of spinal cord origin and 90 mcg/day to 700 mcg/day for spasticity of cerebral origin; Titrate GABLOFEN to maintain some degree of muscle tone and allow occasional spasms.
• Screening: Patients who do not respond to a 100 mcg intrathecal bolus should not be considered for an implanted pump for chronic infusion.
• Dose Titration: Spasticity may be necessary to sustain upright posture and balance in locomotion or may be useful to obtain optimal function and care.

Administration:

• GABLOFEN is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 50 mcg/mL, 500 mcg/mL, 1,000 mcg/mL, 2,000 mcg/mL

This medicine is available in fallowing brand namesː

• GABLOFEN

What side effects can this medication cause?

The most common adverse reactions in patients with spasticity of spinal origin:

• somnolence
• dizziness
• nausea
• hypotension
• headache
• convulsions
• hypotonia

The most common adverse reactions in patients with spasticity of cerebral origin:

• agitation
• constipation
• somnolence
• leukocytosis
• chills
• urinary retention
• hypotonia

What special precautions should I follow?

• Do not directly inject GABLOFEN into the pump catheter access port, as this may cause a life-threatening overdose.
• Potential for contamination due to non-sterile external surface of prefilled syringe. Procedures should also be put in place while refilling implantable intrathecal pumps in an outpatient setting to avoid contamination of sterile surfaces through contact with the non-sterile exterior of the GABLOFEN prefilled syringe.
• Potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure; Resuscitative equipment and trained staff must be available during screening, dose titration, and refills.
• Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma. Extreme caution must be used when filling the implantable pump.
• Possible exacerbation of psychotic disorders, schizophrenia or confusional states. GABLOFEN and kept under careful surveillance, because exacerbations of these conditions have been observed with oral administration.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.

Management of overdosage:

• There is no specific antidote for treating overdoses of GABLOFEN; however, the following steps should ordinarily be undertaken:
• Residual intrathecal baclofen solution should be removed from the pump as soon as possible.
• Patients with respiratory depression should be intubated if necessary, until the drug is eliminated.

• Anecdotal reports suggest that intravenous physostigmine may reverse central side effects, notably drowsiness and respiratory depression.
• Physostigmine may not be effective in reversing large overdoses and patients may need to be maintained with respiratory support.
• If lumbar puncture is not contraindicated, consideration should be given to withdrawing 30 to 40 mL of CSF to reduce CSF baclofen concentration.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of GABLOFEN in pregnant women.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 4 have not been established.
• Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion.

What are the active and inactive ingredients in this medicine?

Active Ingredient:

• BACLOFEN

Inactive Ingredients:

• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Distributed By:

• Piramal Critical Care, Inc.
• Schelden Circle
• Bethlehem, PA , USA

What should I know about storage and disposal of this medication?

• GABLOFEN does not contain any antioxidants, preservatives or other potentially neurotoxic additives.
• Each single-dose vial or syringe is intended for single use only.
• Discard any unused portion.
• Does not require refrigeration.
• Do not store above 86°F (30°C).
• Do not freeze.
• Do not heat sterilize.

• Dailymed label info on Gablofen
• FDA Gablofen

Gablofen Resources
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