Frequently Asked Questions
Get answers to your most frequently asked questions about Gablofen® (baclofen injection)
What is Gablofen® (baclofen injection)?
Gablofen® is a muscle relaxant and antipastic gamma-aminobutyric acid (GABA) ergic agonist. Gablofen’s precise mechanism of action is not fully understood. Gablofen® inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA), and may exert its effect by stimulation of the GABAB receptor subtype.
When Gablofen® is introduced directly into the intrathecal space, it permits effective CSF concentrations to be achieved with resultant plasma concentrations 100 times less than those occurring with oral administration.2
Who is Gablofen® appropriate for?
Gablofen® is indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients aged 4 years and above. It must 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. Patients with spasticity due to traumatic brain injury should wait at least one year after injury before considering Gablofen® therapy.2
If my patient fails oral baclofen, what may be the next step?
Gablofen® should be reserved for patients unresponsive to oral baclofen therapy or those who experience intolerable central nervous system side effects at effective doses. After a patient fails oral baclofen, it may be time to consider intrathecal baclofen therapy. This is an important decision. Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long-term infusion via an implantable pump. A Gablofen® screening dose is available in a prefilled syringe.2
What if I am unsure a patient will respond positively to Gablofen®?
Patients should first respond to a screening dose of intrathecal baclofen prior to consideration for long term infusion via an implantable pump. The Gablofen® screening dose is used to determine if a patient will demonstrate a positive clinical response to Gablofen®.2
How is Gablofen® administered to patients?
Gablofen® is intended for use by the intrathecal route in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, only with the Medtronic SynchroMed II Programmable Pump or other pumps labeled for intrathecal administration of Gablofen®. Gablofen® is available in prefilled syringes and factory-sealed vials.2
SynchroMed is a registered trademark of Medtronic, Inc.
For which intrathecal pumps is Gablofen® approved?
Gablofen® is FDA-approved for use in pumps labeled for intrathecal administration of Gablofen®, including the Medtronic SynchroMed® II Programmable Pump.2 Clinicians should refer to the pump manufacturer’s manual and follow the specific instructions and precautions for programming the pump and/or refilling the reservoir.
SynchroMed is a registered trademark of Medtronic, Inc.
What concentrations are available?
Gablofen® is available in a screening dose of 50 mcg/mL. There are also 3 refill concentrations: 500 mcg/mL, 1,000 mcg/mL, and 2,000 mcg/mL concentrations in both prefilled syringes and factory-sealed vials.2
All packaging options are manufactured under Current Good Manufacturing Practices (CGMP). You can use the Concentration Calculator to determine the days between pump refills at certain concentrations of Gablofen®. Please note the Concentration Calculator is only an aid and does not replace medical expertise.
Are Gablofen® and Lioresal® therapeutically equivalent?
Yes, Gablofen® is listed in the FDA Orange Book as an AP-rated intrathecal baclofen at the 50 mcg/mL, 500 mcg/mL, and 2,000 mcg/mL concentrations. Gablofen® can be substituted for Lioresal at those particular concentrations.1
Gablofen® is also available in the exclusive FDA-approved 1,000 mcg/mL concentration. Lioresal is not available in a 1,000 mcg/mL concentration.1 Lioresal is a registered trademark of Medtronic, Inc.
What is the shelf life of Gablofen®?
Gablofen® prefilled syringes and factory-sealed vials have a shelf life of 3 years. Gablofen does not require refrigeration. Do not freeze.2
How is reimbursement handled for Gablofen®?
The following pre-existing intrathecal baclofen codes are available:
- J0475, Injection, baclofen, 10 mg.
- J0476, Injection, baclofen, 50 mcg for intrathecal trial (screening).8
Reimbursement coverage for Gablofen® includes Commercial, Medicaid and Medicare.
Check with your local Medicare contractor or other payers for specific coding and billing instructions.