What is Gablofen (baclofen injection)?

Gablofen is a gamma-aminobutyric acid (GABA) ergic agonist indicated for use in the management of severe spasticity of cerebral or spinal origin in adult and pediatric patients age 4 years and above. It 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. Patients with spasticity due to traumatic brain injury should wait at least one year after injury before considering Gablofen therapy.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 age 4 years and above. It 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. 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?

A Gablofen screening dose is used to determine if a patient can demonstrate a positive clinical response to Gablofen prior to pump implantation.2

How is Gablofen administered to patients?

Gablofen is administered with the SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration.2 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. 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.2

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.

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).

Reimbursement coverage for Gablofen includes Commercial, Medicaid, and Medicare.

Check with your local Medicare contractor or other payers for specific coding and billing instructions.

Get details about reimbursement.

Download the reimbursement form


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