For the first time since the introduction of intrathecal baclofen therapy in 1992, Gablofen® (baclofen injection) offers a new choice for treating patients with severe spasticity.
Ingenuity. Pure and simple.™
Gablofen is an FDA-approved, AP-rated generic intrathecal baclofen. The Gablofen product line is the result of feedback from physicians, pharmacists, nurses and clinicians who helped guide us in developing practical and important product improvements.
We listened – starting with replacing ampules with ready-to-use vials and pre-filled syringes. We offer hospitals and clinics the ordering flexibility they need through either wholesaler or direct channels. We responded to requests for GPO partnerships with agreements with Novation and Premier.
Whether it's the safety and convenience of vials and the efficiency of fully outfitted refill convenient kits, or easy ordering and competitive pricing, leading ITB centers are now choosing Gablofen as their intrathecal baclofen of choice.
Gablofen saves time for clinicians, caregivers and patients.
The days of having to break open glass ampules are long gone. Gablofen® (baclofen injection) was designed to ensure a safe and efficient pump refilling process. Clinicians can reduce drug preparation time for screening doses and pump refills with ready to use vials and pre-filled syringes. Convenient refill kits* provide everything needed for pump refills.
Ordering is easy through CNS Therapeutics or major drug wholesalers – and discover savings with Gablofen pricing and compliance under your GPO membership.
Stable and compatible with the Medtronic SynchroMed® II Programmable Pump.
Gablofen concentrations met FDA requirements for safety, quality and stability and have been tested and approved for use in the Medtronic SynchroMed® II Programmable Pump. CNS Therapeutics studied pump performance with Gablofen® (baclofen injection) and showed that the Medtronic SynchroMed® II Programmable Pump performed well within the manufacturer's specifications. Stability tests showed Gablofen is stable in the SynchroMed II pump for up to 180 days (6 months). Gablofen is approved for use with the Medtronic Synchromed® II Programmable pump or other pumps labeled for intrathecal administration of Gablofen® (baclofen injection).
Refer to the pump manufacturer's manual and follow the specific instructions and precautions for programming the pump and/or refilling the reservoir.
Efficacy, safety and stability.
Gablofen® (baclofen injection) was approved by the FDA based on published clinical data on the safety and efficacy of intrathecal baclofen. In more than 20 years of clinical studies, intrathecal baclofen has been shown to effectively reduce severe spasticity of spinal cord and cerebral origin. Results vary; not every individual will receive the same benefits.
The most common adverse reaction in patients with spasticity of spinal origin were somnolence, dizziness, nausea, hypotension, headache, convulsions, and hypotonia.
The most common adverse reactions in patients with spasticity of cerebral origin were agitation, constipation, somnolence, leukocytosis, chills, urinary retention, and hypotonia.
Rare cases of overdose and withdrawal may be life threatening.
CNS Therapeutics conducted two-year shelf life testing for Gablofen. Test results varied only slightly over time and remained well within the acceptance criteria.
* It is important to select the appropriate refill kit for the pump used to administer Gablofen. Gablofen is not to be compounded with other medications.
Gablofen® (baclofen injection) is indicated for use in the management of severe spasticity of cerebral or spinal cord origin. (View full prescribing information.) Gablofen can be substituted for Lioresal® Intrathecal (baclofen injection) in the same standard concentrations (50 mcg/mL, 500 mcg/mL, and 2,000 mcg/mL).
An FDA-approved, AP-rated generic equivalent.
Gablofen® (baclofen injection) can be substituted for Lioresal® Intrathecal (baclofen injection).
Compare >
Gablofen and GPO Contracts
Gablofen is the only intrathecal baclofen available on Premier and Novation contracts.
The FDA definition of Therapeutic Equivalence (TE):
Additional information about the definition of therapeutic equivalence and the criteria required for drug products to be considered therapeutically equivalent.
Read more >The FDA definition of Therapeutic Equivalence (TE):
Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria:
- They are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
- They are assigned by FDA the same therapeutic equivalence codes starting with the letter "A ." To receive a letter "A", FDA
- Designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD)
- Assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).
Refill Convenience Kit with
each order.
Everything needed for efficient pump refilling in one tidy kit. Conveniently stocked separately from Gablofen.
What's included >