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  • INTRATHECAL PRODUCTS

    We provide physicians and patients with a comprehensive suite of intrathecal products for use in the management of cerebral or spinal spasticity.
     
    With the acquisition of CNS Therapeutics in October 2012, we now offer products for use in the management of severe spasticity of cerebral or spinal origin with an R&D pipeline of additional presentations and strengths and pain products for intrathecal administration.
     
    Our portfolio of branded intrathecal products includes: 
     
    GablofenTM (baclofen injection) 500 mcg/mL Ready-to-use vial
    GablofenTM (baclofen injection) 1000 mcg/mL Ready-to-use vial
    GablofenTM (baclofen injection) 2000 mcg/mL Ready-to-use vial
    GablofenTM (baclofen injection) 50 mcg/mL Screening dose
    GablofenTM (baclofen injection) 500 mcg/mL Prefilled syringe
    GablofenTM (baclofen injection) 1000 mcg/mL Prefilled syringe
    GablofenTM (baclofen injection) 2000 mcg/mL Prefilled syringe 
     
    INDICATIONS AND USAGE

    • Gablofen (baclofen injection) 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.
    • 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.

    IMPORTANT RISK INFORMATION

    WARNING: DO NOT DISCONTINUE ABRUPTLY 

    Abrupt discontinuation of intrathecal baclofen, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.
     
    Prevention of abrupt discontinuation of intrathecal baclofen requires careful attention to programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early symptoms of baclofen withdrawal. Special attention should be given to patients at apparent risk (e.g. spinal cord injuries at T-6 or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen). Consult the technical manual of the implantable infusion system for additional post-implant clinician and patient information. 

    Click “Learn More” for boxed warning and U.S. Full Prescribing Information for additional Important Risk Information.
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    To learn more about Gablofen, please visit www.Gablofen.com.