Larinate-120 Injection_

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

• Use Only in Medtronic SynchroMed ® Programmable Pump (or other pumps labeled for intrathecal administration of GABLOFEN) GABLOFEN is approved only for use with the Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN
• Refer to the manufacturer’s manual for specific instructions and precautions for programming the pump and/or refilling the reservoir
• 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
• Screening Phase Prior to pump implantation and initiation of chronic infusion of GABLOFEN, patients must demonstrate a positive clinical response to a GABLOFEN bolus dose administered intrathecally in a screening trial
• The screening trial employs GABLOFEN at a concentration of 50 mcg/mL
• A 1 mL syringe (50 mcg/mL) is available for use in the screening trial
• The screening procedure is as follows
• An initial bolus containing 50 micrograms in a volume of 1 milliliter is administered into the intrathecal space by barbotage over a period of not less than one minute
• The patient is observed over the ensuing 4 to 8 hours
• A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms
• If the initial response is less than desired, a second bolus injection may be administered 24 hours after the first
• The second screening bolus dose consists of 75 micrograms in 1.5 milliliters
• Again, the patient should be observed for an interval of 4 to 8 hours. …

GABLOFEN (baclofen injection) is a clear, colourless solution available as: Single-dose syringe containing 50 mcg/mL Single-dose syringes and vials of 10,000 mcg per 20 mL (500 mcg/mL) Single-dose syringes and vials of 20,000 mcg per 20 mL (1,000 mcg/mL) Single-dose syringes and vials of 40,000 mcg per 20 mL (2,000 mcg/mL) Injection: 50 mcg/mL, 500 mcg/mL, 1,000 mcg/mL, and 2,000 mcg/mL (3)

• Children should be of sufficient body mass to accommodate the implantable pump for chronic infusion
• Please consult pump manufacturer's manual for specific recommendations
• Safety and effectiveness
• In pediatric patients below the age of 4 have not been established

• Risks Related to Sudden Withdrawal of GABLOFEN Advise patients and caregivers that sudden withdrawal of GABLOFEN, regardless of the cause, can result in serious complications that include high fever, confusion, muscle stiffness, multiple organ-system failure, and death
• Inform patients that early symptoms of GABLOFEN withdrawal may include increased spasticity, itching, and tingling of extremities
• If GABLOFEN withdrawal or a pump malfunction is suspected, patients should be brought immediately to a hospital for assessment and treatment. …

• GABLOFEN is contraindicated in patients with a hypersensitivity to baclofen
• Do not use GABLOFEN for intravenous, intramuscular, subcutaneous or epidural administration. · Hypersensitivity to baclofen · Do not use GABLOFEN for intravenous, intramuscular, subcutaneous or epidural administration

There is inadequate systematic experience with the use of intrathecal baclofen in combination with other medications to predict specific drug-drug interactions. Interactions attributed to the combined use of GABLOFEN and epidural morphine include hypotension and dyspnea. Combined use with morphine: hypotension and dyspnea ( 7 )

5.1 Risk of Life-Threatening Overdose During Pump Refills Use extreme caution when filling the Medtronic SynchroMed ® Programmable Pump which is equipped with an injection port that allows direct access to the intrathecal catheter. Direct injection into the catheter through the catheter access port may cause a life-threatening overdose. Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Carefully calculate refill intervals to prevent depletion of the reservoir, as this would result in the return of severe spasticity and possibly symptoms of withdrawal. …

6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia. Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions. …

8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of GABLOFEN in pregnant women. In animal studies, oral administration of baclofen to pregnant rats produced an increase in fetal malformations (see Data) . There are no animal data on developmental risk associated with baclofen administered via continuous intrathecal infusion. …

Special attention must be given to recognizing the signs and symptoms of overdosage, especially during the initial screening and dose-titration phase of treatment, but also during re-introduction of GABLOFEN after a period of interruption in therapy. Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration. In most cases reported, coma was reversible without sequelae after drug was discontinued. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.