Mallinckrodt, the Pharmaceuticals business of Covidien (NYSE: COV), today announced the U.S. Food and Drug Administration (FDA) approval of Gablofen ® (baclofen injection) in prefilled syringes. The Gablofen prefilled syringe was created to reduce preparation steps, helping to simplify the pump refill process for patients receiving ITB Therapy SM (Intrathecal Baclofen Therapy) to treat severe spasticity of cerebral and spinal origin.
“The launch of Gablofen prefilled syringe enhances our product portfolio and provides a known treatment in a convenient delivery technology,” said Mark Trudeau, President, Mallinckrodt. “The prefilled syringe has the opportunity to replace the traditional glass ampules and simplify the pump refill process for healthcare providers treating appropriate patients with severe spasticity.”
A Refill Convenience Kit has been re-designed to include what is needed for pump refills using Gablofen prefilled syringes. It includes snug compartments to help ensure that each component stays in place.
Gablofen was developed by CNS Therapeutics, which was recently acquired by Mallinckrodt. Gablofen prefilled syringes will be available in February 2013. Gablofen is currently available in ready-to-use vials in the following concentrations: 50 mcg/mL (screening dose), 500 mcg/mL, new 1,000 mcg/mL and 2,000 mcg/mL. Gablofen 1,000 mcg/mL, introduced in 2012, was the first new refill concentration added in 20 years.PLEASE SEE IMPORTANT RISK INFORMATION, INCLUDING BOXED WARNING BELOW. SEE LINK TO FULL PRESCRIBING INFORMATION FOR ADDITIONAL IMPORTANT RISK INFORMATION. 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.
- Hypersensitivity to baclofen.
- Do not use Gablofen for intravenous, intramuscular, subcutaneous or epidural administration.
- Use only with Medtronic SynchroMed ® II Programmable Pump (or other pumps labeled for intrathecal administration of Gablofen (baclofen injection))
- Risk of life-threatening overdose during pump refills. Use extreme caution when filling the Medtronic SynchroMed ® II 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.
- Resuscitative equipment and trained staff must be available during screening dose, dose titration, and refills due to the potential life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure.
- Overdose may cause drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma.
- Use with caution in patients with psychotic disorders, schizophrenia or confusional state as it may exacerbate condition(s).
- Fatalities have been reported with intrathecal baclofen use.
- Caution should be used in patients with a history of autonomic dysreflexia.
- Presence of infection may increase the risk of surgical complication and complicate dosing of Gablofen.
- May cause drowsiness: use caution in operation of automobiles, dangerous machinery and activity that made hazardous by decreased alertness. Other CNS depressants and alcohol may add to this effect.
- Potential development of intrathecal mass formation. Clinicians should monitor for signs and symptoms of new neurologic symptoms including the use of imagining diagnostic modalities.
- Oral baclofen use has been associated with a dose related increase in incidence of ovarian cysts.
- Pregnancy Category C. The effect of baclofen in labor and delivery is unknown
- Balcofen is excreted into breast milk at oral therapeutic doses.
- Pediatric use: Safety and effectiveness in pediatric patients below the age of 4 years have not been established.
- Sudden withdrawal of Gablofen 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 overdose may occur suddenly or insidiously, and that symptoms may include confusion, drowsiness, lightheadedness, dizziness, slow or shallow breathing, seizures, loss of muscle tone, loss of consciousness, and coma.
- Other serious adverse events may include: potential development of intrathecal mass formation, drainage, infection, meningitis, unmanageable trunk control, CSF leakage, coma and death.
- The most common adverse reactions in patients with spasticity of spinal origin were hypotonia (25.3%) somnolence (20.9%), dizziness, nausea/vomiting, hypotension, headache, and convulsions.
- The most common adverse reactions in patients with spasticity of cerebral origin were hypotonia (34.7%), somnolence (18.7%), headache (10.7%) agitation, constipation, leukocytosis, chills, and urinary retention.
- Other common adverse events may include hypoventilation, hypertonia, paresthesia, increased salivation, back pain, pruritus, diarrhea, peripheral edema, asthenia, pain, confusion, speech disorder, amblyopia, accidental injury and dry mouth.