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WARNING: DO NOT DISCONTINUE ABRUPTLY.
See full prescribing information for complete boxed warning.
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 postimplant clinician and patient information [see Warnings and Precautions].
In clinical trials, intrathecal baclofen injection was shown to reduce severe spasticity. Results may vary: not every individual will receive the same benefits.
The most common adverse reactions 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.
Call your doctor for medical advice about side effects. To report SUSPECTED ADVERSE REACTIONS, contact CNS Therapeutics Inc. at 1-877-384-0857 or FDA at 1-800-FDA-1088 or the MedWatch website.
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©2012 CNS Therapeutics, Inc.
All rights reserved. | PRT-059
Gablofen® is a registered trademark of CNS Therapeutics, Inc.
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SynchroMed® is a registered trademark of Medtronic Inc.
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