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Clinicians must be vigilant for any indication of an adverse event during all phases of ITB Therapy (intrathecal baclofen therapy). Refer to the Lioresal® Intrathecal (baclofen injection) prescribing information for a complete listing of potential drug-related adverse events.
Patients vary in their sensitivity to Lioresal® Intrathecal. The most commonly observed side effects, which are typically managed through dose titration or adjuvant medications, are:
Clinicians must always be alert to the symptoms of overdose, especially during the screening test, post-implant dose titration, and whenever ITB Therapy has been interrupted and reintroduced. Early symptoms of overdose include:
If untreated, overdose can progress and produce the following:
To safeguard against overdose:
An emergency procedure and treatment protocol for overdose is available. In the United States, emergency technical support is available 24 hours/day for clinicians managing patients with Medtronic SynchroMed™ infusion systems: 800-707-0933. In other world areas, contact your Medtronic representative.
Withdrawal of intrathecal baclofen presents with a wide spectrum of severity and symptoms. It is important to act quickly if withdrawal is suspected, as symptoms can quickly escalate. Treat suspected baclofen withdrawal as a medical emergency.
Symptoms of advanced withdrawal include, but may not be limited to:
In rare instances, if withdrawal is left untreated, rhabdomyolysis, multiple organ-system failure, and/or death may result.
It is important to note that an advanced case of intrathecal baclofen withdrawal may resemble the following conditions:
All patients receiving intrathecal baclofen are potentially at risk of withdrawal. The primary cause of intrathecal baclofen withdrawal is abrupt discontinuation of drug delivery. To safeguard against withdrawal:
Rapid, accurate diagnosis and treatment of intrathecal baclofen withdrawal in an emergency department or intensive-care setting are important to prevent potentially life-threatening effects on the central nervous system and systemically.
The suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted. However, if restoration of intrathecal delivery is delayed, treatment with GABA-ergic agonistic drugs such as oral or enteral baclofen, or oral, enteral, or intravenous benzodiazepines may prevent potentially fatal sequelae. Oral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal.
An emergency procedure and treatment protocol for withdrawal is available. In the United States, emergency technical support is available 24 hours/day for clinicians managing patients with Medtronic SynchroMed™ infusion systems: 800-707-0933. In other world areas, contact your Medtronic representative.
Common Adverse Reactions
Serious Adverse Reactions
For more information, including BOXED WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at lioresal.com/prescribinginformation.