POST-IMPLANT FOLLOW-UP Intrathecal Baclofen Therapy with Lioresal®
Long-term, post-surgical management ensures the greatest benefit from ITB Therapy with Lioresal® Intrathecal (baclofen injection). Regular patient follow-up is necessary to refill the pump, ensure ITB Therapy is providing optimal therapy outcomes, confirm the programmable infusion system component integrity and performance, and measure the battery life of the drug infusion pump.
The goal in long-term ITB Therapy patient management is to provide dosing to maintain muscle tone as close to normal as possible, and to reduce the frequency and severity of spasticity without inducing intolerable side effects. Some ITB Therapy patient management considerations continue throughout the course of the patient's treatment.
ITB Therapy patient management considerations include:
Pump refills generally occur every 3-6 months, depending on the dose and size of the pump. The refill procedure involves a specific set of steps that must be followed precisely to help ensure patient safety during ITB Therapy. Before clinicians perform refills, they must be trained in the correct procedures.
A typical ITB Therapy refill appointment takes about 30 minutes and usually includes:
The pump is refilled by inserting a needle through the skin into the pump septum. A refill template, included in the Lioresal® Intrathecal (baclofen injection) refill kit, can be used to assist in locating the refill septum.
The goal of ITB Therapy for severe spasticity is to determine for each patient the drug dose that achieves optimal spasticity control without intolerable adverse effects. It is important to observe patients for symptoms of drug overdose, withdrawal, tolerance, and ineffective dosing during ITB Therapy.
The SynchroMed™ II infusion system is equipped for precise dose titration as well as flexible programming options during ITB Therapy. The lowest dose with an optimal response should be used. On each occasion that the dosing rate of the pump is adjusted, close medical monitoring is required until it is certain that the patient's response to the new infusion is acceptable and reasonably stable. Spasticity can often be managed more effectively by programming the pump to deliver medication at different rates throughout the day and/or on different days of the week.
Drug dosage will vary with each patient. Encourage patients to notify their clinicians of unusual symptoms, drug overdose, withdrawal, or loss of drug effect. If drug tolerance, disease progression, or psychosocial issues that may impact therapeutic effect are ruled out, evaluate the infusion system for malfunction.
Common Adverse Reactions
Serious Adverse Reactions
For more information, including BOX WARNING, refer to Lioresal® Intrathecal (baclofen injection) prescribing information, located at www.lioresal.com/prescribinginformation