More than 60,000 implanted pumps for the use of Intrathecal Baclofen Therapy (ITB) have been implanted worldwide since 1992. Studies show that ITB Therapy reduces spasticity and spasms. Speak to your doctor about ITB Therapy if you did not have relief, or had side effects you could not tolerate from taking baclofen by mouth.7
ITB therapy stands for Intrathecal Baclofen Therapy, which refers to baclofen medication that is administered directly into the spinal cord. In order to support ITB, an implantable pump is placed under the skin of your abdomen by a surgeon. Baclofen is filled into the chamber of the pump. The pump is programmed to send medication continuously and is monitored and refilled by your doctor as needed for your specific needs. The liquid baclofen medication passes from the pump through a tiny tube into the space around your spine, referred to as the intrathecal space. The sealed ITB pump has an internal chamber which holds enough liquid baclofen to provide up to 180 days of treatment doses for some patients. The pump can be programmed to meet your specific needs.
Baclofen taken by mouth must move through your digestive system before reaching a certain point in your central nervous system. An ITB pump sends the medicine right to the fluid in your spine. Because of this, it works at a lower dose than oral baclofen and may result in lessened side effects.
In oral therapy, you may need to take baclofen as often as often as 3 to 4 times a day. With an ITB pump, you do not need to take baclofen orally, but instead, the drug is being released reliably at the right dose into your system, as programmed by your doctor.
ITB Therapy has proven useful for long-term management of severe spasticity for some patients:
You will need to see your doctor or healthcare professional for refills. They will make sure the pump is working the right way and monitor the dose to meet your needs. The pump chamber is refilled via needle injection through the skin into the chamber of the pump, a process that is quick and convenient.
The pump battery can last 4 to 7 years before it needs to be replaced. The pump can be replaced or removed by your surgeon if needed.
ITB Therapy is a service mark of Medtronic, Inc.
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MITIGO™ (Morphine Sulfate Injection, USP – Preservative-free) is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.
Neuraxial administration of MITIGO is contraindicated in patients with:
Most serious adverse reactions were respiratory depression, apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Other common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, and constipation.
To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care, Inc. at 1-888-822-8431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional Important Risk Information, including boxed warning, see enclosed Full Prescribing Information.
MITIGO™ (Morphine Sulfate Injection, USP – Preservative-free) is an opioid agonist, for use in continuous microinfusion devices and indicated only for intrathecal or epidural infusion in the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
WARNING: RISKS WITH NEURAXIAL ADMINISTRATION; LIFE-THREATENING RESPIRATORY DEPRESSION; RISK OF ADDICTION, ABUSE, AND MISUSE; NEONATAL OPIOID WITHDRAWAL SYNDROME; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS
See full prescribing information for complete boxed warning.
Neuraxial administration of MITIGO is contraindicated in patients with:
Most serious adverse reactions were respiratory depression, apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Other common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, and constipation.
To report SUSPECTED ADVERSE REACTIONS, contact Piramal Critical Care, Inc. at 1-888-822-8431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
For additional Important Risk Information, including boxed warning, see enclosed Full Prescribing Information.