About ITB Therapy

ITB Therapy is an established and widely accepted treatment option for severe spasticity.7

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

How ITB Works7

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.

Why Pump Therapy is Different7

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.

Long-Term Management7

ITB Therapy has proven useful for long-term management of severe spasticity for some patients:

  • Patients who did not see response from oral dosage of baclofen may see therapeutic effects from ITB.
  • Patients who experience dose limiting side effects from oral baclofen may be able to tolerate ITB at lower doses and see therapeutic effects they could not experience from oral baclofen. ITB works at a lower dose than oral baclofen because it is delivered directly to the area where it is needed.

Refilling and Programming the Pump7

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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Use the MedWatch form to report adverse events that you observe or suspect for human medical products, including serious drug side effects, product use/medication error, product quality problems, and therapeutic failures. Visit http://www.fda.gov/medwatch, or call 1.800.FDA.1088.

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.

IMPORTANT RISK INFORMATION

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 post-implant clinician and patient information.

CONTRAINDICATIONS

  • Hypersensitivity to baclofen.
  • Do not use Gablofen for intravenous, intramuscular, subcutaneous or epidural administration.

WARNINGS AND PRECAUTIONS

  • 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.
  • Use only with Medtronic SynchroMed® II Programmable Pump (or other pumps labeled for intrathecal administration of Gablofen (baclofen injection)).
  • Potential for contamination due to non-sterile external surface of prefilled syringe. Although the drug solution and pathway in the Gablofen prefilled syringes are sterile, the external surface of the prefilled syringes (all strengths, including the 50 mcg/mL strength) are non-sterile and have the potential to lead to contamination and consequent adverse reactions. The use of Gablofen prefilled syringe in an aseptic setting (e.g., operating room) to fill sterile intrathecal pumps prior to implantation in patients is not recommended, unless the external surface of the prefilled syringe is treated to ensure sterility. Gablofen supplied in vials may be used with conventional aseptic technique to fill intrathecal pumps prior to implantation.
  • 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 states 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 may be 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 imaging diagnostic modalities.
  • Oral baclofen use has been associated with a dose-related increase in incidence of ovarian cysts.

ADVERSE REACTIONS

  • Serious Adverse Reactions
    • 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 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.
  • Common Adverse Reactions
    • 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.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. The effect of baclofen in labor and delivery is unknown.
  • Breastfeeding: Baclofen 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.
Important Risk Information View Full