Why Gablofen®
Are you currently taking oral baclofen to manage your muscle and joint problems? Are you not getting the relief and results you want or expect from it? Are you experiencing negative side effects? If you answered yes to any of these questions, talk to your doctor about switching to Gablofen, an intrathecal baclofen.
What Gablofen Does
Gablofen, intrathecal baclofen, treats side effects such as muscle tightness, spasms, and fatigue, and frozen or stiff joints.
After receiving a trial dose of Gablofen, eligible patients undergo surgery to implant the pump which will delivery the drug directly into the spinal fluid.4
Who Gablofen Helps
- Gablofen can be used by patients ages 4 years and older who suffer from symptoms related to the result of a stroke, brain or spinal cord injury or a diagnosis such as Multiple Sclerosis, or Cerebral Palsy.
- Symptoms include, but are not limited to muscle tightness, muscle fatigue, muscle and/or joint deformities, and frozen or immobile joints.
- Through the use of Gablofen, patients experience improvements in their mobility and pain, increases in their daily functionality and ability to perform routine life tasks. They report being more independent and active.
4 Conditions that Lead to Severe Spasticity
See How Gablofen Has Impacted Real People
Giving People Their Life Back
One day while in a rush to get to work, Rafael was involved in an auto accident that left him with a spinal cord injury. The injury caused severe spasticity in his back and legs, made his legs always feel heavy, made life for Rafael extremely uncomfortable, and made Rafael drowsy, unhappy, and irritable. After being introduced to ITB Therapy by his doctor, Rafael chose it as his treatment option and couldn’t be happier with the results. He is more active, more positive, and says he can finally relax. Getting his spasticity under control means it no longer interferes with his routine or leisure activities, including national wheelchair tennis competitions, hand cycling, water-skiing, a full-time job and more. He has peace of mind, as he no longer has to worry about how to deal with situations that severe spasticity causes to be more difficult. “ITB has allowed me to accept my spinal cord injury. After 15 years of being in denial, I have a positive perspective and finally wake up every day with my life back!”
No More Missing Family Events
Four years ago Ruby was diagnosed with MS which caused symptoms like pain, spasms, cramping and stiffness. She tried 5 different oral medications to help her manage her symptoms but still struggled to eat, bathe, dress, and walk without help. Ruby accepted that she would just have to live with these symptoms and daily difficulties. But, when she had to miss a family reunion because her stiffness made a three-hour car ride too tough, she knew she had to look for another way to treat her symptoms. Her doctor agreed to a trial of ITB Therapy during which Ruby said her range of motion improved and her stiffness lessened. Now two years into treatment, Ruby no longer has pain or stiffness in her lower limbs and her ability to perform those daily activities has increased. Ruby said she wishes she had tried ITB Therapy sooner.
Have a Specific Question?
Important Risk Information
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.
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
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.
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.