The Gablofen® Experience
More than just drug therapy for spasticity treatment and management
Support for Medical Providers
When you choose Gablofen® for your patients’ intrathecal baclofen therapy, you’re getting more than just spasticity treatment and management. You’re getting Piramal Critical Care’s network of support and resources:
- Convenient, easy-to-use products
- Customized, 1-on-1 support
- Educational trainings and programs
- Opportunities to provide feedback for product improvements
Convenient, easy-to-use products
Not only can Gablofen be more convenient for patients, but it can also be more convenient for medical providers, too.
- Only FDA-approved intrathecal baclofen packaged in prefilled syringes and vials
- No need to worry about drawing or measuring the medication
- Eliminates the need to break glass ampules, reducing your risk of injury due to broken glass, and reducing drug waste
When you order Gablofen, you’ll receive a complimentary Pump Refill Convenience Kit with everything you need for a pump refill.
- 3 concentration levels available – 500mcg/mL, 1000mcg/mL, and 2000mcg/mL
- Shipped separately from your order
- Speeds up the refill process
Additionally, the prefilled syringe is available in a 50mcg/mL screening dose, allowing your patients to receive an injection of Gablofen and experience the drug’s effects before undergoing pump implantation to start ITB therapy with Gablofen.
Learn more about the screening dose and the ITB therapy trial process.
1-on-1 support
You’ll have access to a team of dedicated Territory Managers and Customer Service Specialists ready to provide 1-on-1 customized support and assist you at any time. They’ll introduce you to ITB best practices, provide hands-on training, oversee refill maintenance, and more.
Educational Trainings and Programs
Whether you’re new to intrathecal baclofen therapy and spasticity management or would like a refresher on how to perform pump refills, our educational trainings and programs are designed to provide you with the information you need to administer Gablofen to your patients.
You can utilize our educational speaker programs to learn from Key Opinion Leaders and leading medical providers as they share best practices, new discoveries, and their experiences.
If you’re looking to engage with your peers, consider attending or participating in one of our collegiate roundtable forums.
Advancing IT Therapy: Empowerment Through Education is our unbranded program and provides education on different core topics:
- Pump Refill Training
- Spasticity Management & The Impact of ITB Therapy
- ITB Best Practices
We also offer in-person, on-site training and demonstrations to support new residents, clinicians, and pharmacists and reinforce best practices and behaviors for established providers.
To learn more about our educational opportunities, schedule a meeting.
Your Opinion Matters
As a leader in intrathecal baclofen therapy treatment, Piramal Critical Care’s mission is to give medical providers and their patients the best experience possible. Your opinion is important to us and can help inform product and educational updates. That’s why we routinely ask for your thoughts and feedback. Don’t be shy about sharing when the opportunity arises. After all, we can’t keep innovating if we don’t know what you need!
Ready to experience the benefits of Gablofen and Piramal Critical Care?
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.