CNS Therapeutics | Advancing Intrathecal Pharmaceuticals Gablofen® (intrathecal baclofen)

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INDEX

  • LEGAL NOTICE
  • ABOUT THE INFORMATION ON THIS WEB SITE
  • DO NOT RELY ON INFORMATION IN THIS SITE—SEEK MEDICAL ADVICE
  • OUR COPYRIGHTS AND TRADEMARKS
  • LINKS TO THIS WEB SITE AND USE OF CNS THERAPEUTICS MARKS
  • LINKS TO OTHER WEB SITES
  • YOUR FEEDBACK, COMMENTS AND IDEAS
  • NO WARRANTIES
  • LIMITATION OF LIABILITY
  • LIMITED REMEDY
  • OTHER RULES ABOUT THIS WEBSITE
  • QUESTIONS, COMMENTS, AND NOTICES

LEGAL NOTICE

Please read these terms of use carefully. CNS Therapeutics invites visitors to access this website subject to the terms and conditions below and the Privacy Policy set forth elsewhere on this site. This website is owned and operated by CNS Therapeutics Inc. When we use the words we or our, we mean CNS Therapeutics. We may change these Terms of Use at any time. Please review the Terms of Use each time you visit the website. By using this website, it means you accept the most recent version of the Terms of Use. By using this website, you agree that the only proper jurisdiction and venue for any dispute with CNS Therapeutics, or in any way relating to your use of this website, is in the state and federal courts in the State of Minnesota, U.S.A. You further agree and consent to the exercise of personal jurisdiction in these courts in connection with any dispute involving CNS Therapeutics or its affiliates, employees, officers, directors, agents, or suppliers. These Terms of Use are governed by the internal substantive laws of the State of Minnesota, without respect to its conflict of laws principles, and the federal laws of the United States.

ABOUT THE INFORMATION ON THIS WEBSITE.

Much of the information on this website relates to products offered by CNS Therapeutics. This website contains information about CNS Therapeutics products that are under investigational use and is intended for a United States audience. If you live outside the U.S., you may see information on this website about products or therapies that are not available or authorized in your country.

DO NOT RELY ON INFORMATION IN THIS SITE—SEEK MEDICAL ADVICE.

This website may contain information about health and/or medical conditions and their treatment. This information is not a substitute for seeking the advice of a medical professional. This information should not be used to diagnose or treat and health and/or medical condition. The use of CNS Therapeutics’ products must be under the supervision of a licensed medical professional.

THIS WEBSITE DOES NOT PROVIDE MEDICAL ADVICE. IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY, CALL YOUR DOCTOR OR 911 IMMEDIATELY. To report SUSPECTED ADVERSE REACTION, contact CNS Therapeutics Inc. at 1-877-384-0857 or FDA at 1-800-FDA-1088 or the MedWatch website.

OUR COPYRIGHTS AND TRADEMARK.

The materials on this website are Copyright 2010 CNS Therapeutics. These materials belong to or are licensed to CNS Therapeutics. The materials are protected by United States and foreign copyright laws. Title to the materials remains with us or with the authors of the materials contained on this website. All rights not expressly granted are reserved. There are some important rules about copying these materials.

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LINKS TO THIS WEB SITE AND USE OF CNS THERAPEUTICS MARKS.

You are hereby granted a non-exclusive, limited, and revocable license to link to this website. CNS Therapeutics reserves the right to revoke this license generally, or your right to use specific links, at any time. If CNS Therapeutics revokes this license, you agree to remove and disable any and all of your links to this web site immediately.

You agree not to present the link to this website in such a way that it is associated with advertising or appears to be an endorsement of any organization, product, or service. You agree that the link will not appear on a website that a reasonable person may consider obscene, defamatory, harassing, grossly offensive, or malicious. Under no circumstances may you "frame" this web site or any of its content or copy portions of this web site to a server. You agree not to display or use the CNS Therapeutics logo or trademark in any manner without our prior written permission.

LINKS TO OTHER WEBSITES.

Certain links on this website lead to other resources on servers maintained by third parties over whom CNS Therapeutics has no control. By clicking on these links you will be leaving the CNS Therapeutics website and entering the website of another completely independent website. We provide these links for your convenience, but we do not review, control, or monitor the materials on any other web sites. These websites may contain information about uses of CNS Therapeutics products or therapies that have not been approved in the United States. We do not control or endorse this type of information. We are not responsible for the information provided on them, performance of those web sites or for your business dealings with them. Your use of other websites is subject to the terms of use of those websites.

YOUR FEEDBACK, COMMENTS AND IDEAS.

CNS Therapeutics does not want to receive confidential or proprietary information from you trough its website. While we are pleased to receive feedback, comments and ideas from visitors to this web site, we want you to understand that any information that you submit through this web site will be considered non-personal, non-confidential, and non-proprietary (other than personal information, as that term is defined in our Privacy Policy). If you transmit any ideas, information, concepts, know-how or techniques or materials to us through this web site, you hereby grant CNS Therapeutics an unrestricted, royalty-free, irrevocable license to use, reproduce, display, perform, modify, transmit and distribute them in any medium, and agree that CNS Therapeutics is free to use them for any purpose, including for the development, manufacturing and marketing or products.

NO WARRANTIES.

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LIMITATION OF LIABILITY.

YOU AGREE THAT NEITHER CNS THERAPEUTICS NOR ANY OF ITS OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS OR ANY OTHER PARTY WHO IS INVOLVED IN CREATING, PRODUCING OR DELIVERING CONTENT FOR THIS WEBSITE (TOGETHER CALLED “CNS THERAPEUTICS AND OTHERS”), SHALL BE LIABLE FOR ANY DAMAGE RESULTING FROM YOUR USE OR INABILITY TO USE THIS WEB SITE OR THE MATERIALS ON THIS WEB SITE. THIS PROTECTION COVERS CLAIMS BASED ON WARRANTY, CONTRACT, TORT, STRICT LIABILITY, AND ANY OTHER LEGAL THEORY. THIS PROTECTION COVERS ALL LOSSES INCLUDING, WITHOUT LIMITATION, DIRECT OR INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY, AND PUNITIVE DAMAGES, PERSONAL INJURY/WRONGFUL DEATH, LOST PROFITS, OR DAMAGES RESULTING FROM LOST DATA OR BUSINESS INTERRUPTION.

LIMITED REMEDY.

THE TOTAL LIABILITY OF CNS THERAPEUTICS AND OTHERS SHALL BE LIMITED TO THE AMOUNT OF YOUR ACTUAL DAMAGES, NOT TO EXCEED U.S. $100.00. THE LIMIT OF LIABILITY MAY NOT BE EFFECTIVE IN SOME STATES.

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Your obligations under this section and the sections called "Your Feedback", "No Warranties" and "Limitation of Liability" will survive termination of these Terms of Use.

QUESTIONS, COMMENTS, AND NOTICES.

CNS Therapeutics may deliver notice to you by electronic mail, a general notice on this web site, or by written communication delivered by First Class U.S. Mail to your address on record with CNS Therapeutics. You may deliver notice to CNS Therapeutics by using the address below:

CNS Therapeutics Inc.
332 Minnesota Street
St. Paul, MN   55101
Attention: Webmaster

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.

WARNING: DO NOT DISCONTINUE ABRUPTLY

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

  • Use only with Medtronic SynchroMed® II Programmable Pump or other pumps labeled for intrathecal administration of Gablofen (baclofen injection).
  • 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.
  • Resuscitative equipment and trained staff must be available during screening dose, dose titration, and refills due to the potential for life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure.

WARNINGS AND PRECAUTIONS (CONTINUED)

  • 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 state, 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 made hazardous by decreased alertness. Other CNS depressants and alcohol may add to this effect.
  • Potential for intrathecal mass formation. Clinicians should monitor for signs and symptoms of new neurologic symptoms including the use of imagining diagnostic modalities.
  • Oral baclofen use has been associated with a dose-related increase in incidence of ovarian cysts.
  • Pregnancy Category C. The effect of baclofen in labor and delivery is unknown.
  • Balcofen 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.

Serious Adverse Events

  • 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. 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 for intrathecal mass formation, drainage, infection, meningitis, unmanageable trunk control, CSF leakage, coma, and death.

Common Adverse Events

  • 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.

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CNS Therapeutics, Inc.
332 Minnesota St.
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© 2013 CNS Therapeutics, Inc. January 2013
All rights reserved. | PRT-105

Ingenuity. Pure and Simple. and Gablofen are registered trademarks of CNS Therapeutics, Inc.

ITB Therapy is a service mark of Medtronic, Inc.

Lioresal and SynchroMed are registered trademarks of Medtronic, Inc.

ChloraPrep is a registered trademark of CareFusion 2200, Inc.

Aplicare is a registered trademark of Clorox Professional Products Company.

Scroll down for additional important risk information

WARNING: DO NOT DISCONTINUE ABRUPTLY

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.