gablofen
Gablofen (Baclofen) is a gamma-aminobutyric acid-ergic agonist used to treat Neurogenic Urinary Bladder, Cerebral Palsy, Hiccup, Huntington Disease.
Baclofen · by Piramal Critical
Available as a generic: Baclofen
Key facts
- Active ingredient
- Baclofen
- Drug class
- Gamma-Aminobutyric Acid-Ergic Agonist
- Form
- Injectable
- Strength
- Baclofen 0.05MG/ML · Baclofen 0.5MG/ML · Baclofen 1MG/ML · Baclofen 2MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- neurogenic urinary bladder, cerebral palsy, hiccup
- Manufacturer
- Piramal Critical
- Half-life
- about 5.7 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.55 for 30 — not your price
- FDA application
- NDA022462
- FDA boxed warning
- Yes — see the boxed warning
What is Gablofen?
From the FDA label:GABLOFEN (baclofen injection) is a muscle relaxant and antispastic. Baclofen's pharmacological class is a gamma-aminobutyric acid (GABA) ergic agonist. Baclofen's chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is: Baclofen C 10 H 12 ClNO 2 Baclofen is a white to off-white powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform. GABLOFEN is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37°C and compatible with CSF. Each mL of GABLOFEN contains baclofen USP 50 mcg, 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5. structure
How to use
2.1 Use Only in Medtronic SynchroMed ® Programmable Pump (or other pumps labeled for intrathecal administration of GABLOFEN) GABLOFEN is approved only for use with the Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN. Refer to the manufacturer’s manual for specific instructions and precautions for programming the pump and/or refilling the reservoir. It is important to select the appropriate refill kit for the pump used to administer GABLOFEN. GABLOFEN is not to be compounded with other medications. 2.2 Screening Phase Prior to pump implantation and initiation of chronic infusion of GABLOFEN, patients must demonstrate a positive clinical response to a GABLOFEN bolus dose administered intrathecally in a screening trial. The screening trial employs GABLOFEN at a concentration of 50 mcg/mL. A 1 mL syringe (50 mcg/mL) is available for use in the screening trial. The screening procedure is as follows. An initial bolus containing 50 micrograms in a volume of 1 milliliter is administered into the intrathecal space by barbotage over a period of not less than one minute. The patient is observed over the ensuing 4 to 8 hours. A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms. If the initial response is less than desired, a second bolus injection may be administered 24…
Side effects
6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials, the most common adverse reactions associated with use of intrathecal baclofen which were not seen at an equivalent incidence among placebo-treated patients were: somnolence, dizziness, nausea, hypotension, headache, convulsions and hypotonia. Adverse Reactions Associated with Discontinuation of Treatment 8/474 patients with spasticity of spinal cord origin receiving long term infusion of intrathecal baclofen in pre- and post-marketing clinical studies in the U.S. discontinued treatment due to adverse reactions. These include: pump pocket infections (3), meningitis (2), wound dehiscence (1), gynecological fibroids (1) and pump overpressurization (1) with unknown, if any, sequela. Eleven patients who developed coma secondary to overdose had their treatment temporarily suspended, but all were subsequently re-started and were not, therefore, considered to be true discontinuations. Fatalities - [see Warnings and Precautions ( 5.6 )] . Incidence in Controlled Trials Experience with intrathecal baclofen obtained in parallel, placebo-controlled, randomized studies provides only a limited basis for estimating the incidence of adverse reactions because the studies were of very brief duration (up to three days of infusion) and…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 [ see Warnings and Precautions (5.4) ]. 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. ( 5.4 )
Warnings
Important safety information
5.1 Risk of Life-Threatening Overdose During Pump Refills Use extreme caution when filling the Medtronic SynchroMed ® 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. Reservoir refilling must be performed by fully trained and qualified personnel following the directions provided by the pump manufacturer. Carefully calculate refill intervals to prevent depletion of the reservoir, as this would result in the return of severe spasticity and possibly symptoms of withdrawal. Strict aseptic technique in filling is required to avoid bacterial contamination and serious infection. A period of observation appropriate to the clinical situation should follow each refill or manipulation of the drug reservoir. 5.2 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. This has 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. Procedures should also be put in place while refilling implantable intrathecal pumps in an outpatient setting to avoid contamination of sterile surfaces through contact with the non-sterile exterior of the GABLOFEN prefilled syringe. 5.3 Prescriber, Caregiver and Patient Training and Screening Procedure/Post-Implantation Environment GABLOFEN is for use in single bolus intrathecal injections (via a catheter placed in the lumbar intrathecal space or injection by lumbar puncture) and in the implantable Medtronic SynchroMed ® Programmable Pump or other pumps labeled for intrathecal administration of GABLOFEN. Because of the possibility of potentially life-threatening CNS depression, cardiovascular collapse, and/or respiratory failure, physicians must be adequately trained and educated in chronic intrathecal infusion therapy. The pump system should not be implanted until the patient's response to bolus GABLOFEN injection is adequately evaluated. Evaluation (consisting of a screening procedure) requires that GABLOFEN be administered into the intrathecal space via a catheter or lumbar puncture [see Dosage and Administration (2.2)] . Because of the risks associated with the screening procedure and the adjustment of dosage following pump implantation, these phases must be conducted in a medically supervised and adequately equipped environment following the instructions outlined in the Dosage and Administration section [see Dosage and Administration (2.2 and 2.5)] . Resuscitative equipment should be available. Following surgical implantation of the pump, particularly during the initial phases of pump use, the patient should be monitored closely until it is certain that the patient's response to the infusion is acceptable and reasonably stable. On each occasion that the dosing rate of the pump and/or the concentration of GABLOFEN in the reservoir is adjusted, close medical monitoring is required until it is certain that the patient's response to the infusion is acceptable and reasonably stable. It is mandatory that the patient, all patient caregivers, and the physicians responsible for the patient receive adequate information regarding the risks of this mode of treatment. All medical personnel and caregivers should be instructed in 1) the signs and symptoms of overdose, 2) procedures to be followed in the event of overdose and 3) proper home care of the pump and insertion site. 5.4 Overdose Signs of overdose may appear suddenly or insidiously. Acute massive overdose may present as coma. Less sudden and/or less severe forms of overdose may present with signs of drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma. Should overdose appear likely, the patient should be taken immediately to a hospital for assessment and emptying of the pump reservoir. In cases reported to date, overdose has generally been related to pump malfunction or dosing error [ see Overdosage ( 10 )] Extreme caution must be used when filling the implantable pump. Medtronic SynchroMed ® Programmable Pump should only be refilled through the reservoir refill septum. The Medtronic SynchroMed ® Programmable Pump is also equipped with a catheter access port that allows direct access to the intrathecal catheter. Direct injection into this catheter access port may cause a life-threatening overdose. 5.5 Withdrawal Abrupt withdrawal of intrathecal baclofen, regardless of the cause, has resulted in sequelae that included high fever, altered mental status, exaggerated rebound spasticity and muscle rigidity that in rare cases progressed to rhabdomyolysis, multiple organ-system failure, and death. In the first 9 years of post-marketing experience, 27 cases of withdrawal temporally related to the cessation of baclofen therapy were reported; six patients died. In most cases, symptoms of withdrawal appeared within hours to a few days following interruption of baclofen therapy. Common reasons for abrupt interruption of intrathecal baclofen therapy included malfunction of the catheter (especially disconnection), low volume in the pump reservoir, and end of pump battery life; human error may have played a causal or contributing role in some cases. Cases of intrathecal mass at the tip of the implanted catheter leading to withdrawal symptoms have also been reported, most of them involving pharmacy compounded analgesic admixtures [see Warnings and Precautions (5.10)] . 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. All patients receiving intrathecal baclofen therapy are potentially at risk for withdrawal. Early symptoms of baclofen withdrawal may include return of baseline spasticity, pruritus, hypotension, and paresthesias. Some clinical characteristics of the advanced intrathecal baclofen withdrawal syndrome may resemble autonomic dysreflexia, infection (sepsis), malignant hyperthermia, neuroleptic-malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis. Rapid, accurate diagnosis and treatment in an emergency-room or intensive-care setting are important in order to prevent the potentially life-threatening central nervous system and systemic effects of intrathecal baclofen withdrawal. The suggested treatment for intrathecal baclofen withdrawal is the restoration of intrathecal baclofen at or near the same dosage as before therapy was interrupted. However, if restoration of intrathecal delivery is delayed, treatment with GABA-ergic agonist drugs such as oral or enteral baclofen, or oral, enteral, or intravenous benzodiazepines may prevent potentially fatal sequelae. Oral or enteral baclofen alone should not be relied upon to halt the progression of intrathecal baclofen withdrawal. Seizures have been reported during overdose and with withdrawal from intrathecal baclofen as well as in patients maintained on therapeutic doses of intrathecal baclofen. 5.6 Possible Exacerbation of Psychotic Disorders, Schizophrenia, or Confusional States Patients…
Who should not take Gablofen
GABLOFEN is contraindicated in patients with a hypersensitivity to baclofen. Do not use GABLOFEN for intravenous, intramuscular, subcutaneous or epidural administration. · Hypersensitivity to baclofen (4) · Do not use GABLOFEN for intravenous, intramuscular, subcutaneous or epidural administration. (4)
Overdose — what happens if you take too much
Special attention must be given to recognizing the signs and symptoms of overdosage, especially during the initial screening and dose-titration phase of treatment, but also during re-introduction of GABLOFEN after a period of interruption in therapy. Symptoms of Intrathecal Baclofen Overdose Drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia and loss of consciousness progressing to coma of up to 72 hours duration. In most cases reported, coma was reversible without sequelae after drug was discontinued. Symptoms of intrathecal baclofen overdose were reported in a sensitive adult patient after receiving a 25 mcg intrathecal bolus. Treatment Suggestions for Overdose There is no specific antidote for treating overdoses of GABLOFEN; however, the following steps should ordinarily be undertaken: 1) Residual intrathecal baclofen solution should be removed from the pump as soon as possible. 2) Patients with respiratory depression should be intubated if necessary, until the drug is eliminated. Anecdotal reports suggest that intravenous physostigmine may reverse central side effects, notably drowsiness and respiratory depression. Caution in administering physostigmine is advised, however, because its use has been associated with the induction of seizures and bradycardia. Physostigmine Doses for Adult Patients Administer…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
There is inadequate systematic experience with the use of intrathecal baclofen in combination with other medications to predict specific drug-drug interactions. Interactions attributed to the combined use of GABLOFEN and epidural morphine include hypotension and dyspnea. Combined use with morphine: hypotension and dyspnea ( 7 )
How long does Baclofen stay in your body?
The elimination half-life of baclofen is about 5.7 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent elimination half-life of the parent drug. Baclofen is not a prodrug and has no active metabolite that outlasts it — the label states it is excreted primarily by the kidney in unchanged form, so the half-life reflects renal clearance directly. Because of that, elimination is slower in people with reduced kidney function (renal impairment) and in older adults, in whom the drug can accumulate and the dose may need to be reduced. The label also notes large intersubject variation in absorption and/or elimination, so individual half-life can differ. Half-life is not the same as a drug-test detection window: baclofen is essentially cleared within about 72 hours of a dose, but detectability depends on the test.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Baclofen oral solution — FDA label (DailyMed), Clinical Pharmacology.
Drug class
May treat (source: NIH RxClass)
See how Gablofen ranks — best-rated gamma-aminobutyric acid-ergic agonist for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Gablofen treat?
- Gablofen (Baclofen) may be used to treat neurogenic urinary bladder, cerebral palsy, hiccup, huntington disease, multiple sclerosis, muscle spasticity, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Gablofen cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.55 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Gablofen?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Gablofen. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Gablofen?
- Gablofen is marketed by Piramal Critical. You can see Piramal Critical's full profile, rating, and other products on pharmaranks.
- Is Gablofen a brand-name or generic drug?
- Gablofen is a brand-name product with the active ingredient Baclofen. Lower-cost generic equivalents containing Baclofen are available — ask your pharmacist.
- Is Gablofen available over the counter?
- No. Gablofen is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Gablofen come in?
- Gablofen is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Gablofen?
- Gablofen is classified as gamma-aminobutyric acid-ergic agonist, per the FDA's Established Pharmacologic Class.
- Is Gablofen FDA-registered?
- Gablofen is on record with the U.S. FDA under application number NDA022462. You can verify this on its official FDA label.
- Is Gablofen safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Gablofen. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Gablofen?
- Gablofen's side effects are taken directly from its FDA label. From the label: 6.1 Spasticity of Spinal Cord Origin Most Common Adverse Reactions in Patients with Spasticity of Spinal Origin In pre- and post-marketing clinical trials,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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