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GABLOFEN is a brand name for Baclofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Adults Gablofen is indicated in patients with severe chronic spasticity resulting from trauma, multiple sclerosis or other spinal cord disorders, who are unresponsive to oral baclofen or other orally administered antispastic medicinal products and/or those patients who experience unacceptable side-effects at effective…
Verbatim from this product's MHRA label. Tap a section to expand.
Efficacy of baclofen intrathecal has been demonstrated in clinical studies with an EU certified pump. This is an implantable administration system with a refillable reservoir that is implanted subcutaneously, usually in the abdominal wall.
The instrument is connected to an intrathecal catheter that passes subcutaneously into the subarachnoid space. Intrathecal administration of Gablofen through an implanted delivery system should only be undertaken by physicians with the necessary knowledge and experience.
Specific instructions for implantation, programming and/or refilling of the implantable pump are given by the pump manufacturers, and must be strictly adhered to. Posology Gablofen 50 micrograms/1ml is intended for administration in single bolus test doses (via spinal catheter or lumbar puncture) and, for chronic use, in implantable pumps suitable for continuous administration of Gablofen 500 micrograms/ml, 1000 micrograms/ml, or 2000 micrograms/ml into the intrathecal space (EU certified pumps).
Establishment of the optimum dose schedule requires that each patient undergoes an initial screening phase with intrathecal bolus, followed by a very careful individualized dose titration prior to maintenance therapy. The testing, implantation and dosage-titration phases of the intrathecal administration must be performed under in-patient conditions in centres with specific experience with close medical supervision by suitably qualified physicians.
Intensive medical care should be immediately available owing to possible life-threatening events or serious adverse reactions. Only pumps constructed of material known to be compatible with the product and incorporating an in-line bacterial retentive filter should be used.
Before Gablofen is administered, the subarachnoid space of patients with post- traumatic spasticity should be investigated by an appropriate imaging technique (myelography) as clinically indicated. If radiological signs of arachnoiditis are found, treatment with Gablofen should not be instituted.
Before administration of Gablofen, the solution should be checked for clarity and colourlessness. Only clear solutions practically free from particles should be used. If clouding or discoloration is evident, then the solution should not be used and should be discarded.
Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (frequency cannot be estimated from the available data).
Metabolism and nutrition disorders Common:
Decreased appetite.
Uncommon:
Dehydration.
Psychiatric disorders Common:
Depression, Confusional state, Disorientation, Agitation, Anxiety.
Uncommon:
Suicidal ideation, Suicide attempt, Paranoia, Hallucinations, Dysphoria, Euphoric mood.
Nervous system disorders Very common:
Somnolence.
Common:
Convulsion, Lethargy, Dysarthria, Headache, Paraesthesia, Insomnia, Sedation, Dizziness. Convulsion and headache occur more frequently in patients with cerebral spasticity.
Uncommon:
Ataxia, Hypothermia, Memory impairment, Nystagmus.
Eye disorders Common:
Accommodation disorders with vision blurred or diplopia.
Cardiac disorders Uncommon:
Bradycardia.
Vascular disorders Common:
Orthostatic hypotension Uncommon: Deep vein thrombosis, Hypertension, Flushing, Pallor.
Baclofen may be administered only with special caution to patients with: - impaired CSF circulation due to passage constriction, - epilepsy or other cerebral seizure illnesses, - bulbar paralytic symptoms or partial paralysis of the respiratory musculature, - acute or chronic confusional states, - psychotic states, schizophrenia or Parkinson's disease, - a history of dysreflexia of the autonomic nervous system, - cerebrovascular and respiratory failure, - pre-existing hypertension of the bladder sphincter, - impaired renal function, - peptic ulcers, - severe hepatic dysfunction.
Patients with additional suicidal risk factors must be closely monitored while undergoing drug treatment with Gablofen Intrathecal. Patients (as well as their carers) must be made aware of the need for monitoring of worsening clinical symptoms, suicidal behavior or ideation, or unusual behavioral changes, and instructed to seek medical assistance immediately if these symptoms appear.
e. at least one year after the injury). The testing, implantation and dosage-titration phases of the intrathecal treatment must be performed in hospital under close medical supervision by suitably qualified doctors in centres with specific experience in order to ensure the continuous monitoring of the patients.
Owing to possible life-threatening events or severe adverse reactions, suitable intensive medical care facilities should be immediately available. Suitable precautionary measures must be taken before the start of treatment. After refilling the pump, the patient must be supervised for 24 hours.
A doctor must be rapidly accessible during this period. In the event of abrupt discontinuation of intrathecal administration of baclofen, sequelae such as high fever, changes in mental state, increased spasticity as a rebound effect, and muscle rigidity may occur regardless of the cause of the discontinuation, and in rare cases may progress to seizures / status epilepticus, rhabdomyolysis, multiple organ failure and death.
1. Therapy-resistant epilepsy. The medicinal product should not be administered by any route other than intrathecal. Gablofen must not be administered by the intravenous, intramuscular, subcutaneous or epidural routes.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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5. Every pre-filled syringe is intended for single use only. Every vial is intended for single use only. Adult screening phase Prior to pump implantation and initiation of chronic infusion of baclofen, patients must demonstrate a positive response to intrathecal test dose in an initial test phase.
Usually, a bolus test dose is administered via lumbar puncture or an intrathecal catheter, in order to provoke a response. Patients should be infection-free prior to screening, as the presence of a systemic infection may prevent an accurate assessment of the response.
The initial test phase must only be performed with low concentration solution containing 50 micrograms baclofen in 1 ml. The screening procedure is as follows. The usual initial test dose in adults is 25 or 50 micrograms which is administered slowly into the intrathecal space by barbotage (alternating intrathecal baclofen administration and distraction of cerebrospinal fluid to obtain an appropriate mixture) over a period of not less than one minute.
A positive response consists of a significant decrease in muscle tone and/or frequency and/or severity of spasms. At intervals of at least 24 hours the dosage can be increased by increments of 25 micrograms to a maximum test dosage of 100 micrograms, if the response is less than desired.
After every bolus injection the patient must be supervised for 4 to 8 hours. The action of a single intrathecal dose generally sets in ½ to 1 hour after administration. The maximum spasmolytic effect sets in about 4 hours after administration and lasts about 4 to 8 hours.
The time to onset of action, the peak action and the duration of action vary from patient to patient and are dependent on the dosage, on the severity of symptoms, and on the mode and speed of administration. There is much variability with regard to sensitivity to intrathecal baclofen between patients.
Signs of severe overdose (coma) have been observed in an adult after a single test dose of 25 micrograms. Patients who do not respond to a 100 micrograms test dose should not be given further dose increments and treatment should not progress to continuous intrathecal infusion.
Resuscitative equipment and trained staff must be available during screening, dose titration, and refills. Monitoring of respiratory and cardiac function is essential during this phase, especially in patients with cardiopulmonary disease and respiratory muscle weakness or those being treated with benzodiazepine-type preparations or opiates, who are at higher risk of respiratory depression.
Paediatric population screening phase The recommended initial lumbar puncture test dose for patients 4 to <18 years of age is 25 - 50 micrograms/day which is administered slowly into the intrathecal space by barbotage over a period of not less than one minute.
Patients who do not experience a response may receive a 25 micrograms/day dose escalation every 24 hours. The maximum screening dose should not exceed 100 micrograms/day in paediatric patients. Dose titration phase Once the patient's responsiveness to baclofen has been established, an intrathecal infusion may be introduced.
Baclofen is most often administered using an infusion pump which is implanted in the chest wall or abdominal wall tissues. Implantation of pumps should only be performed in experienced centres to minimise risks during the perioperative phase.
Infection may increase the risk of surgical complications and complicate attempts to adjust the dose. A very careful patient tailored dosage titration is necessary because of the potential for […]
Respiratory, thoracic and mediastinal disorders Common:
Respiratory depression, Aspiration Pneumonia, Dyspnoea, Bradypnoea.
Gastrointestinal disorders Common:
Vomiting, Constipation, Diarrhoea, Nausea, Dry mouth, Salivary hypersecretion. Nausea and vomiting occur more frequently in patients with cerebral spasticity Uncommon: Ileus, Hypogeusia, Dysphagia.
Skin and subcutaneous tissue disorders Common:
Urticaria, Pruritus.
Uncommon:
Alopecia, Hyperhidrosis.
Musculoskeletal and connective tissue disorders Very common:
Hypotonia.
Common:
Hypertonia Not known: Scoliosis Renal and urinary disorders Common: Urinary retention, Urinary incontinence. Urinary retention occurs more frequently in patients with cerebral spasticity.
Reproductive system and breast disorders Common:
Sexual dysfunction.
Not known:
Erectile dysfunction General disorders and administration site conditions Common: Oedema peripheral, Face oedema, Pain, Pyrexia, Chills, Asthenia Rare: Life-threatening withdrawal symptoms due to drug delivery failure A reliable causal connection between the observed adverse events and the administration of intrathecal baclofen is not always possible as some of the observed adverse events could also be symptoms of the underlying illness being treated.
Particularly frequently occurring adverse events such as dizziness, light-headedness, somnolence, headache, nausea, drop in blood pressure, and muscle weakness are usually due to the medication. Seizures, headache, nausea, vomiting and urinary retention occur more often in patients with spasticity of cerebral origin than in patients with spasticity of spinal origin).
Ovarian cysts have been found by palpation in about 5% of the multiple sclerosis patients who were treated with oral baclofen for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the medicinal product.
Ovarian cysts are known to occur spontaneously in a proportion of the normal female population. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
In order to prevent abrupt discontinuation of intrathecal administration of baclofen, special attention should be paid to the correct programming and monitoring of the infusion system, to the time schedules and procedures for refilling the pump and to the alarm signals of the pump.
g. priapism). , patients with spinal cord injuries in the region of the sixth thoracic vertebra or higher, patients who have difficulty making themselves understood, or patients who already have a history of exhibiting withdrawal symptoms after discontinuing oral or intrathecal baclofen).
The manufacturers of infusion systems give specific instructions for the programming and refilling of the pumps, and these must be followed exactly. Experience with continuous intrathecal baclofen infusion is available only for the use of one particular pump model.
Confirmed experience with other implantable pump systems is not available. Preconditions for treatment with intrathecal baclofen include the ability to tolerate and respond to the single intrathecal injection of a dose of up to 100 micrograms of baclofen as a bolus injection in the form of intrathecal solution containing 50 micrograms baclofen in 1 ml.
Before the start of treatment with baclofen, any unsatisfactory treatment with other antispastic medications should be tailed off. Medical Support The infusion system should not be implanted before the reaction of the patient to the single intrathecal injections of baclofen 50 micrograms/1 ml is sufficiently established.
The first intrathecal administration, the implantation of the infusion system, and the first infusion and dosage-titration of baclofen are associated with risks such as CNS suppression, cardiovascular collapse and respiratory failure.
These steps must therefore be performed under in-patient conditions with the availability of intensive medical care, and the instructions on dosage must be observed. The necessary facilities and support for immediate resuscitation in cases of life- threatening symptoms should be available.
The treating physician must have specific experience in dealing with intrathecal administration and related infusion systems. Monitoring the patients After surgical implantation of the pump and particularly during the initial phase of pump activity and on changing the baclofen concentration or the infusion rate, the patient must be monitored closely until his/her condition is stable.
The treating doctor, the patient and the hospital staff as well as other persons involved in the care of the patient must be adequately informed about the risks of this method of treatment. In particular, the symptoms of overdosing or sudden withdrawal, the measures to be taken in these cases, and the care of the pump and of the implantation site must be known.
Inflammatory mass at the tip of the implanted catheter:
Cases of inflammatory mass at the tip of the implanted catheter that can result in serious neurological impairment, have been reported. However, a causal relationship with intrathecal baclofen could not be established. The most frequent symptoms associated with inflammatory mass are: 1) decreased therapeutic response (worsening spasticity, return of spasticity when previously well controlled, withdrawal symptoms, poor response to escalating doses, or frequent or large dosage increases), 2) pain, 3) neurological deficit/dysfunction.
Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, especially if using pharmacy compounded drugs or admixtures that include […]