FELBAMATE PACKAGE INSERT PDF
See package insert. How to take and store Felbamate? Follow your doctor’s directions. Call if you have any questions. Usually, your doctor will tell you to start by. Felbatol is the brand name used in the United States for felbamate. Read the black box warning in the Package Insert to your patient and obtain any necessary . Felbamate, also known as Felbatol, has been approved by the Food and Drug about all potential risks before using this drug and read the package insert.
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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. Felbamate may cause hepatotoxicity and hepatic failure. Felbamate is contraindicated in patients felbaate current or previous hepatic disease or dysfunction e. In Septemberthe manufacturer issued a letter stating 8 cases of acute hepatic failure, including 4 deaths, were associated with the use of felbamate.
It is thought that hepatic failure in felbamate-treated patients greatly exceeds that which occurs in the general population. Therefore, it is recommended that felbamate only be used in patients with severe epilepsy for which the benefits of the drug outweigh the risks of hepatic failure and other toxicities. Whether pre-existing hepatic disease increases the risk of felbamate-induced hepatotoxicity is unknown.
It is not known if other risk factors exist, such as dose, concurrent use of other medications, or length of therapy. Therefore, all patients receiving felbamate should be monitored for signs of hepatotoxicity.
Monitoring packae include baseline liver function tests i. While frequent monitoring of liver function tests may increase the packae of early detection, the precise schedule for monitoring is a matter of clinical judgement. Patients should be advised to be alert for eflbamate of liver dysfunction jaundice, anorexia, gastrointestinal complaints, malaise, etc.
Felbamate should be discontinued if either serum AST or ALT levels become increased 2 or more times the upper limit of normal ULNor if clinical signs and symptoms suggest liver failure. Any patient withdrawn from the drug for liver injury are considered at increased risk for such problems if the drug is re-introduced.
Do not restart felbamate in these patients. Oral anticonvulsant agent chemically similar to meprobamate, but does not possess muscle-relaxant activity.
Used for partial seizures in adults and Lennox-Gastaut syndrome in children and adults. Previously untreated patients should be titrated under close clinical supervision. The dosage reduction of other AEDs will help maintain plasma concentrations and reduce side effects of concurrent phenytoin, valproic acid, or carbamazepine and its metabolites. Serum concentrations of other anticonvulsants should be obtained and dosage adjustments made as necessary.
The manufacturer advises to avoid use of felbamate in patients with pre-existing hepatic disease. Felbamate should only be initiated or continued in the management of seizures when, in the physician’s opinion, the patient’s seizure disorder is refractory to alternative safer anticonvulsant therapy and is so severe that the benefit from therapy outweighs the risk of acute hepatic failure and aplastic anemia.
For storage information, see specific product information within the How Supplied section. A Inserg will be available that discusses the risk of suicidal thoughts and behaviors associated with the use of anticonvulsant medications. Shake the oral suspension well before using. The effect of food on GI absorption from the oral suspension has not been evaluated. Felbamate is contraindicated in patients with a felbamate or carbamate hypersensitivity.
Patients sensitive to carbamate derivatives e. The use of felbamate is associated with a marked increase in the fflbamate of aplastic anemia pancytopenia in the presence of a bone marrow largely depleted of hematologic precursor cells. Felbamate should only be used in patients with epilepsy that is so severe that the risk of aplastic anemia is acceptable in accordance felbamxte the benefits associated with felbamate use.
A hematologic consultation is recommended to determine appropriateness of use prior to treatment. Among felbamate-treated patients, aplastic apckage occurs at an incidence that may be more than fold greater than that seen in the untreated population e.
Too little is known about felbamate-induced aplastic anemia to determine fatality percentages felbaate which patients are more at risk for this serious adverse reaction. Clinical manifestations may not be present for several months after therapy is initiated; where data are available the onset has ranged from 5 to 30 weeks after the start of therapy.
Bone marrow stem cell changes may occur weeks to months earlier than clinical presentation. Patients who are discontinued off the drug therefore remain at risk for aplastic anemia for an unknown time after drug discontinuation. It is not known if the duration of felbamate exposure or the dose used influences the risk for aplastic anemia.
It is also not known if concurrent therapies may influence this risk. Clinical signs and symptoms may include infection, bleeding, or anemia. Routine laboratory testing of the blood cannot be packave used to reduce the incidence of aplastic anemia.
Felbamate is contraindicated in patients with a history of any hematological disease e. A baseline CBC with platelets and reticulocytes should be obtained, as well as routine laboratory monitoring throughout treatment.
Felbamate should be discontinued if signs and symptoms of hematologic abnormalities febamate any sign of bone marrow depression occurs. Patients who are discontinued from felbamats remain at risk for developing anemia for an uncertain length of time.
Use felbamate with caution in patients with pre-existing renal impairment, particularly renal failure. The half-life of the drug is prolonged and clearance reduced. Dosage adjustments are recommended. In Januarythe FDA alerted healthcare professionals of an increased risk of suicidal ideation and behavior in patients receiving anticonvulsants to treat epilepsy, psychiatric disorders, or other conditions e.
This alert followed an initial request by the FDA in March for manufacturers of marketed anticonvulsants to provide data from existing controlled clinical trials for analysis. Prior to this request, preliminary evidence had suggested a possible link between anticonvulsant use and suicidality. There were 4 completed suicides among patients in drug treatment groups versus none in the placebo groups. Patients receiving anticonvulsants had approximately twice the risk of suicidal behavior or ideation 0.
The relative risk for suicidality was higher in patients with epilepsy compared to those with other conditions; however, the absolute risk differences were similar in trials for epilepsy and psychiatric indications.
Age was not a determining factor. The increased risk of suicidal ideation and behavior was observed between 1 and 24 weeks after therapy initiation. However, a longer duration of therapy should not preclude the possibility of an association to the drug since most studies included in the analysis did not continue beyond 24 weeks.
Data were analyzed from drugs with adequately designed clinical trials including carbamazepine, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine, topiramate, valproate, and zonisamide. However, this is considered to be a class effect. Patients and caregivers should be informed of the increased risk of suicidal thoughts and behaviors and should be advised to immediately report the emergence or worsening of depression, the emergence of suicidal thoughts or behavior, thoughts of self-harm, or other unusual changes in mood or behavior.
Anticonvulsants such as felbamate should be prescribed in the smallest quantity consistent with good patient management in order to reduce the risk of overdose.
Felbatol (felbamate) dose, indications, adverse effects, interactions from
Felbamate is classified as FDA pregnancy risk category C. There are no studies in pregnant women to determine the effect of felbamate on the fetus. It is not teratogenic in animal models. However, in rats, there was a decrease in pup weight and an increase in pup deaths during the post-birth lactation period; the cause for these deaths is not known.
In addition, as a result of the synthesis process, felbamate could contain small amounts of two known animal carcinogens, the genotoxic compound ethyl carbamate urethane and the non-genotoxic compound methyl carbamate.
The serious toxicities of felbamate, such as aplastic anemia, would also warrant that felbamate be used during pregnancy only if clearly needed.
The effect of felbamate on labor and delivery in humans is unknown. Physicians are advised to recommend that pregnant patients receiving felbamate enroll in the North American Antiepileptic Drug NAAED Pregnancy Registry to provide information about the effects of in utero exposure to the drug. Patients must call to enroll in the registry. According to the manufacturer, felbamate is excreted into breast milk, but its effects on the infant are unknown.
In rats, there was a decrease in pup weight and an increase in pup deaths during lactation; the reason for the deaths is not determined. Inser of the serious toxicities associated with the drug, including aplastic anemia and hepatic failure, breast-feeding should generally be avoided during treatment with felbamate.
Consider the benefits of breast-feeding, the risk of potential drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding baby experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse inssrt to the FDA.
The safety and efficacy of felbamate in children, other than those with Lennox-Gastaut syndrome, have not been studied. The drug is not recommended for children under the age of 2 years or in infants. No insetr studies of felbamate in geriatric patients have been conducted. Clinical studies did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently to felbamate than younger adults.
Other reported clinical experience has not identified differences in responses. In general, dosage telbamate for geriatric patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. According to the Beers Criteria, anticonvulsants such as felbamate are considered potentially inappropriate medications PIMs in geriatric patients with a history of falls or fractures and should be avoided in these patient populations, with the exception of treating seizure and mood disorders, since anticonvulsants can produce ataxia, impaired psychomotor function, syncope, and additional falls.
If felbamate must be used, consider reducing use of other CNS-active medications that increase inseet risk of falls and fractures and implement other strategies to reduce fall risk. According to the OBRA guidelines, some anticonvulsants may be used to treat disorders other than seizures e. The need for indefinite continuation in treating any condition should be based on confirmation of the condition and its potential cause s.
Determining effectiveness and tolerability through evaluation of symptoms should be used to adjust doses. Therapeutic drug monitoring is not required or available for most anticonvulsants. In addition, significant signs and symptoms of toxicity can occur at normal or low serum concentrations, and symptom control for seizures or behavior can occur at subtherapeutic serum concentrations. Obtaining serum medication concentrations may assist in felbamaye toxicity.
High or toxic serum concentrations should become a consideration for dosage adjustments.
Anticonvulsants may cause liver dysfunction, blood dyscrasias, and serious skin rashes requiring treatment discontinuation. When an anticonvulsant is being used to manage behavior, stabilize mood, or treat a psychiatric disorder, the facility should attempt periodic tapering of the medication or provide documentation of medical necessity in accordance with OBRA guidelines. Major Avoid concurrent use of dolutegravir with felbamate, as coadministration may result in decreased dolutegravir plasma concentrations.
Felbamate is an inducer of CYP3A, dolutegravir is partially metabolized by this isoenzyme. Moderate Concomitant administration of alprazolam with CNS-depressant drugs, including anticonvulsants, can potentiate the CNS effects of either agent. Moderate Amoxapine, when used concomitantly with anticonvulsants, can increase CNS depression and may also lower the seizure threshold, leading to pharmacodynamic interactions.
Major Coadministration of felbamate and clarithromycin may decrease clarithromycin serum concentrations due to CYP3A4 enzyme induction. While the OH-clarithromycin active metabolite concentrations are increased, this metabolite has different antimicrobial activity compared to clarithromycin. The intended therapeutic effect of clarithromycin could be decreased.