"The U.S. Food and Drug Administration today approved Aptiom (eslicarbazepine acetate) as an add-on medication to treat seizures associated with epilepsy.
Epilepsy is a brain disorder caused by abnormal or excessive activity in the brain"...
Patients should be informed that the use of Felbatol® is associated with aplastic anemia and hepatic failure, potentially fatal conditions acutely or over a long term.
The physician should obtain written acknowledgement prior to initiation of Felbatol® therapy (see PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM section).
Patients should be instructed to read the Medication Guide supplied as required by law when Felbatol® is dispensed. The complete text of the Medication Guide is reprinted at the end of this document.
Aplastic anemia in the general population is relatively rare. The absolute risk for the individual patient is not known with any degree of reliability, but patients on Felbatol® may be at more than a 100 fold greater risk for developing the syndrome than the general population.
The long term outlook for patients with aplastic anemia is variable. Although many patients are apparently cured, others require repeated transfusions and other treatments for relapses, and some, although surviving for years, ultimately develop serious complications that sometimes prove fatal (e.g., leukemia).
At present there is no way to predict who is likely to get aplastic anemia, nor is there a documented effective means to monitor the patient so as to avoid and/or reduce the risk. Patients with a history of any blood dyscrasia should not receive Felbatol®.
Patients should be advised to be alert for signs of infection, bleeding, easy bruising, or signs of anemia (fatigue, weakness, lassitude, etc.) and should be advised to report to the physician immediately if any such signs or symptoms appear.
Hepatic failure in the general population is relatively rare. The absolute risk for an individual patient is not known with any degree of reliability but patients on Felbatol® are at a greater risk for developing hepatic failure than the general population.
At present, there is no way to predict who is likely to develop hepatic failure, however, patients with a history of hepatic dysfunction should not be started on Felbatol®.
Patients should be advised to follow their physician's directives for liver function testing both before starting Felbatol® (felbamate) and at frequent intervals while taking Felbatol®.
Patients should be advised to be alert for signs of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they should occur.
Full hematologic evaluations should be performed before Felbatol® therapy, frequently during therapy, and for a significant period of time after discontinuation of Felbatol® therapy. While it might appear prudent to perform frequent CBCs in patients continuing on Felbatol®, there is no evidence that such monitoring will allow early detection of marrow suppression before aplastic anemia occurs, (see BOXED WARNINGS). Complete pretreatment blood counts, including platelets and reticulocytes should be obtained as a baseline. If any hematologic abnormalities are detected during the course of treatment, immediate consultation with a hematologist is advised. Felbatol® should be discontinued if any evidence of bone marrow depression occurs.
See BOXED WARNINGS for recommended monitoring of serum transaminases. If significant, confirmed liver abnormalities are detected during the course of Felbatol® treatment, Felbatol® should be discontinued immediately with continued liver function monitoring until values return to normal, (see PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).
Suicidal Thinking and Behavior
Patients, their caregivers, and families should be counseled that AEDs, including Felbatol®, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Patients should be encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if they become pregnant. This registry is collecting information about the safely of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 (see Pregnancy section).
PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM
FELBATOL® (felbamate) SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS.
All patients treated with Felbatol should acknowledge that they understand the risks and other information about Felbatol discussed below, and physicians should acknowledge this discussion.
IMPORTANT INFORMATION AND WARNING:
Felbatol®, taken by itself or with other prescription and/or non-prescription drugs, can result in a severe, potentially fatal blood abnormality ("aplastic anemia") and/or severe, potentially fatal liver damage.
Do not sign this form if there is anything you do not understand about the information you have received. Ask your doctor about anything you do not understand before you initial any of the items below or sign this form.
My [My son, daughter, ward________________________________________________________?s] treatment with Felbatol® has been personally explained to me by Dr.____________________________.
The following points of information, among others, have been specifically discussed and made clear and I have had the opportunity to ask any questions concerning this information:
1.1,____________________________________________________________(Patient's Name), understand that Felbatol® is used to treat certain types of seizures and my physician has told me that I have this type(s) of seizures;
2.1 understand that Felbatol® is being used because my seizures have not been satisfactorily treated with other antiepileptic drugs;
3.1 understand that there is a serious risk that I could develop aplastic anemia and/or liver failure, both of which are potentially fatal, by using Felbatol®; INITIALS:_________________________
4.1 understand that there are no laboratory tests which will predict if I am at an increased risk for one of the potentially fatal conditions; INITIALS:_________________________
5.1 understand that I should have the recommended blood work before my treatment with Felbatol® is begun (baseline) and periodically thereafter as clinical judgement warrants. I understand that although this blood work may help detect if I develop one of these conditions, it may do so only after significant, irreversible and potentially fatal damage has already occurred; INITIALS:_________________________
6. If I am currently taking other antiepileptic drugs, I understand that the manufacturer of Felbatol® recommends that the dosage of these other drugs be decreased by a certain amount when Felbatol® is started; if my physician determines that this should not be done in my case, he/she has explained the reason(s) for this decision; INITIALS:_________________________
7.1 understand that I must immediately report any unusual symptoms to Dr.______________________ and be especially aware of any rashes, easy bruising, bleeding, sore throats, fever, and/or dark urine; INITIALS:_________________________
8.1 understand that antiepileptic drugs such as Felbatol® may increase the risk of suicidal thoughts and behavior. I understand that I must immediately report any unusual changes in mood or behavior, symptoms of depression or thoughts about self-harm to Dr.___________________.
Patient, Parent, or Guardian
I have fully explained to the patient,_________________________________________, the nature and purpose of the treatment with Felbatol (felbamate) and the potential risks associated with that treatment. I have asked the patient if he/she has any questions regarding this treatment or the risks and have answered those questions to the best of my ability. I also acknowledge that I have read and understand the prescribing information.
Physician ................ Date ..............
NOTE TO PHYSICIAN: It is strongly recommended that you retain a signed copy of the Patient/Physician Acknowledgment Form with the patient's medical records.
Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.
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