FELBAMATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FELBAMATE (UNII: X72RBB02N8) (FELBAMATE - UNII:X72RBB02N8)

Available from:

Alvogen Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Felbamate tablets, USP are not indicated as a first line antiepileptic treatment (see WARNINGS). Felbamate tablets are recommended for use only in those patients who respond inadequately to alternative treatments and whose epilepsy is so severe that a substantial risk of aplastic anemia and/or liver failure is deemed acceptable in light of the benefits conferred by its use. If these criteria are met and the patient has been fully advised of the risk, and has provided written acknowledgment, Felbamate tablets can be considered for either monotherapy or adjunctive therapy in the treatment of partial seizures, with and without generalization, in adults with epilepsy and as adjunctive therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children. Felbamate tablets are contraindicated in patients with known hypersensitivity to felbamate, its ingredients, or known sensitivity to other carbamates. It should not be used in patients with a history of any blood dyscras

Product summary:

Felbamate Tablets, USP contain 400 mg or 600 mg of felbamate, USP. The 400 mg tablet is white to off-white, modified capsule shaped, functionally scored, bisected tablet “FE 400” debossed on bisect side (upper) and “ALV550” on opposite side (bottom) of the tablet. They are available as follows: NDC 47781-627-01 bottles of 100 tablets The 600 mg tablet is white to off-white, modified capsule shaped, functionally scored, bisected tablet “FE 600” debossed on bisect side (upper) and “ALV551” on opposite side (bottom) of the tablet. They are available as follows: NDC 47781-630-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . PI267-00 Rev. 08/2018

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FELBAMATE- FELBAMATE TABLET
Alvogen Inc.
----------
MEDICATION GUIDE
Medication Guide
FELBAMATE TABLETS, USP
(fel bam' ate)
400 mg and 600 mg
Read this Medication Guide before you start taking felbamate tablets
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about felbamate
tablets?
Do not stop taking felbamate tablets without first talking to your
healthcare provider. Stopping felbamate
tablets suddenly can cause serious problems.
Felbamate tablets can cause serious side effects, including:
1.
Felbamate tablets may cause serious blood problems that may be
life-threatening.
Call your healthcare provider right away if you have any of the
following symptoms:
•
Fever, sore throat or other infections that come and go or do not go
away
•
Frequent infections or an infection that does not go away
•
Easy bruising
•
Red or purple spots on your body
•
Bleeding gums or nose bleeds
•
Severe fatigue or weakness
2.
Liver problems that may be life-threatening. Call your healthcare
provider right away if you have
any of these symptoms:
•
yellowing of your skin or the whites of your eyes (jaundice)
•
dark urine
•
nausea or vomiting
•
loss of appetite
•
pain on the right side of your stomach (abdomen)
3.
Like other antiepileptic drugs, felbamate tablets may cause suicidal
thoughts or actions in a very
small number of people, about 1 in 500.
4.
Call your healthcare provider right away if you have any of these
symptoms, especially if they are
new, worse, or worry you:
•
thoughts about suicide or dying
•
attempts to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (m

Summary of Product characteristics

FELBAMATE- FELBAMATE TABLET
ALVOGEN INC.
----------
RX ONLY
BEFORE PRESCRIBING FELBAMATE TABLETS, THE PHYSICIAN SHOULD BE
THOROUGHLY FAMILIAR WITH THE DETAILS
OF THIS PRESCRIBING INFORMATION.
FELBAMATE TABLETS SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS
BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT, PARENT OR
GUARDIAN HAS BEEN PROVIDED THE FELBAMATE TABLETS WRITTEN
ACKNOWLEDGMENT (SEE PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).
WARNING
1. APLASTIC ANEMIA
THE USE OF FELBAMATE TABLETS IS ASSOCIATED WITH A MARKED
INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY,
FELBAMATE TABLETS SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY
IS SO SEVERE THAT THE RISK OF APLASTIC ANEMIA IS DEEMED ACCEPTABLE
IN LIGHT OF THE BENEFITS CONFERRED BY ITS USE (SEE INDICATIONS).
ORDINARILY, A PATIENT SHOULD NOT BE PLACED ON AND/OR CONTINUED
ON FELBAMATE TABLETS WITHOUT CONSIDERATION OF APPROPRIATE
EXPERT HEMATOLOGIC CONSULTATION.
AMONG FELBAMATE TABLET TREATED PATIENTS, APLASTIC ANEMIA
(PANCYTOPENIA IN THE PRESENCE OF A BONE MARROW LARGELY DEPLETED
OF HEMATOPOIETIC PRECURSORS) OCCURS AT AN INCIDENCE THAT MAY BE
MORE THAN A 100-FOLD GREATER THAN THAT SEEN IN THE UNTREATED
POPULATION (I.E., 2 TO 5 PER MILLION PERSONS PER YEAR). THE RISK OF
DEATH IN PATIENTS WITH APLASTIC ANEMIA GENERALLY VARIES AS A
FUNCTION OF ITS SEVERITY AND ETIOLOGY; CURRENT ESTIMATES OF THE
OVERALL CASE FATALITY RATE ARE IN THE RANGE OF 20% TO 30%, BUT
RATES AS HIGH AS 70% HAVE BEEN REPORTED IN THE PAST.
THERE ARE TOO FEW FELBAMATE TABLET ASSOCIATED CASES, AND TOO
LITTLE KNOWN ABOUT THEM TO PROVIDE A RELIABLE ESTIMATE OF THE
SYNDROME'S INCIDENCE OR ITS CASE FATALITY RATE OR TO IDENTIFY THE
FACTORS, IF ANY, THAT MIGHT CONCEIVABLY BE USED TO PREDICT WHO IS
AT GREATER OR LESSER RISK.
IN MANAGING PATIENTS ON FELBAMATE TABLETS, IT SHOULD BE BORNE IN
MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT
BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBAMATE TABLETS FOR
SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBAMATE
TABLET EXPOSED PATIE