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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (F's) » Felbamate



DESCRIPTION

FELBATOL (felbamate)
Tablets 400 mg and 600 mg,
Oral Suspension 600 mg/5 mL

Before Prescribing Felbatol (felbamate), the physician should be thoroughly familiar with the details of this prescribing information. FELBATOL SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND THE PATIENT, PARENT, OR GUARDIAN HAS PROVIDED WRITTEN INFORMED CONSENT (SEE PATIENT INFORMATION SECTION).

WARNING 

1. APLASTIC ANEMIA

THE USE OF FELBATOL (felbamate) IS ASSOCIATED WITH A MARKED INCREASE IN THE INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY FELBATOL 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 FELBATOL WITHOUT CONSIDERATION OF APPROPRIATE EXPERT HEMATOLOGIC CONSULTATION.

AMONG FELBATOL 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 FELBATOL 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 FELBATOL, IT SHOULD BE BORNE IN MIND THAT THE CLINICAL MANIFESTATION OF APLASTIC ANEMIA MAY NOT BE SEEN UNTIL AFTER A PATIENT HAS BEEN ON FELBATOL FOR SEVERAL MONTHS (E.G., ONSET OF APLASTIC ANEMIA AMONG FELBATOL EXPOSED PATIENTS FOR WHOM DATA ARE AVAILABLE HAS RANGED FROM 5 TO 30 WEEKS). HOWEVER, THE INJURY TO BONE MARROW STEM CELLS THAT IS HELD TO BE ULTIMATELY RESPONSIBLE FOR THE ANEMIA MAY OCCUR WEEKS TO MONTHS EARLIER. ACCORDINGLY, PATIENTS WHO ARE DISCONTINUED FROM FELBATOL REMAIN AT RISK FOR DEVELOPING ANEMIA FOR A VARIABLE, AND UNKNOWN, PERIOD AFTERWARDS.

IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING APLASTIC ANEMIA CHANGES WITH DURATION OF EXPOSURE. CONSEQUENTLY, IT IS NOT SAFE TO ASSUME THAT A PATIENT WHO HAS BEEN ON FELBATOL WITHOUT SIGNS OF HEMATOLOGIC ABNORMALITY FOR LONG PERIODS OF TIME IS WITHOUT RISK.

IT IS NOT KNOWN WHETHER OR NOT THE DOSE OF FELBATOL AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.

IT IS NOT KNOWN WHETHER OR NOT CONCOMITANT USE OF ANTIEPILEPTIC DRUGS AND/ OR OTHER DRUGS AFFECTS THE INCIDENCE OF APLASTIC ANEMIA.

APLASTIC ANEMIA TYPICALLY DEVELOPS WITHOUT PREMONITORY CLINICAL OR LABORATORY SIGNS, THE FULL BLOWN SYNDROME PRESENTING WITH SIGNS OF INFECTION, BLEEDING OR ANEMIA. ACCORDINGLY, ROUTINE BLOOD TESTING CANNOT BE RELIABLY USED TO REDUCE THE INCIDENCE OF APLASTIC ANEMIA, BUT, IT WILL, IN SOME CASES, ALLOW THE DETECTION OF THE HEMATOLOGIC CHANGES BEFORE THE SYNDROME DECLARES ITSELF CLINICALLY. FELBATOL SHOULD BE DISCONTINUED IF ANY EVIDENCE OF BONE MARROW DEPRESSION OCCURS.

2. HEPATIC FAILURE

HEPATIC FAILURE RESULTING IN FATALITIES HAS BEEN REPORTED WITH A MARKED INCREASE IN THE FREQUENCY IN PATIENTS RECEIVING FELBATOL (felbamate). ACCORDINGLY, FELBATOL SHOULD ONLY BE USED IN PATIENTS WHOSE EPILEPSY IS SO SEVERE THAT THE RISK OF LIVER FAILURE IS OUTWEIGHED BY THE POTENTIAL BENEFITS OF SEIZURE CONTROL. 

ALTHOUGH FULL INFORMATION IS NOT YET AVAILABLE, THE NUMBER OF CASES REPORTED GREATLY EXCEEDS THE NUMBER THAT IS EXPECTED BASED ON THE ANNUAL INCIDENCE OF ACUTE LIVER FAILURE IN THE UNITED STATES (I.E., ABOUT 2,000 CASES PER YEAR).

THERE ARE TOO FEW FELBATOL ASSOCIATED CASES OF HEPATIC FAILURE AND TOO LITTLE KNOWN ABOUT THEM TO PROVIDE EITHER A RELIABLE ESTIMATE OF ITS INCIDENCE OR TO IDENTIFY THE FACTORS, IF ANY, THAT MIGHT BE USED TO PREDICT WHICH PATIENT IS AT GREATER OR LESSER RISK.

IT IS NOT KNOWN WHETHER OR NOT THE RISK OF DEVELOPING HEPATIC FAILURE CHANGES WITH DURATION OF EXPOSURE.

IT IS NOT KNOWN WHETHER OR NOT THE DOSAGE OF FELBATOL AFFECTS THE INCIDENCE OF HEPATIC FAILURE.

IT IS NOT KNOWN WHETHER CONCOMITANT USE OF OTHER ANTIEPILEPTIC DRUGS AND/ OR OTHER DRUGS AFFECTS THE INCIDENCE OF HEPATIC FAILURE. 

FELBATOL SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A HISTORY OF HEPATIC DYSFUNCTION.

PATIENTS PRESCRIBED FELBATOL SHOULD HAVE LIVER FUNCTION TESTS (AST, ALT, BILIRUBIN) PERFORMED BEFORE INITIATING FELBATOL AND AT 1- TO 2- WEEK INTERVALS WHILE TREATMENT CONTINUES. A PATIENT WHO DEVELOPS ABNORMAL LIVER FUNCTION TESTS SHOULD BE IMMEDIATELY WITHDRAWN FROM FELBATOL TREATMENT.

Felbatol® (felbamate) is an antiepileptic available as 400 mg and 600 mg tablets and as a 600 mg/5 mL suspension for oral administration. Its chemical name is 2-phenyl-1,3-propanediol dicarbamate.

Felbamate is a white to off-white crystalline powder with a characteristic odor. It is very slightly soluble in water, slightly soluble in ethanol, sparingly soluble in methanol, and freely soluble in dimethyl sulfoxide. The molecular weight is 238.24; felbamate's molecular formula is C11H14N2O4.

The inactive ingredients for Felbatol® (felbamate) tablets 400 mg and 600 mg are starch, microcrystalline cellulose, croscarmallose sodium, lactose, magnesium stearate, FD&C Yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg tablets only). The inactive ingredients for Felbatol® (felbamate) suspension 600 mg/5 mL are sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharin sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water.





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