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Prescribing Information
 




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About Felbatol
CAN FELBATOL HELP REFRACTORY EPILEPSY?
FELBATOL is an effective medication for the treatment of severe refractory epilepsy. The medicine can have serious side effects. This means that doctors will prescribe FELBATOL only if the risks from seizures are greater than the possible side effects of the medication. You must understand these risks and provide written informed consent before taking FELBATOL. In adults, FELBATOL may help control partial seizures. This type of seizure starts with a "stray spark" in one area of the brain. The seizure affects the part of the body that the area of the brain controls. Partial seizures can sometimes become generalized (spreading to both sides of the brain). In children, FELBATOL may help control seizures associated with Lennox-Gastaut syndrome. This kind of refractory epilepsy is characterized by different types of seizures, including, among others:
  • Tonic-clonic (grand mal) seizures - the child may pass out, fall down, and the whole body can become stiff and spasm
  • Atonic seizures (drop attacks) - the child suddenly loses muscle tone, and the head may drop forward; the arms and legs can get weak and the child may fall over
Common side effects
More common side effects of FELBATOL include weight loss, problems sleeping, headache, and nausea. If these side effects occur, tell your doctor right away. You should also tell your doctor about all other medications you or your child are taking because FELBATOL might interact with these drugs.

WHAT ARE THE SERIOUS SIDE EFFECTS?
FELBATOL has been associated with serious side effects. One of them is called aplastic anemia. This happens when the marrow (tissue inside the bones) is damaged and cannot make as many blood cells. Aplastic anemia can be fatal.

Symptoms include:
  • Fever/chills
  • Fatigue
  • Bleeding
  • Easy bruising
  • Signs of infection
Liver failure is a serious side effect that can be fatal. Symptoms may include:
  • Dark urine along with nausea/vomiting
  • Yellowing of the skin and eyes (jaundice) along with nausea/vomiting If you experience any of the above symptoms, contact your doctor immediately.
How to recognize serious side effects
Have regular blood tests
  • Your doctor will order routine blood tests
  • It is your responsibility to make sure that the doctor has received the lab results
See the warning signs
  • Watch for symptoms listed in the section on the left page
  • If you see or experience any of these symptoms, contact your doctor right away
  • Do not stop taking the medication without first talking with your doctor
Talk with your doctor
  • Check back with your doctor on a regular basis
  • Report progress, setbacks, side effects, and other observations related to treatment
  • Request regular checkups if your doctor has not set them up
IS FELBATOL RIGHT FOR ME?
Doctors offer FELBATOL as an option when patients face the serious risks of severe refractory epilepsy. Only you and your doctor can decide if FELBATOL is right for you or your child.

As previously outlined, FELBATOL has been associated with serious side effects. Patients with a history of blood disorders or liver problems should not take FELBATOL. Your doctor, who is familiar with your epilepsy and your medical history, can explain the possible risks and the potential benefits of treatment with FELBATOL.

Consider these facts when you talk with your doctor:
  • Refractory epilepsy may pose significant health risks
  • Quality of life should be improved when uncontrolled seizures are effectively treated
  • Some patients with refractory epilepsy can benefit from trying new medication
  • FELBATOL has been effective in treating refractory epilepsy in some patients

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Indication
  • FELBATOL (felbamate) should not be used as initial therapy in epilepsy (see Warnings in full Prescribing Information).
  • FELBATOL is recommended for use only in those patients who do not respond well to other treatments and whose epilepsy is so severe that the potential risk of developing aplastic anemia (a severe blood disorder) or liver failure is outweighed by the potential benefit of felbamate treatment.
  • After the patient or their caregiver has discussed the potential risks of Felbatol treatment with their doctor and have provided written consent, FELBATOL treatment can be considered. FELBATOL, by itself or in combination with other drugs is approved for the treatment of partial seizures, with or without generalization, in adults with epilepsy, and as combination therapy in the treatment of partial and generalized seizures associated with Lennox-Gastaut syndrome in children.
Important Risk Information
  • FELBATOL should not be used in patients with a history of any blood or liver problems.
  • Routine blood tests should be performed that can help identify potential blood or liver problems.
  • FELBATOL should be discontinued if there is evidence that blood or liver problems have occurred.
  • Monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
  • The most common adverse experiences observed in clinical studies are loss of appetite, vomiting, insomnia, nausea, headache, and sleepiness.
Please see the full Prescribing Information for additional safety information.


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
EVALUATION OF POSTMARKETING EXPERIENCE SUGGESTS THAT ACUTE LIVER FAILURE IS ASSOCIATED WITH THE USE OF FELBATOL®. THE REPORTED RATE IN THE U.S. HAS BEEN ABOUT 6 CASES OF LIVER FAILURE LEADING TO DEATH OR TRANSPLANT PER 75,000 PATIENT YEARS OF USE. THIS RATE IS AN UNDERESTIMATE BECAUSE OF UNDER REPORTING, AND THE TRUE RATE COULD BE CONSIDERABLY GREATER THAN THIS. FOR EXAMPLE, IF THE REPORTING RATE IS 10%, THE TRUE RATE WOULD BE ONE CASE PER 1,250 PATIENT YEARS OF USE. OF THE CASES REPORTED, ABOUT 67% RESULTED IN DEATH OR LIVER TRANSPLANTATION, USUALLY WITHIN 5 WEEKS OF THE ONSET OF SIGNS AND SYMPTOMS OF LIVER FAILURE. THE EARLIEST ONSET OF SEVERE HEPATIC DYSFUNCTION FOLLOWED SUBSEQUENTLY BY LIVER FAILURE WAS 3 WEEKS AFTER INITIATION OF FELBATOL®. ALTHOUGH SOME REPORTS DESCRIBED DARK URINE AND NONSPECIFIC PRODROMAL SYMPTOMS (E.G., ANOREXIA, MALAISE, AND GASTROINTESTINAL SYMPTOMS), IN OTHER REPORTS IT WAS NOT CLEAR IF ANY PRODROMAL SYMPTOMS PRECEDED THE ONSET OF JAUNDICE. 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 AFFECT THE INCIDENCE OF HEPATIC FAILURE.
FELBATOL® SHOULD NOT BE PRESCRIBED FOR ANYONE WITH A HISTORY OF HEPATIC DYSFUNCTION. TREATMENT WITH FELBATOL® SHOULD BE INITIATED ONLY IN INDIVIDUALS WITHOUT ACTIVE LIVER DISEASE AND WITH NORMAL BASELINE SERUM TRANSAMINASES. IT HAS NOT BEEN PROVED THAT PERIODIC SERUM TRANSAMINASE TESTING WILL PREVENT SERIOUS INJURY BUT IT IS GENERALLY BELIEVED THAT EARLY DETECTION OF DRUG-INDUCED HEPATIC INJURY ALONG WITH IMMEDIATE WITHDRAWAL OF THE SUSPECT DRUG ENHANCES THE LIKELIHOOD FOR RECOVERY. THERE IS NO INFORMATION AVAILABLE THAT DOCUMENTS HOW RAPIDLY PATIENTS CAN PROGRESS FROM NORMAL LIVER FUNCTION TO LIVER FAILURE, BUT OTHER DRUGS KNOWN TO BE HEPATOTOXINS CAN CAUSE LIVER FAILURE RAPIDLY (E.G., FROM NORMAL ENZYMES TO LIVER FAILURE IN 2-4 WEEKS). ACCORDINGLY, MONITORING OF SERUM TRANSAMINASE LEVELS (AST AND ALT) IS RECOMMENDED AT BASELINE AND PERIODICALLY THEREAFTER. WHILE THE MORE FREQUENT THE MONITORING THE GREATER THE CHANCES OF EARLY DETECTION, THE PRECISE SCHEDULE FOR MONITORING IS A MATTER OF CLINICAL JUDGEMENT. FELBATOL® SHOULD BE DISCONTINUED IF EITHER SERUM AST OR SERUM ALT LEVELS BECOME INCREASED = 2 TIMES THE UPPER LIMIT OF NORMAL, OR IF CLINICAL SIGNS AND SYMPTOMS SUGGEST LIVER FAILURE (SEE PRECAUTIONS). PATIENTS WHO DEVELOP EVIDENCE OF HEPATOCELLULAR INJURY WHILE ON FELBATOL® AND ARE WITHDRAWN FROM THE DRUG FOR ANY REASON SHOULD BE PRESUMED TO BE AT INCREASED RISK FOR LIVER INJURY IF FELBATOL® IS REINTRODUCED. ACCORDINGLY, SUCH PATIENTS SHOULD NOT BE CONSIDERED FOR RETREATMENT.