Felbatol (Page 5 of 7)

DRUG ABUSE AND DEPENDENCE

Abuse: Abuse potential was not evaluated in human studies.

Dependence: Rats administered felbamate orally at doses 8.3 times the recommended human dose 6 days each week for 5 consecutive weeks demonstrated no signs of physical dependence as measured by weight loss following drug withdrawal on day 7 of each week.

OVERDOSAGE

Four subjects inadvertently received Felbatol® (felbamate) as adjunctive therapy in dosages ranging from 5400 to 7200 mg/day for durations between 6 and 51 days. One subject who received 5400 mg/day as monotherapy for 1 week reported no adverse experiences. Another subject attempted suicide by ingesting 12,000 mg of Felbatol® in a 12-hour period. The only adverse experiences reported were mild gastric distress and a resting heart rate of 100 bpm. No serious adverse reactions have been reported. General supportive measures should be employed if overdosage occurs. It is not known if felbamate is dialyzable.

DOSAGE AND ADMINISTRATION

Felbatol® (felbamate) has been studied as monotherapy and adjunctive therapy in adults and as adjunctive therapy in children with seizures associated with Lennox-Gastaut syndrome. As Felbatol® is added to or substituted for existing AEDs, it is strongly recommended to reduce the dosage of those AEDs in the range of 20-33% to minimize side effects (see Drug Interactions subsection).

Dosage Adjustment in the Renally Impaired: Felbamate should be used with caution in patients with renal dysfunction. In the renally impaired, starting and maintenance doses should be reduced by one-half (see CLINICAL PHARMACOLOGY / Pharmacokinetics and PRECAUTIONS). Adjunctive therapy with medications which affect felbamate plasma concentrations, especially AEDs, may warrant further reductions in felbamate daily doses in patients with renal dysfunction.

Adults (14 years of age and over) The majority of patients received 3600 mg/day in clinical trials evaluating its use as both monotherapy and adjunctive therapy.

Monotherapy: (Initial therapy) Felbatol® (felbamate) has not been systematically evaluated as initial monotherapy. Initiate Felbatol® at 1200 mg/day in divided doses three or four times daily. The prescriber is advised to titrate previously untreated patients under close clinical supervision, increasing the dosage in 600-mg increments every 2 weeks to 2400 mg/day based on clinical response and thereafter to 3600 mg/day if clinically indicated.

Conversion to Monotherapy: Initiate Felbatol® at 1200 mg/day in divided doses three or four times daily. Reduce the dosage of concomitant AEDs by one-third at initiation of Felbatol® therapy. At week 2, increase the Felbatol® dosage to 2400 mg/day while reducing the dosage of other AEDs up to an additional one-third of their original dosage. At week 3, increase the Felbatol® dosage up to 3600 mg/day and continue to reduce the dosage of other AEDs as clinically indicated.

Adjunctive Therapy: Felbatol® should be added at 1200 mg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma concentrations of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of Felbatol® by 1200 mg/day increments at weekly intervals to 3600 mg/day. Most side effects seen during Felbatol® adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.

Table 6 Dosage Table (adults)
*See Adjunctive and Conversion to Monotherapy sections.

Dosage reduction of concomitant AEDs

WEEK 1 REDUCE original dose by20–33%*

WEEK 2 REDUCE original dose byup to an additional 1/3*

WEEK 3 REDUCE asclinicallyindicated

Felbatol®Dosage

1200 mg/day Initial dose

2400 mg/dayTherapeutic dosage range

3600 mg/dayTherapeutic dosage range

Children with Lennox-Gastaut Syndrome (Ages 2-14 years)
Adjunctive Therapy: Felbatol® should be added at 15 mg/kg/day in divided doses three or four times daily while reducing present AEDs by 20% in order to control plasma levels of concurrent phenytoin, valproic acid, phenobarbital, and carbamazepine and its metabolites. Further reductions of the concomitant AEDs dosage may be necessary to minimize side effects due to drug interactions. Increase the dosage of Felbatol® by 15 mg/kg/day increments at weekly intervals to 45 mg/kg/day. Most side effects seen during Felbatol® adjunctive therapy resolve as the dosage of concomitant AEDs is decreased.

HOW SUPPLIED

Felbatol® (felbamate) Tablets, 400 mg, are yellow, scored, capsule-shaped tablets, debossed 0430 on one side and FELBATOL 400 on the other; available in bottles of 100 (NDC 0037-0430-01). Felbatol® (felbamate) Tablets, 600 mg, are peach-colored, scored, capsule-shaped tablets, debossed 0431 on one side and FELBATOL 600 on the other; available in bottles of 100 (NDC 0037-0431-01). Felbatol® (felbamate) Oral Suspension, 600 mg/5 mL, is peach-colored; available in 8 oz bottles (NDC 0037-0442-67) and 32 oz bottles (NDC 0037-0442-17).

Shake suspension well before using. Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in tight container.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured for:
MEDA Pharmaceuticals Inc.
Somerset, NJ 08873 U.S.A.

FELBATOL is a registered trademark of Meda Pharmaceuticals Inc., a Mylan company

© 2018 Mylan Specialty LP

IN-00431-19/140907-0218 Rev. 2/2018
SOV-IN-00431-19/500489-02 Rev. 2/2018

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.

PATIENT ACKNOWLEDGMENT:

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. I, (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;
INITIALS:

2. I understand that Felbatol® is being used because my seizures have not been satisfactorily treated with other antiepileptic drugs;
INITIALS:

3. I 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. I 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. I 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. I 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. I 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. .
INITIALS:


Patient, Parent, or Guardian


Address


Telephone

PHYSICIAN STATEMENT:
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

Revised: 7/11

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.

SUPPLY OF PATIENT/PHYSICIAN ACKNOWLEDGMENT FORMS: A supply of “Patient/Physician Acknowledgement ” Forms as printed above is available, free of charge, from your local MEDA Pharmaceuticals representative, or may be obtained by calling 1-800-526-3840. Permission to use the above Patient/Physician Acknowledgment Form by photocopy reproduction is also hereby granted by MEDA Pharmaceuticals Inc.

MEDA Pharmaceuticals®
MEDA Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

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