Felbatol: Package Insert and Label Information (Page 4 of 5)

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

Medication Guide

FELBATOL (Fel-ba-taal)

(felbamate)

Tablets and Oral Suspension

IS-00431-02 Rev. 2/2018
SOV-IS-00431-02 Rev. 2/2018

Read this Medication Guide before you start taking FELBATOL 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 FELBATOL?
Do not stop taking FELBATOL without first talking to your healthcare provider.
Stopping FELBATOL suddenly can cause serious problems.

FELBATOL can cause serious side effects, including:

1. FELBATOL 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, FELBATOL may cause suicidal thoughts or actions in a very small number of people, about 1 in 500.

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 (mania)
other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?

Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
Keep all follow-up visits with your healthcare provider as scheduled.

Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop FELBATOL without first talking to a healthcare provider.

Stopping FELBATOL suddenly can cause serious problems. You should talk to your health care provider before stopping. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures.

Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

What is FELBATOL?

FELBATOL is a prescription medicine used when other treatments have failed in:

adults alone or with other medicines to treat:
partial seizures with and without generalization
children with other medicines to treat:
seizures associated with Lennox-Gastaut syndrome

Who should not take FELBATOL?

Do not take FELBATOL if you:

are allergic to felbamate, carbamates or any of the ingredients in FELBATOL. See the end of this Medication Guide for a complete list of ingredients in FELBATOL.
have or have had blood problems
have or have had liver problems

What should I tell my healthcare provider before taking FELBATOL?

Before you take FELBATOL, tell your healthcare provider if you:

have kidney problems
have or have had depression, mood problems, or suicidal thoughts or behavior
have any other medical conditions
are pregnant or plan to become pregnant. It is not known if FELBATOL can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking FELBATOL. You and your healthcare provider will decide if you should take FELBATOL while you are pregnant.
If you become pregnant while taking FELBATOL, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy. You can enroll in this registry by calling 1-888-233-2334.
are breastfeeding or plan to breastfeed. FELBATOL may pass into your breast milk. You and your healthcare provider should decide if you should take FELBATOL while you breastfeed.

Tell your healthcare provider about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking FELBATOL with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take FELBATOL?

Take FELBATOL exactly as your healthcare provider tells you. Your healthcare provider will tell you how much FELBATOL to take and when to take it.
Your healthcare provider may change your dose of FELBATOL. Do not change your dose of FELBATOL without talking to your healthcare provider.
Because of the risk of serious blood and liver problems, your healthcare provider may do blood tests before you start and while you take FELBATOL.
If you take too much FELBATOL, call your healthcare provider or local Poison Control Center right away.
Do not stop FELBATOL without first talking to your healthcare provider.

What should I avoid while taking FELBATOL?

FELBATOL can cause drowsiness and dizziness. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking FELBATOL, until you talk with your doctor. Taking FELBATOL with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.

What are the possible side effects of FELBATOL?

See “What is the most important information I should know about FELBATOL?”

FELBATOL may cause serious side effects including:

The most common side effects of FELBATOL include:

weight loss
vomiting
trouble sleeping
nausea
dizziness
sleepiness
headache
double-vision
changes in the way that food tastes

These are not all the possible side effects of FELBATOL. For more information, ask your healthcare provider or pharmacist.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FELBATOL?

Store FELBATOL at room temperature between 68°F to 77°F (20°C to 25°C).

Keep FELBATOL and all medicines out of the reach of children.

General information about FELBATOL.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FELBATOL for a condition for which it was not prescribed. Do not give FELBATOL to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about FELBATOL. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FELBATOL that is written for health professionals.

What are the ingredients in FELBATOL?

Active Ingredient: felbamate

Tablet Inactive Ingredients: starch, microcrystalline cellulose, croscarmellose sodium, lactose, magnesium stearate, FD&C yellow No. 6, D&C Yellow No. 10, and FD&C Red No. 40 (600 mg tablets only).

Suspension Inactive Ingredients: sorbitol, glycerin, microcrystalline cellulose, carboxymethylcellulose sodium, simethicone, polysorbate 80, methylparaben, saccharain sodium, propylparaben, FD&C Yellow No. 6, FD&C Red No. 40, flavorings, and purified water.

For more information, go to www. FELBATOL.com or call 1-800-526-3840.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

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

Issued 2/2018

IS-00431-02 Rev. 2/2018
SOV-IS-00431-02 Rev. 2/2018

Rx Only

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