FELBAMATE suspension

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Novitium Pharma LLC

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Felbamate oral suspension is not indicated as a first line antiepileptic treatment (see Warnings ). Felbamate oral suspension is 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 acknowledgement, felbamate oral suspension 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 oral suspension is 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 hi

Prehľad produktov:

Felbamate Oral Suspension, USP 600 mg/5 mL, is a pink colored homogeneous suspension free from visible agglomeration with bubblegum odor available in 8 oz bottles (NDC 70954-051-10) and 16 oz bottles (NDC 70954-051-20). Shake suspension well before using. Store oral suspension at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].  Dispense in a tight container.   To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 05/2022 LB4039-03

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

FELBAMATE - FELBAMATE SUSPENSION
Novitium Pharma LLC
----------
SPL MEDGUIDE
Felbamate (fel-BAM-ate) Oral Suspension, USP
Read this Medication Guide before you start taking felbamate oral
suspension 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
oral suspension?
Do not stop taking felbamate oral suspension without first talking to
your healthcare provider.
Stopping felbamate oral suspension suddenly can cause serious
problems.
Felbamate oral suspension can cause serious side effects, including:
1. Felbamate oral suspension 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 oral suspension 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 in

Súhrn charakteristických

FELBAMATE - FELBAMATE SUSPENSION
NOVITIUM PHARMA LLC
----------
FELBAMATE ORAL SUSPENSION, USP 600 MG/5 ML
BEFORE PRESCRIBING FELBAMATE, THE PHYSICIAN SHOULD BE THOROUGHLY
FAMILIAR
WITH THE DETAILS OF THIS PRESCRIBING INFORMATION.
FELBAMATE 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 WRITTEN ACKNOWLEDGEMENT (SEE
PATIENT/PHYSICIAN ACKNOWLEDGMENT FORM).
BOXED WARNING
1. APLASTIC ANEMIA
THE USE OF FELBAMATE IS ASSOCIATED WITH A MARKED INCREASE IN THE
INCIDENCE OF APLASTIC ANEMIA. ACCORDINGLY, FELBAMATE 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 WITHOUT CONSIDERATION OF APPROPRIATE EXPERT
HEMATOLOGIC CONSULTATION.
AMONG FELBAMATE 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 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, 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 FOR SEVERAL MONTHS (E.G., ONSET
OF APLASTIC ANEMIA AMONG FELBAMATE EXPOSED PATIENTS FOR WHOM DATA
ARE AVAILABLE