BRIVIACT- brivaracetam tablet, film coated BRIVIACT- brivaracetam solution BRIVIACT- brivaracetam injection, suspension

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

brivaracetam (UNII: U863JGG2IA) (brivaracetam - UNII:U863JGG2IA)

Boleh didapati daripada:

UCB, Inc.

INN (Nama Antarabangsa):

brivaracetam

Komposisi:

brivaracetam 10 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Hypersensitivity to brivaracetam or any of the inactive ingredients in BRIVIACT (bronchospasm and angioedema have occurred) [see Warnings and Precautions (5.4)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as BRIVIACT, during pregnancy. Encourage patients who are taking BRIVIACT during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series are insufficient to identify a risk of major birth defects, miscarriage or other maternal or fetal outcomes associated with BRIVIACT use during pregnancy. In animal studies, briva

Ringkasan produk:

BRIVIACT Tablets BRIVIACT Oral Solution BRIVIACT Injection Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze BRIVIACT injection or oral solution. Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle. BRIVIACT injection vials are single-dose only [see Dosage and Administration (2.3)] .

Status kebenaran:

New Drug Application

Risalah maklumat

BRIVIACT- BRIVARACETAM SOLUTION
BRIVIACT- BRIVARACETAM INJECTION, SUSPENSION
UCB, Inc.
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MEDICATION GUIDE
BRIVIACT® (BRIV EE AKT) CV
(BRIVARACETAM)
TABLETS, ORAL SOLUTION, AND INJECTION FOR INTRAVENOUS USE
This Medication Guide has been approved by the U.S. Food
and Drug Administration
Revised: 5/2023
What is the most important information I should know about BRIVIACT?
BRIVIACT is a federally controlled substance (CV) because it can be
abused or lead to dependence.
Keep BRIVIACT in a safe place to prevent misuse and abuse. Selling or
giving away BRIVIACT may
harm others and is against the law.
Like other antiepileptic drugs, BRIVIACT may cause suicidal thoughts
or actions in a very small number
of people, about 1 in 500 people taking it.
Call a 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
•
new or worse depression
•
feeling agitated or restless
•
trouble sleeping (insomnia)
•
acting aggressive, feeling angry, or being
violent
•
an extreme increase in activity and
talking (mania)
•
attempts to commit suicide
•
new or worse anxiety
•
panic attacks
•
new or worse irritability
•
acting on dangerous impulses
•
other unusual changes in behavior or mood
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.
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 BRIVIACT without first talking to a healthcare provider.
•
Stopping BRIVIACT suddenly can cause serious problems.
•
Stopping a seizure medicine suddenly can cause seizures that will not
stop (status epilepticus

Ciri produk

BRIVIACT- BRIVARACETAM TABLET, FILM COATED
BRIVIACT- BRIVARACETAM SOLUTION
BRIVIACT- BRIVARACETAM INJECTION, SUSPENSION
UCB, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BRIVIACT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BRIVIACT.
BRIVIACT (BRIVARACETAM) TABLETS, FOR ORAL USE, CV
BRIVIACT (BRIVARACETAM) ORAL SOLUTION, CV
BRIVIACT (BRIVARACETAM) INJECTION, FOR INTRAVENOUS USE, CV
INITIAL U.S. APPROVAL: 2016
INDICATIONS AND USAGE
BRIVIACT is indicated for the treatment of partial-onset seizures in
patients 1 month of age and older. (1)
DOSAGE AND ADMINISTRATION
_Adults (16 Years and Older):_ The recommended starting dosage for
monotherapy or adjunctive therapy
is 50 mg twice daily (100 mg per day). Based on individual patient
tolerability and therapeutic response,
the dosage may be adjusted down to 25 mg twice daily (50 mg per day)
or up to 100 mg twice daily
(200 mg per day). (2.1)
_Pediatric Patients (1 Month to less than 16 Years):_ The recommended
dosage is based on body weight
and is administered orally twice daily (2.1)
_Injection:_ for intravenous use only when oral administration is
temporarily not feasible; dosing is the
same as oral regimen. (2.1, 2.3)
_Hepatic Impairment:_ Dose adjustment is recommended for all stages of
hepatic impairment. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg (3)
Oral solution: 10 mg/mL (3)
Injection: 50 mg/5 mL single-dose vial (3)
CONTRAINDICATIONS
Hypersensitivity to brivaracetam or any of the inactive ingredients in
BRIVIACT. (4)
WARNINGS AND PRECAUTIONS
_Suicidal Behavior and Ideation_: Monitor patients for suicidal
behavior and ideation. (5.1)
_Neurological Adverse Reactions_: Monitor for somnolence and fatigue,
and advise patients not to drive
or operate machinery until they have gained sufficient experience on
BRIVIACT. (5.2)
_Psychiatric Adverse Reactions_: Behavioral reactions including
psychotic symptoms, irritability,
depression, aggressiv