VIMPAT- lacosamide tablet, film coated VIMPAT- lacosamide injection VIMPAT- lacosamide solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LACOSAMIDE (UNII: 563KS2PQY5) (LACOSAMIDE - UNII:563KS2PQY5)

Available from:

UCB, Inc.

INN (International Name):

LACOSAMIDE

Composition:

LACOSAMIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

VIMPAT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as VIMPAT, during pregnancy. Encourage women who are taking VIMPAT during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 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 with VIMPAT use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Lacosamide produced developmental toxicity (increased em

Product summary:

VIMPAT (lacosamide) Tablets VIMPAT (lacosamide) Injection VIMPAT (lacosamide) Oral Solution Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Do not freeze VIMPAT injection or oral solution. Discard any unused VIMPAT oral solution remaining after six (6) months of first opening the bottle.

Authorization status:

New Drug Application

Patient Information leaflet

VIMPAT- LACOSAMIDE INJECTION
VIMPAT- LACOSAMIDE SOLUTION
UCB, Inc.
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This Medication Guide has been approved by the
U.S. Food and Drug Administration
Revised: 9/2022
MEDICATION GUIDE
VIMPAT (VIM-păt)
(lacosamide)
film coated tablet, for oral use, CV
VIMPAT (VIM-păt)
(lacosamide)
injection, for intravenous use, CV
VIMPAT (VIM-păt)
(lacosamide)
oral solution, CV
Read this Medication Guide before you start taking VIMPAT and each
time you get a refill. There may
be new information. This Medication Guide describes important safety
information about VIMPAT. 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 VIMPAT?
Do not stop taking VIMPAT without first talking to your healthcare
provider. Stopping VIMPAT
suddenly can cause serious problems. Stopping seizure medicine
suddenly in a patient who has epilepsy
can cause seizures that will not stop (status epilepticus).
VIMPAT can cause serious side effects, including:
1.
Like other antiepileptic drugs, VIMPAT may cause suicidal thoughts or
actions in a very small
number of people, about 1 in 500.
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
•
attempt 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, especiall

Summary of Product characteristics

VIMPAT- LACOSAMIDE TABLET, FILM COATED
VIMPAT- LACOSAMIDE INJECTION
VIMPAT- LACOSAMIDE SOLUTION
UCB, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIMPAT SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VIMPAT.
VIMPAT (LACOSAMIDE) FILM COATED TABLET, FOR ORAL USE, CV
VIMPAT (LACOSAMIDE) INJECTION, FOR INTRAVENOUS USE, CV
VIMPAT (LACOSAMIDE) ORAL SOLUTION, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Dosage and Administration (2.1)
4/2023
Dosage and Administration (2.2)
10/2023
INDICATIONS AND USAGE
VIMPAT is indicated for:
Treatment of partial-onset seizures in patients 1 month of age and
older (1.1)
Adjunctive therapy in the treatment of primary generalized
tonic-clonic seizures in patients 4 years of
age and older (1.2)
DOSAGE AND ADMINISTRATION
_Adults (17 years and older):_
Initial dosage for monotherapy for the treatment of partial-onset
seizures is 100 mg twice daily (2.1)
Initial dosage for adjunctive therapy for the treatment of
partial-onset seizures or primary
generalized tonic-clonic seizures is 50 mg twice daily (2.1)
Maximum recommended dosage for monotherapy and adjunctive therapy is
200 mg twice daily (2.1)
_Pediatric Patients 1 month to less than 17 years_: The recommended
dosage is based on body weight
and is administered orally twice daily (2.1)
Increase dosage based on clinical response and tolerability, no more
frequently than once per week
(2.1)
Injection: for intravenous use only when oral administration is
temporarily not feasible; the
recommended dosage is based on body weight and is administered two or
three times daily over 15 to
60 minutes; obtaining ECG before initiation is recommended in certain
patients (2.7, 5.3)
Dose adjustment is recommended for severe renal impairment (2.4, 12.3)
Dose adjustment is recommended for mild or moderate hepatic
impairment; use in patients with
severe hepatic impairment is not recommended (2.5, 12.3)
DOSAGE FORMS AND STRENGTHS
50 mg, 100 mg, 150 mg, 200 mg table