LACOSAMIDE injection

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Fresenius Kabi USA, LLC

Toedieningsweg:

INTRAVENOUS

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 17 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT ® (lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as Lacosamide, during pregnancy. Encourage women who are taking Lacosamide 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 There are no adequate data on the developmental risks associated with the use of Lacosamide in pregnant women. Lacosamide produced developmental toxicity (increased embryofetal and perinatal mortality, growth deficit) in rats following administration during pregnancy. Develo

Product samenvatting:

Lacosamide Injection, USP 200 mg per 20 mL (10 mg per mL) is a clear, colorless sterile solution supplied in 20 mL colorless single-dose glass vials. 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 Lacosamide Injection, USP. The container closure is not made with natural rubber latex. Discard unused portion.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Fresenius Kabi USA, LLC
----------
Dispense with Medication Guide available at:
www.Fresenius-kabi.com/us/documents/Lacosamide_Inj_MedGuide.pdf
This Medication Guide has been approved by the
U.S. Food and Drug Administration.
Revised: 6/2022
MEDICATION GUIDE
Lacosamide (la koe' sa mide)
Injection, USP, for intravenous use, CV
Read this Medication Guide before you start taking lacosamide and each
time you get a refill. There may be
new information. This Medication Guide describes important safety
information about lacosamide. 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 Lacosamide
Injection?
Do not stop taking Lacosamide without first talking to your healthcare
provider.
Stopping Lacosamide suddenly can cause serious problems. Stopping
seizure medicine suddenly in a patient
who has epilepsy can cause seizures that will not stop (status
epilepticus).
Lacosamide can cause serious side effects, including:
1. Like other antiepileptic drugs, Lacosamide 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, especially if
you

Productkenmerken

LACOSAMIDE- LACOSAMIDE INJECTION
FRESENIUS KABI USA, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LACOSAMIDE INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LACOSAMIDE INJECTION.
LACOSAMIDE INJECTION, FOR INTRAVENOUS USE, CV
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage (1.1)
10/2021
Dosage and Administration (2.1, 2.6)
10/2021
INDICATIONS AND USAGE
Lacosamide injection is indicated for:
Treatment of partial-onset seizures in patients 17 years of age and
older (1.1)
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 is 50 mg twice daily
(2.1)
Maximum recommended dosage for monotherapy and adjunctive therapy is
200 mg 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 administered two or three times daily over 15 to
60 minutes; obtaining ECG
before initiation is recommended in certain patients (2.6, 5.3)
Dose adjustment is recommended for severe renal impairment (2.3, 12.3)
Dose adjustment is recommended for mild or moderate hepatic
impairment; use in patients with
severe hepatic impairment is not recommended (2.4, 12.3)
DOSAGE FORMS AND STRENGTHS
200 mg per 20 mL single-dose vial for intravenous use (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Monitor patients for suicidal behavior and ideation (5.1)
Lacosamide may cause dizziness and ataxia (5.2)
Cardiac Rhythm and Conduction Abnormalities: Obtaining ECG before
beginning and after titration to
steady-state maintenance is recommended in patients with underlying
proarrhythmic conditions or on
concomitant medications that affect cardiac conduction; closely
monitor