LACOSAMIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Virtus Pharmaceuticals, LLC

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Available data from the North American Antiepileptic Drug (NAAED) pregnancy registry, a prospective cohort study, case reports, and a case series with lacosamide use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or oth

Product summary:

Lacosamide Injection, USP 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. Discard unused portion.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Virtus Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Lacosamide (la-KOE-sa-mide) Injection, USP
for intravenous use, CV
Read this Medication Guide before you start taking lacosamide
injection and each time you get a
refill. There may be new information. This Medication Guide describes
important safety
information about lacosamide injection. 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 injection 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 injection 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 are worried about
symptoms.
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare

Summary of Product characteristics

LACOSAMIDE- LACOSAMIDE INJECTION, SOLUTION
VIRTUS PHARMACEUTICALS, 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
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/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 these patients (5.3, 7.2)
Lacosamide may cause syncope (5.4)
Lacosamide should be graduall