LACOSAMIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lacosamide tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets. 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. Developmental neurotoxicity was observed in rats following administration during a period of postnatal development corresponding to the third trimester of human pregnancy. These effects were observed at doses associated with clinically relevant plasma exposures  (see Data) .  In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.  Animal Data  Oral administration of lacosamide to pregnant rats (20, 75, or 200 mg/kg/day) and rabbits (6.25, 12.5, or 25 mg/kg/day) during the period of organogenesis did not produce any effects on the incidences of fetal structural abnormalities. However, the maximum doses evaluated were limited by maternal toxicity in both species and embryofetal death in rats. These doses were associated with maternal plasma lacosamide exposures (AUC) approximately 2 and 1 times (rat and rabbit, respectively) that in humans at the maximum recommended human dose (MRHD) of 400 mg/day. In two studies in which lacosamide (25, 70, or 200 mg/kg/day and 50, 100, or 200 mg/kg/day) was orally administered to rats throughout pregnancy and lactation, increased perinatal mortality and decreased body weights in the offspring were observed at the highest dose tested. The no-effect dose for pre- and postnatal developmental toxicity in rats (70 mg/kg/day) was associated with a maternal plasma lacosamide AUC similar to that in humans at the MRHD.  Oral administration of lacosamide (30, 90, or 180 mg/kg/day) to rats during the neonatal and juvenile periods of development resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The early postnatal period in rats is generally thought to correspond to late pregnancy in humans in terms of brain development. The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide AUC less than that in humans at the MRHD.  In Vitro Data  Lacosamide has been shown  in vitro  to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential adverse effects on CNS development related to this activity cannot be ruled out.  Risk Summary  There are no data on the presence of lacosamide in human milk, the effects on the breastfed infant, or the effects on milk production. Studies in lactating rats have shown excretion of lacosamide and/or its metabolites in milk.  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lacosamide and any potential adverse effects on the breastfed infant from lacosamide or from the underlying maternal condition.  Partial-Onset Seizures Safety and effectiveness of lacosamide for the treatment of partial-onset seizures have been established in pediatric patients 4 years to less than 17 years of age. Use of lacosamide in this age group is supported by evidence from adequate and well-controlled studies of lacosamide in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data in 328 pediatric patients 4 years to less than 17 years of age [see Adverse Reactions (6.1),  Clinical Pharmacology (12.3) and  Clinical Studies (14.1, 14.2)] . Safety and effectiveness in pediatric patients below 1 month of age have not been established. Animal Data  Lacosamide has been shown  in vitro  to interfere with the activity of collapsin response mediator protein-2 (CRMP-2), a protein involved in neuronal differentiation and control of axonal outgrowth. Potential related adverse effects on CNS development cannot be ruled out. Administration of lacosamide to rats during the neonatal and juvenile periods of postnatal development (approximately equivalent to neonatal through adolescent development in humans) resulted in decreased brain weights and long-term neurobehavioral changes (altered open field performance, deficits in learning and memory). The no-effect dose for developmental neurotoxicity in rats was associated with a plasma lacosamide exposure (AUC) less than that in humans at the maximum recommended human dose of 400 mg/day.  Additional pediatric use information is approved for UCB, Inc.’s VIMPAT ® (lacosamide) tablets. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. There were insufficient numbers of elderly patients enrolled in partial-onset seizure trials (n=18) to adequately determine whether they respond differently from younger patients. No lacosamide dose adjustment based on age is necessary. In elderly patients, dose titration should be performed with caution, usually starting at the lower end of the dosing range, reflecting the greater frequency of decreased hepatic function, decreased renal function, increased cardiac conduction abnormalities, and polypharmacy  [see Dosage and Administration (2.1,  2.3,  2.4)  and   Clinical Pharmacology (12.3)] .  Based on data in adults, no dose adjustment is necessary in adult and pediatric patients with mild to moderate renal impairment (CL CR ≥30 mL/min). In adult and pediatric patients with severe renal impairment (CL CR <30 mL/min) and in those with end-stage renal disease, a reduction of 25% of the maximum dosage is recommended  [see Dosage and Administration (2.3)  and   Clinical Pharmacology (12.3)] .  In all patients with renal impairment, dose titration should be performed with caution.  Lacosamide is effectively removed from plasma by hemodialysis. Dosage supplementation of up to 50% following hemodialysis should be considered.  Based on data in adults, for adult and pediatric patients with mild to moderate hepatic impairment, a reduction of 25% of the maximum dosage is recommended. Patients with mild to moderate hepatic impairment should be observed closely during dose titration  [see Dosage and Administration (2.4),  Clinical Pharmacology (12.3)] . The pharmacokinetics of lacosamide has not been evaluated in severe hepatic impairment. Lacosamide use is not recommended in patients with severe hepatic impairment.  Lacosamide is a Schedule V controlled substance. In a human abuse potential study, single doses of 200 mg and 800 mg lacosamide produced euphoria-type subjective responses that differentiated statistically from placebo; at 800 mg, these euphoria-type responses were statistically indistinguishable from those produced by alprazolam, a Schedule IV drug. The duration of the euphoria-type responses following lacosamide was less than that following alprazolam. A high rate of euphoria was also reported as an adverse event in the human abuse potential study following single doses of 800 mg lacosamide (15% [5/34]) compared to placebo (0%) and in two pharmacokinetic studies following single and multiple doses of 300 to 800 mg lacosamide (ranging from 6% [2/33] to 25% [3/12]) compared to placebo (0%). However, the rate of euphoria reported as an adverse event in the lacosamide development program at therapeutic doses was less than 1%.  Abrupt termination of lacosamide in clinical trials with diabetic neuropathic pain patients produced no signs or symptoms that are associated with a withdrawal syndrome indicative of physical dependence. However, psychological dependence cannot be excluded due to the ability of lacosamide to produce euphoria-type adverse events in humans. 

Product summary:

Lacosamide tablets, USP 50 mg, are supplied as pink, oval shaped, film-coated tablets debossed with "A93" on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 42291-860-60 Lacosamide tablets, USP 100 mg, are supplied as dark yellow, oval shaped, film-coated tablets debossed with "A924" on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 42291-861-60 Lacosamide tablets, USP 150 mg, are supplied as beige, oval shaped, film-coated tablets debossed with "A925" on one side and plain on the other side. They are available as follows: Bottles of 60: NDC 42291-862-60 Lacosamide tablets, USP 200 mg, are supplied as blue, oval shaped, film-coated tablets debossed with "A926" on one side and plain on the other side. They are supplied as follows: Bottles of 60: NDC 42291-863-60 Store 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]. For more information, go to www.avkare.com or call 1-855-361-3993.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AvKARE
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MEDICATION GUIDE
Lacosamide (la koe´ sa mide) Tablets, USP CV
Read this Medication Guide before you start taking lacosamide tablets
and each time you get a refill.
There may be new information. This Medication Guide describes
important safety information about
lacosamide tablets. 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
tablets?
Do not stop taking lacosamide tablets without first talking to your
healthcare provider. Stopping
lacosamide tablets 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 tablets can cause serious side effects, including:
1. Like other antiepileptic drugs, lacosamide tablets 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
•
trouble sleeping (insomnia)
•
attempt to
commit suicide
•
new or worse irritability
•
new or worse
depression
•
acting aggressive, being angry, or violent
•
new or worse
anxiety
•
acting on dangerous impulses
•
feeling agitated
or restless
•
an extreme increase in activity and talking (mania)
•
panic attacks
•
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 provider may check for other
causes.

Summary of Product characteristics

LACOSAMIDE- LACOSAMIDE TABLET
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
LACOSAMIDE TABLETS, FOR ORAL USE, CV
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LACOSAMIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LACOSAMIDE TABLETS.
INITIAL U.S. APPROVAL: 2008
RECENT MAJOR CHANGES
Indications and Usage ( 1.1) 10/2021
Dosage and Administration ( 2.1, 2.5) 10/2021
Warnings and Precautions ( 5.2) 11/2020
INDICATIONS AND USAGE
Lacosamide tablets are indicated for:
Treatment of partial-onset seizures in patients 4 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)
_Pediatric Patients 4 years 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)
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
Lacosamide tablets, USP: 50 mg, 100 mg, 150 mg, 200 mg tablets (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 gradually w