pharmacopeia
GET
/api/v1/drug/lacosamide
2D structure
(2R)-2-acetamido-N-benzyl-3-methoxypropanamide
SMILES CC(=O)N[C@H](COC)C(=O)NCC1=CC=CC=C1
InChIKey VPPJLAIAVCUEMN-GFCCVEGCSA-N

Mechanism of action

Sourced from openFDA

The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.

Indications

Sourced from openFDA
  • Lacosamide injection is indicated for: Treatment of partial-onset seizures in patients 4 years 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) 1.1 Partial-Onset Seizures Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT® (lacosamide) injection.ICD-10: G40.909

Contraindications

Sourced from openFDA
  • None .contraindicated

Dosage & administration

Sourced from openFDA

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 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) 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) 2.1 Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in patients 4 years of age and older and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 4 years of age and older is included in Table 1. In pediatric patients 4 years to less than 17 years of age, the recommended dosing regimen is dependent upon body weight.

Warnings & precautions

Sourced from openFDA

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 withdrawn to minimize the potential of increased seizure frequency (5.5) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/ Multi-Organ Hypersensitivity: Discontinue if no alternate etiology (5.6) 5.1 Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including lacosamide, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Pooled analyses of 199 placebo-controlled clinical trials (mono- and adjunctive therapy) of 11 different AEDs showed that patients randomized to one of the AEDs had approximately twice the risk (adjusted Relative Risk 1.8, 95% CI:1.2, 2.7) of suicidal thinking or behavior compared to patients randomized to placebo.

Adverse reactions

Sourced from openFDA

The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [see Warnings and Precautions (5.1)] Dizziness and Ataxia [see Warnings and Precautions (5.2)] Cardiac Rhythm and Conduction Abnormalities [see Warnings and Precautions (5.3)] Syncope [see Warnings and Precautions (5.4)] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [see Warnings and Precautions (5.6)] Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence (6.1) Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies (6.1) Pediatric patients: Adverse reactions are similar to those seen in adult patients (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at 1- 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Laboratory Abnormalities Abnormalities in liver function tests have occurred in controlled trials with lacosamide in adult patients with partial-onset seizures who were taking 1 to 3 concomitant anti-epileptic drugs. Elevations of ALT to ≥3x ULN occurred in 0.7% (7/935) of lacosamide patients and 0% (0/356) of placebo patients.

Use in specific populations

Sourced from openFDA

Pregnancy: Based on animal data, may cause fetal harm (8.1) 8.1 Pregnancy 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 other adverse maternal or fetal outcomes . 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) . The background risk of major birth defects and miscarriage for the indicated population is unknown.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of lacosamide have been studied in healthy adult subjects (age range 18 to 87), adults with partial-onset seizures, adults with diabetic neuropathy, and subjects with renal and hepatic impairment. The pharmacokinetics of lacosamide are similar in healthy subjects, patients with partial-onset seizures, and patients with primary generalized tonic-clonic seizures.

Overdosage

Sourced from openFDA

Events reported after an intake of more than 800 mg (twice the maximum recommended daily dosage) of lacosamide include dizziness, nausea, and seizures (generalized tonic-clonic seizures, status epilepticus). Cardiac conduction disorders, confusion, decreased level of consciousness, cardiogenic shock, cardiac arrest, and coma have also been observed. Fatalities have occurred following lacosamide overdoses of several grams. There is no specific antidote for overdose with lacosamide. Standard decontamination procedures should be followed. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of patient. A Certified Poison Control Center should be contacted for up to date information on the management of overdose with lacosamide. Standard hemodialysis procedures result in significant clearance of lacosamide (reduction of systemic exposure by 50% in 4 hours). Hemodialysis may be indicated based on the patient's clinical state or in patients with significant renal impairment.

Approval history

Sourced from openFDA
  • Oct 28, 2008NDANDA022254Ucb Inc
  • Oct 28, 2008NDANDA022253Ucb Inc
  • Apr 20, 2010NDANDA022255Ucb Inc
  • Mar 17, 2022ANDAANDA204974Alembic
  • Mar 17, 2022ANDAANDA205006Glenmark Pharms Ltd
  • Mar 17, 2022ANDAANDA204787Hetero Labs Ltd V
  • Mar 17, 2022ANDAANDA208308Regcon Holdings
  • May 4, 2023NDANDA216185Aucta

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
36,182 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Seizure6,70619%
  2. 2Drug Ineffective4,02611%
  3. 3Off Label Use3,85411%
  4. 4Dizziness1,6394.5%
  5. 5Somnolence1,4524.0%
  6. 6Fatigue1,4233.9%
  7. 7Fall1,3753.8%
  8. 8Epilepsy1,3683.8%
  9. 9Status Epilepticus1,2393.4%
  10. 10Overdose1,2353.4%
  11. 11Generalised Tonic-clonic Seizure1,1503.2%
  12. 12Death1,0582.9%
  13. 13Headache1,0502.9%
  14. 14Drug Interaction9702.7%
  15. 15Convulsion9372.6%

Literature

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Recent PubMed references pinned to Lacosamide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 120 ClinicalTrials.gov registrations naming Lacosamide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Lacosamide work?
The precise mechanism by which lacosamide exerts its antiepileptic effects in humans remains to be fully elucidated. In vitro electrophysiological studies have shown that lacosamide selectively enhances slow inactivation of voltage-gated sodium channels, resulting in stabilization of hyperexcitable neuronal membranes and inhibition of repetitive neuronal firing.
What is Lacosamide used for?
According to FDA labeling, Lacosamide carries indications including: Lacosamide injection is indicated for: Treatment of partial-onset seizures in patients 4 years 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) 1.1 Partial-Onset Seizures Lacosamide injection is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT® (lacosamide) injection.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Lacosamide?
Lacosamide is classified as Other antiepileptics, Sodium Channel Interactions, Decreased Central Nervous System Disorganized Electrical Activity.
What are the brand names for Lacosamide?
Lacosamide is marketed under brand names including Motpoly, Vimpat.
What are the contraindications for Lacosamide?
Lacosamide labeling lists contraindications including: None .. Always consult the full prescribing information and a clinician.
Note. Data for lacosamide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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