Dosing and uses of Vimpat (lacosamide)
Adult dosage forms and strengths
tablet: Schedule V
- 50mg
- 100mg
- 150mg
- 200mg
injectable solution: Schedule V
- 200mg/20mL
oral solution: Schedule V
- 10mg/mL
Partial Onset Seizures
Indicated as monotherapy or adjunctive therapy for partial onset seizures
Monotherapy
- 100 mg PO/IV q12hr initially, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 150-200 mg BID
- Alternate loading dose schedule: 200 mg PO/IV as a single dose, followed ~12 hr later by starting 100 mg PO/IV BID x 1 week, THEN increase dose at weekly intervals by 50 mg BID; up to a recommended dose of 150-200 mg BID
- In patients already taking an antiepileptic drug (AED), maintain lacosamide at recommended maintenance dose of 150-200 mg PO BID for at least 3 days before initiating withdrawal of the previous AED
Adjunctive therapy
- Initial: 50 mg PO/IV q12hr
- Based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended dose of 100-200 mg BID
Dosage modifications
Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Renal impairment
- Severe (CrCl <30 mL/min): Not to exceed 300 mg/day
- Hemodialysis: Supplement with up to 50% of dose after dialysis
Hepatic impairment
- Mild to moderate: Not to exceed 300 mg/day
- Severe: Not recommended
Dosing Considerations
IV administration indicated as short-term replacement when PO administration is not feasible
Administration
Oral: May take with or without food
Pediatric dosage forms and strengths
<17 years: Safety and efficacy not established
Vimpat (lacosamide) adverse (side) effects
>10%
Dizziness (31%)
Headache (13%)
Diplopia (11%)
Nausea (11%)
1-10%
Vomiting (9%)
Ataxia (8%)
Blurred vision (8%)
Tremor (7%)
Nystagmus (5%)
Balance disorder (4%)
Diarrhea (4%)
Injection site discomfort (2.5%)
Depression (2%)
Memory impairment (2%)
Pruritus (2%)
Increased ALT (1%)
Local irritation (1%)
<1%
Anemia
Cerebellar syndrome
Dyspepsia
Hepatitis
Atrial fibrillation/flutter
Atrioventricular block
Mood changes
Muscle spasm
Hypoesthesia
Neutropenia
Xerostomia
Nephritis
Palpitation
Postmarketing Reports
Blood and lymphatic system disorders: Agranulocytosis
Cardiac disorders: Bradycardia
Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder
Skin and subcutaneous tissue disorders: Angioedema, rash, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis
Warnings
Contraindications
None
Cautions
Increase the risk of suicidal thoughts or behavior; monitor for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior
Dizziness and ataxia reported; may impair ability to perform hazardous tasks
Dose-dependent prolongations in PR interval observed in clinical studies in patients and in healthy volunteers; caution in patients with known conduction problems (eg, marked first-degree AV block, second-degree or higher AV block, and sick sinus syndrome without pacemaker), sodium channelopathies (eg, Brugada Syndrome), on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure, or structural heart disease)
Increased incidence of syncope in patients with diabetic neuropathy
Oral solution contains aspartame, a source of phenylalanine; 200 mg dose (20 mL) contains 0.32 mg of phenylalanine
One case of multiorgan hypersensitivity reaction reported consisting of symptomatic hepatitis and nephritis
Withdraw gradually over 1 week; do not discontinue abruptly because of risk for increased frequency of seizures
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in breast milk; use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Vimpat (lacosamide)
Mechanism of action
Antiepileptic effects unknown; may slowly inactivate voltage-gated Na channels
Binds to collapsin response mediator protein-2 (CRMP-2), a phosphoprotein that is expressed mainly in the nervous system and is involved in neuronal differentiation and control of axonal outgrowth
Absorption
Bioavailability: ~100%
Peak plasma time: 1-4 hr
Distribution
Protein bound: <15%
Vd: 0.6 L/kg
Metabolism
Predominantly by CYP isoenzymes 3A4 and 2C9; also 2C19
Major metabolite: O-desmethyl-lacosamide (inactive)
Elimination
Half-life: 13 hr
Excretion: Urine
Dialyzable: Yes (hemodialysis)
Administration
IV Preparation
May be administered without dilution or diluted in compatible solutions: 0.9% NaCl, D5W, Lr
IV Administration
Infuse IV over 15-60 min; 30 to 60 min preferable, and should be used when a 15 min administration is not required
IV lacosamide may cause bradycardia or AV bock in patients with underlying cardiac disease
Monitor infusion closely patients with known cardiac conduction problems, on concomitant medications that prolong PR interval, or with severe cardiac disease (eg, myocardial ischemia, heart failure)
