Dosing & Uses
Dosage Forms & 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 (300-400 mg/day) OR
- Alternate initial loading dose schedule: 200 mg PO/IV as a single loading dose, followed 12 hr later by 100 mg PO/IV BID; THEN increase dose at weekly intervals by 50 mg BID; up to a recommended dose of 150-200 mg BID (300-400 mg/day)
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 (200-400 mg/day)
Conversion from single AED to lacosamide monotherapy
- Maintain lacosamide at recommended maintenance dose for at least 3 days before initiating withdrawal of the previous AED
- Patients currently treated with a single antiepileptic (AED) who will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days
- Gradual withdrawal of the initial AED over at least 6 weeks is recommended
- When discontinuing lacosamide, gradually withdraw treatment over at least 1 week is recommended
Primary Generalized Tonic-Clonic Seizures
Indicated as adjunctive therapy for primary generalized tonic-clonic seizures
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 (200-400 mg/day)
Dosage Modifications
Renal impairment
- Mild-to-moderate: no dose adjustment required
- Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25%
- Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Hepatic impairment
- Mild-to-moderate: No dose adjustment required
- Severe: Not recommended
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Dosing Considerations
IV administration indicated as short-term replacement (up to 5 consecutive days) when PO administration is not feasible
Dosage Forms & 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 in children aged ≥4 years
<4 years: Safety and efficacy not established
4-17 years
- 11 to <30 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID; up to a recommended 3-6 mg/kg PO/IV BID (6-12 mg/kg/day)
- 30 to <50 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID; up to a recommended 2-4 mg/kg PO BID (4-8 mg/kg/day)
- ≥50 kg: 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy
Conversion from single AED to lacosamide monotherapy
- Maintain lacosamide at recommended maintenance dose for at least 3 days before initiating withdrawal of the previous AED
- Patients currently treated with a single antiepileptic (AED) who will convert to lacosamide monotherapy, withdrawal of the concomitant AED should not occur until the therapeutic dosage of lacosamide is achieved and has been administered for at least 3 days
- Gradual withdrawal of the initial AED over at least 6 weeks is recommended
- When discontinuing lacosamide, gradually withdraw treatment over at least 1 week is recommended
Primary Generalized Tonic-Clonic Seizures
Indicated as adjunctive therapy for primary generalized tonic-clonic seizures in patients aged ≥4 years with idiopathic generalized epilepsy
<4 years: Safety and efficacy not established
4-17 years
- 11 to <30 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID; up to a recommended 3-6 mg/kg PO/IV BID (6-12 mg/kg/day)
- 30 to <50 kg: 1 mg/kg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO/IV BID; up to a recommended 2-4 mg/kg PO/IV BID (4-8 mg/kg/day)
- ≥50 kg: 50 mg PO/IV BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO/IV BID; up to a recommended 150-200 mg PO/IV BID (300-400 mg/day) for monotherapy or 100-200 mg PO/IV BID (200-400 mg/day) for adjunctive therapy
Dosage Modifications
Renal impairment
- Mild-to-moderate: no dose adjustment required
- Severe (CrCl <30 mL/min) or ESRD: Reduce maximum dosage by 25%
- Hemodialysis: Consider supplementing with up to 50% of dose after 4-hr dialysis session
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Hepatic impairment
- Mild-to-moderate: No dose adjustment required
- Severe: Not recommended
- Coadministration with strong CYP3A4 or CYP2C9 inhibitors: Lacosamide systemic exposure may increase; consider dose reduction
Dosing Considerations
IV administration indicated as short-term replacement (up to 5 consecutive days) when PO administration is not feasible
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Tablets and oral solution
- Dizziness (16-53%)
- Diplopia (6-16%)
- Blurred vision (2-16%)
- Nausea (7-17%)
- Vomiting (6-16%)
- Fatigue (7-15%)
- Ataxia (11-14%)
- Nystagmus (2-10%)
IV
- Fatigue (20-63%)
- Somnolence (26-34%)
- Headache (4-16%)
- Diplopia (4-20%)
- Nausea (14-24%)
- Dry mouth (6-12%)
- Vomiting (4-12%)
- Fatigue (12-18%)
- Chest pain (3-12%)
1-10%
Tablets and oral solution
- Nystagmus (2-10%)
- Memory impairment (1-6%)
- Balance disorder (1-6%)
- Diarrhea (3-5%)
- Gait disturbance (<1-4%)
- Asthenia (1-3%)
- Vertigo (1-4%)
- Pruritus (2-3%)
- Depression (2%)
IV
- Oral paresthesia (4-8%)
- Oral hypoesthesia (5-8%)
- Diarrhea (4-8%)
- Paresthesia (4-8%)
- Gait disturbance (2-8%)
- Hyperhidrosis (2-8%)
- Tremor (4-6%)
- Abnormal coordination (3-6%)
- Pruritus (4-6%)
Frequency Not Reported
Blood and lymphatic system disorders: Neutropenia, anemia
Cardiac disorders: Palpitations Ear and labyrinth disorders: Tinnitus
Gastrointestinal disorders: Constipation, dyspepsia, dry mouth, oral hypoaesthesia
General disorders and administration site conditions: Irritability, pyrexia, feeling drunk
Injury, poisoning, and procedural complications: Fall
Musculoskeletal and connective tissue disorders: Muscle spasms
Nervous system disorders: Paresthesia, cognitive disorder, hypesthesia, dysarthria, disturbance in attention, cerebellar syndrome
Psychiatric disorders: Confusional state, mood altered, depressed mood
Postmarketing Reports
Blood and lymphatic system disorders: Agranulocytosis
Psychiatric disorders: Aggression, agitation, hallucination, insomnia, psychotic disorder
Neurologic disorders: New or worsening seizures
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
Blurred vision and diplopia may occur during therapy; consider increased monitoring in patients with preexisting ocular conditions or vision-related issues
Oral solution contains aspartame, a source of phenylalanine; 200 mg dose (20 mL) contains 0.32 mg of phenylalanine
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multi-organ hypersensitivity, reported with antiepileptic drugs; some of these events have been fatal or life- threatening; monitor for signs and symptoms of possible disparate manifestations associated with lymphatic hepatic, renal, and/or hematologic organ systems; may require gradual discontinuation and conversion to alternate therapy
Use caution in renal and hepatic impairment; dosage adjustments may be required
Withdraw gradually over 1 week; do not discontinue abruptly because of risk for increased frequency of seizures
Cardiac rhythm and conduction
- Both atrial fibrillation and atrial flutter reported in open label partial-onset seizure trials and in postmarketing experience; therapy may predispose to atrial arrhythmias (atrial fibrillation or flutter), especially in patients with diabetic neuropathy and/or cardiovascular diseaseCardiac arrhythmias reported, including bradycardia, AV block, and ventricular tachyarrhythmia, which have rarely resulted in asystole, cardiac arrest, and death
- Most, although not all, cases occurred in patients with underlying proarrhythmic conditions, or in those taking concomitant medications that affect cardiac conduction or prolong the PR interval
- Events occurred with both PO or IV administration and at prescribed doses, as well as in the setting of overdose
- Caution with underlying proarrhythmic conditions (eg, marked first-degree AV block, second-degree or higher AV block and sick sinus syndrome without pacemaker), severe cardiac disease, including myocardial ischemia or heart failure, or structural heart disease, and cardiac sodium disorders (eg, Brugada Syndrome)
Drug interactions overview
- Patients with renal or hepatic impairment who are taking strong CYP3A4 and CYP2C9 inhibitors may have a significant increase in exposure to lacosamide; dose reduction may be necessary
-
Concomitant medications that prolong PR interval
- Use with caution when administered concomitantly with medications that affect cardiac conduction, including sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers, and medications that prolong the PR interval; obtain an ECG before beginning therapy, and after titrating to steady-state maintenance dose, in such patients; closely monitor if intravenous route used to administer medication
- Obtain an ECG before initiating and after titrated to steady-state; additionally, monitor closely if administered IV
Pregnancy & Lactation
Pregnancy
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs); to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/
There are no adequate data on the developmental risks associated with lacosamide use 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
Lactation
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
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
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
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
Primarily eliminated by renal excretion and biotransformation
Excretion: 95% urine; <5% feces
Dialyzable: Yes (hemodialysis)
Administration
IV Compatibility
0.9% NaCl, D5W, LR
IV Preparation
May be administered without dilution or diluted in compatible solutions; (see IV Compatibility)
Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit
Product with particulate matter or discoloration should not be used
Vials is for single-dose only; discard any unused portion of lacosamide injection
IV Administration
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)
Adults
- Administer by IV infusion over 30-60 minutes
- May administer as rapidly as 15 minutes if needed
Children
- Administer by IV infusion over 30-60 minutes
- Infusion duration <30 minutes not recommended
Oral Administration
Tablets or oral solution: Take with or without food
Swallow tablets whole with liquid; do not divide tablets
Oral solution
- Use calibrated measuring device to measure and deliver the prescribed dose accurately
- May be administered using a nasogastric tube or gastrostomy tube; discard any unused lacosamide oral solution remaining after 7 weeks of first opening the bottle
Storage
Tablet: Store at room temperature, 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze lacosamide oral solution
Oral solution: Store at room temperature, 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F); do not freeze lacosamide oral solution; discard any unused oral solution remaining after 7 weeks of first opening the bottle
Injection: Store at room temperature, 20-25°C (68-77°F); excursions are permitted between 15-30°C (59-86°F); do not freeze
Diluted IV solution: Store at room temperature, 20-25°C (68-77°F); for up to 4 hr
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Patient Handout
Formulary
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