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 in adults and children aged ≥4 years
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)
- Alternate 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)
- 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 (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
Conversion from singe AED to lacosamide monotherapy
- 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
Dosage Forms & Strengths
tablet: Schedule V
- 50mg
- 100mg
- 150mg
- 200mg
oral solution: Schedule V
- 10mg/mL
Partial Onset Seizures
Tabletsa and oral solution indicated as monotherapy or adjunctive therapy for partial onset seizures in children aged ≥4 years; IV administration is not indicated in children aged <17 years
<4 years: Safety and efficacy not established
4-17 years
- 11 to <30 kg: 1 mg/kg PO BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO BID; up to a recommended 3-6 mg/kg PO BID (6-12 mg/kg/day)
- 30 to <50 kg: 1 mg/kg PO BID, THEN, based on response and tolerability, increase dose at weekly intervals by 1 mg/kg PO BID; up to a recommended 2-4 mg/kg PO BID (4-8 mg/kg/day)
- ≥50 kg: 50 mg PO BID, THEN, based on response and tolerability, increase dose at weekly intervals by 50 mg PO BID; up to a recommended 150-200 mg PO BID (300-400 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
Conversion from singe AED to lacosamide monotherapy
- 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
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
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
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
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
- Caution if coadministered with medications that prolong PR interval because of risk for AV block or bradycardia, (eg, beta-blockers, calcium channel blockers)
- 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
Infuse IV over 15-60 min; 30-60 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)
Oral Administration
Tablets or oral solution: Take with or without food
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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