Usual Adult Dose for Epilepsy

MONOTHERAPY FOR PARTIAL-ONSET SEIZURES:
Initial dose: 100 mg orally twice a day

• Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability

Maintenance dose: 150 to 200 mg orally twice a day

ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES OR GENERALIZED TONIC-CLONIC SEIZURES: :
Initial dose: 50 mg orally twice a day

• Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability

Maintenance dose: 100 to 200 mg orally twice a day

Alternatively, may initiate therapy with a loading dose:
LOADING DOSE: 200 mg oral/IV once, followed in 12 hours with 100 mg oral/IV every 12 hours for at least 1 week; subsequent dose titrations should be performed as described above

• Due to increased incidence of CNS adverse reactions, the loading dose should be administered under medical supervision

Comments:

• Therapy may be administered either orally or via IV infusion using the same dosing regimen; IV infusion should preferably be over 30 to 60 minutes, although may be infused over 15 minutes if needed; experience with IV therapy is limited to 5 days of consecutive treatment.
• In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
• If converting from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Use: As monotherapy for partial-onset seizures or adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures in patients 17 years and older

Usual Adult Dose for Seizures

MONOTHERAPY FOR PARTIAL-ONSET SEIZURES:
Initial dose: 100 mg orally twice a day

• Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability

Maintenance dose: 150 to 200 mg orally twice a day

ADJUNCTIVE THERAPY FOR PARTIAL-ONSET SEIZURES OR GENERALIZED TONIC-CLONIC SEIZURES: :
Initial dose: 50 mg orally twice a day

• Titrate in increments of 100 mg (50 mg twice a day) no more frequently than once a week based on clinical response and tolerability

Maintenance dose: 100 to 200 mg orally twice a day

Alternatively, may initiate therapy with a loading dose:
LOADING DOSE: 200 mg oral/IV once, followed in 12 hours with 100 mg oral/IV every 12 hours for at least 1 week; subsequent dose titrations should be performed as described above

• Due to increased incidence of CNS adverse reactions, the loading dose should be administered under medical supervision

Comments:

• Therapy may be administered either orally or via IV infusion using the same dosing regimen; IV infusion should preferably be over 30 to 60 minutes, although may be infused over 15 minutes if needed; experience with IV therapy is limited to 5 days of consecutive treatment.
• In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
• If converting from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Use: As monotherapy for partial-onset seizures or adjunctive therapy for partial-onset seizures or primary generalized tonic-clonic seizures in patients 17 years and older

Usual Pediatric Dose for Epilepsy

AGE: 1 month or older:
WEIGHT: Less than 6 kg: Monotherapy Only

• Initial dose: 2 mg/kg/day as 0.66 mg/kg IV 3 times a day OR 1 mg/kg orally 2 times a day
• Titrate by 2 mg/kg/day no more frequently than once a week based on response and tolerability
• Maintenance dose: 7.5 to 15 mg/kg/day as 2.5 to 5 mg/kg IV 3 times a day OR 3.75 to 7.5 mg/kg orally 2 times a day

WEIGHT: 6 to less than 11 kg: Monotherapy Only

• Initial dose: 1 mg/kg oral/IV 2 times a day
• Titrate by 1 mg/kg twice a day no more frequently than once a week based on response and tolerability
• Maintenance dose: 3 to 6 mg/kg oral/IV twice a day

AGE: 4 to less than 17 years:
WEIGHT: 11 to less than 30 kg:

• Initial dose: 1 mg/kg oral/IV 2 times a day
• Titrate by 1 mg/kg oral/IV twice a day no more frequently than once a week based on response and tolerability
• Maintenance dose: 3 to 6 mg/kg oral/IV twice a day

WEIGHT: 30 to less than 50 kg:

• Initial dose: 1 mg/kg oral/IV twice a day
• Titrate by 1 mg/kg twice a day no more frequently than once a week based on clinical response and tolerability
• Maintenance dose: 2 to 4 mg/kg oral/IV twice a day

WEIGHT 50 kg or greater:

• Initial dose: 50 mg oral/IV twice a day
• Titrate by 50 mg twice a day no more frequently than once a week based on clinical response and tolerability
• MONOTHERAPY: Maintenance dose: 150 to 200 mg oral/IV twice a day
• ADJUNCTIVE THERAPY: Maintenance dose: 100 to 200 mg oral/IV twice a day

17 years and older: See Adult Dosing

Comments:

• The use of loading dose in pediatric patients has not been established.
• Oral and IV doses are the same unless specified; IV doses should be administered as an IV infusion over 30 to 60 minutes; experience with IV therapy is limited to 5 days of consecutive treatment.
• In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
• If converting from a from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Uses: For the treatment of partial onset seizures in patients 1 month or older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years or older.

Usual Pediatric Dose for Seizures

AGE: 1 month or older:
WEIGHT: Less than 6 kg: Monotherapy Only

• Initial dose: 2 mg/kg/day as 0.66 mg/kg IV 3 times a day OR 1 mg/kg orally 2 times a day
• Titrate by 2 mg/kg/day no more frequently than once a week based on response and tolerability
• Maintenance dose: 7.5 to 15 mg/kg/day as 2.5 to 5 mg/kg IV 3 times a day OR 3.75 to 7.5 mg/kg orally 2 times a day

WEIGHT: 6 to less than 11 kg: Monotherapy Only

• Initial dose: 1 mg/kg oral/IV 2 times a day
• Titrate by 1 mg/kg twice a day no more frequently than once a week based on response and tolerability
• Maintenance dose: 3 to 6 mg/kg oral/IV twice a day

AGE: 4 to less than 17 years:
WEIGHT: 11 to less than 30 kg:

• Initial dose: 1 mg/kg oral/IV 2 times a day
• Titrate by 1 mg/kg oral/IV twice a day no more frequently than once a week based on response and tolerability
• Maintenance dose: 3 to 6 mg/kg oral/IV twice a day

WEIGHT: 30 to less than 50 kg:

• Initial dose: 1 mg/kg oral/IV twice a day
• Titrate by 1 mg/kg twice a day no more frequently than once a week based on clinical response and tolerability
• Maintenance dose: 2 to 4 mg/kg oral/IV twice a day

WEIGHT 50 kg or greater:

• Initial dose: 50 mg oral/IV twice a day
• Titrate by 50 mg twice a day no more frequently than once a week based on clinical response and tolerability
• MONOTHERAPY: Maintenance dose: 150 to 200 mg oral/IV twice a day
• ADJUNCTIVE THERAPY: Maintenance dose: 100 to 200 mg oral/IV twice a day

17 years and older: See Adult Dosing

Comments:

• The use of loading dose in pediatric patients has not been established.
• Oral and IV doses are the same unless specified; IV doses should be administered as an IV infusion over 30 to 60 minutes; experience with IV therapy is limited to 5 days of consecutive treatment.
• In adult clinical trials, adjunctive doses higher than 200 mg twice a day were not more effective and were associated with a substantially higher rate of adverse reactions.
• If converting from a from a single antiepileptic drug (AED) to lacosamide monotherapy, withdrawal of concomitant AED should not occur until a therapeutic dose of lacosamide has been achieved and administered for 3 days, then the concomitant AED may be gradually withdrawn over 6 weeks.

Uses: For the treatment of partial onset seizures in patients 1 month or older and as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years or older.

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl greater than 30 mL/min): No adjustment recommended
Severe renal dysfunction (CrCl less than 30 mL/min [adults] or CrCl less than 30 mL/min/1.73 m2 [pediatrics]) and ESRD: Maximum dose should be reduced by 25%

Dose titration should be performed with caution in patients with renal impairment

Liver Dose Adjustments

Mild to moderate hepatic impairment: Maximum dose should be reduced by 25%
Severe hepatic impairment: Not recommended

Dose titration should be performed with caution in patients with hepatic impairment

Dose Adjustments

Elderly: Dose titration should be cautious, usually starting at the lower end of the dosing ranges

Concomitant Use with Strong CYP450 3A4 or CYP450 2C9 Inhibitors:

• Lacosamide dose reduction may be necessary in patients with renal impairment or hepatic impairment

Therapy Discontinuation:

• Upon discontinuation, this drug should be withdrawn gradually over at least 1 week

Precautions

CONTRAINDICATIONS:

• None

Safety and efficacy have not been established in treating partial onset seizures in patients younger than 1 month
Safety and efficacy have not been established in treating primary generalized tonic-clonic seizures in patients younger than 4 years

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule V

Dialysis

Following a 4-hour hemodialysis treatment, dosage supplementation of up to 50% should be considered as this drug is effectively removed by hemodialysis

Other Comments

Administration advice:
Oral Tablets:

• May be taken with or without food
• Swallow whole with liquid; do not divide tablets

Oral Solution:

• May be taken with or without food
• Use provided calibrated measuring device; do not use a household teaspoon or tablespoon as it is not an adequate measuring device
• May be administered using a nasogastric tube or gastrostomy tube
• Discard unused oral solution 6 months after first opening bottle
• Note: Oral solution contains aspartame, a source of phenylalanine (200 mg dose contains 0.32 mg of phenylalanine)

IV formulation

• Administer as IV infusion preferably over 30 to 60 minutes; if necessary, may infuse over 15 minutes in adults.
• May be administered without further dilution or may be diluted with normal saline, D5W, or lactated ringers; diluted solution should not be stored for more than 4 hours at room temperature

Storage requirements:

• IV injection: Store at 20C to 25C (68F to 77F); Do not freeze
• Diluted IV solution should not be stored for more than 4 hours at room temperature
• Oral solution: Store at 20C to 25C (68F to 77F); do not freeze; discard unused oral solution 6 months after first opening bottle

General:

• This drug is associated with ECG changes that can cause irregular heart beats and syncope; use cautiously in patients with underlying proarrhythmic conditions, severe cardiac disease, cardiac sodium channelopathies, or those receiving concomitant medications that affect cardiac conduction; if used in these patients, obtain an ECG prior to initiation and after titrated to steady-state maintenance dose. If the IV route is used, increased monitoring is recommended.
• Patients with phenylketonuria (PKU) should be aware that the oral solution contains aspartame, a source of phenylalanine.

Monitoring:

• Cardiac: Obtain ECG before initiation and after titration to steady-state maintenance dose in patients with underlying proarrhythmic conditions, severe cardiac disease, cardiac sodium channelopathies, or those receiving concomitant medications that affect cardiac conduction
• Closely monitor patients receiving IV therapy
• Psychiatric: Monitor for unusual changes in mood or behavior, especially the emergence of suicidal thoughts or behaviors

Patient Advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Patients should be aware that this drug is associated with ECG changes that may predispose them to irregular heart beat and syncope; patients should be aware of the cardiac symptoms that should be reported promptly to their healthcare provider.
• Patients should be aware that this drug may increase the risk of suicidal thoughts and behaviors; unusual changes in mood or behaviors should be reported immediately to their healthcare provider.
• Patients should be aware that this drug may cause dizziness, double vision, abnormal coordination and balance, and somnolence; patients should be counseled on the risks of driving and engaging in other hazardous activities.
• Patients should be instructed to speak with their healthcare provider if they are pregnant, intending to become pregnant or breastfeeding.
• Patients should be instructed to promptly report signs or symptoms of hepatotoxicity or early manifestation of hypersensitivity (e.g., fever, lymphadenopathy).