LEVETIRACETAM

LEVETIRACETAM- levetiracetam solution
Marlex Pharmaceuticals Inc

Recent Major Change

Warnings and Precautions (5.1, 5.3, 5.7, 5.8) 03/2015

1 LEVETIRACETAM Indications and Usage

Levetiracetam Oral Solution, USP is indicated for adjunctive therapy in the treatment of:

  • Partial onset seizures in patients 4 years of age and older with epilepsy (1.1)
  • Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
  • Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)

1.1 Partial Onset Seizures

Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.

Information describing the use of levetiracetam in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.2 Myoclonic Seizures i n Patients w ith Juvenile Myoclonic Epilepsy

Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy.

1.3 Primary Generalized Tonic-Clonic Seizures

Levetiracetam Oral Solution, USP is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.

2 DOSAGE AND ADMINISTRATION

  • Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1).
  • For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1)

Partial Onset Seizures

  • 4 Years To < 16 Years: 10 mg/kg twice daily, increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.2)
  • Adults 16 Years And Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily (2.2)

Myoclonic Seizures In Adults and Pediatric Patients 12 Years And Older

  • 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.3)

Primary Generalized Tonic-Clonic Seizures

  • 6 Years To < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.4)
  • Adults 16 Years And Older: 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.4)

Adult Patients With Impaired Renal Function

  • Dose adjustment is recommended, based on the patient’s estimated creatinine clearance (2.5, 8.6)

2.1 Important Administration Instructions

Levetiracetam Oral Solution, USP is given orally with or without food. The Levetiracetam Oral Solution, USP dosing regimen depends on the indication, age group, dosage form (tablets or oral solution), and renal function.

Prescribe the oral solution for pediatric patients with body weight ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients with body weight above 20 kg.

When using the oral solution in pediatric patients, dosing is weight-based (mg per kg) using a calibrated measuring device (not a household teaspoon or tablespoon)

2.2 Partial Onset Seizures

Adults 16 Years a nd Older

Initiate treatment with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Pediatric Patients

Dosing information in pediatric patients less than 4 years of age as adjunctive therapy in the treatment of partial onset seizures is approved for UCB, Inc.’s levetiracetam tablets and oral solution. However, due to UCB, Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

4 Years t o < 16 Years

Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). If a patient cannot tolerate a daily dose of 60 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3000 mg/day.

Levetiracetam Oral Solution Weight-Based Dosing Calculation f or Pediatric Patients

The following calculation should be used to determine the appropriate daily dose of oral solution for pediatric patients:

Total daily dose (mL/day) = Daily dose (mg/kg/day) x patient weight (kg)
100 mg/mL

2.3 Dosing for Myoclonic Seizures i n Patients 12 Years of Age and Older With Juvenile Myoclonic Epilepsy

Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been studied.

2.4 Dosing for Primary Generalized Tonic-Clonic Seizures

Adults 16 Years a nd Older

Initiate treatment with a dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage by 1000 mg/day every 2 weeks to the recommended daily dose of 3000 mg. The effectiveness of doses lower than 3000 mg/day has not been adequately studied.

Pediatric Patients Ages 6 t o <16 Years

Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 20 mg/kg to the recommended daily dose of 60 mg/kg (30 mg/kg twice daily). The effectiveness of doses lower than 60 mg/kg/day has not been adequately studied. Patients with body weight ≤20 kg should be dosed with oral solution. Patients with body weight above 20 kg can be dosed with either tablets or oral solution [see Dosage and Administration (2.1)]. Only whole tablets should be administered.

2.5 Dosage Adjustments in Adult Patients w ith Renal Impairment

Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended dosage adjustments for adults are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this an estimate of the patient’s creatinine clearance (CLcr) in mL/min must first be calculated using the following formula:

CLcr = [140-age (years)] x weight (kg) (x 0.85 for female patients)
72 x serum creatinine (mg/dL)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min/1.73m2)= CLcr (mL/min) x 1.73
BSA subject (m2)

CLcr (mL/min/1.73m2) = CLcr (mL/min) x BSA subject (m2)

Table 1: Dosing Adjustment Regimen for Adult Patients w ith Impaired Renal Function

Group Creatinine Clearance (mL/min/1.73m 2 ) Dosage (mg) Frequency
Normal > 80 500 to 1,500 Every 12 hours
Mild 50 — 80 500 to 1,000 Every 12 hours
Moderate 30 — 50 250 to 750 Every 12 hours
Severe < 30 250 to 500 Every 12 hours
ESRD patients using dialysis —- 500 to 1,000 Every 24 hours1

1. Following dialysis, a 250 to 500 mg supplemental dose is recommended.

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