Levetiracetam

LEVETIRACETAM- levetiracetam injection, solution
Athenex Pharmaceutical Division, LLC.

1 INDICATIONS AND USAGE

1.1 Partial-Onset Seizures

Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.

1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults with juvenile myoclonic epilepsy.

1.3 Primary Generalized Tonic-Clonic Seizures

Levetiracetam in Sodium Chloride Injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy.

1.4 Limitations of Use

Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated for adult patients (16 years and older) when oral administration is temporarily not feasible.

2 DOSAGE AND ADMINISTRATION

2.1 General Information – Administration

Levetiracetam in Sodium Chloride Injection is for intravenous use only. It is available in three different concentrations single-dose 100 mL bag, each containing a different total dosage of levetiracetam: 500 mg (5 mg per mL), 1,000 mg (10 mg per mL), or 1,500 mg (15 mg per mL).

A single-dose 100 mL bag should be administered intravenously over a 15-minute IV infusion period.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

Levetiracetam in Sodium Chloride Injection should not be further diluted prior to use. Any unused portion of the Levetiracetam in Sodium Chloride Injection contents should be discarded.

2.2 Initial Exposure to Levetiracetam

Levetiracetam can be initiated with either intravenous or oral administration.

Partial-Onset Seizures

In clinical trials of oral levetiracetam, daily doses of 1,000 mg, 2,000 mg, and 3,000 mg, given as twice-daily dosing, were shown to be effective. Although in some studies there was a tendency toward greater response with higher dose [see Clinical Studies (14.1)] , a consistent increase in response with increased dose has not been shown.

Treatment should be initiated with a daily dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1,000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3,000 mg. Doses greater than 3,000 mg/day have been used in open-label studies with levetiracetam tablets for periods of 6 months and longer. There is no evidence that doses greater than 3,000 mg/day confer additional benefit.

Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Treatment should be initiated with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1,000 mg/day every 2 weeks to the recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been studied.

Primary Generalized Tonic-Clonic Seizures

Treatment should be initiated with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Dosage should be increased by 1,000 mg/day every 2 weeks to the recommended daily dose of 3,000 mg. The effectiveness of doses lower than 3,000 mg/day has not been adequately studied.

2.3 Switching to Intravenous Dosing

When switching from oral levetiracetam, the initial total daily intravenous dosage of levetiracetam should be equivalent to the total daily dosage and frequency of oral levetiracetam.

2.4 Switching to Oral Dosing

At the end of the intravenous treatment period, the patient may be switched to levetiracetam oral administration at the equivalent daily dosage and frequency of the intravenous administration.

2.5 Adult Patients with Impaired Renal Function

Levetiracetam dosing must be individualized according to the patient’s renal function status. Recommended doses and adjustment for dose for adults are shown in Table 1. To use this dosing table, an estimate of the patient’s creatinine clearance (CLcr) in mL/min is needed.

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

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

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

For doses (e.g., 250 mg and 750 mg) not achievable with the available product strengths, using aseptic technique, withdraw the appropriate dose (see Table 1) from an intact commercial bag and place the measured dose in a separate empty, sterile infusion bag. Administer the prepared dose by intravenous infusion over a period of 15 minutes. The unused portion of the original commercial bag must be discarded. Do not store or reuse.

2.6 Compatibility with Other Antiepileptic Drugs

Levetiracetam in Sodium Chloride Injection is found to be physically compatible and chemically stable for at least 24 hours when mixed with lorazepam, diazepam, and valproate sodium and stored at controlled room temperature 15° to 30°C (59° to 86°F).

There are no data to support the physical compatibility of levetiracetam injection with antiepileptic drugs that are not listed above.

2.7 Discontinuation of Levetiracetam

Avoid abrupt withdrawal from levetiracetam in order to reduce the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.6)].

3 DOSAGE FORMS AND STRENGTHS

Single-dose 100 mL bags of Levetiracetam in Sodium Chloride Injection, a clear, colorless solution, which contain:

  • 500 mg Levetiracetam in 0.82% sodium chloride injection (500 mg per 100 mL)
  • 1,000 mg Levetiracetam in 0.75% sodium chloride injection (1,000 mg per 100 mL)
  • 1,500 mg Levetiracetam in 0.54% sodium chloride injection (1,500 mg per 100 mL)

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