Roweepra (levetiracetam)

Roweepra can cause serious side effects.

Call your healthcare provider right away if you have any of these symptoms:

• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability.
  A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination (problems walking and moving)
• a skin rash. Serious skin rashes can happen after you start taking Roweepra. There is no way to tell if a mild rash will become a serious reaction.

The most common side effects seen in people who take Roweepra include:

• sleepiness
• weakness
• infection
• dizziness

The most common side effects seen in children who take Roweepra include, in addition to those listed above:

• tiredness
• acting aggressive
• nasal congestion
• decreased appetite
• irritability

These side effects can happen at any time but happen more often within the first 4 weeks of treatment except for infection.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Roweepra. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Important Administration Instructions

• Roweepra is given orally with or without food. The Roweepra 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).
• Roweepra tablets should be swallowed whole. Roweepra tablets should not be chewed or crushed.

Dosing For Partial Onset Seizures

Adults 16 Years And Older

• Initiate treatment 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. There is no evidence that doses greater than 3,000 mg/day confer additional benefit.

Pediatric Patients

1 Month to < 6 Months

• Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase the daily dose every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg (21 mg/kg twice daily).
• In the clinical trial, the mean daily dose was 35 mg/kg in this age group. The effectiveness of lower doses has not been studied.

6 Months to <4 Years

• Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).
• Increase the daily dose in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily).
• If a patient cannot tolerate a daily dose of 50 mg/kg, the daily dose may be reduced. In the clinical trial, the mean daily dose was 47 mg/kg in this age group.

4 Years to < 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 3,000 mg/day.
• For Roweepra tablet dosing in pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg given as twice daily dosing (250 mg twice daily). Increase the daily dose every 2 weeks by increments of 500 mg to a maximum recommended daily dose of 1,500 mg (750 mg twice daily).
• For Roweepra tablet dosing in pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1,000 mg/day given as twice daily dosing (500 mg twice daily). Increase the daily dose every 2 weeks by increments of 1,000 mg/day to a maximum recommended daily dose of 3,000 mg (1,500 mg twice daily).

Levetiracetam Oral Solution, USP Weight-Based Dosing Calculation For Pediatric Patients

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

Dosing For Myoclonic Seizures In Patients 12 Years Of Age And Older With Juvenile Myoclonic Epilepsy

• Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase the dosage 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.

Dosing For Primary Generalized Tonic-Clonic Seizures

Adults 16 Years And Older

• Initiate treatment with a dose of 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Increase dosage 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.

Pediatric Patients Ages 6 To <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. Only whole tablets should be administered.

Dosage Adjustments In Adult Patients With Renal Impairment

• Roweepra 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:

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

Table 1: Dosing Adjustment Regimen for Adult Patients with Renal Impairment

• There are no adequate and controlled studies in pregnant women. Levetiracetam is excreted in human milk.
• Because of the potential for serious adverse reactions in nursing infants from Roweepra, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.