Roweepra (levetiracetam)

Roweepra is a prescription medication used to treat:

• partial onset seizures in people of age 1 month and older with epilepsy
• myoclonic seizures in people of age 12 years and older with juvenile myoclonic epilepsy
• primary generalized tonic-clonic seizures in people of age 6 years and older with certain types of generalized epilepsy.

It is not known if Roweepra is safe or effective in children under 1 month of age.

This Medication Guide provides important information about Roweepra. For more information, consult your healthcare provider or call 1-800-273-6729.

What are the side effects of Roweepra?

Roweepra can cause serious side effects.

Contact your healthcare provider immediately if you experience:

• mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, irritability, or psychotic symptoms such as hallucinations, delusions, and unusual behavior
• extreme sleepiness, tiredness, and weakness
• problems with muscle coordination
• a skin rash. Serious skin rashes can occur.

The most common side effects of Roweepra include tiredness, aggressive behavior, nasal congestion, decreased appetite, and irritability. These side effects may occur within the first 4 weeks of treatment except for infection. Inform your healthcare provider if you have any bothersome side effects.

This is not a complete list of side effects. For more information, consult your healthcare provider or pharmacist.

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

What is the dosage for Roweepra?

Important Administration Instructions

• Roweepra is taken orally with or without food. Dosage depends on the indication, age group, dosage form, and renal function.
• Prescribe the oral solution for pediatric patients weighing ≤ 20 kg. Prescribe the oral solution or tablets for pediatric patients weighing above 20 kg.
• When using the oral solution in pediatric patients, dosage is weight-based using a calibrated measuring device.
• Roweepra tablets should be swallowed whole. Do not chew or crush tablets.

Dosing For Partial Onset Seizures

Adults 16 Years And Older

• Initiate treatment with a daily dose of 1,000 mg/day (500 mg twice daily). Increase dose every 2 weeks to a maximum of 3,000 mg/day.

Pediatric Patients

• Initiate treatment with a daily dose of 14 mg/kg in 2 divided doses (7 mg/kg twice daily). Increase dose every 2 weeks to 42 mg/kg (21 mg/kg twice daily).
• In the clinical trial, the mean daily dose was 35 mg/kg. Lower doses have not been studied.
• Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).
• Increase dose every 2 weeks to 50 mg/kg (25 mg/kg twice daily).
• If unable to tolerate 50 mg/kg, reduce dose. In the clinical trial, the mean daily dose was 47 mg/kg.
• Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).
• Increase dose every 2 weeks to 60 mg/kg (30 mg/kg twice daily). If unable to tolerate 60 mg/kg, reduce dose. In the clinical trial, the mean daily dose was 44 mg/kg. The maximum daily dose was 3,000 mg.
• For pediatric patients weighing 20 to 40 kg, initiate treatment with a daily dose of 500 mg (250 mg twice daily). Increase dose every 2 weeks to a maximum of 1,500 mg/day (750 mg twice daily).
• For pediatric patients weighing more than 40 kg, initiate treatment with a daily dose of 1,000 mg/day (500 mg twice daily). Increase dose every 2 weeks to a maximum of 3,000 mg/day (1,500 mg twice daily).

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

Calculate total daily dose (mL/day) using the following equation:

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 (500 mg twice daily). Increase dose by 1,000 mg/day every 2 weeks to 3,000 mg/day.

Dosing For Primary Generalized Tonic-Clonic Seizures

Adults 16 Years And Older

• Initiate treatment with a dose of 1,000 mg/day (500 mg twice daily). Increase dose by 1,000 mg/day every 2 weeks to 3,000 mg/day.

Pediatric Patients Ages 6 And Older

• Initiate treatment with a daily dose of 20 mg/kg in 2 divided doses (10 mg/kg twice daily).
• Increase dose every 2 weeks to 60 mg/kg (30 mg/kg twice daily).
• Lower doses than 60 mg/kg/day have not been adequately studied. Patients weighing ≤20 kg should use oral solution. Patients weighing above 20 kg can use tablets or oral solution. Use only whole tablets.

Dosage Adjustments In Adult Patients With Renal Impairment

• Roweepra dosage should be individualized based on renal function.
• Recommended dosage adjustments for adults are shown in Table 1.
• To calculate the recommended dose for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated.

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

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

What drugs interact with Roweepra?

No information provided

Is Roweepra safe to use while pregnant or breastfeeding?

• No adequate and controlled studies have been conducted in pregnant women. Levetiracetam is excreted in human milk.
• Consider the importance of the drug to the mother when deciding to discontinue nursing or discontinue the drug due to the potential for serious adverse reactions in nursing infants.

Summary

Roweepra (levetiracetam) is a prescription medication used to treat partial onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in people with certain types of epilepsy. The most common side effects include sleepiness, weakness, infection, and dizziness.