General Information

Keppra (levetiracetam) is an anti-epileptic.

Keppra injection is specifically indicated for the following:

• the treatment of partial-onset seizures in patients 1 month of age and older

for adjunctive therapy for the treatment of:

• Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
• Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

Keppra injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible.

Keppra Tablets are specifically indicated for:

• the treatment of partial-onset seizures in patients 1 month of age and older

for adjunctive therapy for the treatment of:

• Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
• Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

The recommended dosing/administration for Keppra injection is:

Partial-Onset Seizures (monotherapy or adjunctive therapy)

• 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily
• 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily
• 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
• Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily

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

Primary Generalized Tonic-Clonic Seizures

• 6 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
• 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

Switching From or To Oral Keppra: When switching from or to oral Keppra, the total daily dosage/frequency of Keppra injection should be equivalent to those of oral Keppra

The recommended dosing/administration of Keppra tablets is: 

Use the oral solution for pediatric patients with body weight ≤ 20 kg 

For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon)

Partial-Onset Seizures (monotherapy or adjunctive therapy)

• 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily
• 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily
• 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
• Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily

 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

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
• 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

 Adult Patients with Impaired Renal Function: Dose adjustment is recommended, based on the patient’s estimated creatinine clearance

Mechanism of Action

Keppra is rapidly absorbed after oral administration and food does not affect the extent of bioavailability. Pharmacokinetics are linear and steady state is achieved after two days of multiple twice daily dosing. Keppra is not protein bound (<10 percent bound) and its metabolism is not liver cytochrome P450 dependent, with sixty-six percent (66 percent) of the dose renally excreted unchanged. Plasma half-life of the medication is approximately 6 to 8 hours but is increased in the elderly (due to age-related decrease in renal function) and in patients with renal impairment. Keppra is unlikely to produce, or be subject to, pharmacokinetic drug interactions.

Side Effects

Although Keppra was well tolerated by participants, the following adverse events were reported during trials:

• somnolence
• asthenia (lack or loss of strength)
• infection
• dizziness

15% of patients receiving Keppra, compared to 11.6% of patients receiving the placebo treatment discontinued therapy or had the dose reduced as a result of an adverse effect.

Exercise caution when giving Keppra to patients with moderate and severe renal impairment and patients undergoing hemodialysis, since levetiracetam is substantially excreted by the kidney.

Clinical Trial Results

Three clinical studies compared 3 distinct dosages of Keppra (1000 mg/day, 2000 mg/day, or 3000 mg/day) with a placebo. All of the 1393 epilepsy patients who participated in the trials had continued to experience seizures during the baseline period despite their being treated with 1-2 antiepileptic drugs. Concomitant AED regimens were held constant during administration of Keppra. Effectiveness of the Keppra therapy was measured primarily by reduction in weekly partial seizure frequency for the entire treatment period.

Results of the trials indicated that Keppra significantly reduces the weekly seizure frequency over a placebo. Percent reduction ranged from 17.1% to 30.1% depending on the study number and the dose of Keppra in the treatment. In general, higher doses yielded greater reduction in number of seizures, although results varied over trials.

Data also showed the overall lack of negative interaction when taken in conjunction with other AEDs.