The proven efficacy of Keppra XR® gives patients the opportunity to reach and stay at the goal of epilepsy therapy.

Significant efficacy for partial-onset seizures established in a Phase III clinical trial1*

  • 12-week, multicenter, randomized, double-blind, placebo-controlled study of Keppra XR® as adjunctive therapy in 158 patients with refractory partial-onset seizures
  • No titration period—patients took the starting dose of Keppra XR® 1000 mg/day throughout the study
*Phase III, multicenter, double-blind, randomized, placebo-controlled, parallel-group study of patients 12 to 70 years of age with refractory partial-onset seizures. After a prospective baseline period of 8 weeks, 158 patients were randomized to receive either placebo (n=79) or Keppra XR® 1000 mg/day (given as two 500-mg tablets once daily; n=79) over a 12-week treatment period. There was no titration period; patients took the starting dose of Keppra XR® (1000 mg/day) throughout the study. The primary efficacy endpoint was the percent reduction over placebo in mean weekly frequency of partial-onset seizures over the treatment period.

10.1% of refractory patients achieved freedom from partial-onset seizures from the FIRST DOSE of Keppra XR® 1000 mg1

Partial-Onset Seizure Freedom From The First Dose Through The 12-Week Treatment Period
†Patients achieving 100% reduction in partial-onset seizures who completed the 12-week treatment period.

Keppra XR® provided significant seizure reduction in refractory patients

  • 46.1% median reduction in weekly partial-onset seizure frequency with Keppra XR® vs. 33.4% with placebo
    — The reduction over placebo in weekly partial-onset seizure frequency was
         statistically significant (14.4%; P=0.038)

More patients taking Keppra XR® achieved ≥50% seizure reduction1

Seizure Frequency

IMPORTANT SAFETY INFORMATION

Keppra XR® extended-release tablets are indicated as adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.

Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Keppra XR® causes somnolence, dizziness, and behavioral abnormalities. The most common adverse reactions observed with Keppra XR® in combination with other AEDs were somnolence and irritability.

The adverse reactions that may be seen in patients receiving Keppra XR® are expected to be similar to those seen in patients receiving immediate-release Keppra® (levetiracetam) tablets.

Keppra® immediate-release tablets cause somnolence and fatigue, coordination difficulties, and behavioral abnormalities (e.g., psychotic symptoms, suicidal ideation, and other abnormalities), as well as hematological abnormalities. In adults experiencing partial onset seizures, the most common adverse reactions observed with Keppra® in combination with other AEDs were somnolence, asthenia, infection, and dizziness.

Keppra XR® should be gradually withdrawn to minimize the potential of increased seizure frequency.

Dosing must be individualized according to the patient’s renal function status. In patients with end stage renal disease on dialysis, it is recommended that immediate-release Keppra® be used instead of Keppra XR®. Please see Keppra.com for the Keppra® immediate-release tablets full prescribing information.

Please see Keppra XR® Medication Guide and Full Prescribing Information.

REFERENCES

1. Data on file. UCB, Inc.

*With this coupon, your patients pay the first $25 of their Keppra XR® or Keppra® co-pay and we pay the remaining out-of-pocket expense up to a maximum of $30. This coupon may not be repsiption. No cash value. Not valid for prescriptions that are reimbursed, in whole or part, under Medicare (including Medicare Part D), Medicaid, similar federal or state funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), private insurance in the Commonwealth of Massachusetts, or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (i.e., Medicare, Medicaid, Medigap, Tricare, VA and DoD) for reimbursement. Offer expires 12/31/2012. UCB may cancel or alter this program at any time without notice.