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IMPORTANT SAFETY INFORMATION
Keppra® tablets and oral solution are indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy, myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy.
Keppra® injection is indicated as adjunctive therapy in the treatment of myoclonic seizures in JME and partial onset seizures in adults with epilepsy. Keppra® injection is an alternative for adult patients when oral administration is temporarily not feasible.
Keppra® tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, and coordination difficulties, as well as hematological abnormalities. In pediatric patients
4-16 years of age experiencing partial onset seizures, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, asthenia, infection and dizziness. In patients 12 years of age and older experiencing myoclonic seizures with JME, the most common adverse events associated with Keppra® in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older experiencing PGTC seizures with idiopathic generalized epilepsy, the most common adverse event associated with Keppra® in combination with other AEDs was nasopharyngitis.
The adverse events that result from Keppra® injection use for myoclonic seizures in
JME and partial onset seizures in adults include all of those associated with Keppra®
tablets and oral solution.
Dosing for all Keppra® formulations must be individualized according to the patient’s
renal function status.
Reference: 1. Brodie MJ, Kwan P. Staged approach to epilepsy management.
Neurology. 2002;58(suppl 5):S2-S8.
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