US FDA Grants Pediatric Exclusivity for UCB's...(as adjunctive therapy forepilepsy. Im...)

Important Safety Information

Keppra(R) 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(R) injection is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy, myoclonic seizures in adults with juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy. Keppra(R) injection is an alternative for patients when oral administration is temporarily not feasible.

Keppra(R) tablets and oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, as well as hematological abnormalities. In adults experiencing partial onset seizures, Keppra(R) is also associated with co- ordination difficulties. In adults experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection and dizziness. In pediatric patients 4-16 years of age experiencing partial onset seizures, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, accidental injury, hostility, nervousness and asthenia. In patients 12 years of age and older with juvenile myoclonic epilepsy, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with Keppra(R) in combination with other AEDs
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