At UCB, patients are at the heart of everything we do. Patient safety is UCB’s highest priority, and we remain committed to improving the lives of those living with epilepsy. KEPPRA received FDA approval 24 years ago, and since then, we have produced and supplied this molecule to people living with epilepsy in more than 100 countries worldwide.

In the US, levetiracetam (KEPPRA^® and KEPPRA XR^®) is indicated for:

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

• as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with Juvenile Myoclonic Epilepsy

• as adjunctive therapy for the treatment of Primary Generalized Tonic-Clonic seizures in patients 6 years of age and older with Idiopathic Generalized Epilepsy.

Statement:

We are aware of the FDA communication about the risk of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) for levetiracetam (Keppra, Keppra XR), which is captured in section 6.2 of the prescribing information. We are working with the FDA to address their concerns related to DRESS. Patient safety is UCB’s highest priority, and we remain committed to improving the lives of those living with epilepsy.

UCB brands KEPPRA and KEPPRA XR are no longer marketed in the U.S, however across oral, injectable and tablet, over 45 generic versions are available for levetiracetam. For KEPPRA, DRESS was approved by the FDA in March 2015 as a post-marketing adverse reaction, reflected in Section 6.2 of the prescribing information.