Información de la droga para KEPPRA XR (UCB, Inc.): 17 PATIENT COUNSELING INFORMATION

  • Patients and caregivers should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to taking KEPPRA XR. The Medication Guide may also be found in the full prescribing information for KEPPRA XR posted on or by calling 1-866-822-0068. Patients should be instructed to take KEPPRA XR only as prescribed.

    Patients, their caregivers, and families should be counseled that AEDs, including KEPPRA XR, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

    Patients should be advised that KEPPRA XR may cause irritability and aggression. In addition, patients should be advised that they may experience changes in behavior that have been seen with other formulations of KEPPRA, which include agitation, anger, anxiety, apathy, depression, hostility, irritability and, in rare cases, psychotic symptoms.

    Patients should be instructed to only take KEPPRA XR as prescribed and to swallow the tablets whole. They should not be chewed, broken, or crushed.

    Patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy. Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334. UCB, Inc. has established the UCB AED Pregnancy Registry to advance scientific knowledge about safety and outcomes in pregnant women being treated with all UCB antiepileptic drugs including KEPPRA XR. To ensure broad program access and reach, either a healthcare provider or the patient can initiate enrollment in the UCB AED Pregnancy Registry by calling (888) 537-7734 (toll free) [see Use In Specific Populations (8.1)].

    Patients should be advised that KEPPRA XR may cause dizziness and somnolence. Accordingly, patients should be advised not to drive or operate heavy machinery or engage in other hazardous activities until they have gained sufficient experience on KEPPRA XR to gauge whether it adversely affects their performance of these activities.

  • Drug Information Provided by National Library of Medicine (NLM).