Brivaracetam

May cause CNS depression (impaired coordination, ataxia, abnormal gait, fatigue, dizziness, and somnolence), which may impair physical or mental abilities. Risk is greatest early in treatment, but may occur at any time. Patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

May cause hematologic abnormalities; significant decreased white blood cell count (9/L) and decreased neutrophil count (9/L) have been reported.

Bronchospasm and angioedema have been reported. Discontinue therapy if a hypersensitivity reaction develops. Multiorgan hypersensitivity syndrome (also known as Drug Rash Eosinophilia and Systemic Symptoms or DRESS), is a serious condition sometimes induced by antiepileptic drugs. DRESS initially presents with fever and rash, then with other organ system involvement that may include eosinophilia, lymphadenopathy, hepatitis, nephritis, and/or myocarditis. If any of these hypersensitivity reactions are suspected and an alternative cause cannot be established, discontinue brivaracetam.

Psychosis, paranoia, hallucinations, and behavioral symptoms (including abnormal behavior, adjustment disorder, affect liability, aggression, agitation, altered mood, anger, anxiety, apathy, belligerence, depression, irritability, mood swings, nervousness, psychomotor hyperactivity, restlessness, and tearfulness) may occur; clinical trials reported events in 13% of patients receiving brivaracetam compared with 8% receiving placebo.

Pooled analysis of trials involving various antiepileptics (regardless of indication) showed an increased risk of suicidal thoughts/behavior (incidence rate: 0.43% treated patients compared with 0.24% of patients receiving placebo); risk observed as early as 1 week after initiation and continued through duration of trials (most trials ≤24 weeks). Monitor all patients for notable changes in behavior that might indicate suicidal thoughts or depression; notify the health care provider immediately if symptoms occur. Disease-related concerns:

Use caution in patients with hepatic impairment; dosage adjustment recommended.

Use caution in patients with renal impairment; not recommended in patients with end-stage renal disease (ESRD) undergoing dialysis. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information. Special populations:

Poor metabolizers of CYP2C19 may require dose reduction. Other warnings/precautions:

Anticonvulsants should not be discontinued abruptly because of the possibility of increasing seizure frequency; therapy should be withdrawn gradually to minimize the potential of increased seizure frequency, unless safety concerns require a more rapid withdrawal.