Drug products: Desitrend, Keppra, Kevesy, Levetiracetam 1A Farma, Levetiracetam 2care4, Levetiracetam Accord, Levetiracetam Actavis, Levetiracetam Actavis Group, Levetiracetam Aristo, Levetiracetam Bluefish, Levetiracetam Desitin, Levetiracetam Ebb, Levetiracetam Hospira, Levetiracetam Medartuum, Levetiracetam Navamedic, Levetiracetam Orifarm, Levetiracetam Orion, Levetiracetam STADA, Levetiracetam SUN, Levetiracetam Teva, Matever
ATC code: N03AX14
Controlled studies on differences between men and women regarding effect of levetiracetam are lacking.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
There is no evidence for relevant sex differences in levetiracetam pharmacokinetics . According to clinical studies done by the original manufacturer (12 men, 11 women), levetiracetam Cmax and AUC were 20% higher in women than men. However, clearances adjusted for body weight were comparable . Another study found no significant sex differences in pharmacokinetic parameters of levetiracetam in children aged 2.3-46.2 months .
In pregnancy, decreasing concentrations are found already from the first trimester and up to 40-60% in the third trimester (increased renal elimination or enzymatic hydrolysis). The inter-individual variation is large and a fast normalization is seen after delivery .
No studies with a clinically relevant sex analysis regarding the effects of levetiracetam have been found.
A clinical trial (30 men, 27 women) found no apparent sexual or endocrine side effects of levetiracetam treatment in men and women (age 18-45 years). Men treated with levetiracetam had lower free testosterone and androstenedione levels than healthy controls, but this was also seen in men treated with either carbamazepine or lamotrigine. This could thus be a difference between persons with and without epilepsy, and not a specific drug effect. Menstrual disturbances were more commonly reported in the epilepsy group than in the control group, but there were no difference in menstrual disturbances between treated women and controls. According to ASEX scores (Arizona Sexual Experience Scale), women using levetiracetam were more satisfied with their sexual lives than healthy controls without epilepsy while no differences were found in men. The etiology of this improvement in women is unclear . A cross-sectional cohort study found no impact of levetiracetam monotherapy for 6 months on serum concentrations of sex-steroid hormones in pre-pubertal children. However, this study had a small sample size (7 boys and 3 girls on levetiracetam). There is reason to assume that levetiracetam monotherapy for 6 months does not result in clinically relevant endocrine side effects in prepubertal children .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2013-03-06
Reviewed by: Expertrådet för neurologiska sjukdomar, Ellen Vinge
Approved by: Karin Schenck-Gustafsson