Drug products: AZILECT, Rasagilin Glenmark, Rasagilin Krka, Rasagilin STADA, Rasagiline Accord, Rasagiline Amneal, Rasagiline Bluefish, Rasagiline Mylan, Rasagiline Sandoz
ATC code: N04BD02
Substances: rasagiline, rasagiline mesilate, rasagiline tartrate
Clinical studies comparing rasagilin (1 mg/day) to placebo did not find any differences between men and women in efficacy of rasagilin as mono therapy or as an additive treatment. No difference between men and women in the safety profile of the drug has been shown.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
No differences in rasagiline pharmacokinetics have been seen between men and women and no sex differentiation in dosing has been recommended by the manufacturer .
A double-blind randomized monotherapy trial, comparing rasagiline 1 mg/day with placebo, could not detect any differences in effectiveness based on age or sex. Nor trials of rasagiline as adjunctive therapy, comparing rasagiline 1 mg/day and placebo, found differences in effectiveness based on age or sex .
Controlled clinical trials of rasagiline as montherapy or adjunctive therapy, have not found any significant differences in the safety profile based on age or sex .
Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2013-04-18
Reviewed by: Expertrådet för neurologiska sjukdomar
Approved by: Mia von Euler