Drug products: Saxenda, Victoza, Xultophy®
ATC code: A10AE56, A10BJ02
Liraglutide is indicated for treatment of type 2-diabetes mellitus in combination with other medicines if these have not given satisfying glycemic control.
Clinical studies on differences between men and women in liraglutide efficacy or safety of are lacking. No clinically relevant differences between men and women in pharmacokinetics have been shown.
The present evidence concerning differences between men and women is limited and do not motivate differentiation in dosing or treatment.
The pharmacokinetics of a single-dose liraglutide has been investigated in healthy men and women in a clinical trial (16 men, 16 women). When adjusted for body weight, pharmacokinetics of liraglutide were similar in men and women . No sex differences in pharmacokinetics of liraglutide have been reported in patients with type 2-diabetes . However, population pharmacokinetic analyses reported in the FDA-approved labeling identified a 34% reduction in weight-adjusted clearance of liraglutide in women compared with men [3, 4]. Based on the pharmacokinetics of liraglutide, no dosage adjustment according to sex is necessary .
At present, there are no published reports on sex differences in efficacy and safety of liraglutide.
No studies with a clinically relevant sex analysis regarding adverse effects of liraglutide have been found.
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2014-04-07
Reviewed by: Mia von Euler
Approved by: Karin Schenck-Gustafsson