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Liraglutide

Classification: B

Drug products: Saxenda, Victoza, Xultophy®

ATC code: A10AE56, A10BJ02

Substances: liraglutide

Summary

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.

Additional information

Pharmacokinetics and dosing

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 [1]. No sex differences in pharmacokinetics of liraglutide have been reported in patients with type 2-diabetes [2]. 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 [3].

Effects

At present, there are no published reports on sex differences in efficacy and safety of liraglutide.

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of liraglutide have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Updated: 2019-02-26

Date of litterature search: 2014-04-07

References

  1. Damholt B, Golor G, Wierich W, Pedersen P, Ekblom M, Zdravkovic M. An open-label, parallel group study investigating the effects of age and gender on the pharmacokinetics of the once-daily glucagon-like peptide-1 analogue liraglutide. J Clin Pharmacol. 2006;46:635-41. PubMed
  2. Victoza (liraglutide). Summary of Product Characteristics. European Medicines Agency (EMA); 2013.
  3. Victoza (liraglutide). DailyMed [www]. US National Library of Medicine. [updated 2013-04-01, cited 2014-04-07]. länk
  4. Sisson EM. Liraglutide: clinical pharmacology and considerations for therapy. Pharmacotherapy. 2011;31:896-911. PubMed
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-05.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson