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Rotigotine

Classification: A

Drug products: Neupro®

ATC code: N04BC09

Substances: rotigotine

Summary

In a small study there was an indication that men developed more impulse control disturbances that women whole treated with rotigotin. Increased risk of impulse control disturbance has been shown in men compared to women when treated with anti-Parkinson drugs.
Plasma concentration of rotigotin is similar in men and women if the doses are weight adjusted.
 
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.

Additional information

Pharmacokinetics and dosing

Women and men have shown to have similar plasma concentrations of rotigotine (body weight normalized) [1]. Rotigotine treatment is initiated at low dose and is gradually titrated according to clinical tolerability to obtain the optimum therapeutic effect. It is not necessary to adjust the dose based on sex, weight or age [2].

Effects

No studies with a clinically relevant sex analysis regarding the effects of rotigotine have been found.

Adverse effects

In a small study (17 women, 11 men), patients with Restless Legs Syndrome (RLS) were treated with low doses of transdermal rotigotine. Six men developed impulse control disorder, none of the women [3]. The study is small and larger studies are needed to confirm the finding. In a larger study including 642 patients impulse control disorder was found more frequently in men using dopamine agonists [4].

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: 2013-04-15

References

  1. Neupro (rotigotine). DailyMed [www]. US National Library of Medicine. [updated 2012-04-01, cited 2013-04-15]. länk
  2. Neupro (rotigotine). Summary of Product Characteristics. European Medicines Agency; 2016. länk
  3. Schreglmann SR, Gantenbein AR, Eisele G, Baumann CR. Transdermal rotigotine causes impulse control disorders in patients with restless legs syndrome. Parkinsonism Relat Disord. 2012;18:207-9. PubMed
  4. Carrière N, Kreisler A, Dujardin K, Destée A, Defebvre L. [Impulse control disorders in Parkinson's disease: A cohort of 35 patients]. Rev Neurol (Paris). 2012;168:143-51. PubMed
  5. Läkemedelsstatistik. Stockholm: Socialstyrelsen. 2015 [cited 2016-04-29] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Expertrådet för neurologiska sjukdomar

Approved by: Mia von Euler