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Mifepristone

Classification: B

Drug products: Mifecur, Mifegyne, Mifepristone Linepharma®

ATC code: G03XB01

Substances: mifepristone

Summary

Mifepristone is approved on indications concerning prevention or termination of pregnancy and therefore analyses of sex or gender differences are not relevant. Mifepristone is also used on other indications but published data with relevant sex or gender analysis are sparse.

Additional information

Mifepristone is a synthetic steroid blocking progesterone [1]. It is approved on the indications induction of abortion during first trimester (in combination with prostaglandins), post coital contraception and cervical ripening prior to suction termination of pregnancy [1-3]. For these indications the substance is only used in women and analyses on sex or gender differences have therefore not been considered relevant.

Mifepristone has also been studied in Cushing’s Disease in patients with ectopic ACTH-secreting neoplasms or adrenocortical carcinoma to control hypercortisolism while waiting for definitive therapy [4-6]. Both men and women have been included in the studies but no analysis of sex differences has been found even though Spitz et al report sex divided data [6]. Clinical studies of the effect of mifepristone on neuroleptic induced weight gain have been performed in men, thus sex-divided analysis in this therapeutic area is also lacking [7, 8].

Pharmacokinetics and dosing

No studies with a clinically relevant sex analysis regarding pharmacokinetics and dosing of mifepristone have been found.

Effects

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

Adverse effects

Controlled studies on adverse effects between men and women in mifepristone safety are lacking although there is one study presenting sex-divided data on adverse events in treatment of Cushing Disease [6].

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: 2017-04-11

References

  1. Dollery C Sir, editor. Therapeutic drugs. 2nd ed. Edinburgh: Churchill Livingstone; 1999
  2. Mifegyne (mifepriston). Fass.se [www]. [updated 2015-12-10, cited 2017-04-11]. länk
  3. Physicians' Desk Reference. http://www.pdr.net. [cited 2017-04-11]. länk
  4. Molitch ME. Diagnosis and Treatment of Pituitary Adenomas: A Review. JAMA. 2017;317:516-524. PubMed
  5. Fleseriu M, Biller BM, Findling JW, Molitch ME, Schteingart DE, Gross C et al. Mifepristone, a glucocorticoid receptor antagonist, produces clinical and metabolic benefits in patients with Cushing's syndrome. J Clin Endocrinol Metab. 2012;97:2039-49. PubMed
  6. Spitz IM, Grunberg SM, Chabbert-Buffet N, Lindenberg T, Gelber H, Sitruk-Ware R. Management of patients receiving long-term treatment with mifepristone. Fertil Steril. 2005;84:1719-26. PubMed
  7. Gross C, Blasey CM, Roe RL, Allen K, Block TS, Belanoff JK. Mifepristone treatment of olanzapine-induced weight gain in healthy men. Adv Ther. 2009;26:959-69. PubMed
  8. Gross C, Blasey CM, Roe RL, Belanoff JK. Mifepristone reduces weight gain and improves metabolic abnormalities associated with risperidone treatment in normal men. Obesity (Silver Spring). 2010;18:2295-300. PubMed
  9. Conicse. Stockholm: eHälsomyndigheten. 2015 [cited 2016-03-23.] länk

Authors: Mia von Euler, Maria Enghag

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson