Information on the combined hormonal contraceptives (CHC) containing the dienogest + ethinyl estradiol combination (Jeanine®)

A. D. Makatsariya; V. O. Bitsadze; D. V. Blinov; D. I. Korabelnikov

doi:10.17749/2313-7347.2019.13.1.007-012

Information on the combined hormonal contraceptives (CHC) containing the dienogest + ethinyl estradiol combination (Jeanine®)

A. D. Makatsariya, V. O. Bitsadze, D. V. Blinov, D. I. Korabelnikov

https://doi.org/10.17749/2313-7347.2019.13.1.007-012

Full Text:

PDF (Rus)

Abstract

In this short communication, the editorial board publishes the information on safety of the combined hormonal contraceptive (CHC) Jeanine®, containing the fixed dose combination of dienogest and ethinyl estradiol. This information has been received from the Russian regulatory authority (Roszdravnadzor) and the manufacturer. According to a metaanalysis of four observational studies, women using the dienogest/ethinyl estradiol fixed dose combination had a higher risk of developing venous thromboembolism (VTE) as compared with women taking the CHCs containing the levonorgestrel/ ethinyl estradiol combination. The estimated risk of developing VTE in women taking the dienogest/ethinyl estradiol combination is 8-11 cases of VTE per 10,000 women per year, while in women taking the CHCs containing levonorgestrel, norethisterone or norgestimate the risk is 5-7 cases of VTE per 10,000 women per year. A patient information leaflet amendment is under consideration by the regulatory authorities. For now, however, hormonal contraceptives containing the dienogest/ethinyl estradiol combination accompanied with the previous version of the instruction are still available in pharmacies. Therefore, when prescribing the combined hormonal contraceptives with dienogest and ethinyl estradiol, the obstetrician-gynecologist should discuss these risks with the woman.

Keywords

chronic endometritis, intestinal and urinary microbiomes, somatic diseases

About the Authors

A. D. Makatsariya

I.M. Sechenov First Moscow State Medical University, Health Ministry of Russian Federation
Russian Federation

Alexander D. MakatsariYa - MD, PhD, Corresponding Member of RAS, Professor, Head of the Department of Obstetrics and Gynecology, Faculty of Clinical and Preventive Medicine, I.M. Sechenov First MSMU HM of RF.

62 St. Zemlyanoi Val, Moscow 109004.

Researcher ID: M-5660-2016

Scopus Author ID: 6602363216

V. O. Bitsadze

I.M. Sechenov First Moscow State Medical University, Health Ministry of Russian Federation
Russian Federation

Viktoriya O. Bitsadze - MD, PhD, Professor, Department of 0bstetrics and Gynecology, Faculty of Clinical and Preventive Medicine, I.M. Sechenov First MSMU.

62 St. Zemlyanoi Val, Moscow 109004.

Scopus Author ID: 6506003478

D. V. Blinov

Institute of Preventive and Social Medicine; Lapino Clinical Hospital, GC «Mother and Child»; Moscow Medico-Social Institute named after F.P. Gaaz
Russian Federation

Dmitry V. Blinov - Head of Scientific and Medical Affairs, Institute of Preventive and Social Medicine; Neurologist, Lapino Clinical Hospital, GC «Mother and Child»; PhD, MBA, Lecturer, Department of Neurology, Psychiatry and Narcology, MMSI n.a. F.P. Gaaz.

4-10 Sadovaya-Triumfalnaya St., Moscow 127006; 111,1-e Uspenskoe shosse, Lapino, Moscow region, 143081; 5, s. 1-1a, 2-ya Brestskaya St., Moscow 123056.

Researcher ID: E-8906-2017

RSCI: 9779-8290

D. I. Korabelnikov

Moscow Medico-Social Institute named after F.P. Gaaz
Russian Federation

Daniil I. Korabelnikov - Rector MMSI n.a. F.P. Gaaz.

5, s. 1-1a, 2-ya Brestskaya St., Moscow 123056.

Теl.: +7(495)1503956.

References

1. About new data on the safety of combined hormonal contraceptives (KGC). Information letter № 01И-778/19 dated 03/20/2019. Federal Service for Supervision in the Sphere of Health (Roszdravnadzor). [0 novyh dannyh po bezopasnosti kombinirovannyh gormonal'nyh kontraceptivov (KGK). Informacionnoe pis'mo № 01I-778/19 ot 20.03.2019. Federal'naya Sluzhba po Nadzoru v Sfere Zdravoohraneniya (Roszdravnadzor)]. (In Russ.). Available at: http://www.roszdravnadzor.ru/spec/drugs/monit-pringlp/documents/58397. [Accessed: 22.03.2019].

2. Dinger J., Assmann A., Mohner S., Minh T.D. Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study. J Fam Plann Reprod Health Care. 2010;36:1239. DOI: 10.1783/147118910791749416.

3. Dinger J.C., Heinemann L.A., Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on 142,475 women-years of observation. Contraception. 2007;75(5):344-54.

4. Byshevsky A.Sh., Polyakova V.A., Karpova I.A. et al. Hemocoagulation and lipid peroxidation in women who took sex steroids with ethinyl estradiol and progestogens. [Gemokoagulyaciya i lipidperoksidaciya u zhenshchin, prinimavshih polovye steroidy s etinilestradiolom i progestagenami]. Vestnik YuUrGU. 2012;(28):58-62. (In Russ.).

5. Dienogest/ethinyl estradiol containing medicinal products indicated in acne. Assessment report, European Medicines Agency. EMA/174401/201. Available at: https://www.ema.europa.eu/en/medicines/human/referrals/dienogestethinylestradiol-containing-medicinal-products-indicated-acne. [Accessed: 22.03.2019].

6. Jeanine. Instructions for medical use. P N013757/01. [Zhanin. Instrukciya po medicinskomu primeneniyu. P N013757/01]. (In Russ.). Available at: http://www.grls.rosminzdrav.ru. [Accessed: 22.03.2019].

7. Dienogest + Ethinyl Estradiol. Instructions for medical use. LP-004470. [Dienogest + Etinilestradiol. Instrukciya po medicinskomu primeneniyu. LP-004470]. (In Russ.). Available at: http://www.grls.rosminzdrav.ru. [Accessed: 22.03.2019].

8. Femiss Messi. Instructions for medical use. LP-004011. [Femiss Messi. Instrukciya po medicinskomu primeneniyu. LP-004011]. (In Russ.). Available at: http://www.grls.rosminzdrav.ru. [Accessed: 22.03.2019].

9. Bonade. Instructions for medical use. LP-002523. [Bonade. Instrukciya po medicinskomu primeneniyu. LP-002523]. (In Russ.). Available at: http://www.grls.rosminzdrav.ru. [Accessed: 22.03.2019].

10. Dietsiklen. Instructions for medical use. LP-001494. [Dieciklen. Instrukciya po medicinskomu primeneniyu. LP-001494]. (In Russ.). Available at: http://www.grls.rosminzdrav.ru. [Accessed: 22.03.2019].

11. Siluet. Instructions for medical use. LP-001145. [Siluet. Instrukciya po medicinskomu primeneniyu. LP-001145]. (In Russ.). Available at: http://www.grls.rosminzdrav.ru. [Accessed: 22.03.2019].

For citation:

Makatsariya A.D., Bitsadze V.O., Blinov D.V., Korabelnikov D.I. Information on the combined hormonal contraceptives (CHC) containing the dienogest + ethinyl estradiol combination (Jeanine®). Obstetrics, Gynecology and Reproduction. 2019;13(1):7-12. (In Russ.) https://doi.org/10.17749/2313-7347.2019.13.1.007-012