Drospirenone/estetrol

Last updated

Drospirenone/estetrol
Combination of
Drospirenone Progestogen
Estetrol (medication) Estrogen
Clinical data
Trade names Nextstellis, Drovelis, Lydisilka, others
Other namesE4/DRSP; FSN-013
AHFS/Drugs.com Monograph
License data
Pregnancy
category
Routes of
administration 		By mouth
ATC code
Legal status
Legal status
Identifiers
ChemSpider
  • None
KEGG

Drospirenone/estetrol, sold under the brand name Nextstellis, among others, is a fixed-dose combination medication containing drospirenone, a progestin, and estetrol, an estrogen, which is used as a combined birth control pill for the prevention of pregnancy in women. [2] [6] It is taken by mouth. [2] [6]

Contents

It was approved for medical use in Canada in March 2021, [3] and in the United States in April 2021. [6]

Medical uses

Drospirenone/estetrol is used as a combined birth control pill to prevent pregnancy in women. [2] [6]

Side effects

Estetrol-containing birth control pills, similarly to estradiol-containing birth control pills, may have a lower risk of venous thromboembolism (VTE) than ethinylestradiol-containing birth control pills based on studies of coagulation. [11] [12] However, it is likely that another decade will be required before post-marketing epidemiological studies of VTE incidence with these birth control pills are completed and able to confirm this. [13]

Pharmacology

Pharmacodynamics

Drospirenone/estetrol has a much lower impact on liver protein synthesis, including of sex hormone-binding globulin, angiotensinogen, and coagulation factors, than does ethinylestradiol/drospirenone. [14]

Society and culture

Drospirenone/estetrol is approved for the use of hormonal contraception in the European Union, [7] [8] the United States, [15] and Canada. [3]

Brand names

Drospirenone/estetrol in sold under the brand names Nexstellis, [3] Drovelis, [7] and Lydisilka. [8]

See also

References

  1. 1 2 "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
  2. 1 2 3 4 "PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION NEXTSTELLIS" (PDF). 5 March 2021. Archived (PDF) from the original on 9 July 2022. Retrieved 4 July 2024.
  3. 1 2 3 4 "Nextstellis Product information". Health Canada. 25 April 2012. Archived from the original on 22 September 2021. Retrieved 4 November 2021.
  4. ↑ "Summary Basis of Decision (SBD) for Nextstellis". Health Canada . 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  5. ↑ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada . 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
  6. 1 2 3 4 5 "Nextstellis- drospirenone and estetrol kit". DailyMed. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
  7. 1 2 3 "Drovelis EPAR". European Medicines Agency (EMA). 24 March 2021. Archived from the original on 4 November 2021. Retrieved 4 November 2021.
  8. 1 2 3 "Lydisilka EPAR". European Medicines Agency (EMA). 24 March 2021. Archived from the original on 4 November 2021. Retrieved 4 November 2021.
  9. ↑ "Drovelis Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  10. ↑ "Lydisilka Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  11. ↑ Morimont L, Haguet H, Dogné JM, Gaspard U, Douxfils J (2021). "Combined Oral Contraceptives and Venous Thromboembolism: Review and Perspective to Mitigate the Risk". Front Endocrinol (Lausanne). 12: 769187. doi: 10.3389/fendo.2021.769187 . PMC   8697849 . PMID   34956081.
  12. ↑ Douxfils J, Morimont L, Bouvy C (November 2020). "Oral Contraceptives and Venous Thromboembolism: Focus on Testing that May Enable Prediction and Assessment of the Risk". Semin Thromb Hemost. 46 (8): 872–886. doi:10.1055/s-0040-1714140. PMID   33080636. S2CID   224821517.
  13. ↑ Grandi G, Facchinetti F, Bitzer J (February 2022). "Confirmation of the safety of combined oral contraceptives containing oestradiol on the risk of venous thromboembolism". Eur J Contracept Reprod Health Care. 27 (2): 83–84. doi: 10.1080/13625187.2022.2029397 . PMID   35133236. S2CID   246651102. Moreover, the introduction of other new natural oestrogenic components, such as estetrol (E4) [12], could have a similar lower VTE impact; however, we will likely need another decade to obtain results from post-marketing studies.
  14. ↑ Farris M, Bastianelli C, Rosato E, Brosens I, Benagiano G (October 2017). "Pharmacodynamics of combined estrogen-progestin oral contraceptives: 2. effects on hemostasis". Expert Rev Clin Pharmacol. 10 (10): 1129–1144. doi:10.1080/17512433.2017.1356718. PMID   28712325. S2CID   205931204.
  15. ↑ "Drug Approval Package: Nextstellis". U.S. Food & Drug Administration (FDA). 12 May 2021. Archived from the original on 6 November 2021. Retrieved 30 November 2021.


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