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Drospirenone/estetrol

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Drospirenone/estetrol
Combination of
DrospirenoneProgestogen
Estetrol (medication)Estrogen
Clinical data
Trade namesNextstellis, Drovelis, Lydisilka, others
Other namesE4/DRSP; FSN-013
AHFS/Drugs.comMonograph
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]

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

Medical uses

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

Side effects

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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

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Pharmacodynamics

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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

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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

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

See also

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References

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  1. ^ a b "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
  2. ^ a b c d "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. ^ a b c d "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. ^ a b c d e "Nextstellis- drospirenone and estetrol kit". DailyMed. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
  7. ^ a b c "Drovelis EPAR". European Medicines Agency (EMA). 24 March 2021. Archived from the original on 4 November 2021. Retrieved 4 November 2021.
  8. ^ a b c "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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  • Clinical trial number NCT02817828 for "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - EU/Russia Study" at ClinicalTrials.gov
  • Clinical trial number NCT02817841 for "E4 FREEDOM (Female Response Concerning Efficacy and Safety of Estetrol/Drospirenone as Oral Contraceptive in a Multicentric Study) - United States/Canada Study" at ClinicalTrials.gov


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