Drospirenone/estetrol

Drospirenone/estetrol
Combination of
DrospirenoneProgestogen
Estetrol (medication)Estrogen
Names
Trade namesNextstellis, Drovelis, Lydisilka, others
Other namesE4/DRSP; FSN-013
Clinical data
Drug classCombined oral birth control[1]
Main usesPrevention of pregnancy[2]
Side effectsIrregular vaginal bleeding, mood changes, headaches, breast pain, acne, increased weight, decreased sex drive[2]
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Pregnancy
category
  • AU: B3
Routes of
use		By mouth
External links
AHFS/Drugs.comMonograph
Legal
License data
Legal status

Drospirenone/estetrol, sold under the brand name Nextstellis among others, is a combination medication used by women to prevent pregnancy.[2] Effectiveness is less in those with a BMI of over 30 kg/m2.[2] It is taken by mouth.[8]

Common side effects include irregular vaginal bleeding, mood changes, headaches, breast pain, acne, increased weight, and decreased sex drive.[2] Serious side effects may include blood clots, high potassium, and gallbladder disease.[2] There is no evidence that use in pregnancy harms the baby, though it should be stopped once pregnancy occurs.[2] It contains drospirenone, a progestin, and estetrol, an estrogen.[8]

The combination was approved for medical use in Canada, Europe, and the United States in 2021.[5][2][8] In the United States it costs about 200 USD per month.[9] In the United Kingdom this amount costs the NHS about £9.[1]

Medical uses

Drospirenone/estetrol is used as a combined birth control pill to prevent pregnancy in women.[4][2]

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.[10][11] 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.[12]

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.[13]

Society and culture

Drospirenone/estetrol is approved for the use of hormonal contraception in the European Union,[7][8] the United States,[14] and Canada.[5]

Brand names

Drospirenone/estetrol in sold under the brand names Nexstellis,[5] Drovelis,[7] and Lydisilka.[8]

See also

References

  1. 1 2 "Estetrol + drospirenone". SPS - Specialist Pharmacy Service. 19 April 2019. Archived from the original on 2 December 2021. Retrieved 30 October 2022.
  2. 1 2 3 4 5 6 7 8 9 10 "Nextstellis- drospirenone and estetrol kit". DailyMed. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
  3. 1 2 "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
  4. 1 2 https://pdf.hres.ca/dpd_pm/00060352.PDF Archived 2022-07-09 at the Wayback Machine
  5. 1 2 3 4 "Nextstellis Product information". Health Canada. 25 April 2012. Archived from the original on 22 September 2021. Retrieved 4 November 2021.
  6. ↑ "Summary Basis of Decision (SBD) for Nextstellis". Health Canada. 23 October 2014. Archived from the original on 30 May 2022. Retrieved 29 May 2022.
  7. 1 2 3 "Drovelis EPAR". European Medicines Agency (EMA). Archived from the original on 4 November 2021. Retrieved 4 November 2021.
  8. 1 2 3 4 5 6 "Lydisilka EPAR". European Medicines Agency (EMA). Archived from the original on 4 November 2021. Retrieved 4 November 2021.
  9. ↑ "Nextstellis". Archived from the original on 30 October 2022. Retrieved 30 October 2022.
  10. ↑ 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.
  11. ↑ 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.
  12. ↑ 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.
  13. ↑ 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.
  14. ↑ "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.
Identifiers:
  • "Drospirenone". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-12-05. Retrieved 2022-06-01.
  • "Estetrol". Drug Information Portal. U.S. National Library of Medicine. Archived from the original on 2021-10-26. Retrieved 2022-06-01.
  • 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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