Drospirenone/estetrol

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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]
Pregnancy
category
  • AU: B3
Routes of
use
By mouth
External links
AHFS/Drugs.comMonograph
US NLMDrospirenone/estetrol
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

Legal status

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. 1.0 1.1 "Estetrol + drospirenone". SPS - Specialist Pharmacy Service. 19 April 2019. Archived from the original on 2 December 2021. Retrieved 30 October 2022.
  2. 2.0 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 "Nextstellis- drospirenone and estetrol kit". DailyMed. Archived from the original on 2 June 2021. Retrieved 1 June 2021.
  3. 3.0 3.1 "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Archived from the original on 28 December 2021. Retrieved 28 December 2021.
  4. 4.0 4.1 https://pdf.hres.ca/dpd_pm/00060352.PDF Archived 2022-07-09 at the Wayback Machine[bare URL PDF]
  5. 5.0 5.1 5.2 5.3 "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. 7.0 7.1 7.2 "Drovelis EPAR". European Medicines Agency (EMA). Archived from the original on 4 November 2021. Retrieved 4 November 2021.
  8. 8.0 8.1 8.2 8.3 8.4 8.5 "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.

External links

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