| Combination of | |
|---|---|
| Drospirenone | Progestogen |
| Estetrol (medication) | Estrogen |
| Clinical data | |
| Trade names | Nextstellis, Drovelis, Lydisilka, others |
| Other names | E4/DRSP; FSN-013 |
| AHFS/ Drugs.com | Monograph |
| License data | |
|
Pregnancy category |
|
|
Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| ChemSpider |
|
| KEGG | |
Drospirenone/estetrol, sold under the brand name Nextstellis, Drovelis, and Lydisilka, 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
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
Legal status
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
- Birth control pill formulations
- List of combined sex-hormonal preparations § Estrogens and progestogens
References
- ^ a b "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Retrieved 28 December 2021.
- ^ a b c d https://pdf.hres.ca/dpd_pm/00060352.PDF [ bare URL PDF]
- ^ a b c d "Nextstellis Product information". Health Canada. 25 April 2012. Retrieved 4 November 2021.
- ^ "Summary Basis of Decision (SBD) for Nextstellis". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
- ^ a b c d e "Nextstellis- drospirenone and estetrol kit". DailyMed. Retrieved 1 June 2021.
- ^ a b c "Drovelis EPAR". European Medicines Agency (EMA). 24 March 2021. Retrieved 4 November 2021.
- ^ a b c "Lydisilka EPAR". European Medicines Agency (EMA). 24 March 2021. Retrieved 4 November 2021.
- ^ "Drovelis Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ "Lydisilka Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ 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.
- ^ 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.
-
^ 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.
- ^ 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.
- ^ "Drug Approval Package: Nextstellis". U.S. Food & Drug Administration (FDA). 12 May 2021. Retrieved 30 November 2021.
External links
- 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
 | This drug article relating to the genito-urinary system is a stub. You can help Wikipedia by expanding it. |
| Combination of | |
|---|---|
| Drospirenone | Progestogen |
| Estetrol (medication) | Estrogen |
| Clinical data | |
| Trade names | Nextstellis, Drovelis, Lydisilka, others |
| Other names | E4/DRSP; FSN-013 |
| AHFS/ Drugs.com | Monograph |
| License data | |
|
Pregnancy category |
|
|
Routes of administration | By mouth |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| ChemSpider |
|
| KEGG | |
Drospirenone/estetrol, sold under the brand name Nextstellis, Drovelis, and Lydisilka, 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
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
Legal status
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
- Birth control pill formulations
- List of combined sex-hormonal preparations § Estrogens and progestogens
References
- ^ a b "Nextstellis". Therapeutic Goods Administration (TGA). 6 December 2021. Retrieved 28 December 2021.
- ^ a b c d https://pdf.hres.ca/dpd_pm/00060352.PDF [ bare URL PDF]
- ^ a b c d "Nextstellis Product information". Health Canada. 25 April 2012. Retrieved 4 November 2021.
- ^ "Summary Basis of Decision (SBD) for Nextstellis". Health Canada. 23 October 2014. Retrieved 29 May 2022.
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Retrieved 25 March 2024.
- ^ a b c d e "Nextstellis- drospirenone and estetrol kit". DailyMed. Retrieved 1 June 2021.
- ^ a b c "Drovelis EPAR". European Medicines Agency (EMA). 24 March 2021. Retrieved 4 November 2021.
- ^ a b c "Lydisilka EPAR". European Medicines Agency (EMA). 24 March 2021. Retrieved 4 November 2021.
- ^ "Drovelis Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ "Lydisilka Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ 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.
- ^ 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.
-
^ 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.
- ^ 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.
- ^ "Drug Approval Package: Nextstellis". U.S. Food & Drug Administration (FDA). 12 May 2021. Retrieved 30 November 2021.
External links
- 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
|
| This drug article relating to the genito-urinary system is a stub. You can help Wikipedia by expanding it. |