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With NEXTSTELLIS, offer a 24/4 monophasic pill with a new low impact* estrogen, E4.1,2

*Based on its selectivity, potency, pharmacokinetics, mechanism of action, and impact on the liver.2

starter

“Starter”

Using contraception for the first time

For young adults or those new to hormonal contraception, starting the pill can seem like a big step. Patients may be reassured by learning more about the selective, targeted way NEXTSTELLIS works in the body.1,6

Starting a Patient on NEXTSTELLIS
switcher

“Switcher”

Wants to switch contraceptive methods

Patients interested in changing contraceptive methods may find it helpful to learn how the estrogen in NEXTSTELLIS compares with other combined hormonal pills. If a patient has concerns about the estrogen in the pill, getting answers about estetrol and how NEXTSTELLIS is different may provide important context to support their decision.2,4

Switching From Another Method
Family planner

“Family Planner”

Not yet ready to expand her family

Patients who are still growing their families may want to know how long after stopping NEXTSTELLIS they can expect to return to fertility. This was a secondary objective of a Phase 2 clinical trial of NEXTSTELLIS. On average, patients in the study resumed ovulation 17 days after stopping NEXTSTELLIS.30

Your “family planner” patients may find it helpful to know that NEXTSTELLIS is easy to start and stop and that there are data supporting a timetable for their return to fertility.

Starting a Postpartum Patient
perimenopausal

“Perimenopausal”

Later in her reproductive life

Considerations for contraception may be more complex for patients later in their reproductive life. These patients may appreciate the metabolic profile of NEXTSTELLIS, which has been shown to have low impact on measures of lipid and glucose metabolism.1,7,25,26

Patient Resources

Your patients may have questions such as:

  • What makes NEXTSTELLIS different from other contraceptive pills?
  • How will it affect my period?
  • What are the side effects?

Help answer these questions and more with this downloadable patient brochure.

Instructions for starting or switching to NEXTSTELLIS1

To prevent pregnancy, patients should be instructed to take NEXTSTELLIS exactly as prescribed; 1 tablet daily for 28 consecutive days; On the first day of period, 1 pink (active) tablet daily for the first 24 days and 1 white (inactive) tablet daily during the following 4 days. Tablets must be taken every day at about the same time so that the interval between 2 tablets is always 24 hours.1 For patient instructions for starting NEXTSTELLIS and for missed pills, see the full Product Information.

2022-06-Blister-simulation-Mayne-Australia-Final

No current hormonal method

Important:

  • In women with irregular menstrual cycles, pregnancy testing may be necessary before initiation of this product.

Day 1 Start:

  • On the first day of a period, take the first tablet from the purple area on the blister pack corresponding to the day of the week.
  • Following the direction of the arrows on the blister pack, take the subsequent pink active tablets once daily at the same time each day for 24 days followed by the white inactive tablets; taking 1 daily for 4 days at the same time of day that the active tablets were taken.
  • Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet).

If not starting on the first day of a period, use a non-hormonal contraceptive (such as condoms) as backup until 1 active tablet has been taken daily for 7 days in a row.

Combined hormonal pill

  • Start NEXTSTELLIS the day after taking your previous contraceptive pill. 

Progestin-only pill

  • Start NEXTSTELLIS the day after the last tablet was taken.
  • If you are switching from a mini pill you will need to use an alternative non-hormonal contraceptive (such as condoms) for 7 consecutive days.

Transdermal patch, vaginal insert,
or injection

  • Start NEXTSTELLIS on the day when the next application, insertion, or injection would have been scheduled.

IUD or implant

  • Start NEXTSTELLIS on the day of removal. Recommend back up contraception until 7 days of active tablet taking.

After pregnancy

Starting NEXTSTELLIS after delivery (>20 weeks gestation)

  • Must not start earlier than 4 weeks after delivery (due to increased risk for thromboembolism).
  • If menstrual cycles have returned, follow instructions for “Starting NEXTSTELLIS in females with no current use of hormonal contraception.”
  • If menstrual cycles have not resumed, consider the possibility of ovulation and pregnancy. If not pregnant, use additional nonhormonal contraception for the first 7 days of NEXTSTELLIS use.

Starting NEXTSTELLIS after abortion or miscarriage

First Trimester

  • After a first-trimester abortion or miscarriage, NEXTSTELLIS may be started immediately. An additional method of contraception is not needed if NEXTSTELLIS is started within 5 days after termination of the pregnancy.
  • If NEXTSTELLIS is not started within 5 days after termination of the pregnancy, the woman should use additional non-hormonal contraception (such as a condom) until pink tablets have been taken for 7 days in a row.

Second Trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with NEXTSTELLIS after having ruled out pregnancy. Use of a non-hormonal contraceptive (such as a condom) is recommended until pink tablets have been taken for 7 days in a row.
EXPAND ALL
COLLAPSE ALL
  • No current hormonal method

    No current hormonal method

    Important:

    • In women with irregular menstrual cycles, pregnancy testing may be necessary before initiation of this product.

    Day 1 Start:

    • On the first day of a period, take the first tablet from the purple area on the blister pack corresponding to the day of the week.
    • Following the direction of the arrows on the blister pack, take the subsequent pink active tablets once daily at the same time each day for 24 days followed by the white inactive tablets; taking 1 daily for 4 days at the same time of day that the active tablets were taken.
    • Begin each subsequent 28-day pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last tablet).

    If not starting on the first day of a period, use a non-hormonal contraceptive (such as condoms) as backup until 1 active tablet has been taken daily for 7 days in a row.

  • Combined hormonal pill

    Combined hormonal pill

      • Start NEXTSTELLIS the day after taking your previous contraceptive pill. 
  • Progestin-only pill

    Progestin-only pill

      • Start NEXTSTELLIS the day after the last tablet was taken.
      • If you are switching from a mini pill you will need to use an alternative non-hormonal contraceptive (such as condoms) for 7 consecutive days.
  • Transdermal patch, vaginal insert, or injection

    Transdermal patch, vaginal insert, or injection

      • Start NEXTSTELLIS on the day when the next application, insertion, or injection would have been scheduled.
  • IUD or implant

    IUD or implant

      • Start NEXTSTELLIS on the day of removal. Recommend back up contraception until 7 days of active tablet taking.
  • After pregnancy

    After pregnancy

    Starting NEXTSTELLIS after delivery (>20 weeks gestation)

    • Must not start earlier than 4 weeks after delivery (due to increased risk for thromboembolism).
    • If menstrual cycles have returned, follow instructions for “Starting NEXTSTELLIS in females with no current use of hormonal contraception.”
    • If menstrual cycles have not resumed, consider the possibility of ovulation and pregnancy. If not pregnant, use additional nonhormonal contraception for the first 7 days of NEXTSTELLIS use.

    Starting NEXTSTELLIS after abortion or miscarriage

    First Trimester

    • After a first-trimester abortion or miscarriage, NEXTSTELLIS may be started immediately. An additional method of contraception is not needed if NEXTSTELLIS is started within 5 days after termination of the pregnancy.
    • If NEXTSTELLIS is not started within 5 days after termination of the pregnancy, the woman should use additional non-hormonal contraception (such as a condom) until pink tablets have been taken for 7 days in a row.

    Second Trimester

    • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start contraceptive therapy with NEXTSTELLIS after having ruled out pregnancy. Use of a non-hormonal contraceptive (such as a condom) is recommended until pink tablets have been taken for 7 days in a row.

 

PBS Information: THIS PRODUCT IS NOT LISTED ON THE PBS.

 

IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (estetrol/drospirenone tablets) 

As NEXTSTELLIS contains estetrol, a new molecular entity, it qualifies for the TGA’s Black Triangle Scheme. ▼ This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems

BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel. EE=ethinylestradiol; DRSP=drospirenone

References

1. NEXTSTELLIS Product Information. 2. Gérard C, et al. Profile of estetrol, a promising native estrogen for oral contraception and the relief of climacteric symptoms of menopause. Expert Review of Clinical Pharmacology 2022; 15:2, 121-137. 3. Drovelis EMEA authorisation. European Medicines Agency (EMA). https://www.ema.europa.eu/en/medicines/human/EPAR/drovelis#authorisation-details-section [accessed on 18 Jul 2022]. 4. Coelingh Bennink HJT, et al. Estetrol review: profile and potential clinical applications. Climacteric. 2008;11(suppl 1):47-58. 5. Lydisilka EMEA authorisation. European Medicines Agency (EMA). https://www.ema.europa.eu/en/medicines/human/EPAR/lydisilka#authorisation-details-section [accessed on 18 Jul 2022]. 6. Foidart JM, et al. Unique vascular benefits of estetrol, a natural fetal estrogen with specific actions in tissues (NEST). In: Brinton RD, Genazzani AR, Simoncini T, Stevenson JC, eds. Sex Steroids’ Effects on Brain, Heart and Vessels. Volume 6: Frontiers in Gynecological Endocrinology. New York, NY: Springer International Publishing; 2019:169‐195. 7. Creinin M, et al. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception. 2021; 104: 222–228 8. Douxfils J, et al. Evaluation of the effect of a new oral contraceptive containing estetrol and drospirenone on hemostasis parameters. Contraception. 2020;102(6): 396–402. 9. Arnal JF, et al. Membrane and nuclear estrogen receptor alpha actions: from tissue specificity to medical implications. Physiol Rev. 2017;97(3):1045-1087. 10. Nextstellis Approval FDA. U.S. Food & Drug Administration (FDA). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=214154 [accessed on 18 Jul 2022]. 11. Stanczyk FZ, et al. Ethinyl estradiol and 17β-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment. Contraception. 2013;87(6):706-727. 12. Jensen JT, et al. Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials. Contraception. 2022; DOI: https://doi.org/10.1016/j.contraception.2022.07.009. Epub ahead of print. PMID: 35921870. 13. Abot A, et al. The uterine and vascular actions of estetrol delineate a distinctive profile of estrogen receptor α modulation, uncoupling nuclear and membrane activation. EMBO Mol Med. 2014;6(10):1328-1346. 14. Ascenzi P, et al. Structure-function relationship of estrogen receptor alpha and beta: impact on human health. Mol Aspects Med. 2006;27(4):299-402. 15. Coelingh Bennink HJT, et al. Oral bioavailability and bone-sparing effects of estetrol in an osteoporosis model. Climacteric. 2008;11(suppl 1):2-14. 16. Benoit T, et al. Estetrol, a fetal selective estrogen receptor modulator, acts on the vagina of mice through nuclear estrogen receptor α activation. Am J Pathol. 2017;187(11):2499-2507. 17. Fruzzetti F, et al. Estetrol: A New Choice for Contraception. J. Clin. Med. 2021, 10, 5625. https://doi.org/10.3390/jcm10235625. 18. Visser M, et al. In vitro effects of estetrol on receptor binding, drug targets, and human liver cell metabolism. Climacteric. 2008;11(suppl 1):64-68. 19. Nextstellis Approval Health Canada. Health Canada, Government of Canada. 25 April 2012. https://health-products.canada.ca/dpd-bdpp/info.do?lang=en&code=100241 [accessed on 18 Jul 2022]. 20. Kestemont P, et al. 2020. Poster 0175 presented at the Society of Family Planning Virtual Annual Meeting October 9 10, 2020. 21. Apter D, et al. Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA). Contraception. 2016;94(4):366-373. 22. Regidor PA, et al. Antiandrogenic and antimineralocorticoid health benefits of COC containing newer progestogens: dienogest and drospirenone. Oncotarget. 2017;8(47):83334-83342. 23. Data on file – Mithra Pharmaceuticals from MIT-ES0001-C301; MIT-ES0001-C302. 24. Kaunitz AM, et al. Pooled analysis of two phase 3 trials evaluating the effects of a novel combined oral contraceptive containing estetrol/drospirenone on bleeding patterns in healthy women. Contraception. 2022 Jul 31:S0010-7824(22)00218-9. doi: 10.1016/j.contraception.2022.07.010. Epub ahead of print. PMID: 35921872. 25. Gemzell-Danielsson K, et al. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG. 2022; 129: 63-71. 26. Klipping C, et al. Endocrine and metabolic effects of an oral contraceptive containing estetrol and drospirenone. Contraception. 2021;103(4): 213–221. 27. Mawet M, et al. Unique effects on hepatic function, lipid metabolism, bone and growth endocrine parameters of estetrol in combined oral contraceptives. Eur. J. Contracept. Reprod. Health Care 2015, 20, 463–475. 28. NEXTSTELLIS ARTG ID 341876 available at http://www.ebs.tga.gov.au [accessed on 21 June 2021]. 29. Chen M, et al. Submitted Manuscript 2022. 30. Duijkers I, et al. Effects of an oral contraceptive containing estetrol and drospirenone on ovarian function. Contraception 103 (2021) 386–393. 31. Holinka CF & Gurpide E. In vivo effects of estetrol on the immature rat uterus. Biology of Reproduction. 1979;20:242-246. 32.  Gérard C, et al. Estetrol is a weak estrogen antagonizing estradiol-dependent mammary gland proliferation. Journal of Endocrinology 2015; 224, 85–95. 33. Lee A & Syed YY. Estetrol/Drospirenone: A Review in Oral Contraception. Drugs. 2022 Jul 4. doi: 10.1007/s40265-022-01738-8. Epub ahead of print. PMID: 35781795. 34. Holinka CF, et al. Estetrol: A unique steroid in human pregnancy. J Steroid Biochem Mol Biol. 2008; 110(1–2): 138–143. 35. Warmerdam EG, et al. A new route of synthesis of estetrol. Climacteric. 2008; 11(suppl 1): 59–63. 36. YAZ Product Information. 37. SLINDA Product Information.

NEXTSTELLIS is a registered trademark used under license. All other brands are trademarks of their respective owners. © 2022 Mayne Pharma International Pty Ltd Main North Rd Salisbury South, SA. 5106
All rights reserved. NEX0015. Aug 2022.