Estrogen matters, so it’s time to get selective

NEXTSTELLIS is the first and only combined oral contraceptive (COC) to contain ESTETROL (E4) – a unique, NATIVE, and SELECTIVE estrogen.1-5

NEXTSTELLIS contains the first new estrogen development in over 60 years and is designed specifically to help overcome the issues associated with synthetic or modified estrogen-based COCs.1-5

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NEXTSTELLIS® – an oral contraceptive combined to be native, selective, and effective1-5

NEXTSTELLIS is the first ever oral contraceptive to combine drospirenone (DRSP) and E4 – a unique and modern estrogen.1-5

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Estetrol (E4) is a native estrogen, circulating at high levels in the mother and fetus during human pregnancy3

E4 is produced from a plant source4

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E4 is a selective estrogen that works differently than all other estrogens8-9

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NEXTSTELLIS has 98% contraceptive efficacy in preventing pregnancy (Pearl Index of 2.65 with a 24/4 monophasic regimen)1-5

Proven in large, robust clinical trials involving 3,632 women observed for >26,000 cycles – with 22% of women having a BMI 30-35 kg/m2 (Pearl Index of 2.94).1-5


If you would like more information, or have any questions, about NEXTSTELLIS, then please submit a request: for example, on our product availability, savings program, sampling, or for details on our patient support services.

What are the benefits to your patients of choosing NEXTSTELLIS?

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No need to compromise – NOW they CAN have a predictable bleeding profile AND good tolerability2

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The only COC that contains estetrol (E4) – a modern, selective estrogen that meets the needs of today’s women1-5

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IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (drospirenone and estetrol tablets 3 mg/14.2 mg)


See full prescribing information for complete boxed warning.

  • Females over 35 years old who smoke should not use NEXTSTELLIS
  • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.



These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.

NEXTSTELLIS (drospirenone and estetrol tablets), for oral use
Initial U.S. Approval: 2021



NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.



NEXTSTELLIS may be less effective in females with a BMI ≥30 kg/m2. In females with BMI ≥30 kg/m2, decreasing effectiveness may be associated with increasing BMI.



  • Take one tablet by mouth at the same time every day.
  • Take tablets in the order directed on the blister pack.



NEXTSTELLIS consists of 28 tablets in the following order:

  • 24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg
  • 4 white inert tablets



  • A high risk of arterial or venous thrombotic diseases
  • Current or history of a hormonally-sensitive malignancy (e.g., breast cancer)
  • Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis
  • Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
  • Abnormal uterine bleeding that has an undiagnosed etiology
  • Renal impairment
  • Adrenal insufficiency



  • Thromboembolic Disorders and Other Vascular Problems: Stop NEXTSTELLIS if a thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors.
  • Hyperkalemia: Check serum potassium concentration during the first NEXTSTELLIS treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration.
  • Hypertension: Monitor blood pressure periodically and stop use if blood pressure rises significantly.
  • Migraine: Discontinue if new, recurrent, persistent, or severe migraines occur.
  • Hormonally-Sensitive Malignancy: Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.
  • Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.
  • Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.
  • Gallbladder Disease and Cholestasis: Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease.
  • Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.



Most common adverse reactions (≥2%): Bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased



  • CYP3A Inducers: May lead to contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use an alternative or back-up contraceptive method during co-administration and up to 28 days after discontinuation of the CYP3A inducer.
  • See full Prescribing Information for additional clinically significant drug interactions.



  • Pregnancy: Discontinue if pregnancy occurs.
  • Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production.

To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or

See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

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




1. Foidart JM, Gaspard U, Pequeux C, et al. Unique vascular benefits of estetrol, a native 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.
2. NEXTSTELLIS [package insert]. Raleigh, NC: Mayne Pharma; July 2022
3. Coelingh Bennink HJT, Holinka CF, Diczfalusy E. Estetrol review: profile and potential clinical applications. Climacteric. 2008;11(suppl 1):47-58.
4. [Last accessed July 8 2022]
5. Data on file. Clinical study report MIT-Es0001-C302. Mayne Pharma US. Raleigh, NC.
6. Stanczyk FZ, Archer DF, Bhavnani BR. Ethinyl estradiol and 17ß-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment. Contraception. 2013;87(6):706-727.
7. FSRH (Faculty of Sexual and Reproductive Healthcare) Guidelines, 2019.
8. Arnal JF, Lenfant F, Metivier R, et al. Membrane and nuclear estrogen receptor alpha actions: from tissue specificity to medical implications. Physiol Rev. 2017;97(3):1045- 1087.
9. Food and Drug Administration. FDA label database. Accessed May 21, 2021.

Learn more about NEXTSTELLIS in this short video