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Drospirenone and Estetrol tablets 3 mg/14.2 mg

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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
&nbsp;
See full prescribing information for complete boxed warning. 
Females over 35 years old who smoke should not use NEXTSTELLIS
&nbsp;
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
<hr />
IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (drospirenone and estetrol tablets 3 mg/14.2 mg)
&nbsp;
HIGHLIGHTS OF PRESCRIBING INFORMATION
&nbsp;
These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.
&nbsp;
NEXTSTELLIS (drospirenone and estetrol tablets), for oral use 
Initial U.S. Approval: 2021
&nbsp;
INDICATIONS AND USAGE
&nbsp;
NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
&nbsp;
Limitations of Use
&nbsp;
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.
&nbsp;
DOSAGE AND ADMINISTRATION
<ul>
<li>Take one tablet by mouth at the same time every day.</li>
<li>Take tablets in the order directed on the blister pack.</li>
</ul>
DOSAGE FORMS AND STRENGTHS
NEXTSTELLIS consists of 28 tablets in the following order:
<ul>
<li>24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg</li>
<li>4 white inert tablets</li>
</ul>
CONTRAINDICATIONS
<ul>
<li>A high risk of arterial or venous thrombotic diseases</li>
<li>Current or history of a hormonally-sensitive malignancy (e.g., breast cancer)</li>
<li>Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis</li>
<li>Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir</li>
<li>Abnormal uterine bleeding that has an undiagnosed etiology</li>
<li>Renal impairment</li>
<li>Adrenal insufficiency</li>
</ul>
WARNINGS AND PRECAUTIONS
<ul>
<li>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.</li>
<li>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.</li>
<li>Hypertension: Monitor blood pressure periodically and stop use if blood pressure rises significantly.</li>
<li>Migraine: Discontinue if new, recurrent, persistent, or severe migraines occur.</li>
<li>Hormonally-Sensitive Malignancy: Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.</li>
<li>Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.</li>
<li>Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.</li>
<li>Gallbladder Disease and Cholestasis: Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease.</li>
<li>Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.</li>
</ul>
ADVERSE REACTIONS
Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased
DRUG INTERACTIONS
<ul>
<li>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.</li>
<li>See full Prescribing Information for additional clinically significant drug interactions.</li>
</ul>
USE IN SPECIFIC POPULATIONS
<ul>
<li>Pregnancy: Discontinue if pregnancy occurs.</li>
<li>Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production.</li>
</ul>
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf" target="_blank" rel="noopener">PATIENT COUNSELING INFORMATION and FDA-approved patient labeling</a>.
BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel.
References
1. NEXTSTELLIS [package insert]. Greenville, NC: Mayne Pharma; April 2021. 2. Szarewski A, Mansour D, Shulman LP. 50 years of “The Pill”: celebrating a golden anniversary. J Fam Plann Reprod Health Care. 2010;36(4):231-238. 3. Hall KS, Trussell J. Types of combined oral contraceptives used by U.S. women. Contraception. 2012;86(6):659-665. 4. Coelingh Bennink HJT, Holinka CF, Diczfalusy E. Estetrol review: profile and potential clinical applications. Climacteric. 2008;11(suppl 1):47-58. 5. New data on NEXTSTELLIS presented at ISSWSH conference. News release. Mayne Pharma. Accessed May 21, 2021. https://www.maynepharma.com/investor-relations/company-announcements 6. 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. 7. Data on file. Clinical study report MIT‐Es0001‐C302. Mayne Pharma US. Greenville, NC. 8. Data on file. Clinical study report MIT‐Es0001‐C201. Mayne Pharma US. Greenville, NC. 9. 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. 10. Moggs JG, Orphanides G. Estrogen receptors: orchestrators of pleiotropic cellular responses. EMBO Rep. 2001;2(9):775-781. 11. Stanczyk FZ, Archer DF, Bhavnani BR. Ethinyl estradiol and 17β-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment. Contraception. 2013;87(6):706-727. 12. Food and Drug Administration. FDA label database. Accessed May 21, 2021. https://nctr-crs.fda.gov/fdalabel/ui/search 13. Abot A, Fontaine C, Buscato M, 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, Bocedi A, Marino M. 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, Heegaard AM, Visser M, Holinka CF, Christiansen C. Oral bioavailability and bone-sparing effects of estetrol in an osteoporosis model. Climacteric. 2008;11(suppl 1):2-14. 16. Benoit T, Valera MC, Fontaine C, 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. Shoham Z, Kopernik G. Tools for making correct decisions regarding hormone therapy. Part I: background and drugs. Fertil Steril. 2004;81(6):1447-1457. 18. Visser M, Foidart JM, Coelingh Bennink JT. In vitro effects of estetrol on receptor binding, drug targets, and human liver cell metabolism. Climacteric. 2008;11(suppl 1):64-68. 19. Blair R, Fang H, Branham WS, et al. The estrogen receptor relative binding affinities of 188 natural and xenochemicals: structural diversity of ligands. Toxicol Sci. 2000;54:138-153. 20. Data on file. Clinical study report MIT‐Es0001‐C103. Mayne Pharma US. Greenville, NC. 21. Visser M, Holinka CF, Coelingh Bennink HJT. First human exposure to exogenous single-dose oral estetrol in early postmenopausal women. Climacteric. 2008;11(suppl 1):31-40. 22. Apter, D, Zimmerman Y, Beekman L, 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. 23. Regidor PA, Schindler A. Antiandrogenic and antimineralocorticoid health benefits of COC containing newer progestogens: dienogest and drospirenone. Oncotarget. 2017;8(47):83334-83342. 24. Blode H, Kowal K, Roth K, Reif S. Pharmacokinetics of drospirenone and ethinyl estradiol in Caucasian and Japanese women. Eur J Contracept Reprod Health Care. 2012;17(4):284-297. 25. Levy T, Yairi Y, Bar-Hava I, et al. Pharmacokinetics of the progesterone-containing vaginal tablet and its use in assisted reproduction. Steroids. 2000;65(10-11):645-649. 26. Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climacteric. 2005;8(suppl 1):3-63. 27. Ortho Tri-Cyclen [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; October 2013. 28. Aygestin [package insert]. Pomona, NY: Duramed Pharmaceuticals Inc; July 2007. 29. Data on file. Clinical study report MIT‐Es0001‐C301. Mayne Pharma US. Greenville, NC. 30. Data on file. Clinical study report MIT‐Es0001‐C202. Mayne Pharma US. Greenville, NC. 31. Food and Drug Administration. Prescription and over-the-counter drug product list: additions/deletions for prescription drug product list. August 2015. Accessed May 21, 2021. https://www.fda.gov/media/93516/download 32. Data on file. Clinical study report ES-C01/PR3095. Mayne Pharma US. Greenville, NC. 33. Data on file. Clinical study report ES-C02. Mayne Pharma US. Greenville, NC. 34. Mayne Pharma and Mithra announce FDA approval of new oral contraceptive NEXTSTELLIS®. News release. Mayne Pharma. Accessed May 21, 2021. https://www.maynepharma.com/media/2506/fda-approval-of-novel-oral-contraceptive-nextstellis.pdf 35. Electronic Code of Federal Regulations. IND safety reporting. 21 CFR §312.32. Accessed May 21, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32 36. Data on file. NEXTSTELLIS New Drug Application, Module 2.5: Clinical Overview. Mayne Pharma US. Greenville, NC. 37. Holinka CF, Gurpide E. In vivo effects of estetrol on the immature rat uterus. Biology of Reproduction. 1979;20:242-246. 38. Coelingh Bennink HJT, Verhoeven C, Zimmerman Y. Pharmacokinetics of the fetal estrogen estetrol in a multiple-rising-dose study in postmenopausal women. Climacteric. 2017;20(3):285-289. 39. Food and Drug Administration. Labeling for combined hormonal contraceptives: guidance for industry. Accessed May 11, 2021. https://www.fda.gov/media/110050/download