10 mcg is the lowest daily dose of ethinyl estradiol among all available OCs3,4
*A 1-year (thirteen 28-day cycles), multicenter, open-label study of 1270 women aged 18-35 years (BMI ≤35 kg/m2) assessed efficacy of Lo Loestrin Fe for 12,482 twenty-eight day evaluable cycles of exposure. Pearl Index was 2.92 (95% CI: 1.94-4.21).3
To achieve maximum contraceptive effectiveness, patients should be instructed to take:
Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see
FDA-approved Patient Labeling.
Incidence of amenorrhea increased over the course of the study, from 32% in Cycle 1 to 49% in Cycle 13
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on combination oral contraceptives (COCs), especially during the first 3 months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in 2 or more consecutive cycles.
†A subject was considered to have amenorrhea for any interval with no reported bleeding or spotting.
‡A 1-year (thirteen 28-day cycles), multicenter, open-label study of 1270 women aged 18 to 35 years designed to assess the efficacy of Lo Loestrin Fe for pregnancy prevention for a total of 12,482 twenty-eight day evaluable cycles of exposure. Safety was evaluated in women aged 18 to 45 years.3
§Intracyclic bleeding was defined as any day in which a subject experienced bleeding of any intensity except light bleeding that did not require sanitary protection; such bleeding was defined as spotting. All bleeding (spotting) days and episodes were counted as intracyclic bleeding/spotting days unless it was the first bleeding episode starting after the last day of active drug intake and before the beginning of the next treatment cycle, or starting within 4 days of the last day of active drug intake and continuing at least through the first day after the end of active drug intake in the treatment cycle. Such bleeding was defined as withdrawal bleeding.5
In the pivotal phase 3 clinical study, Lo Loestrin Fe was evaluated for pregnancy prevention, including:
||The efficacy of Lo Loestrin Fe in women with a BMI of >35 kg/m2 has not been evaluated.
¶New to OCs was defined as not using hormonal contraception at the time of study enrollment.15
REFERENCES
1. IQVIA® National Prescription Audit® - TRx/EUTRx Data: November 2022 – February 2023 (claim derived from the use of information under license from IQVIA, which expressly reserves all
rights, including rights of copying, distribution, and republication). 2. IQVIA® Patients Insights New To Brand (NBRx) Data: since launch – January 2023 (claim derived from the use of
information under license from IQVIA, which expressly reserves all rights, including rights of copying, distribution, and republication). 3. Lo Loestrin® Fe prescribing information. Madison, NJ:
Allergan USA, Inc. 4. U.S. Food and Drug Administration. The Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Available from: https://
www.accessdata.fda.gov/scripts/cder/ob/. Accessed July 2022. 5. Data on file. Allergan USA, Inc.: Madison, NJ. 6. Managed Markets Insight and Technology, LLC™, a trademark of MMIT.
Database as of March 2022. Data are subject to change. 7. Junel® Fe 1/20 prescribing information. North Wales, PA: Teva Pharmaceuticals USA; 2017. 8. The Alan Guttmacher Institute.
Next Steps for America’s Family Planning Program: Leveraging the Potential of Medicaid and Title X in an Evolving Health Care System. https://www.guttmacher.org/sites/default/files/
report_pdf/nextsteps.pdf. Accessed July 2022. 9. Previfem® prescribing information. Huntsville, AL: Qualitest Pharmaceuticals; 2015. 10. Microgestin® Fe 1.5/30 prescribing information.
Greenville, NC: Mayne Pharma; 2020. 11. Ortho Tri-Cyclen® Lo prescribing information. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2019. 12. Nakajima ST, Archer DF, Ellman H.
Contraception. 2007;75(1):16-22. 13. Willis SA, Kuehl TJ, Spiekerman AM, Sulak PJ. Contraception. 2006;74(2):100-103. 14. Spona J, Elstein M, Feichtinger W, et al. Contraception.
1996;54(2):71-77. 15. Archer OF, Nakajima ST, Sawyer AT, et al. Obstet Gynecol. 2013;122(3):601-607.
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