Why Prescribe Lo Loestrin® Fe | For Healthcare Providers

Women may potentially take an oral contraceptive (OC) for many years during their reproductive lives⁶

Lowest dose of daily estrogen among all available OCs.²

With 10 mcg of daily estrogen in a 24/2/2 regimen, Lo Loestrin Fe has 38% less estrogen per month compared with a 20-mcg, 21/7 OC regimen.^2,7

Lo Loestrin Fe, for effective pregnancy prevention,*^,†,‡ is the only available ultra-low-dose OC with just 10 mcg of daily estrogen²

Lo Loestrin Fe has established efficacy among patients aged 18 to 35 years with BMI ≤35 kg/m² (89-260 lb, with a mean weight of 150 lb).^{2,∗,†,‡}

The Pearl Index was 2.92 (95% CI: 1.94-4.21)²
In this study, pregnancy rates in obese and nonobese patients were similar^8,‡
Women aged 18 to 45 years were evaluated in this Phase 3 clinical study²

* Analysis included patients with BMI ≤35 kg/m².

†In a 1-year (thirteen 28-day cycles), multicenter, open-label study of 1270 women aged 18 to 35 years that was designed to assess the efficacy of Lo Loestrin Fe for a total of 12,482 twenty-eight day evaluable cycles of exposure.²

‡Nonobese was defined as BMI <30 kg/m² and obese as BMI ≥30 kg/m².

According to the 2011-2012 nationally representative National Health and Nutrition Examination Survey,⁹ which included 9120 participants, 85% of women aged 20 to 39 years have BMI <35 kg/m².

Incidence of amenorrhea

Incidence of amenorrhea increased over the course of the study, from 32% in Cycle 1 to 49% in Cycle 13^2,4,§

Breakthrough bleeding/spotting decreased over time^2,4,||,¶

Mean number of intracyclic bleeding/spotting days decreased from 3.2 in Cycle 2 to 2.4 in Cycle 4, and 1.8 in Cycle 8^2,3
4% of women discontinued treatment due to bleeding irregularities²

Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on 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.

^|| 1-Year (thirteen 28-day cycles), multicenter, open-label study of 1270 women aged 18 to 35 years that was designed to assess the efficacy of Lo Loestrin Fe for a total of 12,482 twenty-eight day evaluable cycles of exposure.²

^¶ 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.⁴

Lo Loestrin Fe has no generic equivalent available.³

Lo Loestrin Fe has a unique 24/2/2 regimen with a 2-day hormone-free interval²

24 blue, round (active) tablets

each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol.

2 white, hexagonal (active) tablets

each containing 10 mcg ethinyl estradiol.

2 brown, round (nonhormonal placebo) tablets

each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

To achieve maximum contraceptive effectiveness, patients should be instructed to take Lo Loestrin Fe exactly as directed; one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. For patient instructions for missed pills, see FDA-approved Patient Labeling.