LO LOESTRIN FE REQUEST SAMPLES
 

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 50% less estrogen per month compared with a 25 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 similar8,‡
  • 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.

 

May provide short, lighter periods2,3

Mean duration of withdrawal bleeding was <2 days per cycle

Patient-reported intensity of withdrawal bleeding was lighter than normal

 

Incidence of amenorrhea

Incidence of amenorrhea

Incidence of amenorrhea increased over the course of the study, from 32% in Cycle 1 to 49% in Cycle 132,3,§

 

Breakthrough bleeding/spotting decreased over time2,3,||,¶

  • 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 82,3
  • 4% of women discontinued treatment due to bleeding irregularities2
chart bleeding
 

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.3

 

Lo Loestrin Fe has no generic equivalent available.2

 

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.

PRESCRIBING CONSIDERATIONS
 
INDICATIONS AND USAGE

Lo Loestrin® Fe is an estrogen/progestin combination oral contraceptive (COC) indicated for use by women to prevent pregnancy. The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of >35 kg/m2 has not been evaluated.

IMPORTANT SAFETY INFORMATION

Warning: cigarette smoking and serious cardiovascular events Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

Contraindications

Lo Loestrin Fe is contraindicated in pregnant patients, in women with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past, and in women using Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Warnings and Precautions

Discontinue Lo Loestrin Fe if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Lo Loestrin Fe should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.

Lo Loestrin Fe should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are pre-diabetic or diabetic should be monitored while using Lo Loestrin Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Lo Loestrin Fe who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.

Adverse Reactions

In the clinical trial for Lo Loestrin Fe, serious adverse reactions included deep vein thrombosis, ovarian vein thrombosis, and cholecystitis. The most common adverse reactions (incidence ≥2%) were nausea/vomiting, headache, bleeding irregularities, dysmenorrhea, weight fluctuation, breast tenderness, acne, abdominal pain, anxiety, and depression.

Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Please see full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.

 
REFERENCES

1. IMS Health, Inc. TRx by Specialty; February 2017-January 2018 (claim derived from the use of information under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying, distribution, and republication). 2. Lo Loestrin® Fe prescribing information. Irvine, CA: Allergan USA, Inc.; 2017. 3. Data on file. Allergan USA, Inc.: Madison, NJ. 4. Managed Markets Insight and Technology, LLC™, a trademark of MMIT, Database as of May 2018. Data are subject to change. 5. Data on file. May 2017-April 2018. Data are subject to change. 6. The Alan Guttmacher Institute. Fulfilling the promise: public policy and U.S. family planning clinics. http://www.guttmacher.org/pubs/fulfill.pdf. Accessed January 31, 2018. 7. Ortho Tri-Cyclen® Lo prescribing information. Titusville, NJ: Janssen Pharmaceuticals; 2009. 8. Archer OF, Nakajima ST, Sawyer AT, et al. Obstet Gynecol. 2013;122(3):601-607. 9. Ogden CL, Carroll MD, Kit BK, Flegal KM. JAMA. 2014;311 (8):806-814. 10. Nakajima ST, Archer DF, Ellman H. Contraception. 2007;75(1):16-22. 11. Willis SA, Kuehl TJ, Spiekerman AM, Sulak PJ. Contraception. 2006;74(2):100-103. 12. Spona J, Elstein M, Feichtinger W, et al. Contraception. 1996;54(2):71-77.

IMPORTANT SAFETY INFORMATION More Less

Warning: cigarette smoking and serious cardiovascular events Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke.

Contraindications

Lo Loestrin Fe is contraindicated in pregnant patients, in women with a high risk of arterial or venous thrombotic diseases, liver tumors (benign or malignant) or liver disease, undiagnosed abnormal uterine bleeding, or breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past, and in women using Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Warnings and Precautions

Discontinue Lo Loestrin Fe if a thrombotic event occurs, and at least 4 weeks before and through 2 weeks after major surgery. Lo Loestrin Fe should not be started any earlier than 4 weeks after delivery, in women who are not breastfeeding. If jaundice occurs, treatment should be discontinued.

Lo Loestrin Fe should not be prescribed for women with uncontrolled hypertension or hypertension with vascular disease. Women who are pre-diabetic or diabetic should be monitored while using Lo Loestrin Fe. Alternate contraceptive methods should be considered for women with uncontrolled dyslipidemia. Patients using Lo Loestrin Fe who have a significant change in headaches or irregular bleeding or amenorrhea should be evaluated.

Adverse Reactions

In the clinical trial for Lo Loestrin Fe, serious adverse reactions included deep vein thrombosis, ovarian vein thrombosis, and cholecystitis. The most common adverse reactions (incidence ≥2%) were nausea/vomiting, headache, bleeding irregularities, dysmenorrhea, weight fluctuation, breast tenderness, acne, abdominal pain, anxiety, and depression.

Patients should be counseled that COCs do not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Please see full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.