†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. The efficacy of Lo Loestrin Fe in women with a BMI > 35 kg/m2 has not been evaluated. The weight range for those women treated was 89 to 260 lbs with a mean weight of 150 lbs.2
‡Source: Online survey conducted by Harris Poll on behalf of Allergan USA, Inc., between July 7-14, 2014, among 1005 U.S. women aged 18-45 currently using OCs or considering use in the next 6 months.
§Survey respondents could choose from the following to indicate their interest in an OC with the lowest amount of daily estrogen: extremely interested, very interested, somewhat interested, and not at all interested. The 93% value represents those who answered extremely interested, very interested, and somewhat interested.
||Survey respondents could choose from the following to indicate their level of worry about the amount of hormones they are exposed to through the use of OCs: extremely worried, very worried, somewhat worried, and not at all worried. The 78% value represents those who answered extremely worried, very worried, and somewhat worried.
¶Source: Data on file. Allergan USA, Inc.: Madison, NJ.
Data are not guarantee of coverage, or partial or full payment, by any payers listed. Actual benefits are determined by respective plan administrators. Insurer plans, coverage criteria, and formularies are subject to change without notice. Check each patient’s coverage with applicable insurer. AbbVie does not endorse any individual plans. Formulary coverage does not imply efficacy or safety.
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.
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.
ContraindicationsLo Loestrin Fe is contraindicated 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, now or in the past, and in women using Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Warnings and PrecautionsDiscontinue 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 prediabetic or diabetic should be monitored while using Lo Loestrin Fe. Alternative 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. Lo Loestrin Fe should be discontinued during pregnancy.
Adverse ReactionsIn 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.
1. IQVIA® National Prescription Audit® - TRx/EUTRx Data: February 2021 – January 2022 (claim derived from the use of information under license from IQVIA, which expressly reserves all rights, including rights of copying, distribution, and republication). 2. Lo Loestrin® Fe prescribing information. Madison, NJ: Allergan USA, Inc.; 2022. 3. 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 February 2022. 4. Data on file. Allergan USA, Inc.: Madison, NJ. 5. Managed Markets Insight and Technology, LLC™, a trademark of MMIT. Database as of March 2022. 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 February 2022. 7. Junel® Fe 1/20 prescribing information. North Wales, PA: Teva Pharmaceuticals USA; 2017. 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.
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.
ContraindicationsLo Loestrin Fe is contraindicated 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, now or in the past, and in women using Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
Warnings and PrecautionsDiscontinue 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 prediabetic or diabetic should be monitored while using Lo Loestrin Fe. Alternative 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. Lo Loestrin Fe should be discontinued during pregnancy.
Adverse ReactionsIn 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.