INDICATION
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 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 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 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 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.
US-LOL-230029
Please see full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.
IMPORTANT SAFETY INFORMATION
INDICATION
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 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 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 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 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.
US-LOL-230029
Please see full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.
REFERENCES
1. Lo Loestrin® Fe prescribing information. Madison, NJ: Allergan USA, Inc. 2. 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 January 2023. 3. 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). 4. IQVIA® National Prescription Audit® TRx/EUTRx Data: December 2010 – 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). 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 January 2023. 9. Burkman R, Bell C, Serfaty D. Contraception. 2011;84(1):19-34. 10. Rosendaal FR, Helmerhosrt FM, Vandenbroucke JP. Thromb Haemost. 2001;86(1):112-123. 11. Previfem® prescribing information. Chestnut, NY: Par Pharmaceutical, and León, Spain: Laboratorios León Farma S.A.; 2018. 12. Microgestin® Fe 1.5/30 prescribing information. Greenville, NC: Mayne Pharma; 2020. 13. Ortho Tri-Cyclen® Lo prescribing information. Titusville, NJ: Janssen Pharmaceuticals, Inc; 2019. 14. Nakajima ST, Archer DF, Ellman H. Contraception. 2007;75(1):16-22. 15. Willis SA, Kuehl TJ, Spiekerman AM, Sulak PJ. Contraception. 2006;74(2):100-103. 16. Spona J, Elstein M, Feichtinger W, et al. Contraception. 1996;54(2):71-77. 17. Archer OF, Nakajima ST, Sawyer AT, et al. Obstet Gynecol. 2013;122(3):601-607.
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US-LOL-230208
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US-LOL-230208
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.
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.
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.
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.
INDICATION
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 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 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 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 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.
US-LOL-230029
Please see full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.
IMPORTANT SAFETY INFORMATION
INDICATION
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 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 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 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 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.
US-LOL-230029
Please see full Prescribing Information, including Boxed Warning, for Lo Loestrin Fe.