Please see full Prescribing Information, including Boxed Warning. Learn about Lo Loestrin® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets). A combination oral contraceptive with the lowest daily dose of estrogen with just 10 mcg.
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LoLoestrin FE

IMPORTANT SAFETY INFORMATION More Less

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, Lo Loestrin® Fe should not be used by women who are over 35 years of age and smoke.

Contraindications

Lo Loestrin Fe is contraindicated in pregnant patients, and those 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.

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 for Lo Loestrin Fe, including Boxed Warning.

REFERENCES
  1. Lo Loestrin® Fe prescribing information. Rockaway, NJ: Warner Chilcott (US), LLC; 2012.
  2. US Food and Drug Administration. Guidance for industry: labeling for combined oral contraceptives. http://www.fda.gov/downloads/Drugs/Guidance/ComplianceRegulatoryInformation/Guidances/ucm075075.pdf. Published March 2004. Accessed August 24, 2015.
  3. Data on file. Rockaway, NJ: Warner Chilcott (US), LLC.
  4. The Alan Guttmacher Institute. Fulfilling the promise: public policy and U.S. family planning clinics. http://www.guttmacher.org/pubs/fulfill.pdf. Accessed August 24, 2015.
  5. Previfem® prescribing information. Huntsville, AL: Qualitest Pharmaceuticals; 2009.
  6. Oral contraceptive survey. Harris Poll. July 2014.
  7. Nakajima ST, Archer DF, Ellman H. Efficacy and safety of a new 24-day oral contraceptive regimen of norethindrone acetate 1 mg/ethinyl estradiol 20 μg (Loestrin® 24 Fe). Contraception. 2007;75(1):16-22.
  8. Willis SA, Kuehl TJ, Spiekerman AM, et al. Greater inhibition of the pituitary–ovarian axis in oral contraceptive regimens with a shortened hormone-free interval. Contraception. 2006;74(2):100-103.
  9. Spona J, Elstein M, Feichtinger W, et al. Shorter pill-free interval in combined oral contraceptives decreases follicular development. Contraception. 1996;54(2):71-77.
  10. Minastrin® 24 Fe prescribing information. Rockaway, NJ: Warner Chilcott (US), LLC; 2014.