FOR U.S. HEALTHCARE PROFESSIONALS ONLY

Lo Loestrin Fe
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.
FOR U.S. HEALTHCARE PROFESSIONALS ONLY

Intracyclic bleeding

With Lo Loestrin® Fe, breakthrough bleeding and spotting decreased over time.1,*,†

  • 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 81,3
  • 4% of women discontinued treatment due to bleeding irregularities1
Mean number of days of breakthrough bleeding only
Unscheduled (breakthrough or intracyclic) bleeding and spotting sometimes occur in patients on COCs, especially during the first three 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 two or more consecutive cycles.
  • 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.1
  • Bleeding/spotting days 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

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.

IMPORTANT SAFETY INFORMATION More Less

REFERENCES
  1. Lo Loestrin® Fe prescribing information. Irvine, CA: Allergan USA, Inc.; 2017.
  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. Allergan USA, Inc.: Rockaway, NJ.
  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. Contraception. 2007;75(1):16-22.
  8. Willis SA, Kuehl TJ, Spiekerman AM, et al. Contraception. 2006;74(2):100-103.
  9. Spona J, Elstein M, Feichtinger W, et al. Contraception. 1996;54(2):71-77.