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

Why prescribe an OC with low estrogen?

Women may potentially take an OC for many years during their reproductive lives.4

  • Lo Loestrin® Fe, with 10 mcg of daily estrogen, has 65% less estrogen per month compared with a 35 mcg, 21/7 OC regimen1,5
  • Lowest dose of daily estrogen among all available OCs

Most patients using hormonal contraceptives were interested* in an OC with the lowest amount of daily estrogen. A survey of more than 1000 current and potential OC users found that6,†:

  • 93% are interested* in an OC with the lowest amount of daily estrogen
  • 78% worry about the amount of hormones they are exposed to through the use of OCs

Only available ultra-low-dose option with 10 mcg of daily estrogen1

  • 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)1,§,II
  • Unique 24/2/2 regimen1
  • May provide short, lighter periods1,3
    • Mean duration of withdrawal bleeding was <2 days per cycle
    • Patient-reported intensity of withdrawal bleeding was lighter than normal
  • Breakthrough bleeding/spotting that decreased over time1,3
    • 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 8
  • 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.
  • Source: Online survey conducted by Harris Poll on behalf of Allergan Pharmaceuticals International Limited, between July 7–14, 2014 among 1005 U.S. women aged 18 to 45 years currently using oral contraceptives or considering use in the next 6 months.
  • 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.
  • 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
  • Analysis included patients with BMI <35 kg/m2.
  • Maximum savings limits apply; patient out-of-pocket expense may vary. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs.
    Please click here for Program Terms, Conditions, and Eligibility Criteria.

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.