Lo Loestrin® Fe is indicated for pregnancy prevention*

 

WHY LO LOESTRIN FE?

Lo Loestrin Fe is indicated for effective pregnancy prevention with a
Pearl Index of 2.92 (95% CI: 1.94-4.21)†, ‡

Lo Loestrin Fe is the only available ultra-low-dose oral contraceptive (OC) with just 10 mcg of daily ethinyl estradiol2

With 10 mcg of daily estrogen in a 24/2/2 regimen, Lo Loestrin Fe has 38% less estrogen per month compared with a 20-mcg, 21/7 OC regimen2,5

Lo Loestrin Fe has a unique 24/2/2 regimen with a 2-day
hormone-free interval2

4 blue, round (active) tablets

each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol.


2 white, hexagonal (active)
tablets

each containing 10 mcg ethinyl estradiol.

2 brown, round (nonhormonal placebo) tablets

each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.

Lo Loestrin Fe may also provide short, lighter periods2,4

Mean duration of withdrawal bleeding was <2 days per cycle

Patient-reported intensity of withdrawal bleeding was lighter than normal

 

FORMULARY COVERAGE

Lo Loestrin Fe is widely covered6 and available at
$0 out-of-pocket cost for many patients4

  • 83% of commercially insured patients can get Lo Loestrin Fe without restrictions from their insurance plans6,§
  • 57% of Lo Loestrin Fe prescriptions were filled at
    $0 out-of-pocket cost
    4,§

 

PRESCRIBING CONSIDERATIONS

Why an extended regimen?

Decreasing the hormone-free interval from the traditional 7 days:

  • May provide brief and less intense withdrawal bleeds7
  • Increased pituitary-ovarian inhibition that may suppress hormone withdrawal symptoms8
  • Decreased likelihood of follicular development and potential for breakthrough ovulation9

Which oral contraceptive would she choose?

A survey|| of more than 1000 current and potential oral contraceptive (OC) users found that4:

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

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.


REFERENCES
1. IQVIA® National Prescription Audit® - TRx/EUTRx Data: January 2019 — December 2019 (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. Irvine, CA: Allergan USA, Inc.; 2017. 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 October 15, 2020.. 4. Data on file. Allergan USA, Inc.: Madison, NJ. 5. Junel® Fe 1/20 prescribing information. Sellersville, PA: Teva Pharmaceuticals USA; 2014. 6. Managed Markets Insight and Technology, LLC, a trademark of MMIT. Database as of December 2019. Data are subject to change. 7. Nakajima ST, Archer DF, Ellman H. Contraception. 2007;75(1):16-22. 8. Willis SA, Kuehl TJ, Spiekerman AM, Sulak PJ. Contraception. 2006;74(2):100-103. 9. Spona J, Elstein M, Feichtinger W, et al. Contraception. 1996;54(2):71-77.

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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.