Dosage & Administration
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Lo Loestrin FE Prescribing Information
Lo Loestrin Fe is contraindicated in females who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
• Smoke, if over age 35[seeBoxed WarningandWarnings and Precautions (5.1)]
• Have deep vein thrombosis or pulmonary embolism, now or in the past[seeWarnings and Precautions (5.1)]
• Have cerebrovascular disease[seeWarnings and Precautions (5.1)]
• Have coronary artery disease[seeWarnings and Precautions (5.1)]
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation)[seeWarnings and Precautions (5.1)]
• Have inherited or acquired hypercoagulopathies[seeWarnings and Precautions (5.1)]
• Have uncontrolled hypertension[seeWarnings and Precautions (5.5)]
• Have diabetes mellitus with vascular disease[seeWarnings and Precautions (5.7)]
• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35[seeWarnings and Precautions (5.8)] - Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive[seeWarnings and Precautions (5.2)]
- Liver tumors, benign or malignant, or liver disease[seeWarnings and Precautions (5.3)]
- Undiagnosed abnormal uterine bleeding[seeWarnings and Precautions (5.9)]
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to the potential for ALT elevations[seeWarnings and Precautions (5.4)].
- A high risk of arterial or venous thrombotic diseases
- Breast cancer
- Liver tumors or liver disease
- Undiagnosed abnormal uterine bleeding
- Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir
Warnings and Precautions (5.2 Malignant Neoplasms Breast Cancer Lo Loestrin Fe is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications (4) ]. Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer. However, some studies report a small increase in the risk of breast cancer among current or recent users (<6 months since last use) and current users with longer duration of COC use [see Adverse Reactions (6.2) ]. Cervical Cancer Some studies suggest that COCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors. | 04/2022 |
Lo Loestrin® Fe is indicated for use by women to prevent pregnancy
In a one year (thirteen 28-day cycles) multicenter open-label clinical trial, 1,270 women 18 to 35 years of age, were studied to assess the efficacy of Lo Loestrin Fe, completing the equivalent of 12,482 28-day evaluable cycles of exposure. The racial demographic of all enrolled women was: Caucasian (74.9 percent), African-American (11.8 percent), Hispanic (9.8 percent), Asian (1.3 percent), and Other (2.2 percent). Women with body mass index (BMI) greater than 35 kg/m2were excluded from the study. The weight range for those women treated was 89 to 260 lbs., with a mean weight of 150 lbs. Among the women in the trial, 51 percent had not used hormonal contraception immediately prior to enrolling in this study. Of treated women, 13.7 percent were lost to follow-up, 10.7 percent discontinued due to an adverse event, and 8.9 percent discontinued by withdrawing their consent.
The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.
- Take one tablet by mouth at the same time every day for 28 days ()2.1How to TakeLo Loestrin Fe
To achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Lo Loestrin Fe tablets may be administered without regard to meals
[seeClinical Pharmacology (12.3)]. - Take tablets in the order directed on the blister pack ()2.1How to TakeLo Loestrin Fe
To achieve maximum contraceptive effectiveness, Lo Loestrin Fe must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or taken at intervals exceeding 24 hours. Lo Loestrin Fe tablets may be administered without regard to meals
[seeClinical Pharmacology (12.3)].
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister packs.
Each blister pack (28 tablets) contains in the following order:
- 24 blue, round (active) tablets imprinted with “WC” on one side and “421” on the other and each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol.
- 2 white, hexagonal (active) tablets imprinted with “WC” on one side and “422” on the other and each containing 10 mcg ethinyl estradiol.
- 2 brown, round (non-hormonal placebo) tablets imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose.
There is no use for contraception in pregnancy; therefore, Lo Loestrin Fe should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb reduction defects) following exposure to combined hormonal contraceptives (CHCs) before conception or during early pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively.
Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy.