Lo Loestrin Fe
norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate · Kit
Uses
Lo Loestrin ® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Lo Loestrin Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy ( 1 ) The efficacy of Lo Loestrin Fe in women with a body mass index of > 35 kg/m 2 has not been evaluated ( 1 , 8.8 )
Dosage and administration
Take one tablet by mouth at the same time every day for 28 days ( 2.1 ) Take tablets in the order directed on the blister pack ( 2.1 ) 2.1 How to Take Lo 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 [see Clinical Pharmacology (12.3) ] . 2.2 How to Start Lo Loestrin Fe Instruct the patient to begin taking Lo Loestrin Fe on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). One blue tablet should be taken daily for 24 consecutive days, followed by one white tablet daily for 2 consecutive days, followed by one brown tablet daily for 2 consecutive days. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 7 days if she starts taking Lo Loestrin Fe other than on the first day of her menstrual cycle. For postpartum women who do not breastfeed or after a second trimester abortion, Lo Loestrin Fe may be started no earlier than 4 weeks postpartum. Recommend use of a non-hormonal back-up method for the first 7 days. When COCs are used during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered [see Warnings and Precautions (5.1) ] . The possibility of ovulation and conception before starting COCs should also be considered. Lo Loestrin Fe may be initiated immediately after a first-trimester abortion or miscarriage; if the patient starts Lo Loestrin Fe immediately, additional contraceptive measures are not needed. 2.3 Switching from another H ormonal M ethod of C ontraception If the patient is switching from a combination hormonal method such as: ○ Another pill ○ Vaginal ring ○ Patch Instruct her to take the first blue tablet on the day she would have taken her next COC pill. She should not continue taking the tablets from her previous birth control pack and should not skip any days between packs. If she does not have a withdrawal bleed, rule out pregnancy before starting Lo Loestrin Fe. If she previously used a vaginal ring or transdermal patch, she should start using Lo Loestrin Fe on the day she would have resumed the previous product. If the patient is switching from a progestin-only method such as a: ○ Progestin-only pill ○ Implant ○ Intrauterine system ○ Injection Instruct her to take the first blue tablet on the day she would have taken her next progestin-only pill, or had her next injection or on the day of removal of her implant. If switching from an IUD, depending on the timing of removal, back-up contraception may be needed. 2.4 Missed Doses Table 1: Instructions for Missed Lo Loestrin Fe Tablets in a Monthly Dosing Regimen If one blue tablet is missed Take the tablet as soon as possible, even if two tablets are taken in one day. Continue taking one tablet a day until the pack is finished. If two consecutive blue tablets are missed in Week 1 or Week 2 Take the two missed tablets as soon as possible, and the next two tablets the next day. Continue taking the remaining tablets, one tablet a day until the pack is finished. Use ad ditional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets. If two consecutive tablets (blue or white) are missed in Week 3 or Week 4 Throw out the rest of the pack and start a new pack the same day. A withdrawal bleed may not occur. Use ad ditional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets. If three or more consecutive tablets (blue or white) are missed at any time Throw out the rest of the pack and start a new pack that same day. A withdrawal bleeding may not occur. Use a dditional non-hormonal contraception (such as condoms and spermicide) for 7 consecutive days after missing tablets. If either of the brown tablets in Week 4 are missed Throw out the tablet you missed. Start a new pack on the same day a new pack is usually started. 2.5 Advice in Case of Gastrointestinal Disturbances If the patient vomits or has diarrhea (within 3 to 4 hours after she takes a blue or white pill), she should follow the instructions in Missed Doses [see Dosage and Administration (2.4) ] .
Dosage forms and strengths
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. Lo Loestrin Fe consists of 28 tablets in the following order ( 3 ): 24 blue tablets (active), each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol 2 white tablets (active), each containing 10 mcg ethinyl estradiol 2 brown tablets (non-hormonal placebo), each containing 75 mg ferrous fumarate. The ferrous fumarate tablets do not serve any therapeutic purpose
Contraindications
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 [see Boxed Warning and Warnings and Precautions (5.1) ]
• Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1) ]
• Have cerebrovascular disease [see Warnings and Precautions (5.1) ]
• Have coronary artery disease [see Warnings 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) [see Warnings and Precautions (5.1) ]
• Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1) ]
• Have uncontrolled hypertension [see Warnings and Precautions (5.5) ]
• Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.7) ]
• Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35 [see Warnings and Precautions (5.8) ] Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.2) ] Liver tumors, benign or malignant, or liver disease [see Warnings and Precautions (5.3) ] Undiagnosed abnormal uterine bleeding [see Warnings 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 [see Warnings and Precautions (5.4) ] . A high risk of arterial or venous thrombotic diseases ( 4 ) Breast cancer ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )
Warnings and precautions
Vascular risks: Stop Lo Loestrin Fe if a thrombotic event occurs. Stop Lo Loestrin Fe at least 4 weeks before through 2 weeks after major surgery. Start Lo Loestrin Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding ( 5.1 ) Liver disease: Discontinue Lo Loestrin Fe if jaundice occurs ( 5.3 ) High blood pressure: Do not prescribe Lo Loestrin Fe for women with uncontrolled hypertension or hypertension with vascular disease. ( 5.5 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women taking Lo Loestrin Fe. Consider an alternative contraceptive method for women with uncontrolled dyslipidemia ( 5.7 ) Headache: Evaluate significant change in headaches and discontinue Lo Loestrin Fe if indicated ( 5.8 ) Uterine bleeding: Evaluate irregular bleeding or amenorrhea ( 5.9 ) 5.1 Thrombotic and Other Vascular Events Stop Lo Loestrin Fe if an arterial or deep venous thrombotic event occurs. Although use of COCs increases the risk of venous thromboembolism, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of venous thromboembolism in women using COCs is 3 to 9 per 10,000 woman-years. The risk is highest during the first year of use of a COC. Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events. The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued. If feasible, stop Lo Loestrin Fe at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism. Start Lo Loestrin Fe no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest in older (> 35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with underlying risk factors. Oral contraceptives must be used with caution in women with cardiovascular disease risk factors. Stop Lo Loestrin Fe if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately. 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. 5.3 Liver Disease Discontinue Lo Loestrin Fe if jaundice develops. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded. Hepatic adenomas are associated with COC use. An estimate of the attributable risk is 3.3 cases per 100,000 COC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (>8 years) COC users. However, the attributable risk of liver cancers in COC users is less than one case per million users. Oral contraceptive-related cholestasis may occur in women with a history of pregnancy-related cholestasis. Women with a history of COC-related cholestasis may have the condition recur with subsequent COC use. 5.4 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment During clinical trials with the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as COCs. Discontinue Lo Loestrin Fe prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir [see Contraindications (4) ] . Lo Loestrin Fe can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen. 5.5 High Blood Pressure For women with well-controlled hypertension, monitor blood pressure and stop Lo Loestrin Fe if blood pressure rises significantly. Women with uncontrolled hypertension or hypertension with vascular disease should not use COCs. An increase in blood pressure has been reported in women taking COCs, and this increase is more likely in older women with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin. 5. 6 Gallbladder Disease Studies suggest a small increased relative risk of developing gallbladder disease among COC users. 5.7 C arbohydrate and Lipid Metabolic Effects Carefully monitor prediabetic and diabetic women who are taking Lo Loestrin Fe. COCs may decrease glucose tolerance in a dose-related fashion.
Side effects
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and smoking [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea Breast tenderness Headache The most common adverse reactions (≥ 2 percent) are nausea/vomiting (7 percent), headache (7 percent), bleeding irregularities (5 percent), dysmenorrhea (4 percent), weight change (4 percent), breast tenderness (4 percent), acne (3 percent), abdominal pain (3 percent), anxiety (2 percent) and depression (2 percent) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Relevant studies of Risk of Breast Cancer with combined Oral Contraceptives 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice. A multicenter phase 3 clinical trial evaluated the safety and efficacy of Lo Loestrin Fe for pregnancy prevention. The study was a one year, open-label, single-arm, uncontrolled study. A total of 1,660 women aged 18 to 45 were enrolled and took at least one dose of Lo Loestrin Fe [ s ee Clinical Studies (14) ] . Common Adverse Reactions ( ≥ 2 percent of all Treated Subjects ) : The most common adverse reactions reported by at least 2 percent of the 1,660 women using Lo Loestrin Fe were the following in order of decreasing incidence: nausea/vomiting (7 percent), headache (7 percent), bleeding irregularities (including metrorrhagia, irregular menstruation, menorrhagia, vaginal hemorrhage and dysfunctional uterine bleeding) (5 percent), dysmenorrhea (4 percent), weight fluctuation (4 percent), breast tenderness (4 percent), acne (3 percent), abdominal pain (3 percent), anxiety (2 percent), and depression (2 percent). Adverse Reactions Leading to Study Discontinuation : 10.7 percent of the women discontinued from the clinical trial due to an adverse reaction. Adverse reactions occurring in ≥1 percent of subjects leading to discontinuation of treatment were in decreasing order: menstrual irregularities (including metrorrhagia, irregular menstruation, menorrhagia and vaginal hemorrhage) (4 percent), headache/migraine (1 percent), mood disorder (including mood swings, depression, anxiety) (1 percent), and weight fluctuation (1 percent). Serious Adverse Reactions : deep vein thrombosis, ovarian vein thrombosis, cholecystitis. 6.2 Postmarketing Experience Five studies that compared breast cancer risk between ever-users (current or past use) of COCs and never-users of COCs reported no association between ever use of COCs and breast cancer risk, with effect estimates ranging from 0.90 - 1.12 (Figure 1). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 1). One of these studies reported no association between breast cancer risk and COC use. The other two studies found an increased relative risk of 1.19 - 1.33 with current or recent use. Both of these studies found an increased risk of breast cancer with current use of longer duration, with relative risks ranging from 1.03 with less than one year of COC use to approximately 1.4 with more than 8-10 years of COC use. Figure 1. RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.
Drug interactions
No drug-drug interaction studies were conducted with Lo Loestrin Fe. Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding. Counsel patients to use a back-up method or alternative method of contraception when enzyme inducers are used with COCs ( 7.1 ) -- - ---------- ------ USE IN SPECIFIC POPULATIONS---- -- -- --------- ---- Lactation: Not recommended; Lo Loestrin Fe can decrease milk production ( 8.2 ) 7.1 Changes in Contraceptive Effectiveness Associated with Co-Administration of Other Products If a woman on hormonal contraceptives takes a drug or herbal product that induces enzymes, including CYP3A4, that metabolize contraceptive hormones, counsel her to use additional contraception or a different method of contraception. Drugs or herbal products that induce such enzymes may decrease the plasma concentrations of contraceptive hormones, and may decrease the effectiveness of hormonal contraceptives or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: barbiturates bosentan carbamazepine felbamate griseofulvin oxcarbazepine phenytoin rifampin St. John’s wort topiramate HIV protease inhibitors and non-nucleoside reverse transcriptase inhibitors : Significant changes (increase or decrease) in the plasma levels of the estrogen and progestin have been noted in some cases of co-administration of HIV protease inhibitors or of non-nucleoside reverse transcriptase inhibitors. Antibiotics : There have been reports of pregnancy while taking hormonal contraceptives and antibiotics, but clinical pharmacokinetic studies have not shown consistent effects of antibiotics on plasma concentrations of synthetic steroids. Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations. 7.2 Increase i n Plasma Levels of Ethinyl Estradiol Associated with Co-Administered Drugs Co-administration of atorvastatin and certain COCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20 percent. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol levels, possibly by inhibition of conjugation. CYP3A4 inhibitors such as itraconazole or ketoconazole may increase plasma hormone levels. 7.3 Concomitant Use with HCV Combination Therapy – Liver Enzyme Elevation Do not co-administer Lo Loestrin Fe with HCV drug combinations containing ombitasvir/ paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4) ] . 7.4 Changes in Plasma Levels of Co-Administered Drugs COCs containing some synthetic estrogens (for example, ethinyl estradiol) may inhibit the metabolism of other compounds. COCs have been shown to significantly decrease plasma concentrations of lamotrigine, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Consult the labeling of the concurrently-used drug to obtain further information about interactions with COCs or the potential for enzyme alterations.
Use in specific populations
8.1 Pregnancy Risk Summary 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. Data Human Data 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. 8. 2 Lactation Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs can reduce milk production in breastfeeding females. This reduction can occur at any time but is less likely to occur once breastfeeding is well-established. When possible, advise the nursing female to use other methods of contraception until she discontinues breastfeeding. [See also Dosage and Administration (2.2) .] The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Lo Loestrin Fe and any potential adverse effects on the breastfed child from Lo Loestrin Fe or from the underlying maternal condition. 8.4 Pediatric Use Safety and efficacy of Lo Loestrin Fe have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated. 8.5 Geriatric Use Lo Loestrin Fe has not been studied in postmenopausal women and is not indicated in this population. 8.6 Renal Impairment The pharmacokinetics of Lo Loestrin Fe has not been studied in subjects with renal impairment. 8.7 Hepatic Impairment No studies have been conducted to evaluate the effect of hepatic impairment on the disposition of Lo Loestrin Fe. However, steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of COC use until markers of liver function return to normal and COC causation has been excluded [ s ee Contraindications (4) and Warnings and Precautions (5.3) ] . 8.8 Body Mass Index The safety and efficacy of Lo Loestrin Fe in women with a body mass index (BMI) >35 kg/m 2 has not been evaluated [ s ee Clinical Studies (14) ] .
Pregnancy
8.1 Pregnancy Risk Summary 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. Data Human Data 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.
Pediatric use
8.4 Pediatric Use Safety and efficacy of Lo Loestrin Fe have been established in women of reproductive age. Safety and efficacy are expected to be the same in postpubertal adolescents under the age of 18 years as for users 18 years and older. Use of this product before menarche is not indicated.
Geriatric use
8.5 Geriatric Use Lo Loestrin Fe has not been studied in postmenopausal women and is not indicated in this population.
Overdosage
There have been no reports of serious ill effects from overdose of oral contraceptives, including ingestion by children. Overdosage may cause withdrawal bleeding in females and nausea.
Description
Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) provides an oral contraceptive regimen consisting of 24 blue active tablets and 2 white active tablets that contain the active ingredients specified for each tablet below, followed by 2 non-hormonal placebo tablets: 24 blue, round tablets each containing 1 mg norethindrone acetate and 10 mcg ethinyl estradiol 2 white, hexagonal tablets each containing 10 mcg ethinyl estradiol 2 brown, round tablets each containing 75 mg ferrous fumarate Each blue tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, FD&C Blue No. 1 Aluminum Lake, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate. Each white tablet also contains the inactive ingredients mannitol, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, povidone, vitamin E and lactose monohydrate. Each brown tablet contains ferrous fumarate, mannitol, povidone, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, sucralose and spearmint flavor. The ferrous fumarate tablets do not serve any therapeutic purpose. Ferrous fumarate tablets are not USP for dissolution and assay. The empirical formula of ethinyl estradiol is C 20 H 24 O 2 and the structural formula is: The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17α)-]. The empirical formula of norethindrone acetate is C 22 H 28 O 3 and the structural formula is: The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17α)-]. The chemical name of ethinyl estradiol is [19-Norpregna-1,3,5(10)-trien-20-yne-3,17-diol, (17)-]. The chemical name of norethindrone acetate is [19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17)-].
Mechanism of action
12.1 Mechanism of Action CHCs prevent pregnancy primarily by suppressing ovulation.
How supplied
16.1 How Supplied Lo Loestrin ® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister cards (dispensers) containing 28 tablets: NDC 0430-0420-14 Cartons of 5 blister cards (dispensers) NDC 0430-0420-60 Cartons of 30 blister cards (dispensers) Each blister card (28 tablets) contains in the following order: 24 blue, round tablets (active) imprinted with “WC” on one side and “421” on the other and each containing 1 mg norethindrone and 10 mcg ethinyl estradiol 2 white, hexagonal tablets (active) imprinted with “WC” on one side and “422” on the other and each containing 10 mcg ethinyl estradiol 2 brown, round tablets (non-hormonal placebo) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate 16.2 Storage Conditions Store at 25º C (77º F); excursions permitted to 15 - 30º C (59 - 86º F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children. 16.1 How Supplied Lo Loestrin ® Fe (norethindrone acetate and ethinyl estradiol tablets, ethinyl estradiol tablets and ferrous fumarate tablets) is available in blister cards (dispensers) containing 28 tablets: NDC 0430-0420-14 Cartons of 5 blister cards (dispensers) NDC 0430-0420-60 Cartons of 30 blister cards (dispensers) Each blister card (28 tablets) contains in the following order: 24 blue, round tablets (active) imprinted with “WC” on one side and “421” on the other and each containing 1 mg norethindrone and 10 mcg ethinyl estradiol 2 white, hexagonal tablets (active) imprinted with “WC” on one side and “422” on the other and each containing 10 mcg ethinyl estradiol 2 brown, round tablets (non-hormonal placebo) imprinted with “WC” on one side and “624” on the other and each containing 75 mg ferrous fumarate
Storage
16.2 Storage Conditions Store at 25º C (77º F); excursions permitted to 15 - 30º C (59 - 86º F) [see USP Controlled Room Temperature]. Keep this drug and all drugs out of the reach of children.
Patient information
Counsel patients that cigarette smoking increases the risk of serious cardiovascular events from COC use, and that women who are over 35 years old and smoke should not use COCs. Counsel patients that Lo Loestrin Fe does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Counsel patients on the Warnings and Precautions associated with COCs. Counsel patients to take one tablet daily by mouth at the same time every day. Instruct patients what to do in the event pills are missed. See “What to Do if You Miss Pills” section in FDA-Approved Patient Labeling. Counsel patients to use a back-up or alternative method of contraception when enzyme inducers are used with Lo Loestrin Fe. Counsel patients who are breastfeeding or who desire to breastfeed that COCs may reduce breast milk production. This is less likely to occur if breastfeeding is well established. Counsel any patient who starts COCs postpartum, and who has not yet had a period, to use an additional method of contraception until she has taken a blue tablet for 7 consecutive days. Counsel patients that amenorrhea may occur. Rule out pregnancy in the event of amenorrhea in two or more consecutive cycles. Distributed by: AbbVie Inc. North Chicago, IL 60064 Lo Loestrin Fe and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. © 2025 AbbVie. All rights reserved. Rev. 03/2025 2000017944
Label text from the FDA structured product label by Allergan, Inc. (revised Mar 7, 2025). Long sections are shortened; the complete label is on DailyMed.
Lo Loestrin Fe NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-1456 | Kit | A-S Medication Solutions | NDA |
| 0430-0420 | Kit | Allergan, Inc. | NDA |
Frequently asked questions
What is Lo Loestrin Fe used for?
Lo Loestrin ® Fe is indicated for use by women to prevent pregnancy [ see Clinical Studies (14) ] . The efficacy of Lo Loestrin Fe in women with a body mass index (BMI) of > 35 kg/m 2 has not been evaluated. Lo Loestrin Fe is a combination of norethindrone acetate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by women to prevent pregnancy ( 1 ) The efficacy of Lo Loestrin Fe…
What are the side effects of Lo Loestrin Fe?
The following serious adverse reactions with the use of COCs are discussed elsewhere in the labeling: Serious cardiovascular events and smoking [see Boxed Warning and Warnings and Precautions (5.1) ] Vascular events [see Warnings and Precautions (5.1) ] Liver disease [see Warnings and Precautions (5.3) ] Adverse reactions commonly reported by COC users are: Irregular uterine bleeding Nausea… See the full label for the complete list.
Who makes Lo Loestrin Fe?
Lo Loestrin Fe is listed by 2 labelers in the FDA NDC directory, including A-S Medication Solutions, Allergan, Inc..