HAILEY FE 1.5/30
Clinical safety rating
cautionComprehensive clinical and safety monograph for HAILEY FE 1.5/30 (HAILEY FE 1.5/30).
Combination estrogen-progestin contraceptive that suppresses gonadotropin release (FSH and LH) from the pituitary, inhibiting ovulation. Additionally, increases viscosity of cervical mucus and alters endometrial receptivity.
| Metabolism | Ethinyl estradiol: primarily metabolized by CYP3A4 via hydroxylation; undergoes first-pass metabolism in the liver and gut wall. Norethindrone: primarily metabolized via reduction followed by glucuronide conjugation; some involvement of CYP3A4. |
| Excretion | Ethinyl estradiol is primarily excreted renally (40-45%) and via bile/feces (45-55%). Norethindrone is excreted 50-60% renally and 30-40% fecally. |
| Half-life | Ethinyl estradiol: terminal half-life ~17-24 hours; norethindrone: terminal half-life ~5-14 hours (mean 11 hours). The clinical significance is that steady-state is reached within 5-7 days. |
| Protein binding | Ethinyl estradiol: ~97-98% bound to albumin; norethindrone: ~95% bound to albumin and sex hormone-binding globulin (SHBG). |
| Volume of Distribution | Ethinyl estradiol: ~2-4 L/kg; norethindrone: ~2-4 L/kg. Reflects extensive tissue distribution. |
| Bioavailability | Ethinyl estradiol: 40-50% due to first-pass metabolism; norethindrone: 50-70% due to first-pass metabolism. |
| Onset of Action | Oral: Contraceptive effect requires 7 days of consistent dosing; for cycle control, effects begin within the first cycle. |
| Duration of Action | The contraceptive effect lasts for the duration of the 21-day active pill cycle, with withdrawal bleeding occurring during the 7-day placebo period. After discontinuation, contraceptive protection ceases. |
| Molecular Weight | 372.53 |
| Action Class | Oral Contraceptive; Estrogen/Progestin Combination |
One tablet orally once daily for 21 consecutive days, followed by 7 days of placebo tablets.
| Dosage form | TABLET |
| Renal impairment | No dosage adjustment required for renal impairment. Use with caution in severe renal impairment due to potential fluid retention. |
| Liver impairment | Contraindicated in acute hepatitis, severe cirrhosis (Child-Pugh C), or liver tumors. For mild hepatic impairment (Child-Pugh A), no adjustment; use with caution. |
| Pediatric use | Not indicated for premenarchal girls. For postmenarchal adolescents, same dosing as adults. |
| Geriatric use | Not indicated for postmenopausal women due to higher risk of thromboembolic events and lack of efficacy for contraception in this population. |
| 1st trimester | Contraindicated due to risk of birth defects; use during pregnancy is not recommended. |
| 2nd trimester | Contraindicated due to risk of adverse effects on fetus, including potential virilization of female fetuses from progestin component. |
| 3rd trimester | Contraindicated due to risk of adverse effects on fetus, including potential virilization of female fetuses from progestin component. |
Clinical note
Comprehensive clinical and safety monograph for HAILEY FE 1.5/30 (HAILEY FE 1.5/30).
| Placental transfer | Yes, both estrogen and progestin components cross the placenta. |
| Breastfeeding | Excreted in breast milk; may reduce milk production and affect infant. Use only if benefits outweigh risks. |
| Lactation Rating | L3 - Moderately Safe |
| Teratogenic Risk | Category X: Contraindicated in pregnancy. First trimester: Increased risk of neural tube defects, cardiovascular anomalies, and limb reduction defects. Second/third trimesters: Associated with fetal adrenal suppression, hepatic dysfunction, and masculinization of female fetuses. Discontinue immediately if pregnancy occurs. |
| Fetal Monitoring | Baseline pregnancy test before initiation. If accidental exposure occurs, fetal ultrasound for anomalies and echocardiogram. Monitor liver function and blood pressure during use. |
| Fertility Effects | No permanent negative impact on fertility. May delay return to ovulation after discontinuation; reversible within 1-2 cycles. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from combination oral contraceptives. Risk increases with age (especially in women over 35) and with heavy smoking (≥15 cigarettes/day). Women who use combination hormonal contraceptives should be strongly advised not to smoke.
| Common Effects | Nausea, Headache, Breast tenderness, Breakthrough bleeding or spotting, Weight changes, Mood changes, Acne |
| Serious Effects | Venous thromboembolism (VTE), Arterial thromboembolism (e.g., stroke, myocardial infarction), Hepatic adenoma or hepatocellular carcinoma, Hypertension, Gallbladder disease, Thrombotic thrombocytopenic purpura (TTP), Hemolytic uremic syndrome (HUS) |
PregnancyBreast cancerEstrogen-dependent neoplasiaUndiagnosed abnormal genital bleedingActive liver diseaseThromboembolic disordersHistory of thrombophlebitis or pulmonary embolismKnown or suspected pregnancy
| Precautions | Risk of thromboembolic disorders and thrombotic events (e.g., MI, stroke, DVT, PE), Increased risk of cervical cancer and breast cancer (controversial), Hepatic neoplasia (benign and malignant), Gallbladder disease, Hypertension, Impaired liver function, Carbohydrate and lipid effects, Headache/migraine, Bleeding irregularities, Ocular lesions (e.g., retinal thrombosis), Depression, Contact lens intolerance, Fluid retention |
| Food/Dietary | No significant food interactions. Grapefruit juice may increase ethinyl estradiol levels but effect is not clinically significant; no restriction. Iron absorption may be enhanced by vitamin C (e.g., citrus); avoid taking with dairy or antacids that reduce iron absorption, separate by at least 2 hours if needed. |
| Clinical Pearls | HAILEY FE 1.5/30 is a combination oral contraceptive containing ethinyl estradiol 30 µg and norethindrone 1.5 mg, with iron supplementation (ferrous fumarate 75 mg). The iron component is not part of the contraceptive effect but helps maintain iron stores during menstruation. It is typically taken for 21 active pills followed by 7 placebo pills (containing iron). Administer consistently at the same time daily to maintain hormone levels and minimize breakthrough bleeding. Monitor for elevated blood pressure, thromboembolic events, and hepatic adenoma. Smoking increases cardiovascular risk; avoid in women over 35 who smoke. Efficacy may be reduced with hepatic enzyme-inducing drugs (e.g., rifampin, certain anticonvulsants). |
| Patient Advice | Take one tablet daily at the same time each day, even if you do not have sex. · The first 21 pills are active hormones; the last 7 pills (green) contain iron and are placebos. · If you miss a pill, follow the package instructions: take the missed pill as soon as remembered, and use backup contraception if you miss more than one. · Common side effects include nausea, breast tenderness, and breakthrough bleeding, especially in the first few months. · Smoking while on this pill increases risk of serious cardiovascular events; do not smoke. · Contact your healthcare provider if you experience leg pain, chest pain, sudden severe headache, or visual changes. · HAILEY FE does not protect against HIV or other sexually transmitted infections; use condoms for protection. · Inform your doctor of all medications you take, including over-the-counter drugs and supplements. · If you have severe vomiting or diarrhea, use additional contraception. · Store at room temperature away from moisture and heat. |
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