HAILEY 24 FE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HAILEY 24 FE (HAILEY 24 FE).
Combination oral contraceptive containing ethinyl estradiol and norethindrone; inhibits ovulation by suppressing gonadotropin release, increases viscosity of cervical mucus, and alters endometrial receptivity.
| Metabolism | Ethinyl estradiol is primarily metabolized by CYP3A4; undergoes first-pass metabolism in the liver and intestinal mucosa. Norethindrone is metabolized via reduction, hydroxylation, and conjugation, primarily by CYP3A4. |
| Excretion | Ethinyl estradiol is excreted in urine (40%) and feces (60%) as glucuronide and sulfate conjugates. Norethindrone is excreted in urine (30-50%) and feces (20-30%) as metabolites. |
| Half-life | Ethinyl estradiol has a terminal half-life of approximately 13-27 hours (mean 18.5 hours). Norethindrone has a terminal half-life of approximately 8-12 hours. The half-life supports once-daily dosing. |
| Protein binding | Ethinyl estradiol: 97-98% bound to albumin and corticoid-binding globulin (CBG). Norethindrone: 80-90% bound to sex hormone-binding globulin (SHBG) and albumin. |
| Volume of Distribution | Ethinyl estradiol: Vd 2.0-4.5 L/kg, indicating extensive tissue distribution. Norethindrone: Vd 2.0-3.0 L/kg, also widely distributed. |
| Bioavailability | Ethinyl estradiol: 38-48% oral bioavailability due to first-pass metabolism. Norethindrone: 64-70% oral bioavailability. Both are subject to hepatic first-pass metabolism. |
| Onset of Action | Contraceptive effect: 7 days of consistent dosing for full suppression of ovulation; for emergency contraception, onset is not applicable. Maximal contraceptive efficacy requires 7 days of continuous use. |
| Duration of Action | Contraceptive protection persists throughout the 21-day active pill cycle; after the last active pill, protection remains for 7 days if the next pack is started on time. With perfect use, no additional contraception needed during placebo week. |
One tablet orally once daily for 24 weeks. Each tablet contains norethindrone 0.8 mg and ethinyl estradiol 0.02 mg. After 24 weeks, take one inactive (ferrous fumarate) tablet daily for 4 weeks. Total cycle: 28 tablets.
| Dosage form | TABLET |
| Renal impairment | No dosage adjustment required for mild to moderate renal impairment. Use is contraindicated in severe renal impairment or acute renal failure due to potential fluid retention and hyperkalemia from the progestin component. |
| Liver impairment | Contraindicated in Child-Pugh Class B or C (moderate to severe hepatic impairment). For Child-Pugh Class A (mild impairment), use with caution; consider alternative contraceptive methods due to potential altered hormone metabolism. |
| Pediatric use | Postmenarchal adolescents: Same dosing as adults (one tablet daily). Safety and efficacy have been established for females of reproductive age. Not indicated for premenarchal girls. |
| Geriatric use | Not indicated for postmenopausal women. No safety data available for females over 65 years. Contraindicated in women with known or suspected pregnancy or history of thromboembolic disorders. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HAILEY 24 FE (HAILEY 24 FE).
| Breastfeeding | Small amounts of ethinyl estradiol and norethindrone excreted in breast milk. M/P ratio not well defined. May reduce milk production and quality, especially with higher doses. Use not recommended during lactation; alternative contraception advised. |
| Teratogenic Risk | Hailey 24 FE contains ethinyl estradiol and norethindrone. Contraindicated in pregnancy. First trimester: No increased risk of birth defects from inadvertent use based on population data. Second and third trimesters: Known risks include genital abnormalities in female fetuses from androgenic progestins, although norethindrone has low androgenicity. Avoid use during pregnancy. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from oral contraceptive use. Risk increases with age (>35 years) and with heavy smoking (≥15 cigarettes/day). Women >35 years who smoke should not use this product.
| Serious Effects |
["Venous thromboembolism (current or history)","Arterial thromboembolism (current or history, e.g., stroke, MI)","Known thrombophilic conditions (e.g., Factor V Leiden, prothrombin mutation, protein C/S deficiency)","Cerebrovascular or coronary artery disease","Uncontrolled hypertension (≥160/100 mmHg)","Diabetes with vascular involvement","Headaches with focal neurological symptoms or migraine with aura (age ≥35)","Breast cancer (current or history)","Endometrial cancer (current or history)","Undiagnosed abnormal uterine bleeding","Liver disease (acute hepatitis, decompensated cirrhosis, liver tumors)","Known or suspected pregnancy","Hypersensitivity to any component","Concurrent use with Hepatitis C drug combinations containing ombitasvir, paritaprevir, ritonavir, and dasabuvir (increased ALT elevations)"]
| Precautions | ["Thrombotic disorders: Risk of venous and arterial thromboembolism","Cardiovascular disease: Increased risk of myocardial infarction and stroke in smokers >35 years","Hepatic neoplasia: Case reports of liver tumors","Gallbladder disease: Increased risk","Hypertension: May occur","Carbohydrate/lipid metabolism effects","Hereditary angioedema: May exacerbate","Chloasma: May occur","Ocular effects: Retinal thrombosis; discontinue if unexplained loss of vision occurs"] |
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| Fetal Monitoring | If inadvertently used during pregnancy, monitor fetal development via ultrasound. Assess for signs of pregnancy before initiating therapy. No specific ongoing monitoring required in non-pregnant patients. |
| Fertility Effects | Inhibits ovulation. Fertility returns promptly (within 1-2 cycles) after discontinuation. No long-term adverse effects on fertility. |