AUROVELA FE 1.5/30
Clinical safety rating
cautionComprehensive clinical and safety monograph for AUROVELA FE 1.5/30 (AUROVELA FE 1.5/30).
Combination oral contraceptive containing norethindrone acetate and ethinyl estradiol. Norethindrone acetate is a progestin that suppresses gonadotropin release, inhibiting ovulation; ethinyl estradiol is an estrogen that provides feedback inhibition of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), preventing follicular development and ovulation. Additionally, it causes changes in cervical mucus (increased viscosity) and endometrium (reduced receptivity).
| Metabolism | Norethindrone acetate is metabolized primarily in the liver via reduction and conjugation (sulfation and glucuronidation). It is a prodrug, rapidly hydrolyzed to norethindrone. Ethinyl estradiol is metabolized via CYP3A4 in the liver, undergoing hydroxylation, methylation, and conjugation (glucuronidation and sulfation). Both undergo enterohepatic recirculation. |
| Excretion | Renal: ~50-60% as metabolites, <10% unchanged; Fecal: ~40-50% via bile; Ethinyl estradiol undergoes enterohepatic recirculation. |
| Half-life | Norethindrone: 5-14 hours (terminal); Ethinyl estradiol: 10-20 hours (terminal). Steady-state achieved within 5-7 days; contraceptive efficacy maintained with daily dosing. |
| Protein binding | Norethindrone: ~97% (albumin and SHBG); Ethinyl estradiol: ~97-98% (albumin, not SHBG). |
| Volume of Distribution | Norethindrone: 2-5 L/kg (extensive tissue distribution); Ethinyl estradiol: 2-4 L/kg (distributes into breast milk and body fat). |
| Bioavailability | Oral: Norethindrone ~64% (first-pass effect); Ethinyl estradiol ~40-45% (extensive first-pass metabolism). |
| Onset of Action | Oral: 7 days of continuous dosing required for full contraceptive effect; ovulation suppression begins within 3-5 days. |
| Duration of Action | 24 hours; missed pill recommendations based on 12-hour window; continuous daily dosing required for sustained contraceptive efficacy. |
| Molecular Weight | 340.5 |
| Action Class | Oral Contraceptive; Estrogen/Progestin Combination |
One tablet orally once daily at the same time each day for 28 consecutive days.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment required for mild to moderate renal impairment. Not studied in severe renal impairment (GFR <30 mL/min/1.73 m²); use is not recommended. |
| Liver impairment | Contraindicated in severe hepatic disease (Child-Pugh class C). Use with caution and monitor liver function in mild to moderate impairment (Child-Pugh A/B); consider alternative methods if liver function deteriorates. |
| Pediatric use | Not indicated for use before menarche. |
| Geriatric use | Not indicated for use in postmenopausal women. No specific studies in elderly; consider age-related risks of thromboembolism and cardiovascular disease. |
| 1st trimester | Contraindicated due to risk of congenital anomalies; use only if benefit outweighs risk. |
| 2nd trimester | Contraindicated due to risk of fetal harm; use only if benefit outweighs risk. |
| 3rd trimester | Contraindicated due to risk of fetal harm and potential neonatal withdrawal; use only if benefit outweighs risk. |
Clinical note
Comprehensive clinical and safety monograph for AUROVELA FE 1.5/30 (AUROVELA FE 1.5/30).
| Placental transfer | Norethindrone and ethinyl estradiol cross the placenta; both are known to reach fetal circulation with potential for adverse effects. |
| Breastfeeding | Excreted in breast milk; may cause adverse effects in nursing infants. Use is generally avoided. If used, monitor infant for sedation, respiratory depression, and withdrawal symptoms. |
| Lactation Rating | L4 (Possibly Hazardous) |
| Teratogenic Risk | Contraindicated in pregnancy. Use during first trimester associated with oral clefts and cardiac defects; second and third trimester exposure linked to feminization of male fetuses and other anomalies due to progestin effects. Increased risk of ectopic pregnancy. On-label indications exclude pregnancy use. |
| Fetal Monitoring | Monitor blood pressure, liver function tests, and glucose tolerance. Rule out pregnancy before initiation. Assess for thromboembolic symptoms. Fetal monitoring in inadvertent exposure includes ultrasound for anomalies. |
| Fertility Effects | Suppresses ovulation; reversible after discontinuation. Normal fertility expected within 3-6 months post-discontinuation. No long-term adverse effects on fertility. |
■ FDA Black Box Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use. This risk increases with age, especially in women over 35 years of age, and with the number of cigarettes smoked. Women who use combination oral contraceptives should be strongly advised not to smoke.
| Common Effects | Nausea, Headache, Breast tenderness, Weight changes, Irregular uterine bleeding, 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) |
Known or suspected pregnancyBreast cancerUndiagnosed abnormal uterine bleedingLiver disease or hepatic tumorsThrombophlebitis or thromboembolic disordersHypersensitivity to any component
| Precautions | Thrombotic disorders: risk of venous thromboembolism, arterial thromboembolism, stroke, myocardial infarction; increased in smokers, obese, or those with thrombogenic mutations, Hepatic neoplasia: rare cases of benign and malignant liver tumors reported, Ocular effects: retinal thrombosis, papilledema, optic neuritis, Cardiovascular: hypertension, lipid effects, increased risk in women with hypertension or hyperlipidemia, Carbohydrate metabolism: impaired glucose tolerance, increased insulin resistance, Headache/migraine: discontinue if new or worsening migraine or severe headache, Bleeding irregularities: breakthrough bleeding, spotting, amenorrhea, Gallbladder disease: increased risk, Depression: can exacerbate, Hereditary angioedema: may trigger or worsen, Chloasma: may cause melasma, exacerbated by sun exposure, Iron supplementation: caution in hemochromatosis or iron overload disorders, Dental/gingival: gingivitis, Laboratory tests: may affect thyroid, sex hormone-binding globulin, coagulation factors |
| Food/Dietary | Grapefruit and grapefruit juice may increase ethinyl estradiol levels; avoid large quantities. No other significant food interactions. Take with food or milk to reduce gastrointestinal upset if needed. |
| Clinical Pearls | AUROVELA FE 1.5/30 is a combined oral contraceptive containing norethindrone acetate 1.5 mg and ethinyl estradiol 30 mcg. It contains ferrous fumarate as an iron supplement in the placebo pills. Patients with a history of venous thromboembolism, thrombogenic mutations, or estrogen-sensitive malignancies should not use this medication. Baseline blood pressure, lipid profile, and liver function tests are recommended. Counsel patients to take at the same time daily to maintain efficacy. Consider drug interactions with antibiotics, anticonvulsants, and St. John's Wort which may reduce contraceptive effectiveness. |
| Patient Advice | Take one tablet daily at the same time each day, with or without food. · Swallow tablets whole; do not crush or chew. · Missed dose management: if missed by less than 12 hours, take it as soon as remembered; if more than 12 hours, skip the missed dose and continue with next tablet; use back-up contraception if multiple doses missed. · Common side effects include nausea, breast tenderness, weight changes, and breakthrough bleeding; these may improve after 2-3 cycles. · Seek immediate medical attention if you experience leg pain/swelling, chest pain, shortness of breath, severe headache, vision changes, or jaundice. · Does not protect against sexually transmitted infections (STIs); use condoms for STI prevention. · Inform your healthcare provider of all medications, including over-the-counter drugs and herbal supplements. · Continue taking the iron-containing placebo tablets during the placebo week; do not skip. |
Loading safety data…