What are the dosing instructions, contraindications, and side effects for Aurovela Fe 1/20 (1 mg norethindrone acetate/20 µg ethinyl estradiol) tablet?

Aurovela Fe 1/20: Dosing, Contraindications, and Side Effects

Dosing Instructions

Aurovela Fe 1/20 is taken as one tablet daily for 28 consecutive days: 21 white to off-white active tablets (1 mg norethindrone acetate/20 µg ethinyl estradiol) followed by 7 brown ferrous fumarate tablets, with tablets taken at the same time each day, preferably with a meal or at bedtime. 1

Starting Regimens

• Sunday-Start: Begin the first active tablet on the first Sunday after menstrual flow begins (or on that Sunday if flow begins on Sunday). Use backup contraception (condoms) for the first 7 days. 1

• Day-1 Start: Begin the first active tablet on the first day of menstrual bleeding. Apply the appropriate day label sticker over the preprinted days on the blister pack. No backup contraception is required if started within the first 5 days of bleeding; if started after day 5, use backup contraception for 7 consecutive days. 2

• After completing all 21 active tablets, immediately begin the 7 brown ferrous fumarate tablets without interruption, then start a new pack the next day. 1

Missed Pill Management

The 20 µg ethinyl estradiol formulation exhibits greater follicular activity when doses are missed compared to 30-35 µg formulations, increasing pregnancy risk—strict adherence counseling is critical. 2

• One pill missed (<24 hours late): Take immediately, continue remaining tablets on schedule (even if two pills taken in one day), no backup contraception needed. 2

• One pill missed (24-<48 hours): Discard other missed tablets, take the most recent missed tablet immediately, continue remaining tablets on schedule, no backup contraception needed. 2

• ≥2 consecutive pills missed (≥48 hours): Discard all missed tablets, take the most recent missed tablet immediately, continue remaining tablets on schedule, and use backup contraception (condoms) or abstain until 7 consecutive active tablets have been taken. 2

• Pills missed during days 15-21 (last active week): Skip the hormone-free interval—finish active tablets and start a new pack immediately. If unable to start a new pack, use backup contraception until 7 consecutive active days are achieved. 2

• Pills missed during days 1-7 (first week) with unprotected intercourse in the prior 5 days: Consider emergency contraception. 2

Gastrointestinal Interference

• Vomiting or diarrhea <24 hours after taking a tablet: Continue daily dosing at the usual time; no additional contraceptive protection needed. 2

• Vomiting or diarrhea persisting 24-<48 hours: Continue daily dosing but use backup contraception or abstain until 7 consecutive active tablets are taken after symptom resolution. If this occurs during days 15-21, skip the hormone-free interval by starting a new pack immediately. If during days 1-7 with recent unprotected intercourse, consider emergency contraception. 2

• Vomiting or diarrhea ≥48 hours: Same management as 24-<48 hour scenario. 2

Absolute Contraindications

Aurovela Fe 1/20 is contraindicated in the following conditions, as use may result in serious morbidity or mortality: 33

• Pregnancy (Pregnancy Category X—may cause fetal harm including masculinization of female external genitalia and hypospadias in males) 4
• Active or history of arterial thromboembolic disease (stroke, myocardial infarction) 3
• Active or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism) 3
• Breast cancer or other estrogen- or progestin-sensitive malignancy 3
• Carcinoma of the endometrium 3
• Undiagnosed abnormal uterine bleeding 3
• Hepatic adenomas, carcinomas, or active hepatic disease with abnormal liver function 3
• Cholestatic jaundice of pregnancy or jaundice with prior pill use 3
• Cerebrovascular or coronary artery disease 3
• Valvular heart disease with complications 3
• Headaches with focal neurologic symptoms 3
• Migraine with aura at any age, or any migraine in women >35 years 2
• Current smoking in women >35 years of age 2
• Uncontrolled hypertension 2
• Surgery with prolonged immobilization 3
• Hypersensitivity to norethindrone acetate or ethinyl estradiol 3

Adverse Effects and Toxicities

Common Side Effects

The most frequently reported adverse effects include: 33

• Central nervous system: Headache, depression, nervousness, mood changes, migraine 33
• Endocrine: Breast pain/tenderness, irregular menstruation, breakthrough bleeding, menorrhagia, amenorrhea, fluid retention, weight changes 33
• Gastrointestinal: Abdominal pain, nausea, vomiting, abdominal cramps, diarrhea, dyspepsia, appetite changes 33
• Genitourinary: Urinary tract infections, vaginitis, vaginal candidiasis, abnormal uterine bleeding, cervical ectropion, cervical secretion 33
• Dermatologic: Chloasma, melasma, erythema nodosum 3
• Cardiovascular: Edema, varicose vein aggravation 3
• Respiratory: Sinusitis 3

Serious Adverse Effects

Life-threatening complications requiring immediate medical attention include: 34

• Thromboembolic events: Stroke, myocardial infarction, pulmonary embolus, deep vein thrombosis (progestational drugs alter blood-clotting systems, allowing easier clot formation) 4
• Ocular complications: Sudden partial or complete vision loss, blurred vision, sudden onset of bulging eyes, double vision 4
• Hepatic: Cholestatic jaundice, liver tumors 3
• Hematologic: Folate deficiency, porphyria exacerbation 3
• Immunologic: Anaphylaxis, lupus exacerbation 3

Warning Signs Requiring Immediate Provider Contact

Discontinue Aurovela Fe 1/20 and contact your healthcare provider immediately if you experience: 4

• Severe headaches or headaches with focal neurologic symptoms
• Chest pain or shortness of breath
• Pains in the legs
• Changes in vision or speech
• Dizziness and faintness
• Breast lumps

Drug Interactions

Numerous medications can reduce contraceptive efficacy or increase adverse effects: 33

Medications That Decrease Contraceptive Effectiveness

• Antibiotics: Cephalosporins, chloramphenicol, macrolides, penicillins, tetracyclines, sulfonamides 3
• Anticonvulsants: Barbiturates, carbamazepine, phenytoin, primidone, topiramate, felbamate, lamotrigine 33
• Antifungals: Griseofulvin 3
• Antiretrovirals: HIV protease inhibitors (amprenavir, nelfinavir, ritonavir, fosamprenavir, tipranavir), nevirapine, boceprevir, telaprevir 33
• Other: Rifampin, rifabutin, modafinil, bosentan, dabrafenib, St. John's wort, aprepitant, bexarotene, mifepristone, mitotane 33

Medications Whose Levels May Be Altered

• Increased levels: Clozapine, tizanidine, theophylline, fentanyl, paclitaxel, alprazolam, prednisolone 3
• Decreased levels: Lamotrigine, mycophenolate mofetil 33
• Anticoagulants: Warfarin, vitamin K antagonists (monitor INR closely) 3

Baseline and Ongoing Monitoring

Before initiating Aurovela Fe 1/20: 33

• Confirm pregnancy status (urine or serum pregnancy test)
• Measure blood pressure

During ongoing use: 33

• Monitor blood pressure regularly
• Annual breast examination and mammography (more frequent if family history of breast cancer or prior abnormal findings)
• Assess for health status changes at each visit
• For patients with cardiovascular risk factors (hypertension, hyperlipidemia, diabetes, obesity, tobacco use), counsel on risk reduction strategies

Special Populations

Pregnancy and Nursing

• Pregnancy Category X: Absolutely contraindicated—discontinue immediately if pregnancy is detected. 34
• Breastfeeding: The World Health Organization recommends avoiding breastfeeding if possible; infant risk cannot be ruled out. 3

Pediatric Use

• Use before menarche is not indicated. 3
• For adolescents ≥15 years: May be prescribed for contraception or adjuvant acne therapy. 3

Clinical Considerations

The 24-day active/4-day inert regimen (24/4) provides a shorter hormone-free interval than traditional 21/7 regimens, which may reduce follicular activity and improve contraceptive reliability, particularly for women who miss pills. 25

However, the 20 µg ethinyl estradiol dose exhibits significantly greater follicular activity after missed pills compared to 30 µg formulations, increasing pregnancy risk—patients with poor adherence should be counseled to consider long-acting reversible contraception (LARC) such as IUDs or implants. 2

The 24/4 regimen is associated with fewer intracyclic bleeding days, fewer withdrawal bleeding days, and fewer total bleeding/spotting days compared to 21/7 regimens. 5