What is Aurovela (levonorgestrel and ethinyl estradiol) used for and how is it administered?

From the Guidelines

Aurovela, a combination oral contraceptive containing levonorgestrel and ethinyl estradiol, is primarily used for pregnancy prevention and is administered as a daily pill taken by mouth at the same time each day. The medication comes in different formulations, typically in 21-day or 28-day packs, with users taking one hormone-containing pill daily for 21 days, followed by 7 days without pills during which menstruation typically occurs, or taking hormone-containing pills for 21 or 24 days followed by placebo pills for the remaining days to maintain the daily pill-taking routine 1.

Key Administration Guidelines

• For maximum effectiveness, Aurovela should be taken consistently without missing doses.
• If a dose is missed, specific instructions in the package insert should be followed, such as taking the missed pill as soon as it is remembered and using a backup method of contraception for at least 7 days 1.
• Aurovela does not protect against sexually transmitted infections, so users should also use condoms or other barrier methods for protection.
• Certain medications, including some antibiotics like rifampin, may reduce the effectiveness of Aurovela, and alternative methods or dosing may be necessary 1.

Additional Uses and Benefits

• Beyond pregnancy prevention, Aurovela may also be prescribed to regulate menstrual cycles, reduce menstrual pain, treat acne, or manage symptoms of conditions like endometriosis or polycystic ovary syndrome.
• The medication works by preventing ovulation, thickening cervical mucus to block sperm, and thinning the uterine lining to prevent implantation of a fertilized egg.
• Extended or continuous cycles of Aurovela may be useful for treating medical conditions such as anemia, acne, severe dysmenorrhea, endometriosis, and other bleeding diatheses, and for adolescents who prefer amenorrhea 1.

Important Considerations

• Patients should be informed that common transient adverse effects of Aurovela include irregular bleeding, headache, and nausea, and that the most serious adverse event associated with its use is the increased risk of blood clots 1.
• Aurovela should not be prescribed for patients with severe and uncontrolled hypertension, ongoing hepatic dysfunction, complicated valvular heart disease, migraines with aura or focal neurologic symptoms, thromboembolism or thrombophilia, complications of diabetes, and complicated solid organ transplantation 1.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Aurovela (Levonorgestrel and Ethinyl Estradiol) Overview

• Aurovela, a combination of levonorgestrel and ethinyl estradiol, is used as an oral contraceptive to prevent pregnancy 2, 3, 4, 5.
• It works by exerting its contraceptive action at the central (hypothalamic) and peripheral (cervical mucus and endometrium) levels 2.

Administration and Dosage

• Aurovela is administered orally, with each pill containing a specific amount of levonorgestrel and ethinyl estradiol, such as 150 mug LNG and 30 mug EE 2, 5.
• The regimen can vary, including extended-cycle regimens that allow for fewer withdrawal bleeding episodes, such as four times a year 4, 5.
• Examples of regimens include a 91-day extended-cycle oral contraceptive consisting of levonorgestrel/ethinylestradiol 150/30 µg for 84 days and ethinylestradiol 10 µg for 7 days (Seasonique) 5.

Benefits and Risks

• Aurovela can reduce the risk of common menstrual symptoms, endometriosis, or severe dysmenorrhea by offering potentially greater ovarian suppression and preventing endogenous estradiol production 4.
• However, hormonal contraceptives like Aurovela can increase the risk of venous thrombosis and may have other risks and side effects, such as breakthrough bleeding, especially during the initial cycles of use 2, 3, 5.
• The risks associated with Aurovela have been found to be similar to those of traditional oral contraceptive pills, and counseling on the risks and side effects is comparable to that of any combined hormonal contraceptives 4.

Effectiveness

• Aurovela has been shown to be effective in preventing pregnancy, with a Pearl index (pregnancies per 100 woman-years of use) of 0.76 in a large trial of healthy, sexually active women 5.
• The effectiveness of Aurovela can be influenced by user adherence and continuation, as well as individual factors such as fecundability and coital frequency 3.