What is Mirvala (Drospirenone and Ethinyl Estradiol)?

From the Guidelines

Mirvala is a combination oral contraceptive pill containing drospirenone and ethinyl estradiol, used for birth control and treating acne in women who desire oral contraception. The pill works by preventing ovulation and pregnancy through the inhibition of gonadotropin-releasing hormone, follicle stimulating hormone, and luteinizing hormone, and also has anti-androgenic properties that decrease ovarian androgen production, increase sex hormone-binding globulin, and reduce free testosterone 1.

Key Components and Mechanism

• Drospirenone is a fourth-generation progestin with anti-androgenic properties, not derived from testosterone, which makes it beneficial for treating acne and hirsutism in women 1.
• Ethinyl estradiol is the most common estrogen component in combined oral contraceptives (COCs), with daily doses typically ranging from 10-50 µg, and it contributes to the prevention of ovulation and the reduction of androgenic effects 1.
• The combination of drospirenone and ethinyl estradiol yields net anti-androgenic properties, making it effective for treating acne and other conditions related to hormonal imbalance 1.

Usage and Effectiveness

• The standard dosage of Mirvala is one pill daily for 21 days, followed by 7 days of placebo pills or no pills, during which menstruation typically occurs.
• For maximum effectiveness (over 99% when used perfectly), Mirvala should be taken at the same time each day, and if a pill is missed, it should be taken as soon as remembered, with additional contraception possibly needed for 7 days depending on when in the cycle the miss occurred.
• Mirvala also offers non-contraceptive benefits like reduced menstrual pain and more regular periods, but it does not protect against sexually transmitted infections, so barrier methods may still be necessary depending on individual circumstances.

Safety and Side Effects

• Common side effects of Mirvala include nausea, breast tenderness, headaches, and spotting between periods, especially during the first few months of use 2.
• More serious adverse effects associated with COCs, including Mirvala, are thromboembolic events, with the risk of venous thromboembolism being higher in COC users than non-users, but still relatively low 2.
• The risk of cardiovascular events and ischemic stroke is also low in otherwise healthy women taking COCs, and there is evidence that COCs are associated with a net decrease in cancer risk, including a reduced risk of colon, uterine, and ovarian cancer 2.

Recommendations

• Mirvala is conditionally recommended for acne treatment in women who desire oral contraception, based on moderate certainty evidence from recent studies 1.
• The decision to prescribe Mirvala should be based on individual patient needs and medical history, taking into account the potential benefits and risks of the medication.

From the FDA Drug Label

What are Drospirenone and Ethinyl Estradiol Tablets? Drospirenone and ethinyl estradiol tablets are birth control pills. It contains two female hormones, a synthetic estrogen called ethinyl estradiol and a progestin called drospirenone.

Mirvala is another name for Drospirenone and Ethinyl Estradiol, which is a combination of a progestin and an estrogen used for several purposes, including:

• Preventing pregnancy
• Treating symptoms of premenstrual dysphoric disorder (PMDD)
• Treating moderate acne 3

From the Research

Overview of Mirvala (Drospirenone and Ethinyl Estradiol)

• Mirvala, also known as Drospirenone and Ethinyl Estradiol, is a combined oral contraceptive formulation 4.
• It combines drospirenone, a progestin with antimineralocorticoid and antiandrogenic properties, with ethinyl estradiol, a low-dose estrogen 5, 6.

Mechanism of Action and Effects

• Drospirenone has a unique mechanism of action, with antimineralocorticoid and antiandrogenic effects, which may contribute to its benefits in reducing water retention and improving acne 6, 7.
• The combination of drospirenone and ethinyl estradiol has been shown to be effective in preventing pregnancy, with a Pearl Index of 0.57 and an adjusted Pearl Index of 0.09 6.
• It has also been shown to improve premenstrual symptoms, including premenstrual dysphoric disorder (PMDD) and moderate acne vulgaris 4, 8, 7.

Clinical Uses and Efficacy

• Mirvala is approved for the prevention of pregnancy, treatment of PMDD, and treatment of moderate acne vulgaris in women who choose oral contraception for birth control 4, 7.
• Clinical trials have demonstrated its efficacy in these areas, with significant improvements in emotional and physical symptoms associated with PMDD and moderate acne vulgaris 8, 7.
• It has also been shown to be well-tolerated, with adverse events generally typical of those experienced with other combined oral contraceptives 5, 7.

Comparison to Other Oral Contraceptives

• Mirvala has been compared to other oral contraceptives, including those containing levonorgestrel and desogestrel, and has been shown to have similar efficacy and tolerability 5, 8.
• However, its unique mechanism of action and benefits in reducing water retention and improving acne may make it a preferred option for some women 6, 7.