DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM
This medication is a combination oral contraceptive (COC) containing drospirenone (a progestin), ethinyl estradiol (an estrogen), and levomefolate calcium (a B vitamin). It is indicated for females of reproductive potential to prevent pregnancy and to treat symptoms of premenstrual dysphoric disorder (PMDD)—such as anxiety, depressed mood, and physical discomfort—in women who choose an oral contraceptive. It is also approved for the treatment of moderate acne vulgaris in patients at least 14 years of age who desire contraception. Additionally, the inclusion of levomefolate calcium is indicated to increase folate levels in women to reduce the risk of neural tube defects in a pregnancy conceived while taking the product or shortly after discontinuing it. The effectiveness for PMDD beyond three menstrual cycles has not been evaluated.
How DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM Works
Combination oral contraceptives (COCs) prevent pregnancy primarily by suppressing ovulation through the inhibition of gonadotropin release. Secondary mechanisms include alterations in cervical mucus, which inhibit sperm penetration, and changes in the endometrium, which reduce the likelihood of implantation. Drospirenone is a spironolactone analogue with antimineralocorticoid and antiandrogenic activity. Levomefolate calcium is a primary dietary form of folate; its inclusion provides supplementation to reduce the risk of neural tube defects in the event of pregnancy.
Details
- Status
- Prescription
- First Approved
- 2016-10-11
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM Approval History
What DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM Treats
2 indicationsDROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Premenstrual Dysphoric Disorder
- Acne
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM Boxed Warning
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications ( 4 )] . WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS See full prescribing information for complete boxed warning. • Women over 35 years old who smoke should not use Yaz ( 4 ). • Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. ( 4 )
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM FDA Label Details
ProIndications & Usage
FDA Label (PDF)Yaz is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to: • Prevent pregnancy. • Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception. • Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. 1.1 Oral Contraceptive Yaz ® is indicated for use by females of reproductive potential to prevent pregnancy. 1.2 Premenstrual Dysphoric Disorder (PMDD) Ya...
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptives (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.