Classes
DEA Class; Rx
Common Brand Names; Natazia
- Estrogens/Progestins;
- Contraceptives, Oral
Description
Combination oral contraceptive (COC); quadriphasic regimen; estradiol valerate is the estrogen; dienogest, is a potent fourth generation progestin devoid of estrogenic, androgenic, glucocorticoid and mineralocorticoid activities
Used for routine contraception in adolescents and premenopausal adults; this regimen is helpful for patients with heavy menstrual flow
All COCs contain a boxed warning regarding the increased risk for thromboembolism in women who smoke
Indications
Indicated for routine contraception.
Contraindications
Pregnancy
Hypersensitivity
Breast Cancer, or another estrogen- or progestin-sensitive cancer
A high risk of arterial or venous thromboembolic disorders
Undiagnosed uterine bleeding
Adverse Effects
- Headache, including migraines (13.2%)
- Metrorrhagia and irregular menstruation (8%)
- Breast pain, discomfort, or tenderness (6.6%)
- Nausea or vomiting (6.5%)
- Acne (3.9%)
- Weight gain (2.85)
- Venous thromboembolism
- Jaundice or cholestasis
- Gallbladder disease
- Depression
Warnings
Poorly metabolized with hepatic impairment
Use caution in patients with history of migraine, seizure disorder,
Not recommended for women smokers >35 years
Oral contraceptives can reduce production of milk in breastfeeding mothers
Evaluate significant change in headaches and discontinue therapy if indicated
Women taking strong CYP3A4 inducers (for example, carbamazepine, phenytoin, rifampicin, and St. John’s wort) should choose an alternate oral contraceptive due to the possibility of decreased contraceptive efficacy
Discontinue therapy if jaundice occurs
Not for administration for women with uncontrolled hypertension or hypertension with vascular disease
Monitor prediabetic and diabetic women receiving therapy
Consider an alternate contraceptive method for women with uncontrolled dyslipidemia
Evaluate uterine bleeding or amenorrhea
Thromboembolic disease may occur; stop therapy for at least 4 weeks before and through 2 weeks after major surgery; initiate therapy no sooner than 4 weeks after delivery, in women who are not breastfeeding
Safety and efficacy not established for BMI >30 kg/m²
Pregnancy and Lactation
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy
Small amounts of oral contraceptive steroids identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in postpartum period may interfere with lactation by decreasing quantity and quality of breast milk
Maximum Dosage
1 tablet/day PO. Maximum dosage is dependent on the phase within the 28-day cycle; estrogen and progestin dosages vary depending on the phase.
Safety and efficacy have not been established.
1 tablet/day PO. Maximum dosage is dependent on the phase within the 28-day cycle; estrogen and progestin dosages vary depending on the phase.
Safety and efficacy have not been established.
How supplied
Dienogest/estradiol valerate
tablet
- Contains 4 phases of doses for estrogen or combined estrogen/progestin throughout the 28-day cycle
- Days 1-2: estradiol valerate 3 mg
- Days 3-7: estradiol valerate 2 mg and dienogest 2 mg
- Days 8-24: estradiol valerate 2 mg and dienogest 3 mg
- Days 25-26: estradiol valerate 1 mg
- Days 27-28: inert tablets
