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Black Box Warning
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete Boxed Warning.
* 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.
Overview
Estradiol valerate and estradiol valerate/dienogest is a Contraceptive, Estrogen, Hormonal Contraceptive that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include * Headaches, irregular uterine bleeding,headache (including migraines), breast tenderness, pain, menstrual disorders, nausea/ or vomiting,, acne, mood changes and increased weight..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Oral Contraception
Estradiol valerate is indicated for use by women to prevent pregnancy.
The efficacy of Estradiol valerate in women with a body mass index (BMI) of > 30 kg/m2 has not been evaluated.
Heavy Menstrual Bleeding
Estradiol valerate is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception.
How to Take Estradiol valerate
To achieve maximum contraceptive effectiveness Estradiol valerate must be taken exactly as directed. Take one tablet by mouth at the same time every day. Tablets must be taken in the order directed on the blister pack. Tablets should not be skipped or intake delayed by more than 12 hours. For patient instructions for missed pills, see FDA-Approved Patient Labeling.
How to Start Estradiol valerate
Instruct the patient to begin taking Estradiol valerate on Day 1 of her menstrual cycle (that is, the first day of her menstrual bleeding). See FDA-Approved Patient Labeling. Instruct the patient to use a non-hormonal contraceptive as back-up during the first 9 days.
For postpartum women who do not breastfeed or after a second trimester abortion, start Estradiol valerate no earlier than 4 weeks postpartum due to the increased risk of thromboembolism. If the patient starts on Estradiol valerate postpartum and has not yet had a period, evaluate for possible pregnancy, and instruct her to use an additional method of contraception until she has taken Estradiol valerate for 9 consecutive days. The possibility of ovulation and conception prior to initiation of medication should also be considered.
If the patient is switching from a combination hormonal method such as:
Another pill
Vaginal ring
Patch
Instruct her to take the first dark yellow pill on the first day of her withdrawal bleed. She should not continue taking the pills from her previous birth control pack. If she does not have a withdrawal bleed, rule out pregnancy before starting Estradiol valerate.
If she previously used a vaginal ring or transdermal patch, she should start using Estradiol valerate on the day the ring or patch is removed.
Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.
If the patient is switching from a progestin-only method such as a:
Progestin-only pill
Implant
Intrauterine system
Injection
Instruct her to take the first dark yellow pill on the day she would have taken her next progestin-only pill or on the day of removal of her implant or intrauterine system or on the day when she would have had her next injection.
Instruct the patient to use a non-hormonal back-up method such as a condom or spermicide for the first 9 days.
Do not prescribe Estradiol Valerate and Estradiol Valerate/Dienogest to women who are known to have the following:
A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
Smoke, if over age 35.
Have deep vein thrombosis or pulmonary embolism, now or in the past.
Have cerebrovascular disease.
Have coronary artery disease.
Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation).
Have inherited or acquired hypercoagulopathies.
Have uncontrolled hypertension.
Have diabetes mellitus with vascular disease.
Have headaches with focal neurological symptoms or have migraine headaches with or without aura if over age 35.
Undiagnosed abnormal uterine bleeding.
Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past.
Liver tumors, benign or malignant, or liver disease.
Pregnancy, because there is no reason to use COCs during pregnancy.
Warnings
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete Boxed Warning.
* 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.
Thromboembolic Disorders and Other Vascular Problems
Stop Estradiol Valerate and Estradiol Valerate/Dienogest if an arterial or venous thrombotic event (VTE) occurs.
The use of COCs increases the risk of venous thromboembolism. However, pregnancy increases the risk of venous thromboembolism as much or more than the use of COCs. The risk of VTE in women using COCs has been estimated to be 3 to 9 per 10,000 woman-years. The risk of VTE is highest during the first year of use. Data from a large, prospective cohort safety study of various COCs suggest that this increased risk, as compared to that in non-COC users, is greatest during the first 6 months of COC use. Data from this safety study indicate that the greatest risk of VTE is present after initially starting a COC or restarting (following a 4 week or greater pill-free interval) the same or a different COC.
Use of COCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.
The risk of thromboembolic disease due to oral contraceptives gradually disappears after COC use is discontinued.
If feasible, stop Estradiol Valerate and Estradiol Valerate/Dienogest at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism.
Start Estradiol Valerate and Estradiol Valerate/Dienogest no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
COCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes), although, in general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. COCs also increase the risk for stroke in women with other underlying risk factors.
Oral contraceptives must be used with caution in women with cardiovascular disease risk factors.
Stop Estradiol Valerate and Estradiol Valerate/Dienogest if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Estradiol valerate and estradiol valerate/dienogest in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Estradiol valerate and estradiol valerate/dienogest in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Estradiol valerate and estradiol valerate/dienogest in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Estradiol valerate and estradiol valerate/dienogest during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to specific gender populations.
Race
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Estradiol valerate and estradiol valerate/dienogest in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Estradiol valerate and estradiol valerate/dienogest in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Estradiol valerate and estradiol valerate/dienogest in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Estradiol valerate and estradiol valerate/dienogest in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Estradiol valerate and estradiol valerate/dienogest in the drug label.
Pharmacology
There is limited information regarding Estradiol valerate and estradiol valerate/dienogest Pharmacology in the drug label.
There is limited information regarding Patient Counseling Information of Estradiol valerate and estradiol valerate/dienogest in the drug label.
Precautions with Alcohol
Alcohol-Estradiol valerate and estradiol valerate/dienogest interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
