Estradiol valerate
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding. There is no evidence that the use of “natural” estrogens results in a different endometrial risk profile than synthetic estrogens at equivalent estrogen doses [see WARNINGS , Malignant neoplasms , Endometrial cancer ]. CARDIOVASCULAR AND OTHER RISKS Estrogens and progestins should not be used for the prevention of cardiovascular disease [see WARNINGS , Cardiovascular disorders ].
The Women’s Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with oral conjugated estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo [see CLINICAL PHARMACOLOGY , Clinical Studies ].
The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. It is unknown whether this finding applies to younger postmenopausal women or to women taking estrogen alone therapy [see CLINICAL PHARMACOLOGY , Clinical Studies ].
Other doses of oral conjugated estrogens with medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DELESTROGEN (AN ESTROGEN HORMONE)? Estrogens increase the chances of getting cancer of the uterus.
Report any unusual vaginal bleeding right away while you are taking estrogens. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes. Using estrogens with or without progestins may increase your chances of getting…
Handling and access
NIOSH hazardous drug
Table 2NIOSH lists estradiol as a hazardous drug. AHFS class: 68:16.04 estrogens; 92:24 bone resorption inhibitors.
- Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Since the 40 mg potency provides a high concentration in a small volume, particular care should be observed to administer the full dose. DELESTROGEN should be visually inspected for particulate matter and color prior to administration; the solution is clear, colorless to yellow. Storage at low temperatures may result in the separation of some crystalline material which redissolves readily on warming.
Note: A dry needle and syringe should be used. Use of a wet needle or syringe may cause the solution to become cloudy; however, this does not affect the potency of the material. Patients should be started at the lowest dose for the indication. The lowest effective dose of DELESTROGEN has not been determined for any indication.
Drug interactions
Check estradiol valerate against a medication listLabel text (1 paragraph)
Drug Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's Wort preparations (Hypericum perforatum), phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in side effects.
Contraindications
CONTRAINDICATIONS DELESTROGEN should not be used in women with any of the following conditions: 1. Undiagnosed abnormal genital bleeding. 2. Known, suspected, or history of cancer of the breast. 3. Known or suspected estrogen-dependent neoplasia. 4. Active deep vein thrombosis, pulmonary embolism or a history of these conditions. 5. Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction). 6. Liver dysfunction or disease. 7. DELESTROGEN should not be used in patients with known hypersensitivity to its ingredients. 8. Known or suspected pregnancy. There is no indication for DELESTROGEN in pregnancy.
There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins from oral contraceptives inadvertently during early pregnancy [see PRECAUTIONS ].
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for estradiol valerate. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
F. Pregnancy DELESTROGEN should not be used during pregnancy [see CONTRAINDICATIONS ].
Lactation
G. Nursing Mothers Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving this drug. Caution should be exercised when DELESTROGEN is administered to a nursing woman.
Breastfeeding (LactMed)
Limited information on the use of estradiol during breastfeeding indicates that the route of administration and dosage form have influences on the amount transferred into breastmilk. Vaginal administration results in measurable amounts in milk, but transdermal patches do not. Maternal doses of up to 200 mcg daily transdermally do not increase estradiol or estriol in breastfed infants or cause any adverse effects in breastfed infants. Vaginal administration results in unpredictable peak times for estradiol in breastmilk, so timing of the dose with respect to breastfeeding is probably not useful. Milk estradiol levels have not been studied after use of the estradiol gel, but maternal blood levels only increase slightly in a dose-dependent manner. Estrogens can decrease the milk supply, especially if started before the milk supply is well established at about 6 weeks postpartum.
- Ethinyl Estradiol
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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