What to Expect

Estradiol valerate injection, USP contains estradiol valerate, a long-acting estrogen in sterile oil solutions for intramuscular use. These solutions are clear, colorless to pale yellow.

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BOXED WARNING:

ESTROGENS INCREASE THE RISK OF ENDOMETRIAL CANCER

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).

CONTRAINDICATIONS:

Estradiol valerate injection, USP should not be used in women with any of the following conditions:

Undiagnosed abnormal genital bleeding.
Known, suspected, or history of cancer of the breast.
Known or suspected estrogen-dependent neoplasia.
Active deep vein thrombosis, pulmonary embolism or a history of these conditions.

Active or recent (e.g., within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction).
Liver dysfunction or disease.

Estradiol valerate injection, USP should not be used in patients with known hypersensitivity to its ingredients.
Known or suspected pregnancy. There is no indication for Estradiol valerate injection, USP 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.

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