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Delestrogen®

(Estradiol Valerate injection, USP)

See:  Estradiol  Evista  Mircette  Activella  Alora   Climara Pro   CombiPatch  Esclim  Estraderm  Estring  Estrace Tablets   Evamist   Vagifem  Vivelle-Dot

All of these products are used to reduce symptoms of menopause, including feelings of warmth in the face, neck, and chest; the sudden intense episodes of heat and sweating known as "hot flashes"; dry, itchy external genitals; and vaginal irritation. They are also prescribed for other conditions that cause low levels of estrogen, and some doctors prescribe them for teenagers who fail to mature at the usual rate.

Along with diet, calcium supplements, and exercise, Alora, Estraderm, Climara, Vivelle, and Vivelle-Dot are prescribed to prevent osteoporosis, a condition in which the bones become brittle and easily broken.

Delestrogen® (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. Formulations (per mL): 10 mg estradiol valerate in a vehicle containing 5 mg chlorobutanol (chloral derivative/preservative) and sesame oil; 20 mg estradiol valerate in a vehicle containing 224 mg benzyl benzoate, 20 mg benzyl alcohol (preservative), and castor oil; 40 mg estradiol valerate in a vehicle containing 447 mg benzyl benzoate, 20 mg benzyl alcohol, and castor oil.

Estradiol valerate is designated chemically as estra-1,3,5(10)-triene-3, 17-diol(17b)-, 17-pentanoate.
 

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.

CARDIOVASCULAR AND OTHER RISKS

Estrogens with and without progestins should not be used for the prevention of cardiovascular disease.

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 during 5 years of treatment with conjugated equine estrogens (CE 0.625 mg) combined with medroxyprogesterone acetate (MPA 2.5 mg) relative to placebo (see CLININAL PHARMACOLOGY, Clinical Studies). Other doses of conjugated estrogens with medroxyprogesterone, and other combinations of estrogens and progestins were not studied in the WHI 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.