ESTRADIOL VALERATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ESTRADIOL VALERATE (UNII: OKG364O896) (ESTRADIOL - UNII:4TI98Z838E)

Available from:

Hikma Pharmaceuticals USA Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Estradiol Valerate Injection, USP is indicated in the: - Treatment of moderate to severe vasomotor symptoms associated with the menopause. - Treatment of moderate to severe symptoms of vulvar and vaginal atrophy associated with the menopause. When prescribing solely for the treatment of symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered. - Treatment of hypoestrogenism due to hypogonadism, castration or primary ovarian failure. - Treatment of advanced androgen-dependent carcinoma of the prostate (for palliation only). Estradiol Valerate Injection 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.  Live

Product summary:

Estradiol Valerate Injection, USP Multiple Dose Vials Presentation Carton of NDC number 10 mg/mL (5 mL) 20 mg/mL (5 mL) 40 mg/mL (5 mL) 1 vial 0143-9289-01 0143-9290-01 0143-9291-01 Storage Store between 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature] Keep out of reach of children. Protect from light. Store vial in carton until used.     Manufactured by:   HIKMA FARMACÊUTICA (PORTUGAL) S.A.  Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem, SNT, Portugal     Distributed by:   Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: March 2022 PIN556-WES/3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESTRADIOL VALERATE- ESTRADIOL VALERATE INJECTION
HIKMA PHARMACEUTICALS USA INC.
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ESTRADIOL VALERATE INJECTION, USP
RX ONLY
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.)
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 pres