Important Product Information for Patients

Elestrin™ is a prescription medicine that contains an estrogen hormone. Elestrin™ is used after menopause to reduce moderate-to-severe hot flashes.

Estrogens increase the chances of getting cancer of the uterus. Report any unusual vaginal bleeding right away while you are using Elestrin™. 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 estrogen with or without progestins to prevent heart disease, heart attacks or strokes. Using estrogens with or without progestins may increase your chances of getting heart attacks, strokes, breast cancer and blood clots.

Do not use estrogens with or without progestins to prevent dementia.

Using estrogens with or without progestins may increase your risk of dementia, based on a study of women 65 years or older.

Do not use Elestrin™ if you have unusual vaginal bleeding; have or had cancer; had a stroke or heart attack within the past year; have or had blood clots; have or had liver problems; are allergic to any of the ingredients in Elestrin™ (see Patient Information Sheet) or if you may be pregnant or plan to become pregnant.

Tell your healthcare provider if you are breastfeeding; about all of your medical problems; about all prescription and non-prescription medicines, vitamins and supplements that you take; or if you are going to have surgery or will be on bed rest.

Possible side effects of estrogens, although less common, but serious include: breast cancer, cancer of the uterus, stroke, heart attack, blood clots, dementia, gallbladder disease and ovarian cancer.

Some of the warning signs of serious side effects include: breast lumps; unusual vaginal bleeding; dizziness and faintness; changes in speech; severe headaches; chest pain; shortness of breath; pains in your legs; changes in vision; or vomiting. Notify your healthcare provider right away if you get any of these warning signs or any other unusual symptom that concerns you.

The most common side effects that have been reported for estrogens include headache; breast pain; irregular vaginal bleeding or spotting; stomach/abdominal cramps, bloating; nausea and vomiting; or hair loss. These are not all the possible side effects of Elestrin™. For more information, ask your healthcare provider.

Elestrin™ should be used at the lowest dose possible for your treatment and only as long as needed.

It is important that you speak to your healthcare provider regularly about whether you still need treatment with Elestrin™ and about any questions or concerns that you have about Elestrin™.

Please see Package Insert for full Prescribing Information and Patient Information Sheet for additional information.

 

Important Product Information for Healthcare Professionals

Elestrin™ is indicated for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.

Close clinical surveillance of all women taking estrogens is important. Adequate diagnostic measures should be undertaken to rule out malignancy in cases of undiagnosed persistent or recurring abnormal vaginal bleeding.

Long-term continuous administration of estrogen, with or without progestin, has shown an increased risk of endometrial, breast and ovarian cancers.

Estrogens with or without progestins should not be used for the prevention of cardiovascular disease or dementia. An increased risk of developing probable dementia in postmenopausal women 65 years of age or older was reported with estrogen-alone use, as well as, in combination with progestin.

Estrogen-alone therapy has been associated with an increased risk of stroke and deep vein thrombosis. Estrogen plus progestin therapy has been associated with an increased risk of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis. Estrogens should be discontinued immediately if any of these events occur or are suspected.

Estrogen with or without progestin should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the patient.

An increase in gallbladder disease requiring surgery in postmenopausal women receiving estrogens has been reported. Estrogen therapy may lead to severe hypercalcemia in patients with breast cancer and bone metastases. Retinal vascular thrombosis has been reported in patients receiving estrogens.

Estrogen products should not be used in women with undiagnosed abnormal genital bleeding; known, suspected or history of breast cancer; known or suspected estrogen-dependent neoplasia; active or history of deep vein thrombosis or pulmonary embolism; active or recent (within the past year) arterial thromboembolic disease (e.g., stroke, myocardial infarction); liver dysfunction or disease; known or suspected pregnancy.

Blood pressure should be monitored during estrogen use. Caution should be exercised in patients with hypertriglyceridemia, impaired liver function or a history of cholestatic jaundice, conditions that might be influenced by fluid retention, hypocalcemia, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Patients dependent on thyroid hormone replacement therapy may require increased doses of such therapy. The addition of progestin should be considered in patients with residual endometriosis post-hysterectomy. Concomitant application of sunscreen and Elestrin™ to the same site for more than 7 days should be avoided.

The most frequently reported adverse events in clinical trials were nasopharyngitis, breast tenderness, upper respiratory tract infection, and metrorrhagia.

Please see Package Insert for full Prescribing Information.