Prescribing Information | For Patients For US Health Care Professionals Only
Home

Low-dose Vagifem® treats signs and symptoms of vaginal atrophy.

Vagifem® Applicator

Vagifem® 10 mcg was statistically superior to placebo in reducing the severity of a composite score of most bothersome symptoms of vaginal atrophy.1

Vagifem® (estradiol vaginal tablets) 10 mcg is the lowest dose of local vaginal estrogen commercially available.a

Getting patients started.

Getting patients started.

When a patient is ready to begin treatment with Vagifem® (estradiol vaginal tablets) 10 mcg, she may have questions about what to expect. Here's some info for your patients starting Vagifem®, including co-pays and patient assistance: all in one place.


Have the conversation.

Patients count on their health care professionals to help them through important but delicate conversations, including talks about their vaginal symptoms. Some women may even be embarrassed, and your opening the conversation could be a big help.

Support for your practice.

Download or order resources for patients and professionals. All the Vagifem® (estradiol vaginal tablets) 10 mcg tools you need are right here: samples, co-pay cards, and other information.

Have the conversation.

Patients count on their health care professionals to help them through important but delicate conversations, including talks about their vaginal symptoms. Some women may even be embarrassed, and your opening the conversation could be a big help.

Vagifem® at a glance.

Patients count on their health care professionals to help them through important but delicate conversations, including talks about their vaginal symptoms. Some women may even be embarrassed, and your opening the conversation could be a big help.

Getting patients started.

When a patient is ready to begin treatment with Vagifem® 10 mcg, she may have questions about what to expect. Here's some info for your patients starting Vagifem® 10 mcg, including help with co-pays and the Patient Assistance Program, all in one place.


Support for your practice.

Download or order resources for patients and professionals. All the Vagifem® 10 mcg tools you need right here: samples, Co-pay Cards, and other information.

a Based on a 12-week dosing schedule according to Vagifem® Prescribing Information.1

Important Safety Information

Show More

WARNING: CARDIOVASCULAR DISORDERS, ENDOMETRIAL CANCER, BREAST CANCER and PROBABLE DEMENTIA

Estrogen-Alone Therapy

Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding.

Cardiovascular Disorders and Probable Dementia
Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo.

The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg) alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens. 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.

Estrogen Plus Progestin Therapy

Cardiovascular Disorders and Probable Dementia
Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia.

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke and myocardial infarction in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo.

The WHIMS estrogen plus progestin ancillary study of the WHI, reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women.

Breast Cancer
The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA, and other combinations and dosage forms of estrogens and progestins.

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.

The use of Vagifem® is contraindicated in women who exhibit one or more of the following: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, pulmonary embolism or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Vagifem®; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilia disorders; or known or suspected pregnancy.

Vagifem® is intended only for vaginal administration. Systemic absorption occurs with the use of Vagifem®. The warnings, precautions, and adverse reactions associated with the use of systemic estrogen therapy should be taken into account.

The WHI estrogen plus progestin substudy reported a statistically non-significant increased risk of ovarian cancer.

Other warnings include: gallbladder disease, severe hypercalcemia, loss of vision, severe hypertriglyceridemia, cholestatic jaundice, and vaginal abrasion caused by the Vagifem® applicator. Women on thyroid replacement therapy should have their thyroid function monitored.

In a randomized, double-blind, parallel group, placebo-controlled study for Vagifem® 10 mcg, adverse events with an incidence of ≥5% included vulvovaginal mycotic infection, vulvovaginal pruritus, back pain and diarrhea.

Indications and Usage:

Vagifem® (estradiol vaginal tablets) is an estrogen indicated for the treatment of atrophic vaginitis due to menopause.

Please click here for Prescribing Information.

References

  1. Vagifem [package insert]. Princeton, NJ: Novo Nordisk FemCare AG; 2012.