Prescribing Information | For Patients For US Health Care Professionals Only
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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 associated with atrophic vaginitis at Week 12.1

Vagifem® 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 information 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 information 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 are right here: samples, information about co-pay cards, and more.

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

Important Safety Information

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

  • 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.
  • Estrogens with or without progestins 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 estrogen plus progestin substudy also 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 combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo. The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer.
  • 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 alone, relative to placebo. The WHIMS estrogen plus progestin ancillary study also 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 combined with MPA, relative to placebo. It is unknown whether these findings apply to younger postmenopausal women.
  • In the absence of comparable data, these risks should be assumed to be similar for other doses of CE with or without MPA, and other combinations and dosage forms of estrogens with or without 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.

Indications and Usage

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

Contraindications

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.

Warnings and Precautions

  • 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.

Adverse Reactions

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.

Please click here for Prescribing Information.

Reference

  1. Vagifem [package insert]. Princeton, NJ: Novo Nordisk FemCare AG; 2014.