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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Vagifem® (estradiol vaginal inserts) 10 mcg logo

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

Prescribing Information
Important Safety Information | Patient Site

The therapeutic goal should be to use the most appropriate, often lowest, effective dose of systemic estrogen therapy consistent with treatment goals.1

Dosing

Patients should take Vagifem® 10 mcg in a two-step dosing regimen.2

Patients should take Vagifem® 10 mcg in a two-step dosing regimen.2

  • Initial dose: one tablet inserted intravaginally once daily for two weeks
  • Continued dose: one tablet inserted intravaginally twice weekly—for example, Tuesday and Friday

Request Samples

Vagifem® Dosing Chart
Preloaded Vagifem® Applicator

Preloaded applicators2

Preloaded applicators2

The preloaded, single-use Vagifem® 10 mcg applicators come individually packaged in a blister pack and should be discarded after each use.2

The preloaded, single-use Vagifem® 10 mcg applicators come individually packaged in a blister pack and should be discarded after each use.2

Request product samples

Novo Nordisk provides access to complimentary prescription medicine samples to eligible practitioners for appropriate patients. You may place your order through the Novo Nordisk Sample Portal.

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Support for mobile devices is currently limited. Please use a desktop computer or tablet to place your orders. We apologize for the inconvenience.

(Requires a novoMEDLINKTM account)

(Requires a novoMEDLINKTM account)

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Samples are available for this producta

You must be a licensed practitioner who can legally prescribe medication in your state to request Novo Nordisk samples.

You may submit a request once a month.

aSamples for other therapeutic areas may also be available.

Vagifem® Package

Vagifem® 10 mcg

Order your samples with 3 easy steps

1.

2.

3.

Launch the Sample Portal

Launch the Novo Nordisk Sample Portal and if prompted, sign in with your novoMEDLINKTM account.

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Choose your medication samples

Choose your preferred samples and quantities, and then tap or click “Next.”

Sample Request Illustration

Confirm your order details

Confirm your preferences, provide a digital signature and tap or click “Next.”

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Selected Important Safety Information for Vagifem®

  • 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.

Indications and Usage

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

Important Safety Information

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.

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. A meta-analysis of 17 prospective and 35 retrospective epidemiology studies found that women who used hormonal therapy for menopausal symptoms had an increased risk for ovarian cancer. The exact duration of hormone therapy use associated with an increased risk of ovarian cancer, however, is unknown.
  • 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 Vagifem® Prescribing Information, including Boxed Warning.

References

  1. North American Menopause Society. The 2017 hormone therapy position statement of The North American Menopause Society. Menopause: The Journal of the North American Menopause Society. 2017;24(7):728-753.
  2. Vagifem [package insert]. Princeton, NJ Novo Nordisk FemCare AG; 2019.