Vagifem 10 ug/1
estradiol · INSERT · Novo Nordisk
Vagifem is a vaginal insert containing estradiol, an estrogen, used to treat vaginal symptoms of menopause such as dryness, burning, and discomfort. It works by releasing a small amount of estrogen directly into the vaginal tissue.
Key Facts
- Brand Name
- Vagifem
- Generic Name
- estradiol
- NDC Code (Product)
0169-5176- Manufacturer
- Novo Nordisk
- Strength
- 10 ug/1
- Dosage Form
- INSERT
- Route
- VAGINAL
- Marketing Status
- Application #
- NDA020908
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 01/11/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE • Vagifem is an estrogen indicated for the treatment of atrophic vaginitis due to menopause ( 1.1 ). 1.1 Treatment of Atrophic Vaginitis due to Menopause
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus does not need to use a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women with a history of endometriosis may need a progestogen [see Warnings and Precautions (5.3 , 5.15) ] . Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary. Administer Vagifem intravaginally: • 1 insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Tuesday and Friday) ( 2.1 ) 2.1 Treatment of Atrophic Vaginitis due to Menopause Administer Vagifem intravaginally using the supplied applicator: 1 insert daily for 2 weeks, followed by 1 insert twice weekly (for example, Tuesday and Friday).
Contraindications
4 CONTRAINDICATIONS Vagifem is contraindicated in women with any of the following conditions: • Undiagnosed abnormal genital bleeding [see Warnings and Precautions ( 5.3 )]. • Breast cancer or a history of breast cancer [see Warnings and Precautions ( 5.3 )]. • Estrogen-dependent neoplasia [see Warnings and Precautions ( 5.3 )]. • Active DVT, PE, or history of these conditions [see Warnings and Precautions ( 5.2 )]. • Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warnings and Precautions ( 5.2 )]. • Known anaphylactic reaction, or angioedema, or hypersensitivity to Vagifem [see Warnings and Precautions ( 5.16 )] . • Hepatic impairment or disease. • Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders. • Undiagnosed abnormal genital bleeding ( 4 , 5.3 ) • Breast cancer or a history of breast cancer ( 4 , 5.3 ) • Estrogen-dependent neoplasia ( 4 , 5.3 ) • Active DVT, PE, or history of these conditions ( 4 , 5.2 ) • Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions ( 4 , 5.2 ) • Known anaphylactic reaction, angioedema, or hypersensitivity t…
Drug Interactions
7 DRUG INTERACTIONS In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4, such as St. John’s wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine, and rifampin, may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and may result in adverse reactions. • Inducers and inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. ( 7 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.2)] • Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.3)] The most common adverse reactions (incidence ≥5 percent) with Vagifem are: back pain, vulvovaginal pruritus, vulvovaginal mycotic infection and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-888-824-4336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg inserts. Adverse reactions with an incidence of ≥5 percent in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1. Table 1: Treatment-E…
Frequently Asked Questions
What is Vagifem used for?
Vagifem is a vaginal insert containing estradiol, an estrogen, used to treat vaginal symptoms of menopause such as dryness, burning, and discomfort. It works by releasing a small amount of estrogen directly into the vaginal tissue.
Is Vagifem a controlled substance?
Vagifem is not classified as a controlled substance by the DEA.
What is the generic name for Vagifem?
The generic name for Vagifem is estradiol. There are 12 other brand versions of estradiol.
What is the NDC code for Vagifem 10 ug/1?
The NDC (National Drug Code) for Vagifem 10 ug/1 is 0169-5176, listed by Novo Nordisk.