DIVIGEL .5 mg/.5g
estradiol · GEL · Vertical Pharmaceuticals, LLC
DIVIGEL is a gel containing estradiol at .5 mg/.5g, taken topical. Manufactured by Vertical Pharmaceuticals, LLC.
Key Facts
- Brand Name
- DIVIGEL
- Generic Name
- estradiol
- NDC Code (Product)
68025-066- Manufacturer
- Vertical Pharmaceuticals, LLC
- Strength
- .5 mg/.5g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA022038
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 10/27/2014
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 Divigel is an estrogen indicated for the treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ). 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Daily administration of 0.25 to 1.25 grams of Divigel to the right or left upper thigh on alternating days. Women should be started with the lowest effective dose and the dose should be evaluated periodically ( 2 ). 2.1 Important Use Information The timing of Divigel initiation can affect the overall benefit-risk profile. Consider initiating Divigel in women <60 years old or <10 years since menopause onset [see Warnings and Precautions ( 5 ), Use in Specific Populations ( 8.5 ) and Clinical Studies ( 14 )]. When estrogen is prescribed for a menopausal woman with a uterus, the addition of a progestogen has been shown to reduce the risk of endometrial cancer. There are possible risks associated with the use of progestogens plus estrogens that differ from those of estrogen-alone regimens. See prescribing information for progestogens indicated for the prevention of endometrial hyperplasia in non-hysterectomized menopausal women receiving estrogens [see Warnings and Precautions ( 5.2 , 5.3 )] . Generally, a woman without a uterus, does not need to use a progestogen with estrogen therapy. In some cases, however, hysterectomized women with a history of endometr…
Contraindications
4 CONTRAINDICATIONS Divigel is contraindicated in women with any of the following conditions: Abnormal genital bleeding of unknown etiology [see Warning and Precautions ( 5.2 )] Current or history of breast cancer [see Warning and Precautions ( 5.2 )] Estrogen-dependent neoplasia [see Warning and Precautions ( 5.2 )] Active DVT, PE, or history of these conditions [see Warning and Precautions ( 5.1 )] Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warning and Precautions ( 5.1 )] Known anaphylactic reaction, angioedema, or hypersensitivity to Divigel Hepatic impairment or disease [see Warnings and Precautions ( 5.9 )] Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Undiagnosed abnormal genital bleeding ( 4 ) Breast cancer or a history of breast cancer ( 4 , 5.2 ) Estrogen-dependent neoplasia ( 4 , 5.2 ) Active DVT, PE, or history of these conditions ( 4 , 5.1 ) Active arterial thromboembolic disease (e.g., stroke and MI), or history of these conditions ( 4 , 5.1 ) Known anaphylactic reaction, angioedema, or hypersensitivity to Divigel ( 4 ) Hepatic impairment or disease ( 4 , 5.9 ) Pr…
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 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 ( 5.1 )] . Malignant Neoplasms [see Boxed Warning, Warnings and Precautions ( 5.2 )] . The most common adverse reactions (incidence >5 percent and greater than placebo) in any Divigel treatment group are metrorrhagia, breast tenderness, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact VERTICAL PHARMACEUTICALS, LLC at 1-800-541-4802 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. Divigel was studied at doses of 0.25, 0.5 and 1.0 gram per day in a 12-week, double-blind, placebo-controlled study that included a total of 495 postmenopausal women (86.5 percent Caucasian). The adverse reactions that occurred at a rate greater than 5 percent and greate…
Frequently Asked Questions
What is DIVIGEL used for?
DIVIGEL contains estradiol. It is a gel taken topical. Consult your doctor for specific uses.
Is DIVIGEL a controlled substance?
DIVIGEL is not classified as a controlled substance by the DEA.
What is the generic name for DIVIGEL?
The generic name for DIVIGEL is estradiol. There are 12 other brand versions of estradiol.
What is the NDC code for DIVIGEL .5 mg/.5g?
The NDC (National Drug Code) for DIVIGEL .5 mg/.5g is 68025-066, listed by Vertical Pharmaceuticals, LLC.