Minivelle .025 mg/d
estradiol · FILM, EXTENDED RELEASE · Noven Therapeutics, LLC
Minivelle is a prescription estrogen patch that delivers estradiol through the skin to treat menopausal symptoms such as hot flashes and vaginal dryness. The patch releases a steady dose of the hormone over time to help manage these symptoms.
Key Facts
- Brand Name
- Minivelle
- Generic Name
- estradiol
- NDC Code (Product)
68968-6625- Manufacturer
- Noven Therapeutics, LLC
- Strength
- .025 mg/d
- Dosage Form
- FILM, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Marketing Status
- Application #
- NDA203752
- Drug Class
- Estrogen [EPC]
- Marketing Start
- 12/20/2012
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE MINIVELLE is indicated for: MINIVELLE® is an estrogen indicated for: Treatment of moderate to severe vasomotor symptoms due to menopause ( 1.1 ) Prevention of postmenopausal osteoporosis ( 1.2 ) Limitations of Use When prescribing solely for the treatment of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis. 1.1 Treatment of Moderate to Severe Vasomotor Symptoms Due to Menopause 1.2 Prevention of Postmenopausal Osteoporosis Limitation of Use When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
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 who have a history of endometriosis may need a progestogen [see Warnings and Precautions ( 5.2 , 5.14 )] . 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. Start therapy with MINIVELLE® 0.0375 mg per day applied to the skin twice weekly for the treatment of moderate to severe vasomotor symptoms due to menopause. Dosage adjustment should be guided by the clinical response ( 2.1 ) Start therapy with MINIVELLE 0.025 mg per day applied to the skin twice weekly for the prevention of postmenopausal osteoporosis. The dose may be adjusted as necessary ( 2.2 ) Place MINIVELLE on a clean, dry area on the lowe…
Contraindications
4 CONTRAINDICATIONS MINIVELLE is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warnings and Precautions ( 5.2 )] . Breast cancer or a history of breast cancer [see Warnings and Precautions ( 5.2 )] . Estrogen-dependent neoplasia [see Warnings and Precautions ( 5.2 )] . Active DVT, PE, or a history of these conditions [see Warnings and Precautions ( 5.1 )] . Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [see Warnings and Precautions ( 5.1 )] . Known anaphylactic reaction, angioedema, or hypersensitivity to MINIVELLE Hepatic impairment or disease Protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders Undiagnosed abnormal genital bleeding ( 4 , 5.2 ) Breast cancer or a history of breast cancer ( 4 , 5.2 ) Estrogen-dependent neoplasia ( 4 , 5.2 ) Active DVT, PE, or a history of these conditions ( 4 , 5.1 ) Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions ( 4 , 5.1 ) Known anaphylactic reaction, angioedema, or hypersensitivity to MINIVELLE ( 4 ) Hepatic impairment or disease ( 4 , 5.10 ) P…
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/or 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 labeling: Cardiovascular Disorders [see Boxed Warning , Warning and Precaution, ( 5.1 )] Malignant Neoplasms [see Boxed Warning , Warnings and Precautions ( 5.2 )] The most common adverse reactions (greater than or equal to 5 percent) with MINIVELLE are: headache, breast tenderness, back pain, pain in limb, nasopharyngitis, dyspepsia, nausea, sinusitis, and intermenstrual bleeding. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Noven at 1-800-455-8070 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. There were no clinical trials conducted with MINIVELLE. MINIVELLE is bioequivalent to Vivelle ® . The following adverse reactions are reported with Vivelle therapy: Table 1: Summary of Most Frequently Reported Adverse Reactions (Vivelle versus Placebo) Regardless of Relationship Reported at a Frequency…
Frequently Asked Questions
What is Minivelle used for?
Minivelle is a prescription estrogen patch that delivers estradiol through the skin to treat menopausal symptoms such as hot flashes and vaginal dryness. The patch releases a steady dose of the hormone over time to help manage these symptoms.
Is Minivelle a controlled substance?
Minivelle is not classified as a controlled substance by the DEA.
What is the generic name for Minivelle?
The generic name for Minivelle is estradiol. There are 12 other brand versions of estradiol.
What is the NDC code for Minivelle .025 mg/d?
The NDC (National Drug Code) for Minivelle .025 mg/d is 68968-6625, listed by Noven Therapeutics, LLC.