(estradiol transdermal system)
The World's Smallest Estrogen Therapy Patch
MINIVELLE® (estradiol transdermal system), the world’s smallest estrogen therapy patch developed and manufactured by Noven Pharmaceuticals, is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis. It is available in five dosage strengths (0.025, 0.0375, 0.05, 0.075 and 0.10 mg/day). The 0.025 strength is indicated only for the prevention of postmenopausal osteoporosis. Noven markets and sells MINIVELLE through the women’s health unit of its specialty pharmaceuticals subsidiary, Noven Therapeutics, LLC.
MINIVELLE is also available as an authorized generic. Click here to learn more.
MINIVELLE (estradiol transdermal system) is a prescription medicine patch that contains estradiol (an estrogen hormone). MINIVELLE is used to reduce moderate to severe hot flashes due to menopause and to help prevent postmenopausal osteoporosis (thin weak bones). The 0.025 mg/day dose is only approved for the prevention of postmenopausal osteoporosis.
If you use MINIVELLE only to prevent osteoporosis from menopause, talk with your healthcare provider about whether a different treatment or medicine without estrogens might be better for you.
IMPORTANT SAFETY INFORMATION:
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning.
- There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
- Estrogen-alone therapy 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)
- 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
Estrogen Plus Progestin Therapy
- Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
- The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI)
- The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
- The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older
MINIVELLE should not be used if you have unusual vaginal bleeding, currently have or have had certain cancers, had a stroke or heart attack, currently have or have had blood clots, currently have or have had liver problems, have been diagnosed with a bleeding disorder, are allergic to MINIVELLE or any of its ingredients, or think you may be pregnant.
Before you take MINIVELLE, tell your healthcare provider if you have unusual vaginal bleeding, have any other medical conditions, are going to have surgery or will be on bed rest, are breast feeding, and about all of the medicines you take.
MINIVELLE should be used at the lowest effective dose and for the shortest duration consistent with your treatment goals and risks. You and your healthcare professional should talk regularly about whether you still need treatment with MINIVELLE.
The most common side effects that may occur with MINIVELLE are headache, breast tenderness, back and limb pain, common cold, upset stomach, nausea, inflammation of the sinuses and irregular vaginal bleeding or spotting.
These are not all the possible effects of MINIVELLE. Please read the Patient Information section within the full Prescribing Information before taking MINIVELLE . For more information ask your healthcare provider or pharmacist for advice about side effects.
Click here for the full Prescribing Information, including Boxed WARNING.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
MINIVELLE® is a registered trademark of Noven Therapeutics, LLC.
For patient, physician and pharmacist inquiries regarding MINIVELLE, please call 800-455-8070.