ESTRADIOL
TRANSDERMAL SYSTEM

In November 2018, Noven launched ESTRADIOL TRANSDERMAL SYSTEM, the authorized generic to MINIVELLE® (estradiol transdermal system) in the US. This patch, developed and manufactured by Noven, is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of post-menopausal 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 Estradiol Transdermal System through Grove Pharmaceuticals, Noven’s authorized generic division.

Click here to find the authorized generic at a pharmacy near you.

For more information, please call 844-884-6796.

INDICATION

Estradiol Transdermal System is a prescription medicine patch that contains estradiol (an estrogen hormone). Estradiol Transdermal System 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 Estradiol Transdermal System 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 SAFEY INFORMATION:

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA

See full prescribing information for complete boxed warning. 

Estrogen-Alone Therapy

  • 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

Estradiol Transdermal System 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 Estradiol Transdermal System or any of its ingredients, or think you may be pregnant.

Before you take Estradiol Transdermal System, 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.

Estradiol Transdermal System 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 Estradiol Transdermal System.

The most common side effects that may occur with Estradiol Transdermal System 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 Estradiol Transdermal System. Please read the Patient Information section within the full Prescribing Information before taking Estradiol Transdermal System. 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.

For information call 1-800-455-8070. Please see our Privacy Policy for more information.

MINIVELLE® is a registered trademark of Noven Therapeutics, LLC.

For patient, physician and pharmacist inquiries regarding Estradiol Transdermal System, please contact: Tel: 844-884-6796.