COMBIPATCH® (estradiol/norethindrone acetate transdermal system)
First US Combination Patch
COMBIPATCH® (estradiol/norethindrone acetate transdermal system), developed and manufactured by Noven Pharmaceuticals, was the first combination (two-drug) patch approved in the US. COMBIPATCH is a combination transdermal hormone therapy patch containing both estrogen and progestin designed specifically for postmenopausal women who still have their uterus to treat symptoms of moderate to severe hot flashes, and vaginal dryness associated with menopause. It is available in two dosage options (0.05/0.25 mg/day and 0.05/0.14 mg/day). Noven markets and sells COMBIPATCH through the Women’s Health unit of its specialty pharmaceuticals subsidiary, Noven Therapeutics, LLC.
For more information, please visit www.combipatch.com
Note: All commercially available COMBIPATCH stored at room temperature, as previous storage recommendations stated, are still safe and effective for use and can continue to be used by patients.
COMBIPATCH (estradiol/norethindrone acetate transdermal system) is a prescription medicine used to treat moderate to severe hot flashes associated with menopause; treat moderate to severe dryness, itching and burning in or around the vagina associated with menopause; and treat certain conditions in which a young woman’s ovaries do not produce enough estrogens naturally. If you use COMBIPATCH only to treat your dryness, itching and burning in or around the vagina, talk with your healthcare professional about whether a topical vaginal product would 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.
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
- 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
Do not use COMBIPATCH if you have had your uterus removed (hysterectomy). COMBIPATCH should not be used if you have unusual vaginal bleeding; currently have or have had certain cancers, blood clots, or liver problems; had a stroke or heart attack; have been diagnosed with a bleeding disorder; are allergic to COMBIPATCH or any of its ingredients; or think you may be, or know that you are, pregnant.
Before you take COMBIPATCH, 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.
You and your healthcare professional should talk regularly about whether you still need treatment with COMBIPATCH and whether you are taking the lowest dose that works for you.
The most common side effects that may occur with COMBIPATCH are breast pain, vaginal bleeding, and headache. These are not all the possible side effects of COMBIPATCH.
Click here for the Full Prescribing Information, including Boxed WARNING for COMBIPATCH.
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.
COMBIPATCH® is a registered trademark of Noven Pharmaceuticals, Inc.
For patient, physician and pharmacist inquiries regarding COMBIPATCH, please call 800-455-8070