|Categories of California Personal Information Collected||Disclosed for business purposes to the following categories of third parties:|
|Personal and online identifiers (such as first and last name, email address, or unique online identifiers)||All categories listed below.|
|Categories of information described in Section 1798.80(e) of the California Civil Code (such as physical characteristics or description, insurance policy number, bank account number, credit card number, debit card number, or any other financial information, medical information, or health insurance information)||All categories listed below.|
|Characteristics of protected classifications under California or federal law (such as race or gender)||All categories listed below.|
|Commercial or transactions information (such as records of personal property or products or services purchased, obtained or considered)||All categories listed below.|
|Internet or other electronic network activity information (such as browsing history, search history, interactions with a website, email, application, or advertisement)||All categories listed below.|
|Biometric information (such as call recordings)||All categories listed below.|
|Geolocation information||All categories listed below.|
INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
INTRAROSA is contraindicated in women with undiagnosed abnormal genital bleeding.
Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥2 percent were vaginal discharge and abnormal Pap smear.
To report SUSPECTED ADVERSE REACTIONS, contact Millicent Pharma at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information.