Coverage and coding

Indication

INTRAROSA is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Important Safety Information

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.