Demonstrated safety profile

Safety was demonstrated in four 12-week placebo-controlled trials
and one 52-week open-label trial1

Adverse reactions with an incidence ≥2%

Abnormal Pap smear

Abnormal Pap smear Abnormal Pap smear
  • In the 52-week INTRAROSA clinical trial, 11 cases of abnormal Pap smear included 1 case of low-grade squamous intraepithelial lesion (LSIL) and 10 cases of atypical squamous cells of undetermined significance (ASCUS)
Pap Smear Result Pap Smear Result
No FDA boxed warning

No FDA boxed warning1

HPV=human papillomavirus.

Vaginal discharge

Vaginal discharge Vaginal discharge
*No placebo comparison in the 52-week trial.
No FDA boxed warning

No FDA boxed warning1

See More

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 AMAG Pharmaceuticals at 1­-877-411-2510 or FDA at 1-800­-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information.

References: 1. Intrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2018. 2. Data on File. ERC-230 Clinical Study Report. AMAG Pharmaceuticals. 2017.