Intrarosa and Her Body: Pharmacokinetics1

Post Day-7 Cmax

Cmax of prasterone, testosterone, and estradiol on Day 7 following daily administration of placebo or INTRAROSA (mean±SD)1*

Post Day-7 Cmax image
  • Mean prasterone Cmax after 7 days was significantly higher in women treated with INTRAROSA after 7 days vs those treated with placebo. The Cmax of testosterone and estradiol were slightly higher in women treated with INTRAROSA after 7 days vs those treated with placebo.
Post Day-7 Prasterone

Serum concentration of prasterone measured over a 24h period on Day 7 following once-daily bedtime administration of placebo or INTRAROSA1

Post Day-7 Prasterone
  • In 2 primary efficacy trials, daily administration of an INTRAROSA vaginal insert for 12 weeks increased mean serum Ctrough of prasterone and its metabolites testosterone and estradiol by 47%, 21%, and 19% from baseline, respectively. This comparison based on Ctrough may underestimate the magnitude of increase in prasterone and its metabolites’ exposure because it does not take into account the overall concentration-time profile following administration of INTRAROSA
Post Day-7 Testosterone

Serum concentration of testosterone measured over a 24h period on Day 7 following once-daily bedtime administration of placebo or INTRAROSA1

Post Day-7 Testosterone
  • In 2 primary efficacy trials, daily administration of an INTRAROSA vaginal insert for 12 weeks increased mean serum Ctrough of prasterone and its metabolites testosterone and estradiol by 47%, 21%, and 19% from baseline, respectively. This comparison based on Ctrough may underestimate the magnitude of increase in prasterone and its metabolites’ exposure because it does not take into account the overall concentration-time profile following administration of INTRAROSA
Post Day-7 Estradiol (E2)

Serum concentration of estradiol measured over a 24h period on Day 7 following once-daily bedtime administration of placebo or INTRAROSA1

Post Day-7 Estradiol E2
  • In 2 primary efficacy trials, daily administration of an INTRAROSA vaginal insert for 12 weeks increased mean serum Ctrough of prasterone and its metabolites testosterone and estradiol by 47%, 21%, and 19% from baseline, respectively. This comparison based on Ctrough may underestimate the magnitude of increase in prasterone and its metabolites’ exposure because it does not take into account the overall concentration-time profile following administration of INTRAROSA
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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.

Reference: 1. Intrarosa [package insert]. Waltham, MA: AMAG Pharmaceuticals, Inc.; 2018.