Intrarosa

SEPTEMBER 05, 2017
Monica Holmberg, PharmD, BCPS
The FDA has approved intrarosa (prasterone; AMAG Pharmaceuticals, Inc) vaginal inserts to treat moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy (VVA), due to menopause.1 VVA may be caused by declining levels of estrogen in vaginal tissues during menopause, resulting in symptoms such as painful intercourse.2 About 64 million American women are postmenopausal, and about half experience VVA symptoms. Of those women, studies suggest that 44% to 78% experience dyspareunia.3

PHARMACOLOGY AND PHARMACOKINETICS
The active ingredient of Intrarosa, prasterone, is also known as dehydroepiandrosterone.3 It is an inactive endogenous steroid that is converted to active androgens and/or estrogens, which help to restore the vaginal tissue. The exact mechanism of action of Intrarosa has not been fully established.1,3 Treatment with Intrarosa does not result in clinically meaningful increases in serum plasma concentrations.3

DOSAGE AND ADMINISTRATION
One Intrarosa insert should be administered vaginally at bedtime. Each insert contains 6.5 mg of prasterone.1

CLINICAL TRIALS
The effectiveness of Intrarosa on moderate to severe dyspareunia due to menopause was evaluated in two 12-week, randomized, double-blind, placebocontrolled trials of healthy postmenopausal women who reported that painful intercourse was the most bothersome symptom of VVA. In trial 1, study participants aged 40 to 75 were randomized to receive one Intrarosa insert daily, an active comparator vaginal insert, or placebo. In trial 2, study participants aged 40 to 80 were randomized to receive either an Intrarosa insert daily or placebo. Both trials found that patients using Intrarosa demonstrated a significant reduction in the severity of pain during intercourse compared with the placebo.1,2,3

CONTRAINDICATIONS, WARNINGS, AND PRECAUTIONS
The use of Intrarosa is contraindicated in patients with undiagnosed abnormal genital bleeding. Any postmenopausal patient with undiagnosed, persistent, or recurring genital bleeding should be evaluated to establish the cause of bleeding before treatment with Intrarosa is considered.

Intrarosa has not been studied in patients with a history of breast cancer. Estrogen is a metabolite of prasterone, and the use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer.

Intrarosa is indicated for use in only postmenopausal women. It has not been studied in women who are pregnant or breast-feeding. The effect of renal or hepatic impairment on the pharmacokinetics of Intrarosa has not been studied.

The most common adverse reactions are vaginal discharge and abnormal Pap smear.1
Dr. Holmberg earned her PharmD from the University of Connecticut and completed an ambulatory care residency at the Phoenix VA Healthcare System. Her practice has also included pediatrics and inpatient mental health. She resides in Phoenix, Arizona.

References
1. Intrarosa [prescribing information]. Quebec City, Quebec; 2016. www.accessdata.fda.gov/drugsatfda_docs/label/2016/208470s000lbl.pdf. Accessed July 10, 2017.
2. FDA approves Intrarosa for postmenopausal women experiencing pain during sex [news release]:  November 17, 2016. www.fda.gov/newsevents/newsroom/pressannouncements/ucm529641.htm. Accessed July 10, 2017.
3. AMAG pharmaceuticals announces closing of exclusive licensing agreement with Endoceutics for US rights to Intrarosa (prasterone) [news release]. Waltham, MA: April 4, 2017. amagpharma.com/news/amag-pharmaceuticals-announces-closing-of-exclusive-licensing-agreement-with-endoceutics-for-u-s-rights-to-intrarosa-prasterone/. Accessed July 10, 2017.
 


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