Version July 2025
Dosage guidance:
Clinical considerations: Generally reserved for patients who did not respond to nonhormonal therapies (ie, vaginal moisturizer, lubricant), prefer not to use vaginal estrogen, and have no contraindications to use (eg, selected patients with breast cancer) (Ref).
Genitourinary syndrome of menopause (vulvovaginal atrophy) (with dyspareunia), treatment (alternative agent): Intravaginal: One 6.5 mg insert once daily at bedtime.
Missed dose: Canadian labeling: If the next dose is due in ≥8 hours, administer the missed dose as soon as possible. If the next dose is due in <8 hours, skip the missed dose. Do not administer 2 doses at the same time.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: Intravaginal: No dosage adjustment necessary for any degree of kidney dysfunction (minimal systemic absorption (Ref)) (Ref).
Hemodialysis, intermittent (thrice weekly): Intravaginal: No supplemental dose or dosage adjustment necessary (minimal systemic absorption (Ref)) (Ref).
Peritoneal dialysis: Intravaginal: No dosage adjustment necessary (minimal systemic absorption (Ref)) (Ref).
CRRT: Intravaginal: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Intravaginal: No dosage adjustment necessary (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Genitourinary: Vaginal discharge (6% to 14%)
1% to 10%: Genitourinary: Abnormal pap smear (2%)
Undiagnosed abnormal genital bleeding.
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to prasterone or any component of the formulation.
Concerns related to adverse effects:
• Vaginal discharge: May occur with use.
Disease-related concerns:
• Breast cancer: Use caution in patients with a history of known or suspected breast cancer; estrogen is a metabolite of prasterone.
• Vaginal bleeding: Prior to treatment, evaluate and determine cause of any undiagnosed, persistent, or recurring genital bleeding.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Insert, Vaginal:
Intrarosa: 6.5 mg (28 ea)
No
INST (Intrarosa Vaginal)
6.5 mg (per each): $12.63
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Insert, Vaginal:
Intrarosa: 6.5 mg (28 ea)
Insert in vagina at bedtime using supplied applicator (for one time use only). Empty bladder and wash hands prior to insertion.
Genitourinary syndrome of menopause (vulvovaginal atrophy) with dyspareunia, treatment: Treatment of genitourinary syndrome of menopause (vulvovaginal atrophy) with dyspareunia.
None known.
There are no known significant interactions.
Other formulations of prasterone (dehydroepiandrosterone [DHEA]) have been evaluated to improve pregnancy outcomes in patients with diminished ovarian reserve (Gleicher 2011; Narkwichean 2013). This product is only approved for use in postmenopausal patients.
Animal reproduction studies have not been conducted with this preparation; this product is only approved for use in postmenopausal patients.
It is not known if prasterone is present in breast milk following vaginal administration.
Steroids, including prasterone, are endogenous to breast milk (Sahlberg 1986).
Evaluate any persistent or recurring genital bleeding.
An inactive steroid that is converted into active androgens and/or estrogens; the mechanism of action in postmenopausal patients with vulvar and vaginal atrophy is unknown.
Absorption: Intravaginal: Effects limited locally to the vagina without systemic effects (Labrie 2009; Martel 2016).
Metabolism: Metabolized locally via dehydrogenase, reductase, and aromatase to 2 active metabolites (estradiol and testosterone). Prasterone and the resulting estrogen and androgen metabolites formed in the vagina are then inactivated intracellularly prior to being released extracellularly as inactive metabolites (Labrie 2009; Martel 2016).
Excretion: Urine and feces (as inactive glucuronide and sulfate conjugates) (Labrie 2009; Martel 2016).
