Dosing & Uses
Dosage Forms & Strengths
intravaginal insert
- 6.5mg
Dyspareunia
Indicated for moderate-to-severe dyspareunia caused by postmenopausal vulvar/vaginal atrophy
Administer 1 vaginal insert qDay at bedtime using applicator provided
Also see Administration
Safety and efficacy not established
Adverse Effects
Frequency Not Defined
Vaginal discharge
Abnormal Papanicolaou (Pap) smear
Warnings
Contraindications
Undiagnosed abnormal genital bleeding; evaluate and determine cause of bleeding before considering treating with intravaginal prasterone
History of breast cancer
Cautions
Estrogen is a metabolite of prasterone; use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer (see Contraindications)
Pregnancy & Lactation
Pregnancy
No data are available on use in pregnant women since it is indicated only in postmenopausal women
Lactation
Unknown if distributed in human breast milk
Indicated only in postmenopausal women; therefore, there is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Mechanism not fully established regarding use in vulvar/vaginal atrophy
Inactive endogenous steroid that is converted into active androgens and/or estrogens
Absorption
Peak plasma concentration (at Day 7)
- Prasterone: 4.42 ng/mL
- Testosterone: 0.15 ng/mL
- Estradiol: 5.04 ng/mL
AUC (at Day 7)
- Prasterone: 56.17 ng·h/mL
- Testosterone: 2.79 ng·h/mL
- Estradiol: 96.93 ng·h/mL
Metabolism
Human steroidogenic enzymes (eg, hydroxysteroid dehydrogenases, 5-alpha-reductases and aromatases) transform prasterone into androgens and estrogens
Administration
Intravaginal Administration
Administer 1 insert daily at bedtime intravaginally
Use applicator provided; each applicator is for one-time use only
Instruct patient to empty bladder and wash hands before handling the vaginal insert and applicator
Instruct patient to follow the steps (with pictures) provided in patient instructions on how to administer the vaginal insert
Storage
May be stored at room temperature or refrigerated; 41-86°F (5-30°C)
Images
Patient Handout
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
