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Prasterone

Pronunciation

(PRAS ter one)

Index Terms

  • Intrarosa

Pharmacologic Category

  • Steroid, Synthetic

Pharmacology

An inactive steroid that is converted into active androgens and/or estrogens; the mechanism of action in postmenopausal women with vulvar and vaginal atrophy is unknown.

Metabolism

Metabolized via dehydrogenase, reductase, and aromatase to 2 active metabolites (estradiol and testosterone)

Use: Labeled Indications

Dyspareunia: Treatment of moderate to severe dyspareunia (a symptom of vulvar and vaginal atrophy due to menopause)

Contraindications

Undiagnosed abnormal genital bleeding

Dosing: Adult

Dyspareunia: Females: Intravaginal: 6.5 mg once daily at bedtime

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Administration

Insert in vagina at bedtime using supplied applicator (for one time use only). Empty bladder and wash hands prior to insertion.

Storage

Store at 5°C to 30°C (41°F to 86°F).

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%: Genitourinary: Vaginal discharge (6% to 14%)

1% to 10%: Genitourinary: Abnormal pap smear (2%)

Warnings/Precautions

Concerns related to adverse effects:

• Vaginal discharge: May occur with use.

Disease-related concerns:

• Breast cancer: Use caution in women 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 postmenopausal woman with undiagnosed, persistent, or recurring genital bleeding.

Pregnancy Considerations

Animal reproduction studies have not been conducted with this preparation; this product is only approved for use in postmenopausal women.

Other formulations of prasterone (dehydroepiandrosterone [DHEA]) have been evaluated to improve pregnancy outcomes in women with diminished ovarian reserve (Gleicher 2011; Narkwichean 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience vaginal discharge (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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