prasterone, intravaginal (Rx)

Brand and Other Names:Intrarosa, DHEA, intravaginal, more...dehydroepiandosterone, intravaginal
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Dosing & Uses

AdultPediatric

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

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Adverse Effects

Frequency Not Defined

Vaginal discharge

Abnormal Papanicolaou (Pap) smear

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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)

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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.

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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

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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)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.