Prasterone
Generic Name: prasterone
Brand Names:
Intrarosa
11 DESCRIPTION INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19 H 28 O 2 with a molecular weight of 288.424 g/mol. Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS).
Overview
11 DESCRIPTION INTRAROSA (prasterone) vaginal insert is a vaginally administered steroid. Prasterone is identified chemically as 3β-hydroxyandrost-5-en-17-one. It has the empirical formula C 19 H 28 O 2 with a molecular weight of 288.424 g/mol. Prasterone is a white to off-white crystalline powder insoluble in water and soluble in sodium lauryl sulfate (SLS).
Uses
1 INDICATIONS AND USAGE INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION Administer one INTRAROSA vaginal insert once daily at bedtime, using the provided applicator. One vaginal insert, once daily at bedtime. ( 2 )
Side Effects
6 ADVERSE REACTIONS In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent U.S. Inc at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Warnings
5 WARNINGS AND PRECAUTIONS Current or Past History of Breast Cancer. ( 5.1 ) 5.1 Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer. 4 CONTRAINDICATIONS Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding. ( 4 )
Storage
16.2 Storage and Handling Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
Frequently Asked Questions
What is Prasterone used for?▼
1 INDICATIONS AND USAGE INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
What are the side effects of Prasterone?▼
6 ADVERSE REACTIONS In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. ( 6.1 ) In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent U.S. Inc at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
What are the important warnings for Prasterone?▼
5 WARNINGS AND PRECAUTIONS Current or Past History of Breast Cancer. ( 5.1 ) 5.1 Current or Past History of Breast Cancer Estrogen is a metabolite of prasterone. Use of exogenous estrogen is contraindicated in women with a known or suspected history of breast cancer. INTRAROSA has not been studied in women with a history of breast cancer. 4 CONTRAINDICATIONS Undiagnosed abnormal genital bleeding: Any postmenopausal woman with undiagnosed, persistent or recurring genital bleeding should be evaluated to determine the cause of the bleeding before consideration of treatment with INTRAROSA. Undiagnosed abnormal genital bleeding. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.