Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B)
Millicent US, Inc.
VAGINAL
PRESCRIPTION DRUG
INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. 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. Risk Summary INTRAROSA is indicated only in postmenopausal women. There are no data with INTRAROSA use in pregnant women regarding any drug-associated risks. Animal reproduction studies have not been conducted with prasterone. Risk Summary INTRAROSA is indicated only in postmenopausal women. There is no information on the presence of prasterone in human milk, the effects on the breastfed infant, or the effects on milk production. Safety and effectiveness have not been established in pediatric patients. Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinic
INTRAROSA is supplied as white to off-white 1.3 mL solid fat bullet-shaped, smooth vaginal inserts (containing 6.5 mg of prasterone). INTRAROSA is available in small boxes of 4 blister packs containing 7 vaginal inserts (28 vaginal inserts per box). The small box (containing the vaginal inserts) is supplied inside a larger box containing 28 applicators (NDC 72495-401-28). Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.
New Drug Application
INTRAROSA- PRASTERONE INSERT MILLICENT US, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE INTRAROSA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR INTRAROSA . INTRAROSA (PRASTERONE) VAGINAL INSERTS INITIAL U.S. APPROVAL: 2016 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. ( 1) DOSAGE AND ADMINISTRATION One vaginal insert, once daily at bedtime. ( 2) DOSAGE FORMS AND STRENGTHS Vaginal Insert: 6.5 mg of prasterone. ( 3) CONTRAINDICATIONS Undiagnosed abnormal genital bleeding. ( 4) WARNINGS AND PRECAUTIONS Current or Past History of Breast Cancer. ( 5.1) 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. SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 11/2020 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.1 Current or Past History of Breast Cancer 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 8.2 Lactation 8.4 Pediatric Use 8.5 Geriatric Use 8.6 Renal Impairment 8.7 Hepatic Impairment 11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 12.3 Pharmacokinetics ® ® ® ® 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied 16.2 Storage and Handling 17 PATIENT COUNSELING INFORMAT Leggi il documento completo