INTRAROSA- prasterone insert

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

PRASTERONE (UNII: 459AG36T1B) (PRASTERONE - UNII:459AG36T1B)

थमां उपलब्ध:

AMAG Pharmaceuticals, Inc.

INN (इंटरनेशनल नाम):

PRASTERONE

रचना:

PRASTERONE 6.5 mg

प्रशासन का मार्ग:

VAGINAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 clinical t

उत्पाद समीक्षा:

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 64011-601-28). Store at 41°F to 86°F (5°C to 30°C). Can be stored at room temperature or in the refrigerator.

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

INTRAROSA- PRASTERONE INSERT
AMAG PHARMACEUTICALS, INC.
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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 AMAG PHARMACEUTICALS AT
1-877-411-2510 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 2/2018
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 INFOR