INTRAROSA- prasterone insert

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Millicent US, Inc.

প্রশাসন রুট:

VAGINAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

INTRAROSA- PRASTERONE INSERT
MILLICENT US, 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 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
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®
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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