VEVYE- cyclosporine ophthalmic solution solution/ drops

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

Доступно од:

Harrow Eye, LLC

Пут администрације:

OPHTHALMIC

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

VEVYE is indicated for the treatment of the signs and symptoms of dry eye disease. None. Risk Summary There are no adequate and well-controlled studies of VEVYE administration in pregnant women to inform a drug-associated risk. Oral administration of cyclosporine to pregnant rats or rabbits did not produce teratogenicity at clinically relevant doses. VEVYE doses are approximately 4,700 times lower than recommended oral doses, with blood concentrations being undetectable after topical administration. Data Animal Data Oral administration of cyclosporine oral solution to pregnant rats or rabbits was teratogenic at maternally toxic doses of 30 mg/kg/day in rats and 100 mg/kg/day in rabbits, as indicated by increased pre- and postnatal mortality, reduced fetal weight and skeletal retardations. These doses (normalized to body weight) were approximately 7,250 and 48,000 times higher than the daily maximum recommended human ophthalmic dose (MRHOD) of 0.67 mcg/kg/day, respectively. No adverse embryofetal effects were observed in rats or rabbits receiving cyclosporine during organogenesis at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively (approximately 4,100 and 14,500 times higher than the MRHOD, respectively). An oral dose of 45 mg/kg/day cyclosporine (approximately 10,900 times higher than MRHOD) administered to rats from Day 15 of pregnancy until Day 21 postpartum produced maternal toxicity and an increase in postnatal mortality in offspring. No adverse effects in mothers or offspring were observed at oral doses of up to 15 mg/kg/day (3600 times greater than MRHOD). Risk Summary Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. VEVYE doses are approximately 4,700 times lower than recommended oral doses of cyclosporine, with blood concentrations being undetectable after topical administration. However, caution should be exercised when VEVYE is administered to a nursing woman. Safety and effectiveness in pediatric patients below the age of 18 years have not been established. No overall difference in safety or effectiveness has been observed between elderly and younger patients.

Резиме производа:

VEVYE is a sterile, clear, colorless, non-aqueous, non-preserved ophthalmic solution packaged in multiple-dose eye drop bottles delivering single drops of approximately 0.01 mL volume. Each unit contains 2 mL of VEVYE in a 5 mL transparent squeezable polypropylene bottle with a transparent polyethylene tip and a white polyethylene cap with tamper-evident ring. Commercial NDC: 82667-900-02 Sample NDC: 82667-900-00 Storage and Handling Do not use if tamper-evident ring attached to the white cap is not intact. After first opening the tamper-evident ring of the cap remains on the bottle neck. Retain the cap and keep the bottle tightly closed when not in use. Store at 15°C to 25°C (59°F to 77°F). Do not freeze or refrigerate. After opening, VEVYE can be used until the expiration date on the bottle.

Статус ауторизације:

New Drug Application

Карактеристике производа

VEVYE- CYCLOSPORINE OPHTHALMIC SOLUTION SOLUTION/ DROPS
HARROW EYE, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VEVYE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VEVYE.
VEVYE (CYCLOSPORINE OPHTHALMIC SOLUTION) 0.1%, FOR TOPICAL OPHTHALMIC
USE
INITIAL U.S. APPROVAL: 1983
INDICATIONS AND USAGE
VEVYE (cyclosporine ophthalmic solution) 0.1% is a calcineurin
inhibitor immunosuppressant indicated for
the treatment of the signs and symptoms of dry eye disease. ( 1)
DOSAGE AND ADMINISTRATION
Instill one drop of VEVYE twice a day in each eye approximately 12
hours apart. ( 2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing cyclosporine 0.1%. ( 3)
CONTRAINDICATIONS
None. ( 4)
WARNINGS AND PRECAUTIONS
Care should be taken to not touch the eye or other surfaces with the
bottle tip to avoid potential for eye
injury and/or contamination. ( 5.1)
ADVERSE REACTIONS
The most common adverse reaction following the use of VEVYE were
instillation site reactions (8%). ( 6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CCONTACT HARROW EYE, LLC AT 833-4HARROW
OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
REVISED: 11/2023
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 Potential for Eye Injury and Contamination
5.2 Use with Contact Lenses
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
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
*
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
VEVYE is indicated for the treatment of the signs and symptoms of dry
eye disease.
2 DOSAGE AND ADMINISTRATION
Wash hands before using. Instill one drop of