Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Harrow Eye, LLC
OPHTHALMIC
PRESCRIPTION DRUG
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.
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.
New Drug Application
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 Lees het volledige document