uity and field defects, posterior subcapsular cataract formation; delayed wound healing; secondary ocular infection frompathogens including herpes simplex, and perforation of the globe where there is thinning of the cornea or sclera [see Warnings and
Precautions (5)].
DEXTENZA was studied in three randomized, vehicle-controlled studies (n = 351) The mean age of the population was 68 years(range 43 to 87 years), 62% were female, and 85% were white. Forty-six percent had brown iris color and 31% had blue iris color. Themost common ocular adverse reactions that occurred in patients treated with DEXTENZA were: anterior chamber inflammationincluding iritis and iridocyclitis (9%); intraocular pressure increased (5%); visual acuity reduced (2%); eye pain (1%); cystoid macularedema (1%); corneal edema (1%); and conjunctival hyperemia (1%). The most commonly reported adverse reactions that occurred in
1-6% of patients treated with DEXTENZA were increases in intraocular pressure, anterior chamber inflammation, iritis, visual acuityreduced, corneal edema, cystoid macular edema, eye pain, and conjunctival hyperemia.
The most common non-ocular adverse reaction that occurred in patients treated with DEXTENZA was headache (1%).
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate or well-controlled studies with DEXTENZA in pregnant women to inform a drug-associated risk for majorbirth defects and miscarriage. In animal reproduction studies, administration of topical ocular dexamethasone to pregnant mice andrabbits during organogenesis produced embryofetal lethality, cleft palate and multiple visceral malformations [see Animal Data].
Data
Animal Data
Topical ocular administration of 0.15% dexamethasone (0.75 mg/kg/day) on gestational days 10 to 13 produced embryofetal lethalityand a high incidence of cleft palate in a mouse study. A daily dose of 0.75 mg/kg/day in the mouse is approximately 5 times the entiredose of dexamethasone in the DEXTENZA product, on a mg/m2 basis. In a rabbit study, topical ocular administration of0.1% dexamethasone throughout organogenesis (0.36 mg /day, on gestational day 6 followed by 0.24 mg/day on gestational days 7-18) produced intestinal anomalies, intestinal aplasia, gastroschisis and hypoplastic kidneys. A daily dose of 0.24 mg/day isapproximately 6 times the entire dose of dexamethasone in the DEXTENZA product, on a mg/m2 basis.
8.2 Lactation
Systemically administered corticosteroids appear in human milk and could suppress growth and interfere with endogenouscorticosteroid production; however the systemic concentration of dexamethasone following administration of DEXTENZA is low [seeClinical Pharmacology (12.3)]. There is no information regarding the presence of DEXTENZA in human milk, the effects of the drugon the breastfed infant or the effects of the drug on milk production to inform risk of DEXTENZA to an infant during lactation. Thedevelopmental and health benefits of breastfeeding should be considered along with the mother's clinical need for DEXTENZA andany potential adverse effects on the breastfed child from DEXTENZA.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
11 DESCRIPTION
DEXTENZA (dexamethasone ophthalmic insert) is a fluorescent yellow, 3 mm cylindrica |
