dexamethasone intravitreal implant (Rx)

>10%

Increased IOP (25%)

Conjunctival hemorrhage (20%)

1-10%

Headache (3%)

Conjunctival hyperemia (7%)

Eye pain (7%)

Cataract (4%)

Ocular hypertension (4%)

Vitreous detachment (3%)

Postmarking Reports

Complication of device insertion resulting in ocular tissue injury including sclera, subconjunctiva, lens and retina (implant misplacement)

Device dislocation with or without corneal edema

Endophthalmitis

Hypotony of the eye (associated with vitreous leakage due to injection)

Retinal detachment

Contraindications

Hypersensitivity to any components of the product

Ocular or periocular infection

Patients with glaucoma, who have cup to disc ratios of greater than 0.8

Aphakic eyes with rupture of the posterior lens capsule

Eyes with ACIOL (Anterior Chamber Intraocular Lens) and torn and rupture posterior lens capsule

Cautions

Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased IOP, and retinal detachments; monitor patients following the injection

Use of corticosteroids may produce posterior subcapsular cataracts, increased IOP, and glaucoma, and may enhance the establishment of secondary ocular infections caused by bacteria, fungi, or viruses

Use cautiously in patients with a history of ocular herpes simplex; reactivation of viral infection possible; Not for use in presence of active ocular herpes simplex

May mask infections or enhance existing infections

Pregnancy Category: C

Pregnancy

There are no adequate and well-controlled studies in pregnant women; topical ocular administration of dexamethasone in mice and rabbits during period of organogenesis produced cleft palate and embryofetal death in mice, and malformations of abdominal wall/intestines and kidneys in rabbits at doses 5 and 4 times higher than recommended human ophthalmic dose (RHOD) (0.7 milligrams dexamethasone), respectively

Lactation

Systemically administered corticosteroids are present in human milk and can suppress growth and interfere with endogenous corticosteroid production or cause other unwanted effects; there is no information regarding presence of dexamethasone in human milk, effects on breastfed infants, or on milk production to inform risk of therapy to an infant during lactation; the developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for therapy and potential adverse effects on breastfed child

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Dexamethasone, a potent corticosteroid, suppresses inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Absorption

Negligible systemic absorption