Dosing & Uses
Dosage Forms & Strengths
intravitreal implant
- 0.7mg
Macular Edema
Treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion
1 implant (0.7 mg) inserted into affected eye by intravitreal injection
Diabetic Macular Edema
1 implant (0.7 mg) inserted into affected eye by intravitreal injection
Noninfectious Uveitis
Indicated for noninfectious uveitis affecting the posterior segment of the eye
Insert 1 intravitreal implant (0.7 mg) inserted into affected eye
Administration
For ophthalmic intravitreal injection only
Preservative free pouch with a single-use applicator
Procedure should be carried out under controlled aseptic conditions
Following the intravitreal injection, monitor patients for signs and symptoms of endophthalmitis, eye inflammation, increased IOP, and retinal detachments
Refer to manufacturer package instructions for proper administration
Safety and efficacy not established in pediatrics
Adverse Effects
>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 (implant misplacement)
Device dislocation with or without corneal edema
Endophthalmitis
Hypotony of the eye (associated with vitreous leakage due to injection)
Retinal detachment
Warnings
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 & Lactation
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.
Pharmacology
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
Images
Patient Handout
Formulary
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