Dosing and uses of Retisert, Iluvien (fluocinolone intravitreal implant)
Adult dosage forms and strengths
intravitreal insert
- 0.19mg/insert (Iluvien)
- 0.59mg/insert (Retisert)
Uveitis
Indicated for chronic, noninfectious uveitis of posterior segment of eye
Surgically implanted by ophthalmologist
Retisert: Releases 0.6 mcg/day initially; amount released decreases over 1st month to release 0.3-0.4 mcg/day over ~30 months
Replace when evidence of uveitis recurs
Diabetic Macular Edema
Indicated for diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure
Surgically implanted by ophthalmologist
Iluvien: Releases 0.2 mcg/day over ~36 months
Pediatric dosage forms and strengths
intravitreal insert
- 0.59mg/insert
Uveitis (Retisert)
<12 years: Safety and efficacy not established
≥12 years
- As adults; indicated for chronic, noninfectious uveitis of posterior segment of eye
- Surgically implanted by ophthalmologist
- Releases 0.6 mcg/day initially; amount released decreases over 1st month to release 0.3-0.4 mcg/day over approximately 30 months
- Replace when evidence of uveitis recurs
Retisert, Iluvien (fluocinolone intravitreal implant) adverse (side) effects
>10%
Procedural complications and eye pain (>50%)
IOP increased (>50%)
Fever (5-15%)
Pain (5-15%)
Ocular/conjunctival hyperemia, reduced visual acuity, conjunctival hemorrhage (>35%)
Headache (33%)
Rash (5-15%)
Athralgia, back pain, limb pain (5-15%)
Cough, upper respiratory infection, nasopharyngitis, influenza (5-15%)
Blepharitis, corneal edema, eye swelling, photophobia, photopsia, vitreous opacities, eye discharge, retinal hemorrhage (5-9%)
Warnings
Contraindications
Hypersensitivity to product or components
Active viral, bacterial, mycobacterial, and fungal ocular or periocular infection
Glaucoma with cup to disc ratios ≥0.8 (Iluvien)
Cautions
Nearly all phakic patients are expected to develop cataracts and require cataract surgery
Injury to optic nerve reported with prolonged use
Monitor for endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments
May increase IOP or glaucoma; IOP lowering medication required in >75% of patients and filtering surgeries in >35%
Treatment for lowering IOP may be required within 2 years postimplantation
Periodically monitor for integrity of implant
Risk for implant migration into anterior chamber if the posterior capsule of the lens is absent or has a tear
Risk of postoperative infections in both eyes may be reduced by unilateral implantation
May mask or exacerbate existing infection
Corticosteroids are not recommended with a history of ocular herpes simplex; potential for viral reactivation
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk
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 of Retisert, Iluvien (fluocinolone intravitreal implant)
Mechanism of action
Suppresses inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells
Corticosteroids are thought to act by inhibition of phospholipase A2 via induction of inhibitory proteins collectively called lipocortins; it is postulated that these proteins control biosynthesis of potent mediators of inflammation (eg, prostaglandins, leukotrienes) by inhibiting release of the common precursor, arachidonic acid