Diabetic macular edema: Ocular implant (Iluvien): Intravitreal injection: One implant (0.19 mg) injected in affected eye. Note: Implant is designed to release fluocinolone at an initial rate of 0.25 mcg daily lasting 36 months.
Uveitis (chronic):
Ocular implant (Retisert): Intravitreal injection: One silicone-encased tablet (0.59 mg) surgically implanted into the posterior segment of the affected eye. Note: Implant is designed to initially release 0.6 mcg/day, decreasing over 30 days to a steady-state release rate of 0.3 to 0.4 mcg daily for ~30 months. Recurrence of uveitis denotes depletion of tablet, requiring reimplantation.
Ocular implant (Yutiq): Intravitreal injection: One implant (0.18 mg) injected in affected eye. Note: Implant is designed to release fluocinolone at an initial rate of 0.25 mcg daily lasting 36 months.
There are no dosage adjustments provided in the manufacturer’s labeling.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Fluocinolone (ophthalmic): Pediatric drug information")
Uveitis, chronic: Children ≥12 years and Adolescents: Ocular implant (Retisert): Intravitreal injection: One silicone-encased tablet (0.59 mg) surgically implanted into the posterior segment of the affected eye. Note: Implant is designed to release 0.6 mcg/day, decreasing over 30 days to a steady-state release rate of 0.3 to 0.4 mcg daily for 30 months. Recurrence of uveitis denotes depletion of tablet, requiring reimplantation.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Intravitreal, as acetonide:
Iluvien: 0.19 mg (1 ea)
Retisert: 0.59 mg (1 ea)
Yutiq: 0.18 mg (1 ea)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Implant, Intravitreal, as acetonide:
Retisert: 0.59 mg (1 ea)
Ophthalmic implant (intravitreal injection): Administer under controlled aseptic conditions (eg, sterile gloves, sterile drape, sterile eyelid speculum). Administer adequate anesthesia and a broad-spectrum bactericidal to the periocular skin, eyelid, and ocular surfaces prior to injection. Refer to manufacturer’s prescribing information for administration technique.
Iluvien: Visually inspect preloaded applicator to ensure that it contains a drug implant. Optimal placement is inferior to optic disc and posterior to the equator of the eye
Retisert: Handle only by suture tab to avoid damaging the tablet integrity and adversely affecting release characteristics; avoid sheer forces on implant. Do not resterilize.
Yutiq: Optimal placement is inferior to optic disc and posterior to the equator of the eye.
Ophthalmic: Intravitreal injection: Administer under controlled aseptic conditions (eg, sterile gloves, sterile drape, sterile eyelid speculum). Administer adequate anesthesia and a broad-spectrum bactericidal to the periocular skin, eyelid, and ocular surfaces prior to injection. Refer to manufacturer's prescribing information for administration technique.
Retisert: Handle only by suture tab to avoid damaging the tablet integrity and adversely affecting release characteristics. Do not resterilize.
Diabetic macular edema (Iluvien): Treatment of 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.
Uveitis (Retisert, Yutiq): Treatment of chronic, noninfectious uveitis affecting the posterior segment of the eye
Fluocinolone may be confused with fluocinonide
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Central nervous system: Headache (9% to 33%), dizziness (5% to 20%)
Dermatologic: Skin rash (5% to 20%)
Gastrointestinal: Nausea (5% to 20%), vomiting (5% to 20%)
Hematologic & oncologic: Anemia (11%)
Infection: Influenza (5% to 20%)
Neuromuscular & skeletal: Back pain (5% to 20%), limb pain (5% to 20%), arthralgia (2% to 20%)
Ophthalmic: Cataract (50% to 90%), increased intraocular pressure (50% to 90%; ≥10 mm Hg: 22% to 34%; ≥30 mm Hg: 12% to 20%), eye pain (8% to 90%), abnormal sensation in eyes (10% to 40%), blepharoptosis (10% to 40%), blurred vision (10% to 40%), decreased visual acuity (immediate; duration 1 to 4 weeks; 10% to 40%), eyelid edema (10% to 40%), macular edema (10% to 40%), maculopathy (10% to 40%), visual disturbance (10% to 40%), conjunctival hemorrhage (8% to 40%), decreased intraocular pressure (ocular hypotony: 7% to 40%), dry eye syndrome (4% to 40%), eye pruritus (3% to 40%), vitreous opacity (3% to 40%), conjunctival hyperemia (2% to 40%), glaucoma (2% to 40%), vitreous hemorrhage (2% to 40%), eye irritation (1% to 40%), lacrimation (1% to 40%)
Respiratory: Cough (5% to 20%), nasopharyngitis (5% to 20%), sinusitis (5% to 20%), upper respiratory tract infection (5% to 20%)
Miscellaneous: Procedural complications (eg, cataract fragments, implant migration, wound complications; 50% to 90%), fever (5% to 20%)
1% to 10%
Cardiovascular: Hypertension (3%)
Central nervous system: Foreign body sensation of eye (3%)
Ophthalmic: Uveitis (10%), anterior chamber eye hemorrhage (5% to 9%), blepharitis (5% to 9%), choroidal detachment (5% to 9%), diplopia (5% to 9%), retinal detachment (5% to 9%), retinal hemorrhage (5% to 9%), swelling of eye (5% to 9%), synechiae of iris (5% to 9%), corneal edema (4% to 9%), posterior capsule opacification (4% to 9%), eye discharge (2% to 9%), photophobia (2% to 9%), photopsia (2% to 9%), anterior chamber inflammation (5%), conjunctivitis (4%), ocular hyperemia (3% to 4%), ophthalmic inflammation (3%), vitreous disorder (floaters: 3%), eye discomfort (2%), hypopyon (2%), optic atrophy (2%), retinal exudates (2%), retinopathy (macular fibrosis: 2%), chorioretinitis (1%), iridocyclitis (1%), visual field defect (1%,)
Renal: Renal failure (9%)
Respiratory: Pneumonia (7%)
Postmarketing and/or case reports: Endophthalmitis (late onset), secondary infection (bacterial, viral, or fungal)
Hypersensitivity to fluocinolone, other corticosteroids, or any component of the formulation; active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella; active bacterial, mycobacterial or fungal infections of the eye.
Iluvien only: Glaucoma (in patients who have cup to disc ratios of >0.8).
Concerns related to adverse effects:
• Cataract formation: Use of corticosteroids may result in posterior subcapsular cataract formation.
• Glaucoma: Use of corticosteroids (especially long-term use) may cause increased intraocular pressure and glaucoma. Use with caution in patients with glaucoma. Monitor IOP in all patients; within 3 years postimplantation, most patients will require IOP lowering medications and/or filtering procedures to control IOP.
• Immunosuppression: May enhance development of secondary bacterial, fungal, or viral infections. Not recommended in patients with a history of ocular herpes simplex (potential for reactivation). Use with caution in patients with a history of bacterial, mycobacterial, fungal, or viral infections or the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella. In acute purulent conditions, may mask infection. Fungal and viral infections are of particular concern. If corneal ulceration persists, consider fungal infection.
• Ocular effects: Intravitreal injections have been associated with endophthalmitis, eye inflammation, increased intraocular pressure and retinal detachment. Monitor carefully after intravitreal injection. Complications may also include cataract formation, choroidal detachment, hypotony, vitreous hemorrhage, vitreous loss, and wound dehiscence. Procedure may cause optic nerve injury. Visual defects in acuity and field of vision may occur (lasting 1 to 4 weeks postoperatively). Late-onset endophthalmitis has been observed, often associated with surgical site integrity.
• Ocular effects: Retisert: Perforation may occur with topical steroids in diseases which thin the cornea or sclera. Steroid use may delay healing after cataract surgery and increase bleb formation incidence.
Dosage form specific issues:
• Ocular implant: Iluvien, Yutiq: In patients in whom the posterior capsule of the lens is absent or has a tear, implant may migrate into the anterior chamber.
• Ocular implant: Retisert: Recommend unilateral implantation only to minimize risk of postoperative infections developing in both eyes. Due to the potential for separation of the silicone cup reservoir from the suture tab, implant integrity should be monitored during eye exams. Assure tight closure of scleral wound and integrity of overlying conjunctiva at the wound site.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Animal studies have not been conducted with this product; however, adverse events have been observed with corticosteroids in animal reproduction studies. Systemic absorption is below the limit of quantification following ocular administration.
Systemic corticosteroids are present in breast milk.
It is not known if sufficient quantities of fluocinolone are absorbed following ocular administration to produce detectable amounts in breast milk; however, systemic absorption is below the limit of quantification. The decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Iluvien, Yutiq: Following injection, monitor for increased intraocular pressure and endophthalmitis; check for perfusion of optic nerve head immediately after injection, tonometry within 30 minutes, and biomicroscopy between 2 to 7 days after injection.
Retisert: Periodically monitor integrity of implant by visual inspection; recurrence of uveitis (may indicate need for reimplantation); IOP.
Inhibit phospholipase A2 via lipocortin induction Lipocortins may control biosynthesis of prostaglandins and leukotrienes by inhibiting arachidonic acid. Arachidonic acid is released by membrane phospholipids by phospholipase A2.
Duration:
Iluvien, Yutiq: Releases fluocinolone acetonide at an initial rate of 0.25 mcg/day for 36 months
Retisert: Releases fluocinolone acetonide at an initial rate of 0.6 mcg/day, decreasing over 30 days to a steady-state release rate of 0.3 to 0.4 mcg/day for 30 months
Absorption: Systemic absorption is negligible
Distribution: Retisert: Aqueous and vitreous humor
Implant (Iluvien Intravitreal)
0.19 mg (per each): $10,560.00
Implant (Retisert Intravitreal)
0.59 mg (per each): $22,830.00
Implant (Yutiq Intravitreal)
0.18 mg (per each): $10,677.60
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