Version May 2024
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.
Refer to adult dosing.
(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.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
Iluvien:
>10%:
Hematologic & oncologic: Anemia (11%)
Ophthalmic: Cataract (82%), conjunctival hemorrhage (13%), eye pain (15%), increased intraocular pressure (≥10 mm Hg: 34%; ≥30 mm Hg: 20%), vitreous opacity (21%)
1% to 10%:
Nervous system: Headache (9%)
Ophthalmic: Conjunctivitis (4%), corneal edema (4%), eye discharge (2%), eye discomfort (2%), eye irritation (8%), eye pruritus (3%), foreign body sensation of eye (3%), ocular hyperemia (3%), ophthalmic signs and symptoms (anterior chamber cell: 2%), optic atrophy (2%), photophobia (2%), retinal exudates (2%), secondary cataract (9%)
Renal: Renal failure syndrome (9%)
Respiratory: Pneumonia (7%)
Retisert:
>10%:
Dermatologic: Skin rash (5% to 20%)
Gastrointestinal: Nausea (5% to 20%), vomiting (5% to 20%)
Infection: Influenza (5% to 20%)
Nervous system: Dizziness (5% to 20%), headache (33%)
Neuromuscular & skeletal: Arthralgia (5% to 20%), back pain (5% to 20%), limb pain (5% to 20%)
Ophthalmic: Abnormal sensation in eyes (10% to 40%), blepharoptosis (10% to 40%), blurred vision (10% to 40%), cataract (50% to 90%), conjunctival hemorrhage (10% to 40%), conjunctival hyperemia (10% to 40%), decreased visual acuity (10% to 40%), dry eye syndrome (10% to 40%), eye irritation (10% to 40%), eye pain (50% to 90%), eye pruritus (10% to 40%), eyelid edema (10% to 40%), glaucoma (10% to 40%), hypotony of eye (10% to 40%), increased intraocular pressure (50% to 90%), lacrimation (10% to 40%), macular edema (10% to 40%), maculopathy (10% to 40%), ocular hyperemia (10% to 40%), visual disturbance (10% to 40%), vitreous opacity (10% to 40%), vitreous hemorrhage (10% to 40%)
Respiratory: Cough (5% to 20%), nasopharyngitis (5% to 20%), sinusitis (5% to 20%), upper respiratory tract infection (5% to 20%)
Miscellaneous: Fever (5% to 20%)
1% to 10%: Ophthalmic: Anterior chamber eye hemorrhage (5% to 9%), blepharitis (5% to 9%), choroidal detachment (5% to 9%), corneal edema (5% to 9%), diplopia (5% to 9%), eye discharge (5% to 9%), photophobia (5% to 9%), photopsia (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%)
Yutiq:
>10%: Ophthalmic: Cataract (56%), decreased visual acuity (15%), increased intraocular pressure (≥10 mm Hg: 22%; ≥30 mm Hg: 12%)
1% to 10%:
Cardiovascular: Hypertension (3%)
Neuromuscular & skeletal: Arthralgia (2%)
Ophthalmic: Conjunctival hemorrhage (8%), dry eye syndrome (4%), eye discomfort (2%), foreign body sensation of eye (3%), glaucoma (2%), hypotony of eye (7%), lacrimation (1%), secondary cataract (4%), visual field defect (1%), vitreous hemorrhage (2%)
Frequency not defined (any formulation): Ophthalmic: Endophthalmitis (including late onset), ophthalmic inflammation
Postmarketing (any formulation): Ophthalmic: Retinitis (viral) (Takakura 2014), sclera disease (including scleral melt and scleral thinning) (Georgalas 2014), viral corneal disease (cytomegalovirus endotheliitis) (Sims 2010) vitreous disorder (bands) (Georgalas 2014)
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.
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
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): $10,795.20
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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
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
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