Medically reviewed by Drugs.com. Last updated on Jun 15, 2020.
(floo oh SIN oh lone)
- Fluocinolone Acetonide
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)
Brand Names: U.S.
- Corticosteroid, Ophthalmic
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.
Systemic absorption is negligible
Retisert: Aqueous and vitreous humor
Duration of Action
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
Use: Labeled Indications
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
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).
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.
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.
Refer to adult dosing.
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.
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. Do not resterilize.
Yutiq: Optimal placement is inferior to optic disc and posterior to the equator of the eye.
Store at 15°C to 25°C (59°F to 77°F). Retisert: Protect from freezing.
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. Monitor therapy
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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)
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.
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.
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.
What is this drug used for?
• It is used to treat eye swelling.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Blurred vision
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Vision changes
• Eye pain
• Severe eye irritation
• Eye redness
• Unable to pass urine
• Change in amount of urine passed
• Sensitivity to light
• Severe loss of strength and energy
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Frequently Asked Questions
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