Fluocinolone Acetonide eent

Synthetic fluorinated corticosteroid.1

Administration

Ophthalmic Administration

Surgically implant intravitreally through a pars plana incision into posterior segment of eye.1

Maintain aseptic technique prior to and during the procedure to ensure sterility of the surgical field and implants.1 Do not resterilize implants by any method.1

Handle implants only by the suture tab to avoid damaging the implant; damage may increase rate of drug release.1

Avoid simultaneous implantation into both eyes in order to minimize risk of bilateral postoperative infections.1

Following depletion of fluocinolone acetonide from the implant, may remove the implant and replace with a new one to continue therapy.1

During implantation and explantation, avoid applying sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.1

Dosage

Available as fluocinolone acetonide; dosage expressed in terms of the salt.1

Pediatric Patients

Children ≥12 years of age: 0.59 mg (1 implant) in affected eye(s) approximately every 30 months.1 3

Adults

0.59 mg (1 implant) in affected eye(s) approximately every 30 months.1 3

Contraindications

• Viral diseases of the cornea and conjunctiva (e.g., epithelial herpes simplex keratitis [dendritic keratitis], vaccinia, varicella).1

• Mycobacterial infection of the eye.1

• Fungal diseases of ocular structures.1

• Known or suspected hypersensitivity to fluocinolone acetonide, other corticosteroids, or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Potential complications accompanying insertion of the implant may include cataract formation, choroidal or retinal detachment, temporary decrease in visual acuity, endophthalmitis, hypotony, increased intraocular pressure (IOP), exacerbation of intraocular inflammation, vitreous hemorrhage, vitreous loss, and wound dehiscence.1

Immediate and temporary decrease in visual acuity in the implanted eye will occur in most patients and may persist for 1–4 weeks after implantation.1

Risk of glaucoma with prolonged use of corticosteroids; monitor periodically for elevated IOP (e.g., every 3–6 months, more frequently in immediate postimplantation period).1 3 Use with caution in the presence of glaucoma.1

Approximately 60% of patients expected to require drug therapy to reduce IOP within 34 weeks after implantation.1 Within 2 years of implantation, 32% of patients expected to require filtering procedures for IOP control.1

Risk of prolongation or exacerbation of ocular viral infections (e.g., herpes simplex) with ophthalmic corticosteroids.1 Use with extreme caution in patients with history of herpes simplex.1

Risk of secondary ocular infection (bacterial, fungal, or viral) with prolonged use of corticosteroids.1 Consider possibility of fungal infection if persistent corneal ulceration occurs.1

In acute purulent conditions, corticosteroids may mask or enhance existing infections.1

Use of ophthalmic corticosteroids after cataract surgery may delay healing and increase bleb formation.1

General Precautions

Exercise caution in order to maintain sterility of and avoid damage to the implant.1 (See Administration under Dosage and Administration.)

Specific Populations

Category C.1

Caution if used in nursing women.1 Not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.1

Systemically administered corticosteroids appear in milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects.

Safety and efficacy not established in children <12 years of age.1

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Cataracts, increased IOP, ocular pain, and surgical complications (e.g., cataract fragments in the eye, injury, mechanical complications, migration or expulsion of implant; wound complications or wound dehiscence) reported in 50–90% of patients.1

Reduced visual acuity, conjunctival hemorrhage or hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation or inflammation, hypotony, pruritus, vitreous floaters or hemorrhage, ptosis, maculopathy, eyelid edema, increased tearing, and dry eye reported in 10–35% of patients.1

Headache was most frequent systemic effect.1

No formal drug interaction studies have been performed to date.3 However, because of limited systemic exposure, only intraocular interactions would be expected.3

• Importance of informing patients that fluocinolone acetonide treats ocular inflammation only and does not treat underlying disease.1

• Importance of advising patients to return to clinician’s office for follow-up ophthalmologic examinations of both eyes at appropriate intervals following insertion of the implant.1

• Importance of explaining risks of surgical complications, adverse ocular effects, and ocular infections.1

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses, especially glaucoma or existing bacterial, viral, or fungal infections of the eye.1

• Importance of informing patients of other important precautionary information.1 (See Cautions.)