Retisert (fluocinolone acetonide)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Fluocinolone acetonide is a synthetic fluorinated corticosteroid.
Fluocinolone acetonide is a synthetic fluorinated corticosteroid. Corticosteroids inhibit the inflammatory response to mechanical, chemical, or immunologic agents. Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.
Although the precise mechanism of the ocular effects of corticosteroids is unknown, corticosteroids are thought to act by inducing phospholipase A2 inhibitory proteins (collectively referred to as lipocortins); these proteins are postulated to control the biosynthesis of potent inflammatory mediators (e.g., prostaglandins, leukotrienes) by inhibiting the release of their common precursor, arachidonic acid.
Fluocinolone acetonide is commercially available as a sterile intravitreal implant. The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice; the silicone elastomer cup assembly is attached to a polyvinyl alcohol suture tab with silicone adhesive. The implant is designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 mcg daily, decreasing over the first month to a steady state of 0.3-0.4 mcg daily over approximately 30 months.
Following insertion of the implant, plasma concentrations of fluocinolone acetonide at weeks 1, 4, and 34 were below the limit of detection (0.2 ng/mL). Concentrations of the drug in aqueous and vitreous humor appeared to be highly variable, ranging from below the limit of detection to 589 ng/mL throughout the 34-month observation period.
Generic name: fluocinolone acetonide
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Retisert
Indications
The following indications are listed for Retisert:
- Non-Infectious Uveitis Affecting The Posterior Segment Of Eye
Dosing
Dosage of fluocinolone acetonide is expressed in terms of the salt.
The usual dosage of fluocinolone acetonide in adults and pediatric patients 12 years of age and older is 0.59 mg (1 implant) in each affected eye approximately every 30 months. The implant is designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 mcg daily, which decreases over the first month to a steady state of 0.3-0.4 mcg daily for approximately 30 months. Following depletion of fluocinolone acetonide from the implant (as evidenced by recurrence of uveitis), the implant may be removed and replaced with a new implant to continue therapy.
Fluocinolone acetonide is administered as an implant that is inserted intravitreally (through a pars plana incision) into the posterior segment of the affected eye. Simultaneous implantation into both eyes should be avoided to minimize the risk of bilateral postoperative infection. (See Increased Susceptibility to Infection under Warnings/Precautions: Warnings, in Cautions.)
Fluocinolone acetonide implants should be handled with extreme caution and only by the suture tab to avoid damaging the implant; damage to the implant may result in an increased rate of drug release. Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab.
Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure to ensure the sterility of the surgical field and of fluocinolone acetonide implants. Fluocinolone acetonide implants should not be resterilized by any method.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
No formal drug interaction studies have been performed to date. However, because of limited systemic exposure, only intraocular interactions would be expected.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Most viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella (chickenpox)); mycobacterial infections of the eye; and fungal diseases of ocular structures.
Known or suspected hypersensitivity to fluocinolone acetonide, other corticosteroids, or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Adverse ocular effects reported in 50-90% of patients receiving fluocinolone acetonide implants include cataract, increased IOP, ocular pain, and surgical complications (e.g., cataract fragments in the eye; injury; mechanical complication, migration, or expulsion of implant; wound complications or dehiscence). Adverse ocular effects reported in 10-35% of patients include reduced visual acuity, conjunctival hemorrhage, conjunctival hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation, hypotony, pruritus, vitreous floaters, maculopathy, vitreous hemorrhage, ptosis, ocular inflammation, eyelid edema, increased tearing, and dry eye.
The most common adverse systemic effect reported in patients receiving fluocinolone acetonide implants was headache (31%).
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Safety and efficacy not established in children younger than 12 years of age.
Category C. (See Users Guide.)
Systemically administered corticosteroids are distributed into milk and may suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects. Not known whether ocular administration of fluocinolone acetonide could result in sufficient systemic absorption to produce detectable quantities in milk; caution if used in nursing women.
No substantial differences in safety and efficacy relative to younger adults.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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