Adult Dosing
Chronic noninfectious uveitis
- Surgical placement of 0.59 mg implanted into posterior segment of the affected eye
- Replace implant after drug depletion as evidenced by recurrence of uveitis
Note:
- Implant releases 0.6 mcg/day initially, followed by 0.3-0.4 mcg/day over 30 months
Pediatric Dosing
- Safety and effectiveness in pediatric patients <12 years have not been established
Chronic noninfectious uveitis
12-18 yrs
- Surgical placement 0.59 mg implanted into posterior segment of the affected eye
- Replace implant after drug depletion as evidenced by recurrence of uveitis
Note:
- Implant releases 0.6 mcg/day initially, followed by 0.3-0.4 mcg/day over 30 months
[Outline]
See Supplemental Patient Information
- Corticosteroid use may cause posterior subcapsular cataract formation. Almost all phakic eyes are expected to develop cataracts requiring surgery durins the 3-year post implantation period
- Late onset endophthalmitis has been seen with therapy. It is essential to ascertain tight closure of the scleral wound and integrity of the overlying conjunctiva at wound site
- Intravitreous implantation has been associated with post-operative complications including cataract formation, choroidal detachment, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence
- Prolonged corticosteroid therapy may cause elevated IOP and/or glaucoma with optic nerve damage, defects in visual acuity and fields of vision. Use cautiously in patients with glaucoma
- The strength of the adhesive bond between the silicone cup reservoir and the suture tab may reduce over time resulting in separation of components. Periodically monitor for the integrity of the implant
- Ocular corticosteroids may worsen or prolong viral eye infections. Use cautiously in patients with a history of herpes simplex
- Prolonged use of corticosteroids may increase the risk of secondary infections (bacterial, fungal, and viral) due to suppression of host response
- To prevent risk of bilateral post-operative infection, simultaneous bilateral implantation should not be performed
Cautions: Use cautiously in
- Glaucoma
- History of herpes simplex
Supplemental Patient Information
- Advise patients to undergo ophthalmologic follow-up examinations of both eyes at appropriate intervals after implantation
- Inform patients about immediate and temporary decrease in visual acuity in the implanted eye for 1-4 weeks following implantation
- Inform patients about the tendency to develop cataracts during 3 years post-implantation
Pregnancy Category:C
Breastfeeding: Fluocinolone has not been studied during breastfeeding; short-term application of topical corticosteroids (fluocinolone) is not expected to pose a risk to the breastfed infant by passage into breast milk. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 December 2013). It is unknown whether ocular administration of corticosteroids would cause adequate systemic absorption to be detected in human milk. Manufacturer advises caution.
