Fluocinolone Other names: Fluocinolone acetonide

Use of intravitreal corticosteroids may cause cataracts, increased intraocular pressure, glaucoma and may increase the risk of secondary infections.

Phase 3 Diabetic Macular Oedema (FAME) Studies

80% of phakic subjects treated with fluocinolone acetonide underwent cataract surgery. Phakic patients should be closely monitored for signs of cataract after treatment.

38% of patients treated with fluocinolone acetonide required treatment with IOP-lowering medication. Fluocinolone acetonide should be used with caution in patients with high baseline IOP, and IOP must be monitored closely. In the event of IOP increases that do not respond to IOP-lowering medications or IOP-lowering procedures, the fluocinolone implant can be removed by vitrectomy.

There were 24% of subjects in the sham treated group who were treated at any time with either anti-coagulant or anti-platelet medications as compared to 27% in the fluocinolone treated subjects. Subjects treated with fluocinolone concomitantly or within 30 days of cessation of treatment with anti-coagulant or anti-platelet medications experienced a slightly higher incidence of conjunctival haemorrhage versus the sham treated subjects (0.5% sham and 2.7% fluocinolone treated). The only other event reported at a higher incidence rate in the fluocinolone treated subjects was eye operation complication (0% sham and 0.3% fluocinolone treated).

There is limited experience of the effect of fluocinolone acetonide in eyes following vitrectomy. It is likely that drug clearance would be accelerated after vitrectomy, though steady state concentrations are not expected to be affected. This may shorten the duration of action of the implant.

Phase 3 Uveitis Studies

In the uveitis studies, patients treated with fluocinolone acetonide intravitreal implant underwent cataract surgery. Phakic patients should be closely monitored for signs of cataract after treatment.

Additionally, some patients developed elevated intraocular pressure requiring treatment with IOP lowering medication.

Patients in studies treated with fluocinolone acetonide developed hypotony, which started within days of treatment, with many on Day 1 and mostly resolving within 1 week of onset. Patient monitoring of increased or decreased IOP immediately after and within two to eight days following the injections is recommended.

In the treatment of patients with uveitis, it is very important to exclude possible infective causes of uveitis prior to commencing therapy with fluocinolone.

There is a potential for implants to migrate into the anterior chamber, especially in patients with posterior capsular abnormalities, such as tears. This should be taken into consideration when examining patients complaining of visual disturbance after treatment.

There are limited data from the use of intravitreally administered fluocinolone acetonide in pregnant women. Animal studies are insufficient with respect to the reproductive toxicity of intravitreally administered fluocinolone acetonide. Although fluocinolone acetonide is undetectable in the systemic circulation after local, intraocular treatment, fluocinolone is nonetheless a potent corticosteroid and even very low levels of systemic exposure may present some risk to the developing foetus. As a precautionary measure it is preferable to avoid the use of fluocinolone acetonide during pregnancy.

Systemically administered fluocinolone acetonide is excreted in breast milk. Although the systemic exposure of the breast-feeding woman to intravitreally administered fluocinolone acetonide is expected to be very low, a decision must be made whether to discontinue breast-feeding or to abstain from fluocinolone acetonide therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Fertility

There are no fertility data available. However, effects on either male or female fertility are unlikely since the systemic exposure to fluocinolone acetonide following intravitreal administration is very low.

Fluocinolone acetonide has minor influence on the ability to drive and use machines. Patients may experience temporarily reduced vision after administration of fluocinolone acetonide and should refrain from driving or using machines until this has resolved.