ILUVIEN (fluocinolone acetonide)

There are 9 contraindications. Absolute contraindication.

Contraindication List
Fungal infection of eye
Fungal keratitis
Herpes simplex keratitis
Herpes simplex keratoconjunctivitis
Herpes zoster keratitis
Herpes zoster keratoconjunctivitis
Ocular infection
Tuberculosis of the eye
Vaccinia virus keratitis

There are 2 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Glaucoma
Ocular hypertension

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Cataracts

There are 21 severe adverse reactions.

More Frequent	Less Frequent
Blurred vision Cataracts Ocular hypertension Ocular infection Reduced visual acuity Vitreous hemorrhage	Anemia Choroidal detachment Conjunctival hemorrhage Glaucoma Hypertension Pneumonia Pruritus of skin Retinal hemorrhage Vitreous detachment

Rare/Very Rare
Corneal degeneration Endophthalmitis Iridocyclitis Migration of implant Ocular hypotony Retinal detachment

There are 32 less severe adverse reactions.

More Frequent

Less Frequent

Arthralgia Blepharoptosis Dry eye Eye tearing Ocular pain Pharyngitis Visual field defect Vitreous floater

Anterior chamber inflammation Conjunctival hyperemia Conjunctivitis Constipation Corneal edema Cough Dizziness Fever Foreign body sensation of eye Headache disorder Kidney disease with reduction in glomerular filtration rate (GFr) Myopia Ocular discharge Ocular discomfort Ocular inflammation Ocular irritation Ocular itching Optic atrophy Photophobia Posterior capsule opacification Sinusitis Upper respiratory infection Urinary tract infection Visual changes

Rare/Very Rare
None.

Some corticosteroids have been shown to be teratogenic when applied in high dosages to the eyes of pregnant animals. Safety of intensive or protracted use of ophthalmic or otic corticosteroids during pregnancy has not been established. EENT corticosteroids should be used in pregnant women, particularly in large doses or for prolonged periods, only when the possible benefits outweigh the potential risks.

Women should be instructed to inform their physicians if they become or wish to become pregnant while receiving glucocorticoids. If intranasal corticosteroids must be used during pregnancy or if the patient becomes pregnant while taking the drug, the possible benefits should be weighed against the potential risks. Infants born to mothers who receive nasal corticosteroids during pregnancy should be carefully monitored for symptoms of adrenal insufficiency, and appropriate therapy should be begun immediately if such symptoms appear.

It is not known whether topically administered corticosteroids are distributed into milk or whether they can suppress growth or cause other adverse effects in nursing infants. Some manufacturers state that women receiving pharmacologic doses of dexamethasone should be advised not to nurse their infants.

No enhanced Geriatric Use information available for this drug.