fluocinolone intravitreal implant (Rx)

Brand and Other Names:Retisert, Iluvien, more...Yutiq
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal insert

  • 0.18mg/insert (Yutiq)
  • 0.19mg/insert (Iluvien)
  • 0.59mg/insert (Retisert)

Uveitis

Indicated for chronic, noninfectious uveitis of posterior segment of eye

Surgically implanted by ophthalmologist

Retisert

  • Releases 0.6 mcg/day initially; amount released decreases over 1st month to release 0.3-0.4 mcg/day over ~30 months
  • Replace when evidence of uveitis recurs

Yutiq

  • Releases at an initial rate of 0.25 mcg/day over ~36 months

Diabetic Macular Edema

Indicated for diabetic macular edema in patients previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure

Surgically implanted by ophthalmologist

Iluvien: Releases at an initial rate of 0.25 mcg/day over ~36 months

Dosage Forms & Strengths

intravitreal insert

  • 0.59mg/insert

Uveitis (Retisert)

<12 years: Safety and efficacy not established

≥12 years

  • As adults; indicated for chronic, noninfectious uveitis of posterior segment of eye
  • Surgically implanted by ophthalmologist
  • Releases 0.6 mcg/day initially; amount released decreases over 1st month to release 0.3-0.4 mcg/day over approximately 30 months
  • Replace when evidence of uveitis recurs
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Adverse Effects

>10% (Yutiq only)

Cataract (56%)

Reduced visual acuity (15%)

Macular edema (11%)

>10% (Retisert only)

10-40%

  • Headache (33%)
  • Ocular/conjunctival hyperemia
  • Reduced visual acuity, visual disturbance, and blurred vision
  • Glaucoma
  • Conjunctival and vitreous hemorrhage
  • Eyelid edema and macula edema
  • Abnormal sensation in the eye
  • Eye irritation
  • Maculopathy
  • Vitreous floaters
  • Hypotony
  • Pruritus
  • Ptosis
  • Increased tearing
  • Dry eye

>10% (Iluvien only)

Cataract (82%)

Myodesopsia (21%)

Eye pain (15%)

Conjunctival haemorrhage (13%)

Anemia (11%)

1-10% (Yutiq only)

Uveitis (10%)

Conjunctival hemorrhage (8%)

Eye pain (8%)

Hypotony of eye (7%)

Anterior chamber inflammation (5%)

Nasopharyngitis (5%)

Dry eye (4%)

Vitreous opacities (4%)

Conjunctivitis (4%)

Posterior capsule opacification (4%)

Ocular hyperemia (4%)

Hypertension (3%)

Vitreous haze (3%)

Foreign body sensation in eyes (3%)

Vitreitis (3%)

Vitreous floaters (3%)

Eye pruritus (3%)

Conjunctival hyperemia (2%)

Ocular discomfort (2%)

Macular fibrosis (2%)

Glaucoma (2%)

Photopsia (2%)

Vitreous hemorrhage (2%)

Arthralgia (2%)

Iridocyclitis (1%)

Eye inflammation (1%)

Choroiditis (1%)

Eye irritation (1%)

Visual field defect (1%)

Lacrimation increased (1%)

1-10% (Retisert only)

5-9%

  • Eye discharge
  • Photophobia
  • Blepharitis
  • Corneal edema
  • Iris adhesions
  • Choroidal detachment
  • Diplopia
  • Eye swelling
  • Retinal detachment
  • Photopsia
  • Retinal hemorrhage
  • Hyphema

1-10% (Iluvien only)

Headache (9%)

Renal failure (9%)

Posterior capsule opacification (9%)

Eye irritation (8%)

Vitreous detachment (7%)

Pneumonia (7%)

Conjunctivitis (4%)

Corneal oedema (4%)

Foreign body sensation in eyes (3%)

Eye pruritus (3%)

Ocular hyperemia (3%)

Optic atrophy (2%)

Ocular discomfort (2%)

Photophobia (2%)

Retinal exudates (2%)

Anterior chamber cell (2%)

Eye discharge (2%)

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Warnings

Contraindications

Hypersensitivity to product or components

Active viral, bacterial, mycobacterial, and fungal ocular or periocular infection

Iluvien only: Glaucoma with cup to disc ratios >0.8

Cautions

Nearly all phakic patients are expected to develop cataracts and require cataract surgery

Monitor for endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments

Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP) and/or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision

Periodically monitor for integrity of implant

Risk for implant migration into anterior chamber if the posterior capsule of the lens is absent or has a tear

Risk of postoperative infections in both eyes may be reduced by unilateral implantation

May mask or exacerbate existing infection

Corticosteroids are not recommended with a history of ocular herpes simplex; potential for viral reactivation

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Pregnancy & Lactation

Pregnancy

Adequate and well-controlled studies have not been conducted in pregnant women to inform drug associated risk

Animal reproduction studies have not been conducted

Unknown whether fetal harm occurs when administered to a pregnant woman or can affect reproduction capacity

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels

Consider potential benefit justifies the potential risk to the fetus

Lactation

Systemically administered corticosteroids are present in human milk and can suppress growth, interfere with endogenous corticosteroid production

Clinical or nonclinical lactation studies have not been conducted

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Suppresses inflammation by inhibiting multiple inflammatory cytokines, resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells

Corticosteroids are thought to act by inhibition of phospholipase A2 via induction of inhibitory proteins collectively called lipocortins; it is postulated that these proteins control biosynthesis of potent mediators of inflammation (eg, prostaglandins, leukotrienes) by inhibiting release of the common precursor, arachidonic acid

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Administration

Intravitreal administration only

See prescribing information for administration instructions

Storage

Retisert: Store in original container at 15-25°C (59-77°F); protect from freezing

Iluvien and Yutiq: Store at 15-30°C (59-86°F)

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Images

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Code Definition
PA Prior Authorization
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.