fluocinolone intravitreal implant (Rx)

Brand and Other Names:Retisert, Iluvien
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal insert

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

Diabetic Macular Edema

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

Surgically implanted by ophthalmologist

Iluvien: Releases 0.2 mcg/day over ~36 months

Dosage Forms & Strengths

intravitreal insert

  • 0.59mg/insert
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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%

Procedural complications and eye pain (>50%)

IOP increased (>50%)

Fever (5-15%)

Pain (5-15%)

Ocular/conjunctival hyperemia, reduced visual acuity, conjunctival hemorrhage (>35%)

Headache (33%)

Rash (5-15%)

Athralgia, back pain, limb pain (5-15%)

Cough, upper respiratory infection, nasopharyngitis, influenza (5-15%)

Blepharitis, corneal edema, eye swelling, photophobia, photopsia, vitreous opacities, eye discharge, retinal hemorrhage (5-9%)

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Warnings

Contraindications

Hypersensitivity to product or components

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

Glaucoma with cup to disc ratios ≥0.8 (Iluvien)

Cautions

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

Injury to optic nerve reported with prolonged use

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

May increase IOP or glaucoma; IOP lowering medication required in >75% of patients and filtering surgeries in >35%

Treatment for lowering IOP may be required within 2 years postimplantation

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 Category: C

Lactation: Unknown whether distributed in breast milk

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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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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