Retisert (fluocinolone acetonide): FDA label

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Contraindications

Surgical placement of RETISERT is contraindicated in active viral, bacterial, mycobacterial and fungal infections of ocular structures. (4.1)

4.1Viral, Bacterial, Mycobacterial and Fungal Infections of Ocular Structures

Surgical placement of RETISERT is contraindicated in active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in active bacterial, mycobacterial or fungal infections of the eye.

Warnings and precautions

Cataract formation: Nearly all phakic patients are expected to develop cataracts and require cataract surgery. (5.1) Endophthalmitis: Late onset endophthalmitis has been observed. (5.2) Increase in intraocular pressure: Use of corticosteroids may result in elevated IOP and/or glaucoma. (5.3) IOP lowering medications were required in > 75% of patients; filtering surgeries were required in > 35% of patients. (6.1) Separation of implant components: Physicians should periodically monitor the integrity of the implant by visual inspection.

(5.4)

5.1Cataract Formation Use

of corticosteroids may result in posterior subcapsular cataract formation. Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

5.2Endophthalmitis and Surgical Complications

Adverse reactions

Ocular adverse events included procedural complications, and eye pain (> 50%). Thirty-five to forty percent of patients reported ocular/conjunctival hyperemia, reduced visual acuity, and conjunctival hemorrhage. (6.1) The most common non-ocular event reported was headache (33%). (6.2) To report SUSPECTED ADVERSE REACTIONS, contactBausch & Lomb Incorporated at 1-800-553-5340or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials

Experience - Ocular Events The available safety data includes exposure to RETISERT in patients with chronic non-infectious uveitis affecting the posterior segment in two multicenter controlled clinical trials. Patients were randomized to dosage regimens of 0.59 mg or 2.1 mg implants. The most frequently reported ocular adverse events were cataract, increased intraocular pressure, procedural complication, and eye pain.

These events occurred in approximately 50 - 90% of patients. Cataract includes aggravated cataract, and posterior capsular opacification. Procedural complications includes post-op complication, post-op wound complication, post-op wound site erythema, and wound dehiscense. Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.

IOP lowering medications to lower intraocular pressure were required in approximately 77% of patients; filtering surgeries were required to control intraocular pressure in 37% of patients. Ocular adverse events occurring in approximately 10 - 40% of patients in decreasing order of incidence were ocular/conjunctival hyperemia, reduced visual acuity, glaucoma, conjunctival hemorrhage, blurred vision, abnormal sensation in the eye, eye irritation, maculopathy, vitreous floaters, hypotony, pruritus, ptosis, increased tearing, vitreous hemorrhage, dry eye, eyelid edema, macular edema and visual disturbance.

Ocular adverse events occurring in approximately 5 - 9% of patients in decreasing order of incidence were eye discharge, photophobia, blepharitis, corneal edema, iris adhesions, choroidal detachment, diplopia, eye swelling, retinal detachment, photopsia, retinal hemorrhage and hyphema.

6.2Clinical Trials

Experience - Non-Ocular Events The most frequently reported non-ocular adverse event was headache (33%). Other non-ocular adverse events occurring in approximately 5-20% of patients in decreasing order of incidence were nasopharyngitis, arthralgia, sinusitis, dizziness, pyrexia, upper respiratory tract infection, influenza, vomiting, nausea, cough, back pain, limb pain, and rash.

Retisert

Indications

Contraindications

4.1Viral, Bacterial, Mycobacterial and Fungal Infections of Ocular Structures

Warnings and precautions

5.1Cataract Formation Use

5.2Endophthalmitis and Surgical Complications

Two medicines in one question?

5.3Increase in Intraocular Pressure

5.4Separation of Implant Components

5.5Other Corticosteroid Induced Adverse Reactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Adequate

Adverse reactions

6.1Clinical Trials

6.2Clinical Trials

Composition

Official product information

At a glance

Guidelines