Retisert

You should not be treated with this medicine if you have glaucoma or any type of infection in or around your eye, or if you are allergic to steroid medicine.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Retisert is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

0.59 mg fluocinolone acetonide intravitreal implant.

Cataract 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.

Endophthalmitis and Surgical Complications

Late onset endophthalmitis has been observed. These events are often related to the integrity of the surgical wound site. Careful attention to assure tight closure of the scleral wound and the integrity of the overlying conjunctiva at the wound site is important. 

Potential complications accompanying intraocular surgery to place Retisert into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular inflammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.

Following implantation of Retisert, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.

Increase in Intraocular Pressure

Prolonged use of corticosteroids may result in elevated IOP and/or glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Patients must be monitored for elevated IOP. 

Based on clinical trials with Retisert, within 3-years post implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require filtering procedures to control intraocular pressure. (see 6.1 Clinical Trials Experience - Ocular Events section).

Separation of Implant Components

In vitro stability studies show that the strength of the adhesive bond between the silicone cup reservoir and the suture tab is reduced with prolonged hydration, indicating a potential for the separation of these components. The suture tab composition is a silicone elastomer reinforced with a polyester mesh. Physicians should periodically monitor the integrity of the implant by visual inspection. 

Other Corticosteroid Induced Adverse Reactions

Retisert should be used with caution in patients with a history of a viral, bacterial, mycobacterial or fungal infection of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella.

Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution.

Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections (bacterial, fungal, and viral). In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term application of steroids. The possibility of fungal invasion should be considered in any persistent corneal ulceration where steroid treatment has been used. 

Since resistance to infections is known to be reduced by corticosteroids, simultaneous bilateral implantation should not be carried out, in order to limit the potential for bilateral post-operative infection. 

Ocular administration of corticosteroids has also been associated with delayed wound healing and perforation of the globe where there is thinning of the sclera. 

The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.

Pregnancy

Pregnancy Category C

No adequate animal reproduction studies have been conducted with fluocinolone acetonide.

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Fluocinolone acetonide when administered subcutaneously at a dose of 0.13 mg/kg/day (approximately 10,000 times the daily clinical dose of Retisert), during days 6 to 18 of pregnancy in the rabbit, induced abortion at the end of the third and at the beginning of the fourth gestational week. When administered subcutaneously to rats and rabbits during gestation at a maternal toxic dose of 50 µg/kg/day (approximately 4,000 times the clinical dose of Retisert), fluocinolone acetonide caused abortions and malformations in a few surviving fetuses.

There are no adequate and well-controlled studies in pregnant women. Retisert should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemic steroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Caution should be exercised when Retisert is implanted in a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 12 years have not been established.

Geriatric Use

No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Usual Adult Dose for Uveitis:

1 Retisert implant, containing 1 tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye through a pars plana incision

Comments:
-Following depletion of this drug as evidenced by recurrence of uveitis, the implant may be replaced.
-Caution should be used in handling the implant to avoid damage, which may result in an increased rate of drug release from the implant.
-Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
-The Retisert implant should not be resterilized by any method.

Use: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

Usual Adult Dose for Macular Edema:

1 Retisert implant, containing 0.19 mg of fluocinolone acetonide, to be surgically implanted inferior to the optic disc and posterior to the equator of the eye

Comments:
-For ophthalmic intravitreal injection.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure. Consult the manufacturer product information for proper handling.
-Patients should be monitored for elevation in intraocular pressure and for endophthalmitis.
-Patients should be instructed to report any symptoms suggestive of endophthalmitis.

Use: Treatment of 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.

Usual Pediatric Dose for Uveitis:

12 years or older:
1 implant, containing 1 tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye through a pars plana incision

Comments:
-Following depletion of this drug as evidenced by recurrence of uveitis, the implant may be replaced.
-Caution should be used in handling the implant to avoid damage, which may result in an increased rate of drug release from the implant.
-Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
-The implant should not be resterilized by any method.

Use: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.

Since the Retisert implant is surgically put into place, you will not be on a dosing schedule.

If you miss a dose of any medication you take to control pressure inside your eyes, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction to Retisert: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• blurred vision, tunnel vision, problems with peripheral (side) vision;

• eye redness, eye pain or swelling;

• bleeding, oozing, or crusting of your eyes;

• cloudiness in your pupil or iris (colored part of your eyes);

• seeing flashes of light or "floaters" in your vision;

• seeing halos around lights; or

• pale skin, feeling light-headed or short of breath.

Common Retisert side effects may include:

• mild eye redness, dryness, itching, or irritation;

• the feeling that something is in your eye;

• headache, dizziness; or

• your eyes being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.