Vitrasert Side Effects

Generic name: ganciclovir ophthalmic

Note: This document contains side effect information about ganciclovir ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Vitrasert.

Some side effects of Vitrasert may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ganciclovir ophthalmic: intraocular implant, ophthalmic gel

Get emergency medical help if you have any of these signs of an allergic reaction while taking ganciclovir ophthalmic (the active ingredient contained in Vitrasert) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• eye pain, swelling, redness, or watering;

• severe burning or itching of your eyes;

• vision changes, increased sensitivity to light;

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

• seeing flashes of light, halos around lights, or "floaters" in your vision;

• white patches on your eyes;

• cloudiness in the pupils or iris of your eyes;

• bleeding, oozing, or crusting of your eyes; or

• sudden vision loss.

Less serious side effects of ganciclovir ophthalmic may include:

• blurred vision (may last up to 4 weeks after Vitrasert implant surgery);

• mild eye irritation; or

• increased tearing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ganciclovir ophthalmic: intraocular implant, ophthalmic gel

Ocular

Ocular side effects that occur with ganciclovir ophthalmic (the active ingredient contained in Vitrasert) implant are generally confined to the implanted eye. Some of these events (e.g. retinal detachment) will also occur with the natural progression of CMV retinitis and may not necessarily be direct complications of the surgical procedure. However, it is possible that the implant may precipitate some of these conditions.

The most common side effect is a decrease in visual acuity, which occurs in nearly all patients immediately following the implant procedure and lasts 2 to 4 weeks in most cases. In 10% to 20% of the patients, visual acuity loss of 3 lines or more may occur during the first two months postoperatively, as well as vitreous hemorrhage and retinal detachment. Additionally, cataract formation or lens opacities, macular abnormalities, increases in intraocular pressure, optic disc and nerve changes, hyphemas, and uveitis may occur in up to 5% of patients.

Observed in less than 1% of patients are retinopathy, synechia, suprachoroidal hemorrhage, cotton wool spots, keratopathy, astigmatism, endophthalmitis, microangiopathy, sclerosis, choroiditis, chemosis, phthisis bulbi, angle closure traction, hypotony, retinal tear, corneal dellen, choroidal folds, and gliosis. Permanent loss of vision due to endophthalmitis has been reported.

Intravitreous injections of ganciclovir have resulted in scleral induration, corneal ulceration, chemical irritation, cataract formation, transient elevations in intraocular pressure, optic disc and nerve atrophy, vitreous haze, iritis, vitreous and conjunctival hemorrhage, retinal detachment, and infectious endophthalmitis. One case of retinal toxicity and necrosis resulting in visual loss was reported in a patient inadvertently given 40 mg of ganciclovir.

Side effects of ganciclovir ophthalmic gel have included blurred vision (60%), eye irritation (20%), punctate keratitis (5%), and conjunctival hyperemia (5%).

Other

Complications related to the removal of ganciclovir implants have been reported. Rare cases of medical pellet separation from its tab have been reported.

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