Ganciclovir warnings and precautions

Ganciclovir

VITRASERT® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

## Warnings And Precautions

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### Warnings

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CMV retinitis may be associated with CMV disease elsewhere in the body. The Vitrasert Implant provides localized therapy limited to the implanted eye. The Vitrasert Implant does not provide treatment for systemic CMV disease. Patients should be monitored for extraocular CMV disease.

As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place the Vitrasert Implant into the vitreous cavity may include, but are not limited to, the following: vitreous loss, vitreous hemorrhage, cataract formation, retinal detachment, uveitis, endophthalmitis, and decrease in visual acuity.

Following implantation of the Vitrasert Implant, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately two to four weeks post-operatively. This decrease in visual acuity is likely a result of the surgical implant procedure.

### Precautions

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#### General

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As with all intraocular surgery, sterility of the surgical field and the Vitrasert Implant should be rigorously maintained. The Vitrasert Implant should be handled only by the suture tab in order to avoid damaging the polymer coatings since this could affect release rate of ganciclovir inside the eye. The Vitrasert Implant should not be resterilized by any method.

A high level of surgical skill is required for implantation of the Vitrasert Implant. A surgeon should have observed or assisted in surgical implantation of the Vitrasert Implant prior to attempting the procedure.

#### Information for patients

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The Vitrasert Implant is not a cure for CMV retinitis, and some immunocompromised patients may continue to experience progression of retinitis with the Vitrasert Implant. Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of the Vitrasert Implant.

As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place the Vitrasert Implant into the vitreous cavity may include, but are not limited to, the following: intraocular infection or inflammation, detachment of the retina, and formation of cataract in the natural crystalline lens.

Following implantation of the Vitrasert Implant, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately two to four weeks post-operatively. This decrease in visual acuity is likely a result of the surgical implant procedure.

The Vitrasert Implant only treats eyes in which it has been implanted. Additionally, because CMV is a systemic disease, patients should be monitored for extraocular CMV infections (e.g., pneumonitis, colitis) in the body.

Patients should be advised that ganciclovir has caused decreased sperm production in animals and may cause infertility in humans. Women of childbearing potential should be advised that ganciclovir causes birth defects in animals and should not be used during pregnancy.

Patients should be advised that ganciclovir has caused tumors in animals. Although there is no information from human studies, ganciclovir should be considered a potential carcinogen.[1]

## References

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1. ↑ "http://www.drugbank.ca/system/fda_labels/DB01004.pdf?1265922812" (PDF). External link in `|title=` (help)

Adapted from the FDA Package Insert.