"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
(Generic versions may still be available.)
Vitravene (fomivirsen) † is for intravitreal injection use only.
CMV retinitis may be associated with CMV disease elsewhere in the body. Vitravene (fomivirsen) † provides localized therapy limited to the treated eye. The use of Vitravene (fomivirsen) † does not provide treatment for systemic CMV disease. Patients should be monitored for extraocular CMV disease or disease in the contralateral eye.
Vitravene (fomivirsen) † is not recommended for use in patients who have recently (2-4 weeks) been treated with either intravenous or intravitreal cidofovir because of the risk of exaggerated ocular inflammation.
FOR OPHTHALMIC USE ONLY.
Ocular inflammation (uveitis) including iritis and vitritis has been reported to occur in approximately 1 in 4 patients. Inflammatory reactions are more common during induction dosing. Topical corticosteroids have been useful in the medical management of inflammatory changes, and with both medical management and time, patients may be able to continue to receive intravitreal injections of Vitravene (fomivirsen) † after the inflammation has resolved.
Increased intraocular pressure has been commonly reported. The increase is usually a transient event and in most cases the pressure returns to the normal range without any treatment or with temporary use of topical medications. Intraocular pressure should be monitored at each visit and elevations of intraocular pressure, if sustained, should be managed with medications to lower intraocular pressure.
Information for patients
See PATIENT INFORMATION section.
See DRUG INTERACTION section.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No studies have been conducted to evaluate the carcinogenic potential of fomivirsen sodium.
Fomivirsen sodium was not mutagenic in Salmonella/Microsome (Ames) and mouse lymphoma tests or clastogenic in the in vivo mouse micronucleus assay. However, equivocal results were observed in the chromosome aberration tests with Chinese hamster ovary cells.
No studies have been conducted to evaluate the potential of fomivirsen sodium to affect fertility.
Pregnancy Category C. Animal reproductive studies have not been conducted with fomivirsen sodium. It is also not known whether fomivirsen sodium can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
There are no adequate and well-controlled studies in pregnant women. Vitravene (fomivirsen) † should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether fomivirsen sodium is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Vitravene (fomivirsen) †, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies of Vitravene (fomivirsen) † did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently than younger subjects.
This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Vitravene Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Get breaking medical news.