Vitravene (fomivirsen) † is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis.

The diagnosis and evaluation of CMV retinitis is ophthalmologic and should be made by comprehensive retinal examination including indirect ophthalmoscopy. Other conditions that should be considered in the differential diagnosis of CMV retinitis include ocular infections caused by syphilis, candidiasis, toxoplasmosis, histoplasmosis, herpes simplex virus and varicella-zoster virus as well as retinal scars, and cotton wool spots, any of which may produce a retinal appearance similar to CMV. For this reason, it is essential that a physician familiar with the retinal presentation of these conditions establish the diagnosis of CMV retinitis.

Treatment with Vitravene (fomivirsen) † involves an induction and a maintenance phase. The recommended dose of Vitravene (fomivirsen) † is 330 µg (0.05 mL). The induction dose of Vitravene (fomivirsen) † should be one injection every other week for two doses. Subsequent maintenance doses should be administered once every four weeks after induction.

For unacceptable inflammation in the face of controlled CMVR, it is worthwhile interrupting therapy until the level of inflammation decreases and therapy can resume.

For patients whose disease progresses on Vitravene (fomivirsen) † during maintenance, an attempt at reinduction at the same dose may result in resumed disease control.

Instructions for Intravitreal Injection

Vitravene (fomivirsen) † is administered by intravitreal injection (0.05 mL/eye) into the affected eye following application of standard topical and/or local anesthetics and antimicrobials using a 30 gauge needle on a low-volume (e.g., tuberculin) syringe. The following steps should be used:

• Remove plastic cap from vial containing Vitravene (fomivirsen) †.
• Disinfect rubber stopper with 70% ethyl alcohol.
• Attach a 5 micron filter needle to the injection syringe for solution withdrawal (to further guard against the introduction of stopper particulate).
• Withdraw approximately 0.15 mL through the filter needle.
• Remove filter needle and attach a 30 gauge needle to syringe containing Vitravene (fomivirsen) †.
• Eject excess volume and air from syringe.
• Stabilize globe with cotton tip applicator and insert needle fully through an area 3.5 to 4 mm posterior to the limbus (avoiding the horizontal meridian) aiming toward the center of the globe, keeping fingers off the plunger until the needle has been completed inserted. Deliver the injection volume (0.05 mL) by injecting slowly. Roll cotton tip applicator over injection site as needle is withdrawn to reduce loss of eye fluid.

Instructions for Post-Injection Monitoring

Monitor light perception and optic nerve head perfusion: if not completely perfused by 7-10 minutes, perform anterior chamber paracentesis with a 30 gauge needle on a plungerless tuberculin syringe at the slit lamp.

Vitravene† (fomivirsen sodium intravitreal injectable) is supplied in preservative-free, single-use vials containing 0.25 mL, 6.6 mg/mL. The product is intended for intravitreal injection only.

NDC 58768-902-35

Store between 2-25° C (35-77° F). Protect from excessive heat and light.

Rx only

Manufactured by:
Abbott Laboratories
McPherson, KS 67460

Distributed by:
CIBA Vision®
A Novartis Company
Duluth, GA 30097

This product has been discovered and developed by Isis Pharmaceuticals, Inc., Carlsbad, CA 92008

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.