Vitrasert

CMV retinitis may be associated with CMV disease elsewhere in the body. The Vitrasert (ganciclovir) Implant provides localized therapy limited to the implanted eye. The Vitrasert (ganciclovir) 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 (ganciclovir) 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 (ganciclovir) 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.

Serious side effects have been reported with ganciclovir. See the “Ganciclovir Precautions” section.

Capsules and Injection:

Common side effects of ganciclovir include the following:

• change in blood counts
• fever
• infection
• chills
• diarrhea
• loss of appetite
• vomiting
• neuropathy (weakness, numbness and pain, usually in your hands and feet)
• sweating
• itching
• retinal detachment (separation)

Ophthalmic Gel:

• blurred vision
• eye irritation
• watery eyes
• eyes sensitive to light
• red eye
• change in vision

This is not a complete list of ganciclovir side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The Vitrasert implant is surgically placed into the eye. The implant will slowly release ganciclovir into the affected eye over a period of 5 to 8 months.

Use Zirgan gel exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Zirgan is usually applied 5 times each day until your eye ulcer heals. Then the gel is applied 3 times per day for 7 days. Follow your doctor's instructions.

Wash your hands before using the eye drops.

To apply Zirgan:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.

• Use only the number of drops your doctor has prescribed.

• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Ganciclovir does not cure herpes or CMV. Your disease may continue to progress even after you are treated with this medication. Your doctor will need to check your progress on a regular basis, and you will need routine eye exams.

Store Zirgan at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Since the Vitrasert implant is surgically put into place, you will not be on a dosing schedule for this medication. The implant may be removed and replaced after 5 to 8 months.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of ganciclovir eye implants in children younger than 9 years of age with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of ganciclovir eye implants in the elderly with use in other age groups.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems or
• Eye infection—Surgery on the eye is not recommended

It is very important that your doctor check your progress at regular visits. This is to make sure the medicine is working properly and to check for any problems from the surgery, implant, or medicine. This will also help the doctor determine when all of the medicine in the implant has been used up, so it can be removed.

You may notice blurred or decreased vision in the eye where the implant has been placed. This is to be expected and will last for 2 to 4 weeks after the surgery to insert the implant into the eye. Tell your doctor if the blurred or decreased vision gets worse, lasts for more than 4 weeks, or gets better for a while and then gets worse again. Also, tell your doctor right away if any other changes in your vision occur. These may be signs of complications from the surgery.

The Vitrasert Implant is contraindicated in patients with hypersensitivity to ganciclovir or acyclovir, and in patients with any contraindications for intraocular surgery, such as external infection or severe thrombocytopenia.

Revised August 2005

Manufactured for:
Bausch & Lomb, Incorporated
Rochester, NY 14609 USA
800/338-2020

Manufactured by:
AMP, Inc.
Irvine, CA 92618 USA

Vitrasert is a registered trademark of Bausch & Lomb Incorporated.

©Copyright 2003 Bausch & Lomb Incorporated. All rights reserved.

U.S. Patent #5,378,475. Foreign Patents pending.
U.S. Patent #4,355,032, #4,507,305 (ganciclovir compound).
Cytovene is a registered trademark of Roche Laboratories. A member of the Roche Group.

NDC 24208-412-01

Rx only

Vitrasert®
Sterile Intravitreal Implant
with Cytovene®
(ganciclovir, 4.5 mg)

One Sterile Vitreal Implant
For Intraocular Implantation Only

Bausch & Lomb