Ganciclovir (Intraocular Route)

The ganciclovir implant is used to treat a serious condition called cytomegalovirus (CMV) retinitis in persons who have acquired immune deficiency syndrome (AIDS). Ganciclovir will not cure this eye infection, but it may help to keep the symptoms from becoming worse.

After your eye has used up all the medicine in the implant (generally within 5 to 8 months), the implant is removed by surgery and, at the same time, another implant can be inserted.

The surgery, the implant containing this medicine, or the medicine itself may cause some serious side effects, including detachment of the retina, formation of a cataract, and eye infections. Before you receive this implant, you and your doctor should talk about the good this medicine and surgery will do as well as the risks involved.

This medicine is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Implant

Before Using

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.

Drug Interactions

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.

Other Interactions

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 infectiona€”Surgery on the eye is not recommended

Proper Use

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions

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.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Also, ganciclovir has been found to cause cancerous tumors in animals. Discuss these possible effects with your doctor .

Check with your doctor as soon as possible if any of the following side effects occur:

More commona€”Usually occur within the first 2 months after the surgery

• Decrease in vision (severe)


• Seeing flashes or sparks of light


• Seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

Less commona€”Usually occur within the first 2 months after the surgery

• Blurred vision or other change in vision


• Decreased vision or other change in vision


• Eye pain or tearing


• Red or bloodshot eye


• Sensitivity of eye to light

Rarea€”Usually occur within the first 2 months after the surgery

• Eye irritation


• Swelling of the membrane covering the white part of the eye

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decrease in vision lasting approximately 2 to 4 weeks

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

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