Ganciclovir (Intraocular)

Ganciclovir is an antiviral medicine that comes as an implant which is placed in the eye during surgery. The ganciclovir implant is used to treat a serious condition known as cytomegalovirus (CMV) retinitis in people with acquired immune deficiency syndrome (AIDS). Ganciclovir will not cure this eye infection, but it may help prevent the symptoms from worsening.

Once your eye has used all the medicine from the implant (usually within 5 to 8 months), the implant will be removed through surgery, and another implant can be inserted at that time.

The surgery, the implant with this medicine, or the medicine itself may cause serious side effects, such as retinal detachment, cataract formation, and eye infections. Before you receive this implant, you and your doctor should discuss the benefits of this medicine and surgery, as well as the risks involved.

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

It is very important that your doctor checks your progress at regular visits. This is to ensure the medicine is working properly and to check for any problems from the surgery, implant, or medicine. This will also help the doctor know 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 normal 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 improves for a while and then worsens again. Also, tell your doctor right away if you notice any other changes in your vision. These may be signs of complications from the surgery.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine compared to the benefits it will provide. For this medicine, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have any other 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 on the use of ganciclovir eye implants in children younger than 9 years of age compared to other age groups.

Geriatric

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

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

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

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

More common—Usually happen within the first 2 months after the surgery

• Severe decrease in vision
• Seeing flashes or sparks of light
• Seeing floating spots before the eyes, or a veil or curtain appearing across part of vision

Less common—Usually happen within the first 2 months after the surgery

• Blurred vision or other changes in vision
• Decreased vision or other changes in vision
• Eye pain or tearing
• Red or bloodshot eye
• Sensitivity of the eye to light

Rare—Usually happen 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. Your health care professional may also be able to tell you how 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 about 2 to 4 weeks

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

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

In the U.S.

• Vitrasert

Pharmacologic Class: Viral DNA Polymerase Inhibitor

Chemical Class: Guanosine Nucleoside Analog

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.