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|Vitrasert Implantation-Ophthalmic

GANCICLOVIR (Implantation-Ophthalmic)

Some commonly used brand names are:

In the U.S.—

• Vitrasert

Category

• Antiviral, ophthalmic

Description

Ganciclovir (gan-SYE-kloe-veer) is an antiviral medicine that is used in an implant that is inserted into the eye during surgery. 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, in the following dosage form:

• Ophthalmic
• Intravitreal implant (eye implant) (U.S.)

Before Receiving This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ganciclovir or acyclovir. Also tell your health care professional if you are allergic to any other substances, such as certain preservatives.

Pregnancy—The ganciclovir eye implant has not been studied in pregnant women. However, in animals, ganciclovir given by injection has caused cancer and birth defects. Discuss these possible effects with your doctor.

Breast-feeding—It is not known whether ganciclovir from an eye implant passes into breast milk. However, because ganciclovir given by injection to animals has caused serious unwanted effects, it is recommended that breast-feeding be stopped during treatment with this medicine.

Children—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.

Older adults—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.

Other 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 health care professional if you are taking or using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of ganciclovir. 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

Precautions After Receiving This Medicine

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 of This Medicine

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.

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

Developed: 08/14/1998
Revised: 08/14/1998

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