Fomivirsen (Intraocular)

Fomivirsen is an antiviral medicine that is injected into the eye (intravitreal). It is used to treat a serious condition called cytomegalovirus (CMV) retinitis in people who have acquired immune deficiency syndrome (AIDS). Fomivirsen will not cure this eye infection, but it may help to prevent the symptoms from getting worse.

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

It is very important that your doctor checks your progress at regular visits to ensure the medicine is working correctly and to monitor for side effects.

In deciding to use a medicine, you and your doctor must consider the risks of taking it against the benefits it may provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know if you have other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been conducted in adult patients, and there is no specific information comparing the use of fomivirsen in children to other age groups.

Geriatric

Many medicines have not been specifically studied in older adults. Therefore, it may not be known if they work the same way in older people as they do in younger adults, or if they cause different side effects or issues in older adults. There is no specific information comparing the use of fomivirsen in the elderly 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 using 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 could happen. In these situations, your doctor may need to adjust the dose, or other precautions may be required. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine in relation to food, alcohol, or tobacco.

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

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

More common

• Abnormal vision
• blurred vision
• change in how colors look
• decreased vision or other changes in vision
• eye pain
• redness of eye
• seeing flashes or sparks of light
• seeing floating spots before eyes
• sensitivity of eye to light
• veil or curtain appearing across part of vision
• watering of eye

Less common

• Decreased ability to see to the side when looking straight ahead
• itching, redness, or soreness at place of injection
• pain on moving the eye
• soreness of eye
• swelling 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

• Abdominal or stomach pain
• diarrhea
• headache
• nausea
• skin rash
• vomiting
• weakness

Less common

• Back pain
• cough
• dizziness
• loss of appetite
• sweating
• tightness in chest
• weight loss

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.

In the U.S.

• Vitravene

Pharmacologic Class: Antisense Oligonucleotide

This medicine will not cure CMV retinitis, although it may help keep it from getting worse. In addition, it will not help other symptoms of CMV (for example, in the lungs or colon).

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.

• For parenteral-local dosage form (ophthalmic injection): For CMV retinitis: Adults—The usual starting dose is 330 micrograms injected into the eye once every other week for two doses. Then the same dose is used once every four weeks for as long as it is needed. Children—Use and dose must be determined by your doctor.