Pronunciation:

foe-mi-VIR-sen

Brand Names:

• Vitravene

Classifications:

Pharmacologic—

Antisense Oligonucleotide

Uses of This Medicine:

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 persons who have acquired immune deficiency syndrome (AIDS). Fomivirsen will not cure this eye infection, but it may help to keep the symptoms from becoming worse.

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

Before Using This Medicine:

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.

Children—

Studies with this medicine have been done only in adult patients and there is no specific information comparing use of fomivirsen in children 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 fomivirsen in the elderly with use in other age groups.

Breast-feeding—

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

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 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.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure the medicine is working properly and to watch for unwanted effects.

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.

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.