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 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.

fomivirsen is available only with your doctor's prescription.

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 fomivirsen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fomivirsen 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

Studies with fomivirsen 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.

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 fomivirsen in the elderly with use in other age groups.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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.

fomivirsen 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 fomivirsen 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 fomivirsen. 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.

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:

• 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

• 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:

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

• 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.

Consult your pharmacist.

How to use Fomivirsen Solution

Consult your pharmacist.

Fomivirsen has been assigned to pregnancy category C. There are no controlled data in human pregnancy. Fomivirsen should only be given during pregnancy when benefit outweighs risks.