Vitravene

Vitravene (fomivirsen) † is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), who are intolerant of or have a contraindication to other treatment(s) for CMV retinitis or who were insufficiently responsive to previous treatment(s) for CMV retinitis.

The diagnosis and evaluation of CMV retinitis is ophthalmologic and should be made by comprehensive retinal examination including indirect ophthalmoscopy. Other conditions that should be considered in the differential diagnosis of CMV retinitis include ocular infections caused by syphilis, candidiasis, toxoplasmosis, histoplasmosis, herpes simplex virus and varicella-zoster virus as well as retinal scars, and cotton wool spots, any of which may produce a retinal appearance similar to CMV. For this reason, it is essential that a physician familiar with the retinal presentation of these conditions establish the diagnosis of CMV retinitis.

In the U.S.

• Vitravene

Available Dosage Forms:

• Solution

Therapeutic Class: Antiviral

Pharmacologic Class: Antisense Phosphorothioate Oligonucleotide

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.

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.

Pediatric

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.

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.

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.

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.

Applies to fomivirsen ophthalmic: intraocular solution

Along with its needed effects, fomivirsen ophthalmic (the active ingredient contained in Vitravene) 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 while taking fomivirsen ophthalmic:

• 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 of fomivirsen ophthalmic 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