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Vitravene®

Brand Name: Vitravene®
Active Ingredient:   fomivirsen sodium
Strength(s): 6.6mg
Dosage Form(s):   Intravitreal (eye) injection
Company Name:    Isis Pharmaceuticals, Inc.
Availability:         Prescription only
*Date Approved by the FDA:   August 26, 1998
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Vitravene used for? Vitravene is used to treat a virus called cytomegalovirus (CMV). CMV can affect one or both eyes in patients with acquired immunodeficiency syndrome (AIDS) who cannot take other treatment(s) for CMV retinitis or who did not respond to other treatments for CMV retinitis. The diagnosis should be made after a comprehensive eye exam, including indirect ophthalmoscopy.

Warning(s) with Vitravene:

  • Vitravene only works in the eye in which it is injected and does not treat CMV elsewhere in the body. Because CMV may be in other parts of your body and not only in your treated eye, your doctor will monitor you for CMV in the untreated eye or CMV elsewhere in your body (e.g. pneumonitis, colitis).
  • Vitravene is not recommended if you have been treated within the last 2-4 weeks with cidofivir (VistideÒ ) because of the increased risk of eye inflammation.

General Precautions with Vitravene:

  • Vitravene is for eye(s) only.
  • Vitravene is not a cure for CMV retinitis. CMV retinitis in some patients may get worse during or following Vitravene treatment. You should have regular eye exams by your ophthalmologist.
  • Inflammation of the eye (uveitis) occurs in approximately one out of four patients being treated with Vitravene. This type of reaction is most common when starting treatment with Vitravene. Your doctor may prescribe medication to treat the inflammation and may interrupt Vitravene treatment until the inflammation stops.
  • Increased pressure in the eye has been reported as another common side effect of Vitravene injections. Your doctor should monitor the pressure in your eye(s) during each visit and treat the increase in pressure if necessary.
  • If you are receiving Vitravene, you should have regular follow-up eye exams.
  • HIV-infected patients should continue taking their prescribed antiretroviral medications, unless their doctor tells them otherwise.

What should I tell my doctor or health care provider?

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

What are some possible side effects of Vitravene? (This is NOT a complete list of side effects reported with Vitravene. Your health care provider can discuss with you a more complete list of side effects.)  

The most common side effect is eye inflammation. This reaction is most common when starting Vitravene and may be treated by your health care provider (See General Precautions).

Other side effects that may relate to the eye(s) are:

  • Abnormal vision
  • Swelling around the eye
  • Blurred vision
  • Cataract
  • Bleeding in and around the eye
  • Decreased visual sharpness, clearness,
  • Reduced color vision
  • Eye pain
  • Objects in the field of vision (floaters)
  • Increased eye pressure
  • Sensitivity to light
  • Retinal detachment
  • Swelling of the retina
  • Bleeding of the retina
  • Color changes of the retina

Additional non-eye related side effects might include:

  • Stomach pain
  • Low blood count
  • Weakness
  • Diarrhea
  • Fever
  • Headache
  • Infection
  • Nausea
  • Pneumonia
  • Rash
  • Inflammation of the sinuses
  • Vomiting
  • Liver or kidney problems
  • Dehydration
  • Sweating
  • Flu-like symptoms
  • Cough
  • Chest pain

For more detailed information about Vitravene, ask your health care provider.

http://www.fda.gov/cder/foi/label/1998/20961lbl.pdf    Vitravene Approved Label

Date Posted: 10/5/98
Revised: 7/25/00

 

Back to Drug Side Effects


source: FDA


last update: December 2004





This information is not intended to be a substitute for professional medical advice. You should not use this material to diagnose or treat a health condition or disease without consulting with your healthcare provider.
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