Fomivirsen Brand Name– Vitravene
What is Fomivirsen
NOTE: This drug is discontinued in the US.
Fomivirsen (also known as ISIS 2922) is an ophthalmic antiviral agent.
It is administered by intravitreal injection for the treatment of cytomegalovirus (CMV) retinitis in AIDS patients who have failed therapy with other anti-CMV drugs or who are intolerant or have a contraindication to other therapies.
Fomivirsen is the first drug to be approved based on antisense technology.
It causes fewer side effects and is more selective in its actions than other CMV therapies. Because of its mechanism of action, fomivirsen is more potent against CMV than either ganciclovir or foscarnet.
Fomivirsen injection also appears to be associated with a lower incidence of retinal detachment than ganciclovir intravitreal implant.
Fomivirsen can be used in combination with either foscarnet or ganciclovir. Final FDA approval was granted August 27, 1998.
At the time of approval, the incidence of CMV retinitis had declined due to highly active antiretroviral therapies. As a result, full enrollment was not achieved in any of the clinical trials.
However, 330 patients did receive fomivirsen. If the incidence of CMV retinitis rises, the manufacturer has agreed to conduct phase IV study to further determine the role of fomivirsen.
Indications
- cytomegalovirus (CMV)
- cytomegalovirus (CMV) retinitis
- cytomegalovirus (CMV) retinitis prophylaxis
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: cytomegalovirus (CMV)
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
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) or for those who did not respond sufficiently to other treatment(s) for CMV retinitis
Side Effects
- abdominal pain
- anemia
- anorexia
- asthenia
- back pain
- blurred vision
- candidiasis
- cataracts
- chest pain (unspecified)
- conjunctival hyperemia
- conjunctivitis
- corneal edema
- cough
- dehydration
- depression
- diaphoresis
- diarrhea
- dizziness
- dyspnea
- elevated hepatic enzymes
- fever
- headache
- hypotonia
- infection
- injection site reaction
- iritis
- nausea
- neutropenia
- ocular hemorrhage
- ocular hypertension
- ocular inflammation
- ocular irritation
- ocular pain
- optic neuritis
- pancreatitis
- peripheral neuropathy
- photophobia
- photopsia
- rash
- retinal detachment
- retinal edema
- retinal hemorrhage
- retinal pigment changes
- retinopathy
- sinusitis
- thrombocytopenia
- uveitis
- visual impairment
- vomiting
- weight loss
Monitoring Parameters
- ophthalmologic exam
Contraindications
- breast-feeding
- children
- glaucoma
- increased intraocular pressure
- pregnancy
- retinal bleeding
Interactions
There are no drug interactions associated with Fomivirsen products.