Antiviral Agent, Ophthalmic

Local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome who are intolerant or insufficiently responsive to other treatments for CMV retinitis or when other treatments for CMV retinitis are contraindicated

Studies have not been conducted in pregnant women. Should be used in pregnancy only when potential benefit to the mother outweighs the potential risk to the fetus. Excretion in human milk is unknown. Use during breast-feeding is contraindicated - a decision to discontinue nursing or discontinue the drug is should be made.

Hypersensitivity to fomivirsen or any component

For ophthalmic use via intravitreal injection only. Uveitis occurs frequently, particularly during induction dosing. Do not use in patients who have received intravenous or intravitreal cidofovir within 2-4 weeks (risk of exaggerated inflammation is increased). Patients should be monitored for CMV disease in the contralateral eye and/or extraocular disease. Commonly increases intraocular pressure - monitoring is recommended.

5% to 10%:

Central nervous system: Fever, headache

Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting

Hematologic: Anemia

Neuromuscular & skeletal: Asthenia

Ocular: Uveitis, abnormal vision, anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, decreased visual acuity, loss of color vision, eye pain, increased intraocular pressure, photophobia, retinal detachment, retinal edema, retinal hemorrhage, retinal pigment changes, vitreitis

Respiratory: Pneumonia, sinusitis

Miscellaneous: Systemic CMV, sepsis, infection

2% to 5%:

Cardiovascular: Chest pain

Central nervous system: Confusion, depression, dizziness, neuropathy, pain

Endocrine and metabolic: Dehydration

Gastrointestinal: Abnormal LFTs, pancreatitis, anorexia, weight loss

Hematologic: Thrombocytopenia, lymphoma

Neuromuscular & skeletal: Back pain, cachexia

Ocular: Application site reaction, conjunctival hyperemia, conjunctivitis, corneal edema, decreased peripheral vision, eye irritation, keratic precipitates, optic neuritis, photopsia, retinal vascular disease, visual field defect, vitreous hemorrhage, vitreous opacity

Renal: Kidney failure

Respiratory: Bronchitis, dyspnea, cough

Miscellaneous: Allergic reaction, flu-like syndrome, diaphoresis (increased)

Drug interactions between fomivirsen and other medications have not been conducted.

Store between 2°C to 25°C (35°F to 77°F); protect from excessive heat or light

Inhibits synthesis of viral protein by binding to mRNA which blocks replication of cytomegalovirus through an antisense mechanism

Pharmacokinetic studies have not been conducted in humans. In animal models, the drug is cleared from the eye after 7-10 days. It is metabolized by sequential nucleotide removal, with a small amount of the radioactivity from a dose appearing in the urine.

Adults: Intravitreal injection: Induction: 330 mcg (0.05 mL) every other week for 2 doses, followed by maintenance dose of 330 mcg (0.05 mL) every 4 weeks

Immediately after injection, light perception and optic nerve head perfusion should be monitored. Anterior chamber paracentesis may be necessary if perfusion is not complete within 7-10 minutes after injection. Subsequent patient evaluation should include monitoring for contralateral CMV infection or extraocular CMV disease, and intraocular pressure prior to each injection.

No information available to require special precautions

No effects or complications reported

Solution, for ocular injection: 6.6 mg/mL (0.25 mL)

Leeds JM, Henry SP, Bistner S, et al, "Pharmacokinetics of an Antisense Oligonucleotide Injected Intravitreally in Monkeys," Drug Metab Dispos, 1998, 26(7):670-5.

Leeds JM, Henry SP, Truong L, et al, "Pharmacokinetics of a Potential Human Cytomegalovirus Therapeutic, a Phosphorothioate Oligonucleotide, After Intravitreal Injection in the Rabbit," Drug Metab Dispos, 1997, 25(8):921-6.