The most frequently observed adverse experiences have been cases of ocular inflammation (uveitis) including iritis and vitritis. Ocular inflammation has been reported to occur in approximately 1 in 4 patients. Inflammatory reactions are more common during induction dosing. Delaying additional treatment with Vitravene (fomivirsen) † and the use of topical corticosteroids have been useful in the medical management of inflammatory changes (SEE PRECAUTIONS, General).
Adverse experiences reported in approximately 5 to 20% of patients have included:
Ocular: abnormal vision, anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, decreased visual acuity, desaturation of color vision, eye pain, floaters, increased intraocular pressure, photophobia, retinal detachment, retinal edema, retinal hemorrhage, retinal pigment changes, uveitis, vitritis.
Systemic: abdominal pain, anemia, asthenia, diarrhea, fever, headache, infection, nausea, pneumonia, rash, sepsis, sinusitis, systemic CMV, vomiting.
Adverse experiences reported in approximately 2 to 5% of patients have included:
Ocular: application site reaction, conjunctival hyperemia, conjunctivitis, corneal edema, decreased peripheral vision, eye irritation, hypotony, keratic precipitates, optic neuritis, photopsia, retinal vascular disease, visual field defect,vitreous hemorrhage, vitreous opacity.
Systemic: abnormal liver function, abnormal thinking, allergic reactions, anorexia, back pain, bronchitis, cachexia, catheter infection, chest pain, decreased weight, dehydration, depression, dizziness, dyspnea, flu syndrome, increased cough, increased GGTP, kidney failure, lymphoma like reaction, neuropathy, neutropenia, oral monilia, pain, pancreatitis, sweating, thrombocytopenia.
The interaction in humans between fomivirsen sodium and other drugs has not been studied.
Results from in vitro tests demonstrated no inhibition of anti-HCMV activity of fomivirsen by AZT or ddC.