HOW SUPPLIED

lntravitreal injection: preservative-free, 0.25-ml, single-use vials containing 6.6 mg/ml

ACTION

A phosphorothioate oligonucleotide that inhibits human CMV replication by binding to the target mRNA and subsequently inhibiting virus replication.

INDICATIONS & DOSAGE

Local treatment of CMV retinitis in patients with AIDS, who are intolerant of or have a contraindication to other treatments or who were insufficiently responsive to previous treatment -

Adults: induction dose is 330 mcg (0.05 ml) by intravitreal injection every other week for two doses. Subsequent maintenance dose is 330 mcg (0.05 ml) by intravitreal injection once q 4 weeks after induction.

ADVERSE REACTIONS

CNS: asthenia, headache, abnormal thinking, depression, dizziness, neuropathy, pain.

CV: chest pain.

EENT: abnormal or blurred vision, anterior chamber inflammation, 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, vitreitis, 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, sinusitis.

GI: abdominal pain, anorexia, diarrhea, nausea, vomiting, decreased weight, oral candidiasis, pancreatitis.

GU: catheter infection, kidney failure.

Hematologic: anemia, lymphoma-like reaction, neutropenia, thrombocytopenia.

Hepatic: abnormal liver function tests, increased GGT.

Metabolic: dehydration.

Musculoskeletal: back pain.

Respiratory: bronchitis, dyspnea, increased cough, pneumonia.

Skin: rash, sweating. Other: allergic reactions, cachexia, fever, flulike syndrome, infection, sepsis, systemic CMV.

INTERACTIONS

None significant.

EFFECTS ON DIAGNOSTIC TESTS

None reported.

CONTRA INDICATIONS

Contraindicated in patients with hyper­sensitivity to drug or its components or in those who have recently (within 2 to 4 weeks) been treated with either I.V. or intravitreal cidofovir because of an increased risk of exaggerated ocular inflammation.

SPECIAL CONSIDERATIONS

Alert: Drug is for ophthalmic use by intravitreal injection only.

Drug provides localized therapy limited to the treated eye, and does not provide treatment for systemic CMV disease. Patient must be monitored for extraocular CMV disease or disease in the contralateral eye.

Ocular inflammation (uveitis) is more common during induction dosing.

Light perception and optic nerve head perfusion must be monitored postinjection.

Intraocular pressure must be monitored. This is usually transient and returns to normal without treatment or with temporary use of topical medications.

Patient teathing

Drug is not a cure for CMV retinitis. Progression of retinitis may occur during and following treatment.

Drug treats only the eye in which it has been injected, and CMV may also exist in the body. Follow-up visits are important to monitor progress and to check for additional infections.

Patient should have regular ophthalmologic follow-up examinations.

If HIV-infected, continue taking antiretroviral therapy as indicated.