LUCENTIS is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration.

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.

LUCENTIS 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month.

Although less effective, treatment may be reduced to one injection every three months after the first four injections if monthly injections are not feasible. Compared to continued monthly dosing, dosing every 3 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit, on average, over the following 9 months. Patients should be evaluated regularly [see CLINICAL STUDIES].

Using aseptic technique, all (0.2 mL) of the LUCENTIS vial contents are withdrawn through a 5-micron 19-gauge filter needle attached to a 1-cc tuberculin syringe. The filter needle should be discarded after withdrawal of the vial contents and should not be used for intravitreal injection. The filter needle should be replaced with a sterile 30-gauge 1/2-inch needle for the intravitreal injection. The contents should be expelled until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.

The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

Following the intravitreal injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and biomicroscopy between two and seven days following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay. Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before LUCENTIS is administered to the other eye.

No special dosage modification is required for any of the populations that have been studied (e. g. , gender, elderly).

LUCENTIS should be refrigerated at 2°-8°C (36°-46°F). DO NOT FREEZE. Do not use beyond the date stamped on the label. LUCENTIS vials should be protected from light. Store in the original carton until time of use.

DOSAGE FORMS AND STRENGTHS

Single-use glass vial designed to deliver 0.05 mL of 10 mg/mL.

STORAGE AND HANDLING

Each LUCENTIS carton, NDC 50242-080-01, contains one 2-cc glass vial of ranibizumab, one 5-micron, 19-gauge 1-1/2-inch filter needle for withdrawal of the vial contents, one 30-gauge 1/2-inch injection needle for the intravitreal injection, and one package insert [see DOSAGE AND ADMINISTRATION ]. VIALS ARE FOR SINGLE EYE USE ONLY.

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