Drug Class Description
Antineovascularisation agents
Generic Name
Ranibizumab
Drug Description
One ml contains 10 mg ranibizumab. Each vial contains 2.3 mg of ranibizumab in 0.23 ml solution.Ranibizumab is a humanised monoclonal antibody fragment produced in Escherichia coli cells by recombinant DNA technology.
Presentation
Solution for injectionSterile, clear, colourless to pale yellow aqueous solution
Indications
Lucentis is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).
Adult Dosage
Single-use vial for intravitreal use only.
Lucentis must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose for Lucentis is 0.5 mg (0.05 ml).
Lucentis treatment is initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase in which patients should be monitored for visual acuity on a monthly basis. If the patient experiences a loss of greater than 5 letters in visual acuity (ETDRS or one Snellen line equivalent), Lucentis should be administered. The interval between two doses should not be shorter than 1 month.
As with all medicinal products for parenteral use, Lucentis should be inspected visually for particulate matter and discoloration prior to administration.
Before treatment, the patient should be instructed to self-administer antimicrobial drops (four times daily for 3 days before and following each injection).
The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required). The patient's medical history for hypersensitivity reactions should be carefully eva luated prior to performing the intravitreal procedure. The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection.
For information on preparation of Lucentis, see section 6.6.
The injection needle should be inserted 3.5
4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 ml is then delivered; a different scleral site should be used for subsequent injections.
Additional information on special populations
