Ranibizumab
Class: EENT Drugs, Miscellaneous
VA Class: OP900
Chemical Name: Disulfide with human-mouse monoclonal rhuFAB V2 light chain anti-(human vascular endothelial growth factor) Fab fragment (human-mouse monoclonal rhuFAB V2 γ1-chain) immunoglobulin G1
Molecular Formula: C2158H3282N562O681 S12
CAS Number: 347396-82-1
Brands: Lucentis
Introduction
Recombinant humanized immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody fragment; a vascular endothelial growth factor A (VEGF-A) antagonist.
Uses for Ranibizumab
Neovascular Age-related Macular Degeneration
Treatment of neovascular (wet) age-related macular degeneration.
Macular Edema Following Retinal Vein Occlusion
Treatment of macular edema following retinal vein occlusion.
Diabetic Macular Edema
Treatment of diabetic macular edema.
Diabetic Retinopathy in Patients with Diabetic Macular Edema
Treatment of diabetic retinopathy (proliferative or nonproliferative) in patients with diabetic macular edema.
Ranibizumab Dosage and Administration
Administration
Ophthalmic Administration
Administer by intravitreal injection only into the affected eye(s).
Commercially available as single-use vials containing 0.3 or 0.5 mg of the drug for intravitreal injection. Prior to intravitreal administration, withdraw entire contents of the appropriate strength ranibizumab vial a sterile 5-µm, 19-gauge filter needle (provided by manufacturer) into a 1-mL tuberculin syringe using aseptic technique. Next, replace filter needle with a sterile 30-gauge, ½-inch needle (provided by manufacturer) for intravitreal injection. To obtain appropriate dose (0.3 or 0.5 mg), expel contents in tuberculin syringe until plunger tip is aligned with the line that marks 0.05 mL on the syringe.
Inject under controlled aseptic conditions (including use of sterile gloves, sterile drape, a sterile eyelid speculum [or equivalent]) following adequate anesthesia and administration of a broad-spectrum anti-infective agent.
Monitor patients for elevation of IOP prior to and 30 minutes following intravitreal injection using tonometry. Monitoring may include evaluation of optic nerve head perfusion immediately after injection. Monitor patients for any manifestations of endophthalmitis. (See Advice to Patients.)
Each vial should be used only for treatment of a single eye. If contralateral eye requires treatment, use a new vial; change sterile field, syringe, gloves, drape, eyelid speculum, and filter and injection needles before administering to the other eye.
Dosage
Adults
Neovascular Age-related Macular Degeneration
Ophthalmic
Intravitreal injection: 0.5 mg (0.05 mL of a solution containing 10 mg/mL) into the affected eye(s) once every month (approximately every 28 days).
After the first several months of therapy, may reduce dosing frequency to decrease treatment burden; however, less frequent dosing regimens are not as ...