- Indications and Usage Neovascular (Wet) AMD: Indicated for the treatment of neovascular (wet) or exudative age-related macular degeneration. Diabetic Macular Edema (DME): Indicated for the treatment of diabetic macular edema. Macular Edema Following Retinal Vein Occlusion (RVO): Indicated for the treatment of macular edema following retinal artery or vein occlusion. Myopic Choroidal Neovascularization: Indicated for the treatment of neovascularization secondary to myopia.
- Dosage and Administration Dosage: The recommended dose is 0.5 mg (0.05 mL) administered intravitreally. Frequency: Neovascular AMD: Administer monthly for 3 consecutive months, then individualize based on disease activity. DME: Administer monthly until best-corrected visual acuity (BCVA) and disease activity plateau, then individualize. Macular Edema Following RVO: Administer monthly until BCVA and disease activity plateau, then individualize. Administration: Must be administered by a qualified ophthalmologist experienced in intravitreal injections. Strict aseptic technique must be observed. Topical antibiotic eye drops should be used before and after the procedure. Intraocular pressure (IOP) must be monitored after administration.
- Mechanism of Action Ranibizumab is a recombinant humanized monoclonal antibody Fab fragment that binds to and inhibits human vascular endothelial growth factor (VEGF-A). By blocking VEGF, it inhibits the growth of new blood vessels and reduces fluid leakage in the retina.
- Safety and Warnings Endophthalmitis: Serious ocular infections, including endophthalmitis, have been reported following intravitreal administration. Retinal Detachment: Retinal detachment and retinal tears have been reported. Increased Intraocular Pressure: Acute increase in intraocular pressure may occur within 60 minutes of intravitreal administration. Arterial Thromboembolic Events: Serious arterial thromboembolic events (e.g., stroke, myocardial infarction) have been reported. Contraindications: Contraindicated in patients with active or suspected ocular or periocular infections, and in patients with known hypersensitivity to ranibizumab or its excipients.
- Adverse Reactions and Clinical Research Adverse Reactions: The most common adverse reactions include vitreous floaters, conjunctival hemorrhage, eye pain, cataract, and increased intraocular pressure. Clinical Research: Clinical trials have demonstrated significant improvements in visual acuity and reduction in central retinal thickness compared to sham procedures.
- Drug Interactions No specific drug-drug interaction studies have been conducted. Due to the extremely low plasma concentrations following intravitreal administration, systemic drug interactions are considered to be unlikely.
- Pharmaceutical Information Appearance: Clear to slightly opalescent, colorless to pale yellow liquid. Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light. Packaging: Available in single-use pre-filled syringes or single-use cartridges.
Lucentis Ranibizumab Injections
Brand Name: 诺适得 ®（Lucentis®）
Generic Name: Ranibizumab
Strength: 10mg/mL, 0.165mL per pre-filled syringe, 1 syringe per box
Manufacturer: Novartis Pharma Stein AG
Marketing Authorization Holder: Novartis Pharma Stein AG (Domestic distributor: Novartis Pharmaceuticals (China) Co., Ltd.)
Approval Date in China: March 16, 2016
Registration Number: 国药准字SJ20170004
Storage: Store sealed in original packaging at 2°C–8°C, protected from light; do not freeze. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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