Beovu Brolucizumab Injection

1. Indications and Usage
Neovascular (Wet) Age-Related Macular Degeneration (nAMD):
Treatment of patients with nAMD.
Note: This indication improves visual acuity by inhibiting pathological angiogenesis and reducing retinal fluid.
2. Dosage and Administration
Route of Administration:
For Intravitreal Injection ONLY. Must be administered by an ophthalmologist.
Recommended Dosage:
Dose: 6 mg (0.05 mL) per injection.
Schedule:
Initial Phase: Once every 4 weeks (monthly) for the first 3 months.
Maintenance Phase: Once every 8–12 weeks thereafter, based on disease activity.
Critical Administration Instructions:
Sterile Technique: Administer under sterile conditions with appropriate anesthesia and topical broad-spectrum bacteriostatic agent.
Injection Site: Typically injected into the vitreous cavity (e.g., 3–4 mm posterior to the limbus).
3. Mechanism of Action
Single-Chain Antibody Fragment (scFv):
Brolucizumab is a humanized single-chain antibody fragment (approx. 26 kDa), which is significantly smaller than full-length antibodies (e.g., Ranibizumab/Aflibercept).
VEGF Inhibition:
It binds with high affinity to all isoforms of VEGF-A, preventing interaction with VEGFR-1 and VEGFR-2.
Therapeutic Result: Inhibits pathological angiogenesis and reduces vascular permeability (fluid leakage).
Extended Durability:
Due to its small molecular size and high solubility (allowing high drug concentration), it can penetrate retinal tissue more effectively and maintain therapeutic levels for longer periods, allowing for extended dosing intervals (up to 12 weeks).
4. Safety and Warnings
Intraocular Inflammation (IOI):
Serious intraocular inflammation, including retinal vasculitis and retinal vascular occlusion, has been reported.
Action: Monitor patients for signs of inflammation (e.g., floaters, vision loss, redness) after injection. If IOI is suspected, evaluate promptly and treat with corticosteroids.
Endophthalmitis and Retinal Detachment:
Intravitreal injections carry a risk of intraocular infection and retinal detachment.
Intraocular Pressure (IOP) Spikes:
IOP may increase transiently immediately following injection.
Thromboembolic Events:
Non-fatal stroke, myocardial infarction, or vascular death may occur, although the risk is generally low.
Contraindications:
Active or suspected ocular or periocular infections.
Active intraocular inflammation.
Hypersensitivity to the drug.
5.Adverse Reactions
Most Common:
Conjunctival hemorrhage, eye pain, vitreous floaters, vitreous detachment, and intraocular inflammation (including endophthalmitis, uveitis, and vitritis).
6.Drug Interactions
No Clinical Significance:
No specific drug-drug interaction studies have been conducted. Concomitant use with other anti-VEGF agents is generally avoided.
7.Pharmaceutical Information
Chemical Composition:
Active Ingredient: Brolucizumab.
Appearance: Clear, colorless to slightly yellowish solution.
Packaging: Single-dose vial (6 mg/0.05 mL).
Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze or shake.