Brolucizumab-dbll｜Aiabetic Macular Edema｜HongKong DengYue Medicine

Brolucizumab-dbll Application Scope

Indications:

• Treatment of neovascular (wet) age-related macular degeneration (AMD).

• Treatment of diabetic macular edema (DME).

Brolucizumab-dbll Characteristics

Ingredients:

• Active ingredient: Brolucizumab-dbll (6 mg/0.05 mL).

• Inactive ingredients: Polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), Water for Injection, USP.

Properties:

• Molecular weight: ~26 kDa (single-chain antibody fragment).

• Form: Clear to slightly opalescent, colorless to slightly brownish-yellow solution.

• pH: ~7.

Specification:

• Dosage form: Intravitreal injection.

• Strength: 6 mg/0.05 mL (120 mg/mL solution).

Packaging Specification:

• Single-dose vial or prefilled syringe (for one eye only).

Storage:

• Refrigerate at 2°C–8°C (36°F–46°F); do not freeze.

• May be kept at room temperature (20°C–25°C) for up to 24 hours before use.

Expiry Date:

• Refer to the packaging (not explicitly mentioned in sources).

Executive Standard:

• FDA-approved for wet AMD (2019) and DME (2022).

Approval Number:

• US FDA Approval: October 2019 (AMD), June 2022 (DME).

Date of Revision:

• Last label update: 2022 (for DME indication).

Manufacturer:

• Novartis Pharmaceuticals.

Guidelines for the Use of Brolucizumab-dbll

Dosage and Administration:

• For wet AMD:

  • Initial phase: 6 mg (0.05 mL) every 25–31 days for 3 doses.

  • Maintenance: Every 8–12 weeks.

• For DME:

  • Initial phase: 6 mg (0.05 mL) every 6 weeks (39–45 days) for 5 doses.

  • Maintenance: Every 8–12 weeks.

Adverse Reactions:

• Common: Blurred vision, conjunctival hemorrhage, eye pain, floaters.

• Serious:

  • Intraocular inflammation (retinal vasculitis, retinal vascular occlusion).

  • Endophthalmitis, retinal detachment, increased intraocular pressure.

Contraindications:

• Ocular/periocular infections

• Active intraocular inflammation

• Hypersensitivity to brolucizumab.

Precautions:

• Monitor for vision changes, inflammation, or thromboembolic events.

• Avoid pregnancy & breastfeeding (risk of fetal harm).

Brolucizumab-dbll Interactions

Drug Interactions:

• No significant drug interactions reported.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.