Brolucizumab is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of:

• Neovascular (wet) Age-Related Macular Degeneration (AMD)
• Diabetic Macular Edema (DME)

Brolucizumab is a human VEGF inhibitor that binds to the three major isoforms of VEGF-A (including VEGF 110, VEGF 121, and VEGF 165), thereby blocking their interaction with VEGFR-1 and VEGFR-2 receptors. By inhibiting VEGF-A, it reduces endothelial cell proliferation, neovascularization, and vascular permeability. Leakage of blood and fluid from choroidal neovascularization (CNV) can result in retinal thickening or edema. Increased retinal thickness and accumulation of intraretinal fluid (IRF) or subretinal fluid (SRF), as detected by optical coherence tomography (OCT), are associated with nAMD and DME. Treatment with brolucizumab has been shown to reduce central subfield thickness (CST) across clinical studies.

Neovascular (Wet) Age-Related Macular Degeneration (AMD): The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately every 25–31 days) for the first three doses, followed by one dose of 6 mg (0.05 mL) every 8–12 weeks.

Diabetic Macular Edema (DME): The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) every six weeks (approximately every 39–45 days) for the first five doses, followed by one dose of 6 mg (0.05 mL of 120 mg/mL solution) every 8–12 weeks.

Pediatric Use: The safety and efficacy of BEOVU in pediatric patients has not been established.

Ocular or Periocular Infections: Brolucizumab is contraindicated in patients with infections in or around the eye.

Active Intraocular Inflammation: Brolucizumab should not be used in patients with active inflammation inside the eye.

Hypersensitivity: Brolucizumab is contraindicated in patients with known hypersensitivity to the drug or any of its components. Hypersensitivity reactions may include rash, itching, urticaria, redness, or severe intraocular inflammation.

The most commonly reported adverse effects in patients receiving Brolucizumab include blurred vision, cataract, conjunctival hemorrhage, eye pain, and vitreous floaters.

There are no adequate and well-controlled studies of BEOVU (brolucizumab) use in pregnant women. In animal studies, intravitreal administration of brolucizumab to pregnant monkeys every 4 weeks during organ development resulted in fetal loss and structural abnormalities (such as bilateral absent metatarsal) at doses approximately 10 times the maximum recommended human dose (MRHD) based on mg/kg.

There is no available information on the presence of brolucizumab in human milk, its effects on the breastfed infant, or its impact on milk production. Since many drugs can pass into breast milk and may cause adverse effects in infants, breastfeeding is not recommended during treatment and for at least one month after the last dose.

• Endophthalmitis and retinal detachment may occur after intravitreal injection. Patients should be advised to seek immediate medical attention if symptoms appear.
• Retinal vasculitis and/or retinal vascular occlusion have been reported, especially in the presence of intraocular inflammation. Patients should report any sudden vision changes promptly.
• Increased intraocular pressure (IOP) has been observed within 30 minutes following injection.
• There is a potential risk of arterial thromboembolic events (ATE) following intravitreal use of VEGF inhibitors.

Store Brolucizumab in a refrigerator at 2°C to 8°C. Do not freeze. Keep the product in its original outer carton to protect from light.
Before use, the unopened vial or sealed blister pack may be kept at room temperature (20°C to 25°C) for up to 24 hours.