Medically reviewed by Drugs.com. Last updated on Aug 19, 2020.
(BROE lue SIZ ue mab)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravitreal [preservative free]:
Beovu: brolucizumab-dbll 6 mg/0.05 mL (0.05 mL) [contains polysorbate 80]
Brand Names: U.S.
- Ophthalmic Agent
- Vascular Endothelial Growth Factor (VEGF) Inhibitor
Brolucizumab is a recombinant humanized monoclonal antibody vascular endothelial growth factor (VEGF) inhibitor that binds to the 3 major isoforms of VEGF-A, thereby suppressing endothelial cell proliferation, neovascularization, and vascular permeability to slow vision loss.
Not fully characterized; free brolucizumab is expected to undergo proteolysis.
Time to Peak
Serum: 24 hours (free brolucizumab).
4.4 ± 2 days.
Use: Labeled Indications
Neovascular (wet) age-related macular degeneration: Treatment of neovascular (wet) age-related macular degeneration.
Hypersensitivity (eg, rash, pruritus, urticaria, erythema, severe intraocular inflammation) to brolucizumab or any component of the formulation; ocular or periocular infections; active intraocular inflammation.
Neovascular (wet) age-related macular degeneration: Intravitreal: 6 mg once per month (approximately every 25 to 31 days) for 3 months, followed by 6 mg once every 8 to 12 weeks.
Refer to adult dosing.
Each vial should only be used for the treatment of a single eye. Allow vial to reach room temperature; solution should be clear to slightly opalescent and colorless to slightly brownish-yellow. Use the provided sterile 5-micron filter needle (18-gauge × 11/2 inch) attached to a 1 mL syringe (with 0.05 mL dose mark) to withdraw solution from vial. Discard filter needle and replace with a sterile 30 gauge × 1/2-inch needle for injection (do not use filter needle for intravitreal injection). Refer to manufacturer's labeling for detailed information.
Intravitreal: For ophthalmic intravitreal injection only. Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before brolucizumab is administered to the other eye. Adequate anesthesia and a topical broad-spectrum antimicrobial agent should be administered prior to the procedure. Refer to manufacturer's labeling for additional detailed information.
Store at 2°C to 8°C (36°F to 46°F); do not freeze. Protect from light. Vial (unopened) may be kept at 20°C to 25°C (68°F to 77°F) for up to 24 hours prior to use.
There are no known significant interactions.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Immunologic: Antibody development (53% to 67%)
1% to 10%:
Cardiovascular: Arterial thromboembolism (5%)
Hypersensitivity: Hypersensitivity reaction (2%)
Ophthalmic: Abnormal sensation in eyes (1%), blindness (1%), blurred vision (10%), cataract (7%), conjunctival hemorrhage (6%), conjunctival hyperemia (1%), conjunctivitis (3%), corneal abrasion (2%), endophthalmitis (1%), eye pain (5%), increased intraocular pressure (4%), increased lacrimation (1%), intraocular inflammation (4% to 6%), punctate keratitis (1%), retinal artery occlusion (1%), retinal detachment (1%), retinal hemorrhage (4%), retinal hole without detachment (1%), retinal pigment epithelium detachment (1%), retinal pigment epithelium tear (3%), vitreous detachment (4%), vitreous opacity (5%)
Postmarketing: Ophthalmic: Retinal vein occlusion
Concerns related to adverse effects:
• Endophthalmitis and retinal detachment: Intravitreal injections may be associated with endophthalmitis and retinal detachment. Use proper aseptic injection technique. Monitor for and report symptoms (eg, eye pain, redness of the eye, photophobia, blurred vision) immediately.
• Increased intraocular pressure: Acute (within 30 minutes) and sustained increases in increased intraocular pressure (IOP) have occurred. Monitor IOP (via tonometry) and optic nerve head perfusion immediately following administration and manage appropriately.
• Retinal vasculitis/retinal vascular occlusion: Cases of retinal vasculitis and/or retinal vascular occlusion have been reported; usually associated with intraocular inflammation. Monitor for and report any changes in vision immediately.
• Thromboembolic events: Risk of arterial thromboembolic events (eg, nonfatal stroke, nonfatal myocardial infarction, vascular death) may be increased with intravitreal use of vascular endothelial growth factor inhibitors.
Intraocular pressure (via tonometry) and optic nerve head perfusion immediately following administration; symptoms of endophthalmitis and retinal detachment.
Evaluate pregnancy status prior to use in females of reproductive potential. Females of reproductive potential should use highly effective contraception (methods with pregnancy rates <1%) during therapy and for ≥1 month following the last brolucizumab dose.
Brolucizumab is a vascular endothelial growth factor (VEGF) inhibitor; VEGF is required to achieve and maintain normal pregnancies (Peracha 2016). Based on findings in animal reproduction studies and on the mechanism of action, brolucizumab may cause fetal harm if administered to a pregnant female.
What is this drug used for?
• It is used to treat macular degeneration.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Seeing floaters
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Vision changes
• Eye pain
• Severe eye irritation
• Eye redness
• Sensitivity to light
• Heart attack like chest pain; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine’s uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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