Source: FDA, National Drug Code (US) Revision Year: 2020
Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in Escherichia coli cells by recombinant DNA technology.
BEOVU (brolucizumab-dbll) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly brownish-yellow solution in a single-dose vial for intravitreal administration. Each vial is designed to deliver 0.05 mL of solution containing 6 mg brolucizumab-dbll, polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), and Water for Injection, USP and with a pH of approximately 7.2.
| Dosage Forms and Strengths |
|---|
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Intravitreal injection: 6 mg/0.05 mL, clear to slightly opalescent and colorless to slightly brownish-yellow solution in a single-dose vial. |
| How Supplied |
|---|
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BEOVU (brolucizumab-dbll) injection is supplied as a clear to slightly opalescent and colorless to slightly brownish-yellow solution in a single-dose vial. Each BEOVU carton (NDC 0078-0827-61) contains one BEOVU vial and one sterile 5 µm blunt filter needle (18-gauge x 1½ inch, 1.2 mm x 40 mm). |
| Drug | Countries | |
|---|---|---|
| BEOVU | Austria, Canada, Cyprus, Estonia, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom, United States |
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