Source: FDA, National Drug Code (US) Revision Year: 2024
BEQVEZ (fidanacogene elaparvovec-dzkt) is an adeno-associated virus (AAV)-based gene therapy for intravenous infusion. BEQVEZ is based on recombinant DNA technology that consists of a recombinant viral capsid (AAVRh74var) derived from a naturally occurring AAV serotype (Rh74) vector containing the human coagulation factor IX (FIX) transgene modified to a high-specific factor IX activity variant known as FIX-R338L. The AAVRh74var capsid is derived from the Rh74 AAV, which is not known to cause disease in humans.
Each BEQVEZ vial contains 1 × 1013 vector genomes (vg) per mL, and the excipients sodium chloride (10.5 mg/mL), sodium phosphate, monobasic, monohydrate (0.3 mg/mL), sodium phosphate, dibasic, heptahydrate (2.2 mg/mL), and Poloxamer 188 (0.01 mg/mL) in a 1 mL extractable volume. Each 1 mL of BEQVEZ injection contains less than 5 mg each of sodium and phosphorus.
BEQVEZ requires dilution prior to administration [see Dosage and Administration (2.2)]. BEQVEZ is packaged as a sterile suspension and contains no preservative.
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BEQVEZ is supplied as a clear to slightly opalescent, colorless to slightly brown suspension for intravenous infusion with each mL containing 1 × 1013 vector genomes (vg). Each vial of BEQVEZ contains 1 mL of extractable volume. The total number of vials will be customized to meet dosing requirements for individual patients based on their weight [see Dosage and Administration (2.1)]. Vial contents are to be diluted prior to infusion [see Dosage and Administration (2.2)]. |
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BEQVEZ is supplied as a clear to slightly opalescent, colorless to slightly brown suspension with each mL containing 1 × 1013 vg. BEQVEZ is shipped frozen (−100°C to −60°C [−148°F to −76°F]) in plastic vials with an elastomeric stopper and plastic snap fit cap with an extractable volume of 1 mL. BEQVEZ is provided as a customized kit containing the number of vials (NDC 0069-0422-01) required to meet dosing requirements for each patient [see Dosage and Administration (2.1)]. The customized kit is accompanied with patient’s specific identifier number (Pfizer Patient Identifier) on the outer carton. The kit sizes and National Drug Codes (NDC) are provided in Table 6. Table 6. BEQVEZ Multi-Vial Kits:
Manufactured by Pfizer Inc., New York, NY 10001 Distributed by: Pfizer Labs, Division of Pfizer Inc., New York, NY 10001 |
| Drug | Countries | |
|---|---|---|
| BEQVEZ | Canada, United States |
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