Source: FDA, National Drug Code (US) Revision Year: 2023
VYJUVEK (beremagene geperpavec-svdt) is a suspension of a HSV-1 vector-based gene therapy, mixed with the supplied sterile excipient gel for topical application on wounds. VYJUVEK is a live, replication defective HSV-1-based vector that has been genetically modified to express the human type VII collagen (COL7) protein. The parental virus for VYJUVEK was a primary isolate, which was subsequently altered using recombinant methods to result in gene deletions and insertions.
VYJUVEK is an opalescent yellow to colorless biological suspension following thaw from its frozen state. Each 1 mL VYJUVEK vial contains 5 × 109 PFU/mL of VYJUVEK in a solution of 100.0 mL/L Glycerol, 8.0 mg/mL Sodium Chloride, 2.16 mg/mL Sodium Phosphate Dibasic, 0.2 mg/mL Potassium Chloride, 0.2 mg/mL Potassium Phosphate Monobasic.
The excipient gel is a clear viscous solution, following thaw from its frozen state. Each 1.5mL Excipient Gel vial contains 44 mg/mL Hydroxypropyl Methylcellulose in a solution of 0.91 mg/mL Tromethamine, 9.0 mg/mL Sodium Chloride, 0.726 mg/mL Sodium Phosphate Dibasic, 0.21 mg/mL Potassium Phosphate Monobasic.
VYJUVEK biological suspension is mixed into excipient gel prior to administration. After mixing, VYJUVEK gel consists of 5.0 × 109 PFU in a volume of 2.5 mL.
Neither VYJUVEK biological suspension nor the excipient gel contains preservatives.
| Dosage Forms and Strengths |
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VYJUVEK is an opalescent yellow to colorless biological suspension, mixed into excipient gel, for topical application. VYJUVEK biological suspension is supplied as a 1.0 mL extractable volume in a single-use vial with a green cap, at a nominal concentration of 5×109 PFU/mL. The excipient gel is a clear viscous solution supplied as a 1.5 mL fill volume in a separate single-use vial with a blue cap. VYJUVEK biological suspension (1.0 mL) is mixed into the excipient gel vial prior to administration. |
| How Supplied |
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Each carton of VYJUVEK (NDC 82194-510-02) contains one single-dose vial of VYJUVEK biological suspension and one single-dose vial of excipient gel. VYJUVEK biological suspension (inner NDC 82194-501-01), green cap, is supplied as a 1.0 mL extractable volume in a single-use, single-dose vial containing 5 × 109 PFU/mL. Excipient gel (inner NDC 82194-001-01), blue cap, is supplied as a 1.5 mL fill volume in a separate single-use, single-dose vial. |
| Drug | Countries | |
|---|---|---|
| VYJUVEK | United States |
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