Source: FDA, National Drug Code (US) Revision Year: 2026
FAYUVI (rebisufligene etisparvovec-hopf) is a gene therapy product. It is a non-replicating, recombinant adeno-associated serotype 9 (AAV9) based vector containing the cDNA of the R169Q variant of the human SGSH gene under the control of the murine small nuclear RNA promoter U1a. FAYUVI is produced in human embryonic kidney cells by recombinant DNA technology.
FAYUVI is a sterile, preservative-free, clear to translucent, colorless suspension for intravenous infusion. Each vial of FAYUVI contains an extractable volume of 2 mL of rebisufligene etisparvovec-hopf at a concentration of 1.0 × 1013 vector genomes/mL solution ([vg]/mL) and the following excipients: 0.001% poloxamer 188, 20 mM Tris base, 200 mM sodium chloride, 1 mM magnesium chloride hexahydrate, and hydrochloric acid (used to adjust the pH as required). The pH of FAYUVI is 8.0. The osmolality is 386 to 435 mOsm/kg.
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FAYUVI is supplied as a clear to translucent, colorless, sterile suspension for intravenous infusion at a concentration of 1.0 × 1013 vector genomes/mL (vg/mL) solution. Each vial of FAYUVI contains 2 mL of extractable volume. FAYUVI is provided in a kit containing 5 to 105 single-dose vials, with each kit constituting a dosage unit based on the patient's body weight [see How Supplied/Storage and Handling (16.1)]. |
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FAYUVI is supplied as a clear to translucent, colorless, sterile suspension for intravenous infusion. FAYUVI contains 1.0 x 1013 vector genomes per mL. FAYUVI is shipped frozen at ≤ -60°C (−76°F) in 8 mL glass vials (with 2 mL extractable volume). FAYUVI is provided as a kit to meet the dosing requirements for each patient. Each kit contains a specified number of FAYUVI vials (NDC 69794-300-01), with a minimum of 5 vials and a maximum of 105 vials. The total number of vials in each kit corresponds to the dosing requirement for the individual patient based on the patient's weight [see Dosage and Administration (2.1)]. Kit sizes and National Drug Codes (NDC) are provided in Table 5. Table 5. FAYUVI Kits:
Manufactured by: Ultragenyx Pharmaceutical Inc., Novato, CA 94949 |
| Drug | Countries | |
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| FAYUVI | United States |
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