Source: FDA, National Drug Code (US) Revision Year: 2023
ADSTILADRIN (nadofaragene firadenovec-vncg) is a non-replicating adenoviral vector-based gene therapy for intravesical instillation.
It is a recombinant adenovirus serotype 5 vector containing a transgene encoding the human interferon alfa-2b (IFNα2b).
ADSTILADRIN has a nominal concentration of 3 × 1011 vp/mL.
A single-use vial of ADSTILADRIN contains an extractable volume of 20 mL and the following excipients: [N-(3-cholamidopropyl)N(3-lactobionamidopropyl)]-cholamide (Syn3) (0.95 mg/mL), citric acid monohydrate (0.01 mg/mL), glycerol (84 mg/mL), hydroxypropyl-beta-cyclodextrin (7.9 mg/mL), magnesium chloride hexahydrate (0.34 mg/mL), polysorbate 80 (Tween 80) (0.48 mg/mL), sodium dihydrogen phosphate dihydrate (1.4 mg/mL), sucrose (17 mg/mL), tri-sodium citrate dihydrate (0.04 mg/mL), tromethamine (1.4 mg/mL) and Water for Injection (q.s. 1 mL).
ADSTILADRIN is a sterile, clear to opalescent suspension, and contains no preservative.
| Dosage Forms and Strengths |
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ADSTILADRIN is a sterile, clear to opalescent suspension for intravesical instillation, supplied as single-use vials. ADSTILADRIN is provided in a carton containing four (4) vials. All vials have a nominal concentration of 3 × 1011 viral particles (vp)/mL. Each vial of ADSTILADRIN contains an extractable volume of not less than 20 mL. |
| How Supplied |
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ADSTILADRIN is shipped frozen at ≤ -60°C (≤ -76°F) in an insulated shipping box that will maintain the required temperature for a minimum of 72 hours after being sealed. Each carton (NDC 55566-1050-1) contains a removable cardboard nest of four (4) clear glass vials of ADSTILADRIN. Each vial (NDC 55566-1050-0) contains a sterile frozen suspension with an extractable volume of 20 mL and is sealed with a bromobutyl rubber stopper and a tamper-evident aluminum crimp. Manufactured for: Ferring Pharmaceuticals, 2770 Kastrup, Denmark by: FinVector Oy. Kuopio, Finland |
| Drug | Countries | |
|---|---|---|
| ADSTILADRIN | United States |
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