ADSTILADRIN Intravesical suspension Ref.[116667] Active ingredients: Nadofaragene firadenovec

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Ferring Pharmaceuticals A/S, Amager Strandvej 405, 2770 Kastrup, Denmark

Product name and form

ADSTILADRIN 3 × 1011 viral particles/mL intravesical suspension.

Pharmaceutical Form

Intravesical suspension.

Opalescent, colourless suspension.

Qualitative and quantitative composition

Nadofaragene firadenovec is a gene therapy medicinal product that embeds the gene for expression of the human interferon-α2b (IFNα2b) protein in bladder cells. It is a non-replicating recombinant type 5 adenovirus vector containing the cDNA of the IFNα2b transgene under the control of the cytomegalovirus immediate-early promoter.

Nadofaragene firadenovec is produced in human embryonic kidney cells by recombinant DNA technology.

Each vial contains 20 mL suspension of nadofaragene firadenovec with a concentration of 3 × 1011 viral particles (vp)/mL.

Excipients with known effect:

Each vial contains 9.6 mg polysorbate 80.

For the full list of excipients, see section 6.1.

Active Ingredient

Nadofaragene firadenovec is a non-replicating recombinant type 5 adenovirus vector-based gene therapy containing the human IFNα2b transgene. Intravesical administration of nadofaragene firadenovec results in the entry of viral particles into the tumour cells and the urothelium that make up the luminal surface of the bladder, leading to the expression of IFNα2b protein by those cells. In the transduced cells, the viral DNA does not integrate into the genome. Treatment with nadofaragene firadenovec has shown anti-tumour effects in mice with bladder (cancer cell) xenografts.
List of Excipients

Syn3NODA ([N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide)
Citric acid monohydrate (for pH adjustment) (E330)
Sodium citrate (for pH adjustment) (E331)
Polysorbate 80 (E433)
Hydroxypropylbetadex (E459)
Sodium dihydrogen phosphate dihydrate (for pH adjustment) (E339)
Trometamol (for pH adjustment)
Sucrose
Magnesium chloride hexahydrate (E511)
Glycerol (E422)
Water for injections

Pack sizes and marketing

20 mL of intravesical suspension in a single-dose clear Type 1 glass vial with a bromobutyl rubber stopper sealed with a tamper-evident aluminium crimp.

Each carton contains four vials.

Marketing authorization holder

Ferring Pharmaceuticals A/S, Amager Strandvej 405, 2770 Kastrup, Denmark

Marketing authorization dates and numbers

EU/1/26/2035/001

Drugs

Drug Countries
ADSTILADRIN United States
 
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