NADOFARAGENE FIRADENOVEC-VNCG

Other

Brand names: ADSTILADRIN

Intravesical

Mechanism of Action

12.1 Mechanism of Action ADSTILADRIN is a non-replicating adenoviral vector-based gene therapy designed to deliver a copy of a gene encoding a human interferon-alfa 2b (IFNα2b) to the bladder urothelium. Intravesical instillation of ADSTILADRIN results in cell transduction and transient local expression of the IFNα2b protein that is anticipated to have anti-tumor effects.

Indications

See full prescribing information

FDA Warnings

5 WARNINGS AND PRECAUTIONS Delaying cystectomy could lead to the development of metastatic bladder cancer, which can be lethal
1 ) Risk of disseminated adenovirus infection: Persons who are immunocompromised or immunodeficient may be at risk for disseminated infection from ADSTILADRIN due to low levels of replication-competent adenovirus
1 Risk of Muscle Invasive or Metastatic Bladder Cancer with Delayed Cystectomy Delaying cystectomy in patients with BCG-unresponsive CIS could lead to development of muscle invasive or metastatic bladder cancer, which can be lethal
The risk of developing muscle-invasive or metastatic bladder cancer increases the longer cystectomy is delayed in the presence of persisting CIS

Known Side Effects

4 documented side effects by frequency

Fever

1-10%

Fatigue

1-10%

Drug Not Working

1-10%

Headache

0.1-1%

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Formulations

Dosage Forms

Tablet

Route

Intravesical