Adstiladrin

Adstiladrin (nadofaragene firadenovec-vncg) is a prescription gene therapy used to treat certain adults with high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

It works by delivering the interferon alfa-2b gene into cells in the bladder wall. These cells then produce high levels of interferon alfa-2b protein, a naturally occurring protein that helps the body’s immune system identify and fight cancer cells.

Adstiladrin is not chemotherapy. Instead, it helps the immune system target and destroy bladder cancer cells.

Adstiladrin is a localized bladder treatment that stays in the bladder rather than circulating throughout the body. It is administered as an intravesical instillation, meaning the liquid medicine is delivered directly into the bladder through a catheter, typically once every three months.

Adstiladrin is FDA approved for adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

Once every 3 months, your healthcare provider will administer 75 mL (about 2 and a half ounces) of Adstiladrin into your bladder through a urinary catheter and leave it there for 1 hour. During this time, your healthcare provider may move you about every 15 minutes.

After each treatment, you will need to take these steps to prepare your toilet bowl:

• Add about half a cup of bleach to the toilet bowl before you urinate.
• After urinating, wait 15 minutes before flushing the toilet.
• Repeat these steps every time you urinate for the first 2 days after treatment.

People who are immunosuppressed or immunodeficient should not prepare, administer, receive, or come into contact with Adstiladrin.

Adstiladrin warnings and precautions for

• risk of muscle-invasive or metastatic bladder cancer with delayed cystectomy
• risk of disseminated adenovirus infection

You should not receive this treatment if you have a sensitivity to interferon alfa or any of its components.

The most common side effects of Adstiladrin include:

• Urinary discharge
• Fatigue
• Bladder spasm
• Urgent need to urinate
• Blood in the urine
• Increase glucose
• Increased triglycerides
• Increased creatinine
• Decreased phosphate
• Chills
• Fever

These are not all possible side effects. Talk to your healthcare provider for more information about Adstiladrin side effects.

Call your doctor for medical advice about side effects. You may also report side effects to the FDA at 1-800-FDA-1088 or to Ferring Pharmaceuticals at 1-888-337-7464.

Adstiladrin is for intravesical instillation only.

Adstiladrin is not for intravenous, topical, or oral administration.

Usual Adult Dose of Adstiladrin for Bladder Cancer

• 75 mL at a concentration of 3 x 1011 viral particles (vp)/mL, instilled once every three (3) months.

Comments:

• Premedication with an anticholinergic is recommended before each instillation.
• Administer by intravesical instillation only.
• Allow the Adstiladrin to be left in the bladder for 1 hour following instillation.
• Adstiladrin is provided as a sterile frozen suspension. Follow thawing instructions in the Prescribing Information.

Use:

• for the treatment of adult patients with high-risk Bacillus CalmetteGuérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Adstiladrin is administered into the bladder directly, so is it is unlikely to interact with other medicines.