Nadofaragene firadenovec

Nadofaragene firadenovec is used in adults to treat a specific type of bladder cancer.

Nadofaragene firadenovec may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets.

A healthcare provider will give you nadofaragene firadenovec by inserting it into your bladder using a urinary catheter and will keep the medicine in your bladder for 1 hour. During this hour, you need to move around every 15 minutes.

Follow these steps every time you urinate for the first 2 days after treatment:

• Add about half a cup of bleach to the toilet bowl before you urinate.
• After you urinate, wait 15 minutes before flushing the toilet.

You may receive other medications to help prevent serious side effects or allergic reactions. Continue taking these medications for as long as your doctor has instructed.

Waiting too long for a cystectomy (surgery for bladder cancer) when the usual treatment does not work could make the cancer worse. Discuss your risk with your doctor.

People with a weak immune system should not prepare, administer, receive, or come into contact with nadofaragene firadenovec.

People with a weak immune system should not prepare, administer, receive, or come into contact with nadofaragene firadenovec.

You should not use nadofaragene firadenovec if you are allergic to interferon alfa or to any part of nadofaragene firadenovec.

Tell your doctor if you have:

• a weak immune system (caused by a disease or by taking certain medicines).

Nadofaragene firadenovec may harm an unborn baby if the mother or father is using this medicine.

• If you are a woman, you may need a pregnancy test to confirm you are not pregnant. Use birth control while using this medicine and for at least 6 months after your last dose.
• If you are a man, use birth control if your sex partner can get pregnant. Continue using birth control for at least 3 months after your last dose.
• Tell your doctor immediately if a pregnancy happens.

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Nadofaragene firadenovec may cause serious side effects. Call your doctor right away if you have:

• blood in your urine; or
• pressure or pain in your chest.

Common side effects of nadofaragene firadenovec may include:

• abnormal lab results;
• chills;
• fever;
• tiredness;
• discharge from the urinary tract;
• bladder spasms;
• painful urination;
• feeling a strong urge to urinate; or
• blood in your urine.

This is not a complete list of side effects and others may happen. Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Bladder Cancer:

Usual dose: 75 mL at a concentration of 3 x 10(11) viral particles (vp)/mL instilled once every three months into the bladder via a urinary catheterComments:-Administer an anticholinergic as a premedication prior to each instillation of this drug.Use: For the treatment of adult patients with high-risk Bacillus Calmette Guérin (BCG)-unresponsive non-Muscle Invasive Bladder Cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors

Call your doctor for instructions if you miss an appointment for nadofaragene firadenovec.

In a medical setting, an overdose would be treated quickly.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may affect nadofaragene firadenovec, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.