Nadofaragene firadenovec-vncg Intravesical

WHY is this medicine prescribed?

Nadofaragene firadenovec-vncg is used to treat a certain type of bladder cancer that was not effectively treated with another medication (Bacillus Calmette-Guerin; BCG therapy). Nadofaragene firadenovec-vncg is in a class of medications called gene therapy. It works by helping your body to produce interferon alfa-2b, a natural substance that fights cancer cells in your bladder.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Nadofaragene firadenovec-vncg comes as a suspension (liquid) to be infused (injected slowly) through a catheter (small flexible plastic tube) into your bladder while you are lying down. Nadofaragene firadenovec-vncg solution is given by a doctor or a health care provider in a medical office, hospital, or clinic. It is usually given once every 3 months.

You should keep the medication in your bladder for 1 hour or as long as possible. During the hour after the medication is infused, you will lie on your stomach, back, and sides for 15 minutes each. If you cannot keep the medication in your bladder for the entire hour, tell your health care provider. At the end of 1 hour you will empty your bladder.

Your urine should be disinfected for 2 days after the medication is administered. Pour about one half cup (120 mL) of undiluted bleach in the toilet before you urinate. After urinating, wait 15 minutes before flushing.

You may have symptoms of an irritable bladder during or shortly after treatment with nadofaragene firadenovec-vncg suspension such as a sudden need to urinate or leaking of urine. Tell your doctor if you have bladder cramping or if any nadofaragene firadenovec-vncg suspension leaks out of the bladder.

Your doctor will watch you carefully to see how well treatment with nadofaragene firadenovec-vncg works for you. If you do not respond fully to treatment after 3 months or if your cancer returns, your doctor will probably recommend treatment with surgery.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving nadofaragene firadenovec-vncg,

• tell your doctor and pharmacist if you are allergic to nadofaragene firadenovec-vncg, interferon alfa-2b, any other medications, or any of the ingredients in nadofaragene firadenovec-vncg. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you are immunocompromised (have a weakened immune system) due to a medical condition or being on certain medicines that may interfere with your immune response or if you have or have ever had any other medical conditions.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. If you are female, you will need to take a pregnancy test before starting treatment and use effective birth control to prevent a pregnancy during your treatment and for 6 months after your final dose. If you are male, you and your female partner should use effective birth control while you are receiving nadofaragene firadenovec-vncg and for 3 months after the final dose. Talk to your doctor about using birth control to prevent pregnancy during your treatment with nadofaragene firadenovec-vncg. If you or your partner become pregnant while receiving nadofaragene firadenovec-vncg, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a dose of nadofaragene firadenovec-vncg, call your doctor right away.

What SIDE EFFECTS can this medicine cause?

Nadofaragene firadenovec-vncg may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• leakage of urine
• bladder spasms
• frequent, urgent, or painful urination
• tiredness
• chills
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• blood in urine

Nadofaragene firadenovec-vncg may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.