Adstiladrin 3X10exp11 Vp/Ml Intravesical Suspension

GENERIC NAME(S): Nadofaragene Firadenovec-Vncg

OTHER NAME(S): Adstiladrin Suspension

Uses

This product is used to treat a certain type of cancer (bladder cancer). Nadofaragene firadenovec is made from a certain virus that has been specially prepared. The virus is used to carry a certain human gene (interferon alfa) into cells. This type of treatment is known as gene therapy.

How to use Adstiladrin 3X10exp11 Vp/Ml Intravesical Suspension

Read the Patient Information Leaflet if available from your pharmacist before you start using this product and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This product is given into the bladder through a tube (catheter) by a health care professional. It is given as directed by your doctor, usually every 3 months.

The product is left in the bladder for 1 hour and then released by urinating. During the 1 hour, your doctor may have you change positions every 15 minutes to make sure the product gets to all parts of the bladder. Follow your doctor's instructions carefully.

Small amounts of virus may shed in the urine. Since the urine may contain a virus that may infect you or others, you must disinfect the toilet bowl every time you urinate for the first 2 days after treatment. Add half a cup of bleach to the toilet bowl before you urinate. After urinating, wait 15 minutes before you flush the toilet. Talk to your doctor about other important things you must do to prevent infection.

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Side Effects

Tiredness, urinary discharge, difficult/painful/frequent urination, or bladder spasms may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pink/bloody urine, signs of infection (such as such as sore throat that doesn't go away, fever, chills).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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Precautions

Before receiving nadofaragene firadenovec, tell your doctor or pharmacist if you are allergic to it; or to interferon alfa; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this product, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV, certain cancers such as leukemia/lymphoma).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using nadofaragene firadenovec. Nadofaragene firadenovec may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this product passes into breast milk. Consult your doctor before breastfeeding.

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Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as triglyceride levels, blood sugar levels) should be done while you are using this product. Keep all medical and lab appointments.

Missed Dose

It is important to get each dose of this product as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.