ADSTILADRIN is a gene therapy containing the active ingredient nadofaragene firadenovec-vncg in the form of a non-replicating adenoviral vector. It is formulated as a sterile suspension for intravesical instillation, with a nominal concentration of 3 x 10 vp/mL. Key inactive ingredients include glycerol, hydroxypropyl-beta-cyclodextrin, and sucrose. ADSTILADRIN is designed as a recombinant adenovirus serotype 5 vector to deliver human interferon alfa-2b (IFNα2b).

How should I use this medication?

This medication is administered directly into the bladder. It is given by your care team in a hospital or clinic setting.

Handling this medication may be harmful. Talk to your care team about how to handle this medication. Special instructions may apply.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Red or dark brown urine, pain or trouble when passing urine, passing frequent amounts of urine
• Urinary discharge

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Immune system problems
• An unusual or allergic reaction to nadofaragene firadenovec, interferon alfa, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects if taken during pregnancy. A negative pregnancy test is required before starting this medication. A reliable form of contraception is recommended while taking this medication and for 6 months after stopping therapy. Talk to your care team about effective forms of contraception.

Use a condom during sex and for 3 months after stopping treatment. Tell your care team right away if you think your partner might be pregnant. This medication can cause serious birth defects.

This medication requires special bathroom precautions after each treatment. Add a half cup of bleach to the toilet before you urinate. After urinating, wait 15 minutes before flushing the toilet. Repeat each time you urinate for 2 days after each treatment.