Patient Medication Information: uses, side effects, how to take - Adstiladrin
What ADSTILADRIN is used for:
ADSTILADRIN is used in adult patients for the treatment of a certain type of bladder cancer that has not spread to nearby tissue in the bladder but is at high-risk for spreading (high-risk non-muscle invasive bladder cancer [NMIBC]) when:
- your tumour is a type called “carcinoma in situ” (CIS), and
- you have tried treatment with Bacillus Calmette-Guérin (BCG) and it did not work
How ADSTILADRIN works:
ADSTILADRIN is a therapy administered directly into the bladder. The active substance in ADSTILADRIN is based on a virus that has been modified so that it cannot spread in the body (non-replicating). The virus delivers a working copy of the interferon alpha 2b (IFNα2b) gene into the cells in the surface of your bladder. The IFNα2b protein is then produced in the bladder and is anticipated to have anti-tumour effects.
The ingredients in ADSTILADRIN are:
Medicinal ingredient(s): nadofaragene firadenovec
Non-medicinal ingredients: Citric acid monohydrate, glycerol, hydroxypropylbetadex, magnesium chloride hexahydrate, polysorbate 80, sodium dihydrogen phosphate dihydrate, sucrose, syn3NODA ([N-(3-cholamidopropyl)-N-(3-lactobionamidopropyl)]-cholamide), sodium citrate, trometamol, water for injection
ADSTILADRIN comes in the following dosage form(s):
Suspension for intravesical instillation, nominal concentration of 3 x 1011 viral particles (vp)/mL.
Do not use ADSTILADRIN if:
- You are allergic (hypersensitive) to interferon alpha or to any of the ingredients in ADSTILADRIN.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take ADSTILADRIN. Talk about any health conditions or problems you may have, including if you:
- Are, or think you might be, immunocompromised or immune-deficient (when your immune system’s ability to fight infections is reduced), or if someone who cares for you is
- Are pregnant or plan to become pregnant
- Have, or think you might have, a urinary tract infection
- Are breastfeeding or plan to breastfeed
Other warnings you should know about:
Risk of disease progression when delaying cystectomy
- For patients with non-muscle invasive bladder cancer, delaying cystectomy (bladder removal) in order to receive ADSTILADRIN could lead to development of muscle-invasive or metastatic bladder cancer, which can be lethal. This risk could increase the longer cystectomy is delayed. Discuss this risk with your healthcare professional before starting treatment with ADSTILADRIN.
Risk to an immunocompromised or immune-deficient person
- Individuals who are immunosuppressed, immune-deficient, or pregnant should not come into contact with ADSTILADRIN as this may increase the risk of a disseminated adenovirus infection. Discuss this risk with your healthcare professional before starting treatment with ADSTILADRIN.
- Following treatment, ADSTILADRIN may temporarily be present in your urine. Immunosuppressed or immune-deficient individuals should avoid contact with a treated patient’s urine.
- For the first 2 days after you have been given ADSTILADRIN, you should add two cups of household bleach to the toilet bowl prior to passing urine. After passing of urine, you should wait for 15 minutes before flushing the toilet.
Urinary tract infections
- ADSTILADRIN will not be given to you if you have a urinary tract infection.
- Tell your healthcare professional if you have signs of a urinary tract infection, such as cloudy or bloody urine, pain or burning when passing urine, a strong need to urinate often, or fever.
Pregnancy
- You should not use ADSTILADRIN if you are pregnant. If you are pregnant, think you may be pregnant or are planning to have a baby, talk to your healthcare professional before taking this medicine.
- It is not known if ADSTILADRIN can harm your unborn baby.
Breastfeeding
- Tell your healthcare professional if you are breastfeeding or plan to breastfeed.
- It is not known if ADSTILADRIN is passed into breastmilk.
Contraception
- Females who could become pregnant should use an effective double contraceptive (birth control) method during treatment with ADSTILADRIN and for at least 6 months after the last dose of ADSTILADRIN. This recommendation also applies to females who have a male partner who is being treated with ADSTILADRIN.
- Males should use an effective barrier method of birth control during treatment with ADSTILADRIN and for at least 3 months after the last dose of ADSTILADRIN. Patients should not donate sperm, and partners should avoid contact with semen during this period.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take ADSTILADRIN:
ADSTILADRIN will be given to you by a healthcare professional who specializes in the management of your condition.
Before you are given ADSTILADRIN
Your healthcare professional may give you another medicine (an anti-cholinergic agent) on the day you get ADSTILADRIN. This medicine is given to reduce potential irritation of the bladder and to prevent the passing of urine when ADSTILADRIN is given. Take this medicine according to your healthcare professional’s direction.
How you are given ADSTILADRIN
- A urinary catheter (flexible tube) will be inserted into your bladder.
- ADSTILADRIN will be instilled slowly into your bladder through the urinary catheter.
- ADSTILADRIN will be left in your bladder for 1 hour and your healthcare professional may ask you to change position from left to right and back to stomach. This is to ensure that ADSTILADRIN is delivered to the entire surface of your bladder.
- In case you experience bladder cramping or passing of urine during the procedure, your doctor may ask you to change position.
- After 1 hour your doctor will empty your bladder with a urinary catheter, or you may be asked to pass urine.
After you have been given ADSTILADRIN
For the first 2 days after you have been given ADSTILADRIN, you should add two cups of household bleach to the toilet bowl before passing urine. After passing of urine, you should wait for 15 minutes before flushing the toilet.
Usual dose:
The recommended dose is 75 mL of ADSTILADRIN at a concentration of 3 x 1011 viral particles (vp)/mL, instilled once every three months into the bladder via a urinary catheter.
Your healthcare professional will decide how many treatments you need.
Overdose:
If you think you, or a person you are caring for, have taken too much ADSTILADRIN, contact a healthcare professional, hospital emergency department, regional poison control centre, or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using ADSTILADRIN:
These are not all the possible side effects you may have when taking ADSTILADRIN. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of ADSTILADRIN (occurring in more than 10% of patients) include:
- Urinary discharge
- Fatigue
- Bladder spasm
- Urgency to urinate
- Blood in your urine
- Pain or discomfort during urination
- Fever
- Chills
- Headache
- Urinary tract infections
- Diarrhea
- Urinary tract pain
- Abnormally frequent urination
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking the/this drug (if applicable) and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Very Common | |||
| Hematuria (blood in the urine) | ✓ | ||
| Urinary Tract Infection: cloudy or bloody urine, pain or burning when passing urine, a strong need to urinate often, or fever | ✓ | ||
| Common | |||
| Syncope: Fainting | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
ADSTILADRIN will be stored in the hospital or clinic where it is given to you.
If you want more information about ADSTILADRIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website (www.ferring.ca/en/products/), or by calling 1-866-384-1314.
Date of Authorization: March 16, 2026
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