ADSTILADRIN
For when Bacillus Calmette-Guérin (BCG) treatment does not work, and you are unable to or have decided not to have your bladder removed.
INDICATION:
ADSTILADRIN is a treatment for adults who have all the following:
- High-risk non–muscle-invasive bladder cancer
- Cancer that is no longer responding to Bacillus Calmette-Guérin (BCG) therapy
- Cancer that started in the bladder and has not spread (this is called carcinoma in situ or CIS)
- Cancer with or without slender, finger-like tumor growths (papillary tumors) growing into the bladder space, away from the bladder wall
Please see Important Safety Information throughout and full Prescribing Information for ADSTILADRIN.
Living with non–muscle-invasive bladder cancer (NMIBC)
The bladder is a part of our body where urine is stored. NMIBC is bladder cancer that has not spread past the lining of the bladder into the muscle. It is the most common type of bladder cancer.
For early-stage bladder cancer, BCG is a common first therapy. But sometimes, BCG therapy can stop working. When you find that you need additional treatment for bladder cancer, you may be concerned about what comes next.
If BCG therapy stops working, there are only a few approved treatment options available to try before you may need to have your bladder removed. But there are reasons to feel hopeful—and treatments that may help you keep your bladder.
What is ADSTILADRIN?
It is important to learn all you can about treatment, including how it works, how it was studied, and what to expect before, during, and after treatment.
Here are a few quick facts about ADSTILADRIN to help you get started.
Your healthcare team will talk to you about your options. Work closely with them to create a treatment plan that is made just for you.
IMPORTANT SAFETY INFORMATION
Who should not receive ADSTILADRIN?
Do not receive ADSTILADRIN if you have a sensitivity to interferon alfa or any of its components.
Please see Important Safety Information throughout and full Prescribing Information for ADSTILADRIN.
Treatment with ADSTILADRIN
ADSTILADRIN is delivered using a catheter that goes directly into your bladder. This is like the process for BCG treatment. The posttreatment directions are like those for after BCG treatment as well. Learn more about the steps you need to take on page 4.
ADSTILADRIN was shown to be well tolerated and effective
ADSTILADRIN was studied in 98 people with high-risk NMIBC whose cancer did not respond to BCG therapy.
IMPORTANT SAFETY INFORMATION
What are the possible side effects of ADSTILADRIN?
The most common side effects of ADSTILADRIN include: Urinary discharge, fatigue, bladder spasm, urgency to urinate, and blood in your urine.
These are not all the possible side effects of ADSTILADRIN. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.FDA.gov/medwatch or call 1-800-332-1088. You may also contact Ferring Pharmaceuticals at 1-888-FERRING.
Please see Important Safety Information throughout and full Prescribing Information for ADSTILADRIN.
What to expect when taking ADSTILADRIN
Work closely with your healthcare provider before, during, and after your treatment to ensure a successful visit.
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider?
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see Important Safety Information throughout and full Prescribing Information for ADSTILADRIN.
What to expect after ADSTILADRIN treatment
These are not all the possible side effects of ADSTILADRIN. Call your doctor for medical advice about side effects if they continue for more than 2 days after treatment. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Ferring Pharmaceuticals at 1-888-337-7464, option 1.
Other important things to consider:
- Your healthcare team may suggest keeping movement to a minimum
- Ask your team if they suggest any movement restrictions after you have received treatment
- After your first dose, your doctor may monitor how well ADSTILADRIN is working
- They will do this with a procedure that uses a thin, tubelike instrument with a light that allows the doctor to view the inside of your bladder
Please see Important Safety Information throughout and full Prescribing Information for ADSTILADRIN.
Ferring is here to help support you during your treatment
Ferring Access Support is a program that offers patient assistance, coverage support, and other valuable resources.
Your case manager is here to help
It’s important to work closely with your case manager to avoid delays in your treatment. They may call from a phone number that you don’t recognize, so try your best to answer those calls.
Your case manager will work with your health insurer to determine whether ADSTILADRIN is covered by your plan. They can also share information about other programs, such as the ADSTILADRIN Copay Program or Ferring Access Support Patient Assistance Program, to help you get access to ADSTILADRIN. Terms and conditions apply.
Contact your Ferring Access Support case manager right away if you have any change in insurance coverage.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about ADSTILADRIN?
Individuals who are immunosuppressed or immune-deficient should not prepare, administer, receive or come into contact with ADSTILADRIN.
Please see Important Safety Information throughout and full Prescribing Information for ADSTILADRIN.