IMFINZI FAQs

Below are questions you may have about IMFINZI. Remember, your doctor is the best resource for answering specific questions about your treatment.

What is urothelial carcinoma?

While there are different types of bladder cancer, most people have what’s called urothelial carcinoma. It starts in the inner layer of the bladder. As this cancer advances, it spreads to more layers in the bladder and possibly other parts of your body. 

What does it mean when my doctor says my cancer has become “locally advanced or metastatic”?

When bladder cancer first develops, it is only found in 1 layer of cells. But sometimes, even with treatment, the cancer can get worse, return, or progress. That means that it spreads to more layers in the bladder, which is called “locally advanced”. And if it spreads to other parts of the body, this is known as “metastatic”.

How can immunotherapy help?

Immunotherapy is a type of cancer treatment that gives your immune system the power it needs to find and attack cancer cells.

IMFINZI is a specific type of immunotherapy that may help your body fight advanced bladder cancer when platinum-based therapy has stopped working. There is a chance that IMFINZI may affect healthy cells, too.

What is PD-L1?

PD-L1 is a protein that disguises cancer cells from the immune system. This means that your immune system is not able to find and attack cancer cells.

What is IMFINZI?

IMFINZI is FDA approved to treat a type of cancer in the bladder and urinary tract called urothelial carcinoma. It may be right for you if:

  • Your urothelial carcinoma has spread of cannot be removed by surgery, and
  • Chemotherapy containing platinum did not work or is no longer working

It is not known if IMFINZI is safe and effective in children.

IMFINZI was FDA approved based on a clinical study that measured how many patients responded and how long they responded. There are ongoing studies to confirm clinical benefit.

What is a PD-L1 test?

PD-L1 testing is an optional tool that your doctor can use to determine which treatment may be appropriate for you. To test for PD-L1, your doctor will need to do a biopsy. The test measures how much of the PD-L1 protein is expressed either on the tumor or on immune cells surrounding the tumor.

How will I receive IMFINZI?

IMFINZI is given as an IV (intravenous) infusion every 2 weeks. The infusion usually lasts an hour. Your doctor will determine your dosage based on your weight. You won’t have to go to the pharmacy to pick up IMFINZI. Your doctor or infusion center will provide it.

How long will I stay on IMFINZI?

Every person is different. Your doctor will decide how long you will receive IMFINZI and how many treatments you need.

What are the potential side effects of IMFINZI?

IMFINZI works with your immune system to help treat your advanced bladder cancer so it can find and attack cancer cells. While on IMFINZI, you may experience side effects. This is because in some patients, IMFINZI can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Serious side effects of IMFINZI include:

  • Lung problems
  • Liver problems
  • Intestinal problems
  • Hormone gland problems
  • Kidney problems
  • Skin problems
  • Problems in other organs
  • Severe infections
  • Severe infusion reactions

The most common side effects of IMFINZI are:

  • Feeling tired
  • Muscle and/or bone pain
  • Constipation
  • Decreased appetite
  • Nausea
  • Swelling
  • Urinary tract infection

These are not all of the possible side effects of IMFINZI. Please see full Prescribing Information.

What treatment support is available?

Lighthouse is a support program specifically for people receiving or who have received IMFINZI for their advanced bladder cancer.

Lighthouse does not replace the advice of your doctor. In an emergency, you should seek medical care right away.

If you are interested in receiving additional support during your treatment, talk to your doctor about Lighthouse.

To learn more, visit: LighthouseProgram.com.

Is there support available that can help me access my medicine?

Access 360™ provides personal support so you can have access to the medicines you need. The program will help you work through difficult financial and insurance questions that can make accessing your medicines worrisome. Knowledgeable and compassionate Reimbursement Counselors will provide you with the support you need.

Access 360 can help you with:

  • Complicated insurance questions and processes
  • Finding the financial help that is right for you
  • Identifying alternate support programs if you don’t have or have been denied insurance coverage

To learn more visit www.MyAccess360.com or call 1-844-ASK-A360 (1-844-275-2360) Monday-Friday, 8 AM-8 PM ET.

Important Safety Information

What is the most important information I should know about IMFINZI?

IMFINZI is a medicine that may treat a type of cancer in the bladder and urinary tract by working with your immune system.

In some patients, IMFINZI can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:

  • Lung problems (pneumonitis). Signs and symptoms may include new or worsening cough, shortness of breath, and chest pain.

  • Liver problems (hepatitis). Signs and symptoms include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.

  • Intestinal problems (colitis). Signs and symptoms may include diarrhea; more bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.

  • Hormone gland problems (especially the thyroid, adrenals, pituitary, and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches; extreme tiredness; weight gain or weight loss; dizziness or fainting; feeling more hungry or thirsty than usual; hair loss; feeling cold; constipation; your voice gets deeper; urinating more often than usual; nausea or vomiting; stomach area (abdomen) pain; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.

  • Kidney problems, including nephritis and kidney failure. Signs of kidney problems may include producing less urine than normal, blood in your urine, swelling in your ankles, and loss of appetite.

  • Skin problems. Signs may include rash, itching, and skin blistering.

  • Problems in other organs. Signs and symptoms may include neck stiffness; headache; confusion; fever; changes in mood or behavior; blurry vision, double vision, or other vision problems; and eye pain or redness.

  • Severe infections. Signs and symptoms may include fever, cough, frequent urination, pain when urinating, and flu-like symptoms.

  • Severe infusion reactions. Signs and symptoms may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, and facial swelling.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment with IMFINZI if you have severe side effects.

Before you receive IMFINZI, tell your healthcare provider about all of your medical conditions, including if you:

  • Have immune system problems such as Crohn's disease, ulcerative colitis, or lupus
  • Have had an organ transplant
  • Have lung or breathing problems
  • Have liver problems
  • Are being treated for an infection
  • Are pregnant or plan to become pregnant
    • IMFINZI can harm your unborn baby
    • If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Talk to your healthcare provider about which birth control methods to use
    • Tell your healthcare provider right away if you become pregnant during treatment with IMFINZI
  • Are breastfeeding or plan to breastfeed
    • It is not known if IMFINZI passes into breast milk
    • Do not breastfeed during treatment and for at least 3 months after the last dose of IMFINZI

Tell your healthcare provider about all the medicines you take. This includes prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of IMFINZI?

IMFINZI can cause serious side effects (see above).

The most common side effects include:

  • Feeling tired
  • Muscle and/or bone pain
  • Constipation
  • Decreased appetite
  • Nausea
  • Swelling
  • Urinary tract infection

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of IMFINZI. Ask your healthcare provider or pharmacist for more information.

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

Who is IMFINZI for?

IMFINZI (durvalumab) is a prescription medicine used to treat a type of cancer in the bladder and urinary tract called urothelial carcinoma.

IMFINZI may be used when:

  • Your urothelial carcinoma has spread or cannot be removed by surgery, and
  • Chemotherapy containing platinum did not work or is no longer working

It is not known if IMFINZI is safe and effective in children.

IMFINZI was FDA approved based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit.