
For people with previously treated, locally advanced or metastatic urothelial carcinoma (bladder cancer). See Full Indication »
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 or certain types of lung cancer by working with your immune system.
IMFINZI can cause your 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.
IMFINZI® (durvalumab) is a prescription medicine used to treat adults with 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. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit.
It is not known if IMFINZI is safe and effective in children.
Call or see your healthcare provider right away if you develop any symptoms of the following problems or if these symptoms get worse:
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; or are being treated for an infection.
If you are pregnant or plan to become pregnant, tell your healthcare provider. 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.
If you are breastfeeding or plan to breastfeed, tell your healthcare provider. It is not known if IMFINZI passes into breast milk. Do not breastfeed during treatment with IMFINZI 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 in people with urothelial carcinoma include feeling tired, muscle or bone pain, constipation, decreased appetite, nausea, swelling of your arms and legs, and urinary tract infection.
Tell your doctor 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 1-800-FDA-1088.
You may report side effects related to AstraZeneca products by clicking here.
IMFINZI® (durvalumab) is a prescription medicine used to treat adults with 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. IMFINZI was FDA approved for this use based on a clinical study that measured how many patients responded and how long they responded. The study is ongoing to confirm clinical benefit.
It is not known if IMFINZI is safe and effective in children.
Please see complete Prescribing Information, including Patient Information (Medication Guide).