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
- Decreased appetite
- 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?
IMFINZITM (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.
Please see full Prescribing Information and Medication Guide.