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Important Safety Information

What is the most important information I should know about IMFINZI® (durvalumab)?

IMFINZI is a medicine that may treat certain cancers by working with your immune system. IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.

What is IMFINZI?

[IMFINZI may be used in combination with the chemotherapy medicines gemcitabine and cisplatin prior to surgical removal of your bladder (neoadjuvant treatment) followed by IMFINZI alone after surgery (adjuvant treatment) to treat a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body.]

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

Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:

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  • MIBC Lung Problems Icon

    Lung problems: cough, shortness of breath, and chest pain

  • MIBC Intestinal Problems Icon

    Intestinal problems: diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; and severe stomach-area (abdomen) pain or tenderness

  • MIBC Liver Problems Icon

    Liver problems: yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), dark urine (tea colored), and bleeding or bruising more easily than normal

  • MIBC Hormone Gland Problems Icon

    Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

  • MIBC Kidney Problems Icon

    Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, and loss of appetite

  • MIBC Skin Problems Icon

    Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in mouth or nose, throat, or genital area; fever or flu-like symptoms; and swollen lymph nodes

  • MIBC Pancreas Problems Icon

    Pancreas problems: pain in your upper stomach area (abdomen), severe nausea or vomiting, and loss of appetite

  • MIBC Problems in Other Organs Icon

    Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Chest pain, irregular heartbeats, shortness of breath or swelling of ankles; confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems; tingling, numbness or weakness of the arms or legs; double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight; persistent or severe muscle pain or weakness, muscle cramps, joint pain, joint stiffness or swelling; and low red blood cells and bruising

  • MIBC Infusions Reactions Icon

    Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, feel like passing out, fever, and back or neck pain

  • MIBC Complications Icon

    Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with IMFINZI. Your healthcare provider will monitor you for these complications

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 also need to 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 received an organ transplant
  • have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
  • have received radiation treatment to your chest area
  • have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
  • are pregnant or plan to become pregnant. IMFINZI can harm your unborn baby

    • Females who are able to become pregnant:

    • Your healthcare provider will give you a pregnancy test before you start treatment with IMFINZI.
    • You should use an effective method of birth control during your treatment and for 3 months after the last dose of IMFINZI. Talk to your healthcare provider about birth control methods that you can use during this time.
    • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with IMFINZI.
  • are breastfeeding or plan to breastfeed. It is not known if IMFINZI passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of IMFINZI.

Tell your healthcare provider about all the medicines you take, including 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 of IMFINZI when used with gemcitabine and cisplatin in adults with muscle-invasive bladder cancer (MIBC) include low red blood cells (anemia), low white blood cells, increased level of creatinine in the blood, decreased level of sodium in the blood, nausea, increased liver function tests, decreased level of calcium in the blood, decreased blood platelet counts, feeling tired, increase level of potassium in the blood, decreased lymphocyte counts, constipation, decreased level of magnesium in the blood, decreased appetite, increased level of alkaline phosphatase in the blood, rash, fever, diarrhea, vomiting and stomach (abdominal) pain.

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 doctor for medical advice about side effects. You may report side effects related to AstraZeneca products. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

Call your doctor for medical advice about side effects. You may report side effects related to AstraZeneca products . If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

What is IMFINZI?

[IMFINZI may be used in combination with the chemotherapy medicines gemcitabine and cisplatin prior to surgical removal of your bladder (neoadjuvant treatment) followed by IMFINZI alone after surgery (adjuvant treatment) to treat a type of bladder cancer called muscle invasive bladder cancer (MIBC) that has spread into the muscle layer of the bladder but not to other parts of the body.]

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

Please see Full Prescribing Information including Medication Guide for IMFINZI.

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What is IMFINZI?

Important Safety Information

What is the most important information I should know about IMFINZI® (durvalumab)?

IMFINZI is a medicine that may treat certain cancers by work...

IMFINZI is a medicine that may treat certain cancers by working with your immune system.

Read full Important Safety Information

Important Safety Information

What is IMFINZI?

Minimize Expand

IMFINZI may be used in combination with the chemotherapy medicines gemcitabine and cisplatin prior to surgical removal of your bladder (neoadjuvant treatment) followed by IMFINZI alone after surgery...

What is the most important information I should know about IMFINZI® (durvalumab)?

IMFINZI is a medicine that may treat certain cancers by working with your immune system.

IMFINZI is a medicine that may treat certain cancers by working with your immune system.

Read full Important Safety Information