What is the most important information I should know about durvalumab?
Durvalumab works by causing your immune system to attack tumor cells. Durvalumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Call your doctor at once if you have symptoms such as: fever, flu symptoms, muscle pain or weakness, vision changes, chest pain, trouble breathing, severe stomach pain or diarrhea, skin rash, increased or decreased urination, weight changes, hair loss, dark urine, or jaundice (yellowing of your skin or eyes).
What is durvalumab?
Durvalumab is a cancer medicine that works with your immune system to interfere with the growth and spread of cancer cells in the body.
Durvalumab is used to treat cancer of the bladder or urinary tract.
Durvalumab is usually given when the cancer cannot be removed with surgery and has not responded to chemotherapy with other medicines.
Durvalumab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, further studies are needed.
Durvalumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using durvalumab?
You should not use durvalumab if you are allergic to it.
To make sure durvalumab is safe for you, tell your doctor if you have ever had:
- an organ transplant;
- an active infection;
- lung disease or breathing problems;
- liver disease; or
- an autoimmune disorder such as lupus, ulcerative colitis, or Crohn's disease.
Do not use durvalumab if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 3 months after your last dose.
It is not known whether durvalumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 3 months after your last dose.
How is durvalumab given?
Durvalumab is injected into a vein through an IV. A healthcare provider will give you this injection.
This medicine must be given slowly and the IV infusion can take about 1 hour to complete.
Durvalumab is usually given once every 2 weeks. Follow your doctor's instructions.
You may need frequent medical tests to help your doctor determine how long to treat you with durvalumab.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your durvalumab injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while using durvalumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of durvalumab?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, itchy, feverish, chilled, or have neck pain or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).
Durvalumab works by causing your immune system to attack tumor cells. Durvalumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Call your doctor at once if you have:
- chest pain, new or worsening cough, feeling short of breath;
- severe stomach pain, diarrhea, bloody or tarry stools;
- new or worsening skin rash, itching, or blistering;
- fever, flu-like symptoms;
- pain or burning when you urinate;
-
problems in other organs --mood or behavior changes, neck stiffness, confusion, eye pain or redness, vision problems;
-
liver problems --loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
-
kidney problems --little or no urination, red or pink urine, swelling in your feet or ankles; or
-
signs of a hormonal disorder --unusual headaches, feeling light-headed or very tired, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, feeling cold, weight gain, or weight loss.
Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Common side effects may include:
- nausea, constipation, loss of appetite;
- bone pain, muscle pain;
- painful or difficult urination;
- feeling tired; or
- swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect durvalumab?
Other drugs may interact with durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about durvalumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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