durvalumab

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

Durvalumab may cause serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, pituitary, or adrenal glands.

What is durvalumab?

Durvalumab is used to treat cancer of the lungs, bladder, or urinary tract.

Durvalumab is sometimes given when the cancer has spread to other parts of the body or cannot be removed with surgery, or when other treatments did not work or have stopped working.

Durvalumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving durvalumab?

Tell your doctor if you have an active infection, or if you have ever had:

• an organ transplant or stem cell transplant (recent or planned);
• lung disease or breathing problems;
• liver disease;
• radiation treatment of your chest area; or
• an autoimmune disorder such as lupus, ulcerative colitis, or Crohn's disease.

How is durvalumab given?

Durvalumab is given as an infusion into a vein, usually once every 2, 3 or 4 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly and the infusion can take about 1 hour to complete.

You may need frequent medical tests.

What happens if I miss a dose?

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 receiving durvalumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of durvalumab?

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed or itchy, or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

• 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;
• transplant rejection --rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ; 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;
• decreased appetite;
• feeling weak or tired;
• bone or muscle pain;
• cough, feeling short of breath;
• cold symptoms such as stuffy nose, sneezing, sore throat;
• painful urination;
• hair loss;
• rash; or
• swelling in your arms and legs.

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 affect durvalumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about durvalumab.