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.

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

Call your doctor at once if you have new or unusual symptoms, such as: tiredness, mood changes, headaches, vision problems, muscle weakness, stomach problems, weight changes, skin rash, hair loss, bleeding or bruising, yellowing of your skin or eyes, increased or decreased urination, dark urine, bloody or tarry stools, worsening cough, chest pain, or trouble breathing.

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.

Usual Adult Dose for Urothelial Carcinoma:

10 mg/kg IV over 60 minutes every 2 weeks until disease progression or unacceptable toxicity

Uses: For the treatment of patients with locally advanced or metastatic urothelial carcinoma who:
-Have disease progression during or following platinum-containing chemotherapy
-Have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Non-Small Cell Lung Cancer:

10 mg/kg IV over 60 minutes every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months

Use: For patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy

Usual Adult Dose for Small Cell Lung Cancer:

30 kg or less:
20 mg/kg IV every 3 weeks (21 days) for 4 cycles, followed by 20 mg/kg every 4 weeks as a single agent until weight increases to greater than 30 kg
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV every 3 weeks (21 days) for 4 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or unacceptable toxicity
NOTE: When this drug is given in combination with chemotherapy, administer this drug prior to chemotherapy on the same day; refer to the Prescribing Information for etoposide and carboplatin or cisplatin for dosing information.

Use: This drug in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)

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.

Durvalumab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using durvalumab and for at least 3 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using durvalumab, and for at least 3 months after your last dose.

Call your doctor for instructions if you miss an appointment for your durvalumab injection.

Since durvalumab is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

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 or itchy, or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Durvalumab causes your immune system to attack tumor cells, but it could also 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.

Durvalumab may cause serious side effects. 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;

• 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 of durvalumab 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.

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.