Imfinzi is a cancer medicine that works with your immune system to interfere with the growth and spread of cancer cells in the body.

Imfinzi may be used to treat

• non-small cell lung cancer (NSCLC) in patients whose tumors cannot be removed by surgery, and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). It may also be used in combination with Imjudo (tremelimumab-actl) and platinum-based chemotherapy to treat NSCLC that has spread (metastatic NSCLC)
• small cell lung cancer in combination with the chemotherapy medicines etoposide and carboplatin or cisplatin when the cancer has spread within your lungs or to other parts of the body
• biliary tract cancer (including cancer of the bile ducts and gallbladder cancer) in combination with the chemotherapy medicines gemcitabine and cisplatin when the cancer has spread to nearby tissues or to other parts of the body
• unresectable hepatocellular carcinoma in combination with Imjudo (tremelimumab-actl).

Imfinzi works by causing your immune system to attack tumor cells but it may also 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, 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.

Imfinzi 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.

Usual Adult Dose for Non-Small Cell Lung Cancer (NSCLC):

30 kg or less:
10 mg/kg IV every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 12 months

Greater than 30 kg:
10 mg/kg IV every 2 weeks OR 1500 mg every 4 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 Metastatic NSCLC:

30 kg or less:
20 mg/kg every 3 weeks in combination with tremelimumab-actl 1 mg/kg and platinum-based chemotherapy, and then administer Imfinzi 20 mg/kg every 4 weeks as a single agent with histology-based pemetrexed therapy every 4 weeks, and a fifth dose of tremelimumab-actl 1 mg/kg in combination with Imfinzi dose 6 at week 16.

Greater than or equal to 30 kg: 1,500 mg every 3 weeks in combination with tremelimumab-actl 75 mg and platinum-based chemotherapy for 4 cycles, and then administer Imfinzi 1,500 mg every 4 weeks as a single agent with histology-based pemetrexed maintenance therapy every 4 weeks, and a fifth dose of tremelimumab-actl 75 mg in combination with Imfinzi dose 6 at week 16.

Use: the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations in combination with tremelimumab-actl and platinum-based chemotherapy.

Usual Adult Dose for Small Cell Lung Cancer:

30 kg or less:
20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for 4 cycles, followed by 10 mg/kg every 4 weeks as a single agent until disease progression, 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.

Greater than 30 kg:
1500 mg IV in combination with chemotherapy 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: First-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and either carboplatin or cisplatin.

Usual Adult Dose for Biliary Tract Cancer:

30 kg or less:
20 mg/kg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 20 mg/kg every 4 weeks as a single agent until disease progression or until 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 gemcitabine and cisplatin for dosing information.

Greater than 30 kg:
1500 mg IV in combination with chemotherapy every 3 weeks (21 days) for up to 8 cycles, followed by 1500 mg every 4 weeks as a single agent until disease progression or until 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 gemcitabine and cisplatin for dosing information.

Use: Locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin.

Usual Adult Dose for Unresectable Hepatocellular Carcinoma:

Less than 30 kg: 20 mg/kg in combination with tremelimumab-actl 4 mg/kg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks.

Greater than or equal to 30 kg: 1,500 mg in combination with tremelimumab-actl 300 mg as a single dose at Cycle 1/Day 1, followed by Imfinzi as a single agent every 4 weeks.

Use: The treatment of adult patients with unresectable hepatocellular carcinoma in combination with tremelimumab-actl.

You should not use Imfinzi if you are allergic to durvalumab.

To make sure Imfinzi is safe for you, tell your doctor if you have an active infection, or if you have ever had:

• an organ transplant or a 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.

Imfinzi may harm an 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. Tell your doctor if you become pregnant.

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

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

Since this medicine 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 to Imfinzi: 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.

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 Imfinzi 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.

Other drugs may interact with 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.