Durvalumab is used alone to treat non-small cell lung cancer (NSCLC) that spread to nearby tissues and cannot be removed by surgery but has not worsened after being treated with other chemotherapy medications and radiation treatments. It is also used in combination with tremelimumab-actl (Imjudo) and platinum-based chemotherapy to treat a certain type of NSCLC that has spread throughout the lungs and to other parts of the body. Durvalumab injection is also used in combination with chemotherapy agents to treat extensive-stage small cell lung cancer (ES-SCLC) in adults whose cancer has spread throughout the lungs and to other parts of the body. It is also used in combination with chemotherapy agents to treat biliary tract cancer (BTC; cancer in the organs and ducts that make and store bile, the liquid made by the liver) in adults whose cancer has spread to nearby tissues or to other parts of the body. Durvalumab is also used in combination with tremelimumab-actl to treat hepatocellular carcinoma (HCC; a type of liver cancer) that cannot be treated with surgery. Durvalumab injection is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

Durvalumab injection comes as a liquid to be injected into a vein over 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually injected once every 2 weeks, once every 3 weeks, or once every 4 weeks for as long as your doctor recommends you receive treatment. The dosing schedule depends on the type of cancer you have and how your body responds to the medication.

Durvalumab injection may cause serious or life-threatening reactions during an infusion. A doctor or nurse will watch you closely while you are receiving the infusion and shortly after the infusion to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms that may occur during or after the infusion: chills or shaking, itching, rash, flushing, difficulty breathing, wheezing, dizziness, fever, feeling faint, back or neck pain, or swelling of your face.

Your doctor may slow down your infusion, delay or stop your treatment with durvalumab injection, or treat you with additional medications depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during your treatment.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with durvalumab injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving durvalumab injection,

• tell your doctor and pharmacist if you are allergic to durvalumab, any other medications, or any of the ingredients in durvalumab injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had an organ or bone marrow transplant and if you have or have ever had radiation therapy to your chest area. Also tell your doctor if you have or have ever had an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract causing pain, diarrhea, weight loss, and fever), ulcerative colitis (condition that causes swelling and sores in the lining of the colon [large intestine] and rectum), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; diabetes; thyroid problems; or kidney or liver disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving durvalumab injection. You should use effective birth control to prevent pregnancy during your treatment with durvalumab injection and for at least 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving durvalumab injection, call your doctor immediately. Durvalumab injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving durvalumab injection and for 3 months after your final dose.

Unless your doctor tells you otherwise, continue your normal diet.

Durvalumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• swelling of your arms or legs
• constipation
• hair loss
• trouble falling asleep or staying asleep
• muscle or bone pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• new or worsening cough, chest pain, or shortness of breath
• yellowing of your eyes or skin, bleeding or bruising easily, decreased appetite, dark (tea colored) urine, pain in the upper right part of the stomach, extreme tiredness, nausea or vomiting
• diarrhea; stomach pain; or black, tarry, sticky, or bloody stools
• decreased urination, blood in urine, swelling in your ankles, decreased appetite
• fever, cough, chills, flu like symptoms, frequent or painful urination, or other signs of infection
• headaches that won’t go away or unusual headaches; extreme tiredness; weight loss or gain; increased hunger or thirst; feeling dizzy or faint; feeling cold; deepening of voice; constipation; hair loss; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; increased urination; increased sweating; stomach pain
• fast or irregular heartbeat
• numbness or tingling in the arms or legs
• persistent muscle pain, weakness, or muscle cramps
• rash or itching, scaling or blistering skin
• sores in mouth, nose, throat, or genital area
• swollen glands
• neck stiffness
• blurry or double vision, sensitivity to light, or other vision problems, eye redness or pain
• ongoing pain that begins in the stomach area but may spread to the back, nausea, vomiting, or loss of appetite

Durvalumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body’s response to durvalumab injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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