Durvalumab injection

What is this medication?

DURVALUMAB (dur VAL ue mab) is a monoclonal antibody. It is used to treat lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): IMFINZI

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• autoimmune diseases like Crohn's disease, ulcerative colitis, or lupus
• have had or planning to have an allogeneic stem cell transplant (uses someone else's stem cells)
• history of organ transplant
• history of radiation to the chest
• nervous system problems like myasthenia gravis or Guillain-Barre syndrome
• an unusual or allergic reaction to durvalumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

This medication may make you feel generally unwell. Continue your course of treatment even though you feel ill unless your care team tells you to stop.

You may need blood work done while you are taking this medication.

Do not become pregnant while taking this medication or for 3 months after stopping it. Women should inform their care team if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your care team or pharmacist for more information. Do not breast-feed an infant while taking this medication or for 3 months after stopping it.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bloody or watery diarrhea
• Dizziness, loss of balance or coordination, confusion or trouble speaking
• Dry cough, shortness of breath or trouble breathing
• Flushing, mostly over the face, neck, and chest, during injection
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• High thyroid levels (hyperthyroidism)—fast or irregular heartbeat, weight loss, excessive sweating or sensitivity to heat, tremors or shaking, anxiety, nervousness, irregular menstrual cycle or spotting
• Infection—fever, chills, cough, or sore throat
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness, low blood pressure
• Low thyroid levels (hypothyroidism)—unusual weakness or fatigue, increased sensitivity to cold, constipation, hair loss, dry skin, weight gain, feelings of depression
• Pancreatitis—severe stomach pain that spreads to your back or gets worse after eating or when touched, fever, nausea, vomiting
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling or loosening of the skin, including inside the mouth
• Wheezing—trouble breathing with loud or whistling sounds

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Hair loss

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medication is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.