Imfinzi 50 mg/mL intravenous solution

Generic name:
Durvalumab - injection

Pronunciation
(dur-VAL-ue-mab)

Brand name(s)
Imfinzi

Durvalumab is used to treat certain cancers (such as lung, biliary tract, liver). This medication is also used to treat cancer of the uterus lining (endometrial cancer). It works by helping your immune system fight the cancer. This medication belongs to a class of drugs known as monoclonal antibodies.

Read the Medication Guide provided by your pharmacist before you start receiving durvalumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by a health care professional. It is injected slowly into a vein over 60 minutes as directed by your doctor, usually once every 2 to 4 weeks. The dosage and treatment schedule are based on your medical condition, weight, and response to treatment.

Infusion reactions may happen during the infusion of this drug. Your doctor may prescribe other medications before each treatment to help prevent these side effects. Tell your doctor right away if you have any symptoms of infusion reactions such as chills, flushing, itching, dizziness, or shortness of breath. Your doctor may give you other medications to help with these side effects or may slow down or stop your treatment for some time.

To get the most benefit, do not miss any doses. To help you remember, mark your calendar with a reminder.

See also How to Use section.

Tiredness, loss of appetite, nausea, constipation, muscle/bone pain, or swelling hands/ankles/feet may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including:

• signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• new/worsening cough
• diarrhea
• blood/mucus in your stool
• eye/vision problems (such as blurred vision, vision changes, eye pain)
• headache that is severe or doesn't go away
• stiff/painful neck
• unusual weight gain/loss
• mental/mood changes (such as confusion)
• cold or heat intolerance
• fast/slow/pounding/irregular heartbeat
• increased thirst/urination
• muscle weakness
• numbness/tingling of arms/legs
• easy bruising/bleeding
• burning/painful/urgent urination
• signs of kidney problems (such as pink/bloody urine, change in the amount of urine)

Get medical help right away if you have any very serious side effects, including:

• chest pain
• shortness of breath

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using durvalumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• organ transplant
• stem cell transplant with donor cells

Durvalumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using durvalumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using durvalumab. Durvalumab may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Ask about reliable forms of birth control while using this medication and for at least 3 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug and for at least 3 months after the last dose. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests (such as liver/kidney/thyroid function) should be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

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

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.