Durvalumab (dur-VAL-ue-mab)

Treats non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), biliary tract cancer (BTC), liver cancer, and uterine cancer.

Brand Name(s):

Imfinzi

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the IV will have to stay in place for at least 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before receiving this medicine. Use an effective form of birth control during treatment with this medicine and for at least 3 months after your last dose.
• Do not breastfeed during treatment and for 3 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, breathing or lung problems, diabetes, immune system problems, or any type of infection. Tell your doctor if you have had an organ transplant or other transplant (including cornea transplant).
• This medicine may cause the following problems:
  • Severe inflammation, including pneumonitis (lungs), colitis (bowels), hepatitis (liver), nephritis (kidney)
  • Thyroid problems, or similar problems with other organs and body systems (including the nervous system)
  • Serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis)
  • Increased risk of infections
  • Infusion reaction
  • Increased risk of possible organ transplant rejection
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision or changes in vision
• Change in how much or how often you urinate, increased hunger or thirst
• Changes in skin color, dark freckles
• Confusion, seizures, stiff neck, sleepiness, or numbness, tingling, or burning pain in your hands, arms, legs, or feet
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Diarrhea that may contain blood, severe stomach pain
• Fever, chills, cough, runny or stuffy nose, sore throat, trouble breathing, dizziness
• Skin rash while receiving the infusion
• Weakness, headache, weight changes, feeling cold, or changes in mood or behavior

If you notice these less serious side effects, talk with your doctor:

• Constipation
• Hair loss
• Muscle or joint pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088