Durvalumab injection is used to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that spread to nearby tissues or other parts of the body that cannot be removed by surgery and has worsened during or after being treated with other chemotherapy medications. Durvalumab injection is also used 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. 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.
HOW should this medicine be used?
Durvalumab injection comes as a 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 given once every 2 weeks for as long as your doctor recommends you receive treatment.
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, 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 ( Web Site) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
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 transplant. 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 type of lung disease or breathing problems; or liver disease. Also tell your doctor if you are currently being treated for an infection.
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 at least 3 months after your final dose.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What SIDE EFFECTS can this medicine cause?
Durvalumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
bone or muscle pain
swelling of your arms or legs
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, or constipation; hair loss; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; nausea or vomiting; stomach pain
rash, itching, or skin blistering
blurry or double vision, or other vision problems
eye redness or pain
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 ( Web Site ) or by phone (1-800-332-1088).
What OTHER INFORMATION should I know?
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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