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IMFINZI can cause serious side effects (see above): The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. Important things to remember about the side effects of durvalumab: Most people will not experience all of the durvalumab side effects listed. Some side effects can cause severe or life threatening conditions, so even mild side effects must be taken seriously and reported immediately. The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells.. PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. Durvalumab (Imfinzi) These drugs have also been shown to be helpful in treating different types of cancer, and are being studied for use against others. Your healthcare provider will check you for these problems during your treatment with IMFINZI. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). The blockade of interactions between PD-L1/PD-1 and PD-L1/CD80 contributes to an improved immune response to antitumor and increased activation of T cells, enabling tumor cells to be destroyed by the T cells. Bone pain. Other side effects not listed may also occur in some patients. Some people can develop pneumonitis after radiation and that can also be a side effect of the Durvalumab. Side effects are almost always reversible and will go away after therapy is complete. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. They may occur during your treatment, or after your treatment has ended. Getting medical treatment right away may help keep these problems from becoming more serious. treatment may be changed based on the test results and/or other side effects. You may report side effects to FDA at 1-800-FDA-1088. IMFINZI can cause serious side effects (see above): The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Infusion reactions that can sometimes be severe or life-threatening. Call your doctor for medical advice about side effects. locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy; or; who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash. Side effects often show up early in treatment – or months or years later. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. your stomach-area (abdomen), dark urine (tea colored), and bleeding or bruising more easily than normal, Hormone gland problems: headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increase sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, Kidney problems: decrease in your amount of urine, blood in your urine, swelling of your ankles, and loss of appetite, Skin problems: rash; itching; skin blistering or peeling; painful sores or ulcers in mouth or nose, throat, or genital area; All rights reserved. Durvalumab (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs). IMFINZI is a medicine that may treat certain cancers by working with your immune system. Some general potentially serious durvalumab side effects include (1, 6, 21): loss of appetite. Although not all of these side effects may occur, if they do occur they may need medical attention. Applies to durvalumab: intravenous solution. Call your doctor at once if you have: Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immunotherapy can affect many parts of your body. NSCLC is now known to be an immunologically targetable cancer. Along with its needed effects, durvalumab may cause some unwanted effects. Available for Android and iOS devices. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. What are the possible side effects of IMFINZI? Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. a reaction to durvulumab that happens on the day of the infusion or the day after – this might include a red, itchy rash (hives) Durvalumab is also being studied in the treatment of other types of cancer. Other side effects not listed may also occur in some patients. Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. All drugs may cause side effects. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. More About Durvalumab ... actions, interactions, or side effects of this drug, or precautions to be taken while using it. This is not a complete list of durvalumab side effects. Check with your doctor or pharmacist before you start or stop taking any other drugs. Anti-PD1 antibodies (e.g., nivolumab, pembrolizumab [MK-3475]) and anti-PD-L1 antibodies (e.g., atezolizumab [MPDL3280A], durvalumab [MEDI4736]) have shown effectiveness in treating NSCLC. Call your doctor for medical advice about side effects. Stomach pain. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. This is because IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. Side effects can become serious if they are not treated. IMFINZI may be used when your NSCLC has not spread outside your chest, cannot be removed by surgery, and has responded or stabilized with initial treatment with chemotherapy that contains platinum, given at the same time as radiation therapy. Tremelimumab Side Effects. Side effects are often predictable in terms of their onset, duration, and severity. This is not a complete list of durvalumab side effects. Ask your doctor or pharmacist for more information. Immune-mediated reactions , including pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and rash , have been reported and may be severe. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Problems can also happen in other organs and tissues. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Side effects can occur while using Imfinzi, but they’re usually mild. fever or flu-like symptoms; swollen lymph nodes, Problems can also happen in other organs and tissues. The most common side effects in people with non-small cell lung cancer (NSCLC) include cough, feeling tired, inflammation in the lungs, upper respiratory tract infections, shortness of breath, and rash. ©2021 AstraZeneca. IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). durvalumab was detected in breast milk and was associated with premature neonatal death. It is not known if IMFINZI passes into your breast milk. Some side effects can cause severe or life threatening conditions, so even mild side effects must be taken seriously and reported immediately. Last updated on Sep 21, 2020. These problems can sometimes become serious or life-threatening and can lead to death. Because durvalumab enhances your immune system response to cancer, it may cause unintended side effects which can affect healthy cells as well. Portions of this document last updated: Feb. 01, 2021 Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Common (1% to 10%): Immune-mediated endocrinopathies (e.g., hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, hypophysitis/hypopituitarism)[Ref], Very common (10% or more): Rash (dermatitis, dermatitis acneiform, dermatitis psoriasiform, psoriasis, rash maculopapular, rash pruritic, rash papular, rash pustular, skin toxicity, eczema, erythema, erythema multiforme, rash erythematous, acne, lichen planus) (11%)[Ref], Uncommon (0.1% to 1%): Immune-related myocarditis[Ref], Very common (10% or more): Lymphopenia (11%), Very common (10% or more): Urinary tract infection (e.g., cystitis, candiduria, urosepsis) (15%)[Ref], Very common (10% or more): Constipation (21%), nausea (16%), abdominal pain (upper, lower, flank) (14%), diarrhea/colitis (13%), Frequency not reported: Immune-mediated colitis[Ref], Common (1% to 10%): Liver injury, immune-mediated hepatitis, Uncommon (0.1% to 1%): Increased ASO, increased ALT, hyperbilirubinemia, Frequency not reported: Immune-mediated hepatitis[Ref], Very common (10% or more): Decreased appetite/hypophagia (19%), hyponatremia (12%), Common (1% to 10%): Deterioration of general physical health, increased alkaline phosphatase, hypermagnesemia, hypercalcemia, hyperglycemia, neutropenia, hyperkalemia, hypoalbuminemia[Ref], Common (1% to 10%): Infusion-related reactions[Ref], Common (1% to 10%): Infections (e.g., sepsis, necrotizing fasciitis, osteomyelitis)[Ref], Uncommon (0.1% to 1%): Uveitis and keratitis[Ref], Very common (10% or more): Musculoskeletal pain (e.g., back pain, musculoskeletal chest pain, musculoskeletal pain and discomfort, myalgia, neck pain) (24%)[Ref], Common (1% to 10%): Pyrexia/tumor associated fever, Uncommon (0.1% to 1%): Immune-related aseptic meningitis[Ref], Very common (10% or more): Fatigue (e.g., asthenia, lethargy, malaise) (39%), peripheral edema (e.g., edema, localized edema, edema peripheral, lymphedema, peripheral swelling, scrotal edema, scrotal swelling) (15%), pyrexia/tumor associated fever (14%), Common (1% to 10%): Embryofetal toxicity[Ref], Common (1% to 10%): Acute kidney injury, increased creatinine[Ref], Very common (10% or more): Dyspnea/exertional dyspnea (24%), cough/productive cough (10%), Uncommon (0.1% to 1%): Immune-mediated pneumonitis[Ref]. drinking of alcohol (in small amounts) does not appear to affect the safety or These side effects may go away during treatment as your body adjusts to the medicine. ended. Women should wait at least three months after the last dose of durvalumab before breastfeeding. Call your doctor for medical advice about side effects. Because durvalumab enhances your immune system response to cancer, it may cause unintended side effects which can affect healthy cells as well. Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. While on IMFINZI, you may experience side effects. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. You can have more than one of these problems at the same time. IMFINZI is a medicine that may treat certain types of lung cancer by working with your immune system. Durvalumab is a monoclonal human immunoglobulin G1 kappa (IgG1k) antibody that selectively inhibits the binding to PD-1 and CD801 of programmed cell death ligand-1 (PD-L1) (B7.1). Durvalumab is a human monoclonal antibody that selectively binds to programmed cell death ligand-1 (PD-L1), blocking its interaction with the programmed death-1 (PD-1) receptor and with CD80, and thereby potentiating an immune response to tumour cells. Monitor patients for signs and symptoms of hepatitis during and after discontinuation of IMFINZI, including clinical chemistry monitoring. Durvalumab side effects can vary from mild to severe. Because durvalumab enhances your immune system response to cancer, it may cause unintended side effects that are caused by the immune system and affect healthy cells as well. severe and fatal immune-mediated reactions. Call your doctor at once if you have: Women should wait at least three months after the last dose of durvalumab before breastfeeding. These complications can be serious and can lead to death. Many durvalumab side effects can be significant or indicate a serious underlying condition and require medical attention. Immunoglobulins are known to cross the placenta and the fetus may have adverse exposure to durvalumab. This is not a complete list of side effects and others may occur.

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