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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. 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. Less common side effects of durvalumab include: Cough; Anemia, grades 3-4; Infusion-related reactions, grades 3-4; Increased alkaline phosphatase, grades 3-4; Hypermagnesemia, grades 3-4; Hypercalcemia, grades 3-4; Hyperglycemia, grades 3-4; Immune-mediated pneumonitis or ILD; Increased AST, grades 3-4; Immune-mediated hepatitis; Increased ALT, grades 3-4 You should use an effective method of birth control during your treatment and for at least 3 months after the last dose of IMFINZI. Your patient alert card. Tell your doctor if you have any side effect that bothers you or that does not go away. 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. You may report side effects to the FDA at 1-800-FDA-1088. When immunotherapy side effects show up varies, but most immunotherapy patients dealing with side effects see them in the first weeks to months of treatment. Some side effects can cause severe or life threatening conditions, so even mild side effects must be taken seriously and reported immediately. The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs). Common side effects may include: nausea, constipation; decreased appetite; feeling weak or tired; bone or muscle pain; cough, feeling short of breath; cold symptoms such as stuffy nose, sneezing, sore throat; painful urination; hair loss; rash; or swelling in your arms and legs. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Side Effects of Durvalumab Due to the effects of durvalumab on the immune system, many patients taking the immunotherapy medication experience physical side effects. … This is not a complete list of durvalumab side effects. The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs). Check with your physician for additional information about side effects. You may report side effects to the FDA at 1-800-FDA-1088. • The . Immunotherapy can affect many parts of your body. The most common side effects for durvalumab include cough, pneumonitis, infection, rash, pruritus, diarrhea, hypothyroidism and abdominal pain. It is not known if IMFINZI is safe and effective in children. 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]. Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These side effects are called immune-related adverse events. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Data sources include IBM Watson Micromedex (updated 3 Mar 2021), Cerner Multum™ (updated 1 Mar 2021), ASHP (updated 3 Mar 2021) and others. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. SIDE EFFECTS: The table includes adverse events that presented during drug treatment but may not necessarily have a causal relationship with the drug. These problems can sometimes become severe or life-threatening and can lead to death. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. These side effects are called immune-related adverse events. However, many people have no side effects or only have minor side effects. NSCLC is now known to be an immunologically targetable cancer. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Previous studies have shown both mild and serious side effects in mesothelioma patients who receive tremelimumab as treatment. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. What is the most important information I should know about durvalumab (Imfinzi)? You may report side effects related to AstraZeneca products by clicking here. Please see your health care professional for more information about your specific medical condition and the … Stomach pain. Side effect(s) of Durvalumab Read the side effects of Durvalumab as described in the medical literature. 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. If you prefer to report these to the FDA, either visit www.FDA.gov/medwatch or call 1-800-FDA-1088. Hi jese80 I too am on Durvalumab, there is a thread here on Inspire created by a nice ma called Eric his screen name is (peaceborro) it's under Treatment Options but when it was started it was spelled Duravalumab, it was a really active group, but I think I am the only person who posts in there now lol! Because durvalumab enhances your immune system response to cancer, it may cause unintended side effects which can affect healthy cells as well. Both durvalumab and tremelimumab have been tested for mesothelioma alone, but not in combination. Call your doctor for medical advice about side effects. Tell your doctor if you have any side effect that bothers you or that does not go away. 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. Not hungry. are breastfeeding or plan to breastfeed. These problems may happen anytime during treatment or even after your treatment has Getting medical treatment right away may help keep these problems from becoming more serious. Problems can also happen in other organs and tissues. Portions of this document last updated: Feb. 01, 2021 Immunoglobulins are known to cross the placenta and the fetus may have adverse exposure to durvalumab. 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. As such, patients may experience common side effects like coughing, shortness of breath, fatigue, inflammation of the lungs (pneumonitis), upper respiratory tract infections, and/or skin rashes. Your healthcare provider will monitor you for these complications. Tell your doctor if you have any side effects that bother you or that do not go away. Call your doctor for medical advice about side effects. Side Effects What are the side effects of Durvalumab (Imfinzi)?. Side effects range from mild to severe. For the full list of side effects and restrictions of Imfinzi, see the package leaflet. Call your doctor for medical advice about side effects. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. 2. Durvalumab is also being studied in the treatment of other types of cancer. severe and fatal immune-mediated reactions. Learn about side effects, uses, dosage, and more. Please see your health care professional for more information about your specific medical condition and the … Last updated on Sep 21, 2020. These problems can sometimes become serious or life-threatening and can lead to death. Constipation. 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. This is because IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. Some organs that might be affected include the thyroid, pituitary gland, adrenal glands, pancreas, gastrointestinal tract, liver, lungs, skin, kidneys, and others. Durvalumab is also being studied in the treatment of other types of cancer. Some organs that can be affected include the thyroid, pituitary gland, adrenal glands, pancreas, gastrointestinal tract, liver, lungs, skin, kidneys, and others. Developed by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that acts to promote natural immune responses that destroy tumour cells. This phase I trial studies the side effects of durvalumab, tremelimumab, and radiation therapy in treating patients with gynecologic cancer that has spread to other places in the body or cannot be removed by surgery. You may report side effects to FDA at 1-800-FDA-1088. It is not known if IMFINZI passes into your breast milk. NSCLC is now known to be an immunologically targetable cancer. The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash. drinking of alcohol (in small amounts) does not appear to affect the safety or Females of reproductive potential should use effective contraception during therapy and for at least 3 months after the last durvalumab dose. Imfinzi (durvalumab)." If you notice any other effects, check with your healthcare professional. Bone pain. Our Imfinzi (durvalumab) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Please click here for complete Prescribing Information, including Patient Information (Medication Guide). Talk to your healthcare provider about birth control methods that you can use during this time. Withhold IMFINZI for ALT or AST greater than 3 but less than or equal to 8 times the ULN or total bilirubin greater than 1.5 but less than or equal to 5 tim… Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. These are not all of the signs and symptoms of immune system problems that can happen with IMFINZI. Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. severe and fatal immune-mediated reactions. Getting medical treatment right away may help keep these problems from becoming more serious. They may occur during your treatment, or after your treatment has ended. While on IMFINZI, you may experience side effects. Ask your healthcare provider or pharmacist for more information. 95,96 IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. Durvalumab side effects can vary from mild to severe. Some side effects of durvalumab may occur that usually do not need medical attention. Call your doctor for medical advice about side effects. Many durvalumab side effects can be significant or indicate a serious underlying condition and require medical attention. Immune-mediated reactions , including pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and rash , … durvalumab was detected in breast milk and was associated with premature neonatal death. Call your doctor for medical advice about side effects. This could lead to … These are not all of the possible side effects of IMFINZI. Call your doctor at once if you have: Most mild side effects of the drug go away with time and don’t require medical attention. Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. It is important to always have the card with you during treatment and after treatment finishes. Other side effects not listed may also occur in some patients. There are no contraindications for IMFINZI ® (durvalumab).. Immune-Mediated Adverse Reactions. Important things to remember about the side effects of durvalumab: Most people will not experience all of the durvalumab side effects listed. IMFINZI® (durvalumab) is a prescription medicine used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). Durvalumab causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. Women should wait at least three months after the last dose of durvalumab before breastfeeding. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. an infection ; overactive thyroid gland ; low amount of sodium in the blood ; anemia ; decreased blood platelets If the side effects are severe, your doctor might delay giving the checkpoint inhibitor for a period of time to allow the body to recover. Research on Durvalumab in Mesothelioma Treatment. 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. SIDE EFFECTS: The table includes adverse events that presented during drug treatment but may not necessarily have a causal relationship with the drug. For adults with unresectable Stage 3 non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent chemoradiation therapy (CRT). Imfinzi (durvalumab) is a programmed death-ligand 1 (PD-L1) blocking antibody indicated for the treatment of patients with. US-33919; US-47125; US-45120; US-49291 Last Updated 2/21, a type of lung cancer called non-small cell lung cancer (NSCLC). The most common side effects for durvalumab include cough, pneumonitis, infection, rash, pruritus, diarrhea, hypothyroidism and abdominal pain. Durvalumab stimulates the immune system and may cause it to attack healthy organs and tissues. IMFINZI is a medicine that may treat certain types of lung cancer by working with your immune system. This is because IMFINZI can cause your immune system to attack normal organs and tissues and can affect the way they work. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. 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. 1. Nearly all clinical trials of durvalumab involving mesothelioma patients are too new to produce results. 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). interact: with durvalumab. Portions of this document last updated: Feb. 01, 2021 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; Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. bloating or swelling of the face, arms, hands, lower legs, or feet Call your doctor at once if you have: Check with your doctor or pharmacist before you start or stop taking any other drugs. Ask your doctor or pharmacist for more information. 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. Side effects of Durvalumab (frequency of side effects not defined): Endocrine & metabolic: Hypophysitis; Hepatic: Hepatic injury; Infection: Sepsis; Renal: Acute renal failure Some general potentially serious durvalumab side effects include (1, 6, 21): loss of appetite. While on IMFINZI, you may experience side effects. The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash. This information is intended for US consumers only. These side effects may go away during treatment as your body adjusts to the medicine. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Feeling tired or weak. These complications may happen if you underwent transplantation either before or after being treated with IMFINZI. Side effects are almost always reversible and will go away after therapy is complete. Astra-Zeneca Pharmaceuticals, Wilmington, DE. "Product Information. These are not all the possible side effects of IMFINZI. PD1 and PD-L1 Monoclonal Antibody Side Effects. Upset stomach. If you notice any other effects, check with your healthcare professional. ended. a reaction to durvulumab that happens on the day of the infusion or the day after – this might include a red, itchy rash (hives) 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. You can have more than one of these problems at the same time. What are the possible side effects of IMFINZI? durvalumab was detected in breast milk and was associated with premature neonatal death. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with IMFINZI. IMFINZI can cause immune-mediated hepatitis, defined as requiring use of corticosteroids. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include: Chest pain, irregular heartbeats, shortness of breath or swelling of ankles; confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs; double vision, blurry vision, sensitivity to light, eyepain, changes in eyesight; persistent or severe muscle pain or weakness, muscle cramps; and low red blood cells, bruising, Infusion reactions that can sometimes be severe or life-threatening. Learn about side effects, uses, dosage, and more. Ask your doctor or pharmacist for more information. They may occur during your treatment, or after your treatment has ended. IMFINZI can harm your unborn baby. ©2021 AstraZeneca. 2. Some people can develop pneumonitis after radiation and that can also be a side effect of the Durvalumab. What Other Drugs Interact with Durvalumab? More About Durvalumab ... actions, interactions, or side effects of this drug, or precautions to be taken while using it. Fatal cases have been reported. With proper treatment, the side effects can resolve in one to three weeks. Other side effects not listed may also occur in some patients. methotrexate, Keytruda, Avastin, pembrolizumab, cisplatin, nivolumab, Opdivo, Tagrisso, etoposide. Along with its needed effects, durvalumab may cause some unwanted effects. It is an irritation of the lungs and needs to be treated with steroids. INFREQUENT side effects If experienced, these tend to have a Severe expression i . This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands. Muscle pain. Durvalumab may cause serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, pituitary, or adrenal glands. 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. Durvalumab (trade name Imfinzi) is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. Administer corticosteroids for Grade 2 or higher elevations of ALT, AST, and/or total bilirubin. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread. These side effects may go away during treatment as your body adjusts to the medicine. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. 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. 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.

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