tremelimumab package insert

IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. Immune-mediated Thyroiditis: Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab. Information and assistance were provided by The Mesothelioma Center at no cost to our family.". None. The recommended tremelimumab dose for patients weighing 30 kg or more is 75 mg IV every 3 weeks with durvalumab 1500 mg IV and platinum-based Retrieved on November 14, 2019, from https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808, National Cancer Institute. Any unauthorized or illegal use, copying or dissemination will be prosecuted. It is used with (2021, September). In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Retrieved on November 14, 2019, from http://theoncologist.alphamedpress.org/content/12/7/873.full, United States National Library of Medicine. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy, In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in 20% of patients) were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia, In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. 5-star reviewed mesothelioma and support organization. Initiate symptomatic treatment including hormone replacement as clinically indicated. Intestinal perforation has been observed in other studies of tremelimumab-actl in combination with durvalumab. Various grades of visual impairment to include blindness can occur. Infusion-related reactions occurred in 10 (2.6%) patients receiving tremelimumab-actl in combination with durvalumab. AstraZeneca stopped the trial in 2016 when they realized it was not working well enough. It is not a substitute for professional medical advice, diagnosis or treatment. Advise females of reproductive potential that tremelimumab-actl can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Last modified February 24, 2023. https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. Retrieved March 4, 2023, from https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). Tremelimumab may help people live longer with mesothelioma, but the drug may also cause side effects. Other Immune-Mediated Adverse Reactions: The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received tremelimumab-actl in combination with durvalumab or were reported with the use of other immune-checkpoint inhibitors. On October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). In addition to being investigated as a monotherapy treatment for patients with mesothelioma, tremelimumab is currently being studied in combination with Selby, Karen. IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal. Dosage summary: Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. WebOut of more than 180 oncology approvals, less than half of the approvals were successfully converted to full FDA approvals so far. Filing Veterans Benefits for Mesothelioma, COVID-19 Information for Mesothelioma Patients, https://www.sciencedirect.com/topics/neuroscience/tremelimumab, https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808, https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tremelimumab, http://theoncologist.alphamedpress.org/content/12/7/873.full, https://www.clinicaltrials.gov/ct2/show/NCT03075527, https://clinicaltrials.gov/ct2/show/NCT01843374, https://clinicaltrials.gov/ct2/show/record/NCT02592551?view=record. WebUse in Cancer. Registered oncology nurse with more than 30 years experience, Expertise in mesothelioma, health effects of asbestos, cancer therapy and immunotherapy, Assisted surgeons with lung resections, lung transplants and pneumonectomies, Ran tissue procurement program at the University of Florida, Calabro, L. et al. The treatment helps the immune system to find and eliminate cancer cells. Clinical trials often combine the medication with another immunotherapy drug called durvalumab. Journal of Clinical Oncology,34, No. For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter@FDAOncology. Seventeen patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker). Thyroiditis can present with or without endocrinopathy. In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. However, as required by the new California Consumer Privacy Act (CCPA), you may record your preference to view or remove your personal information by completing the form below. Immune checkpoint inhibitors in malignant pleural mesothelioma: promises and challenges. Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab depending on severity. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAsMedWatch Reporting System or by calling 1-800-FDA-1088. If you have been diagnosed with mesothelioma, you are likely entitled to financial compensation. 4 . Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. Medically reviewed by Drugs.com on Nov 29, 2022. Advise females of reproductive potential to use effective contraception during treatment with tremelimumab-actl and for 3 months after the last dose. Retrieved from, ClinicalTrials.gov. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. Monitor for signs and symptoms of infusion-related reactions. She is a registered nurse with a background in oncology and thoracic surgery and was the regional director of a tissue bank before becoming a Patient Advocate at The Mesothelioma Center. The major efficacy outcome was overall survival (OS). All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. The FDA designated the drug as an orphan drug in April 2015. "My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. co-culturing the second population of T cells in the presence of antigen presenting cells that present one or more non-native peptide on a major histocompatibility complex (MHC There are therapies and medications to treat every side effect. Tremelimumab has been tested on a variety of cancers including mesothelioma, lung cancer, melanoma, liver cancer, bladder cancer and head and neck cancer. Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Karen Selby, RN Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. Material safety data sheet: Tremelimumab. Your web browser is no longer supported by Microsoft. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. WebOn October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with WebTremelimumab blocks the binding of the antigen-presenting cell ligands B7.1 and B7.2 to CTLA-4, resulting in inhibition of B7-CTLA-4-mediated downregulation of T-cell activation; 5-Year Mesothelioma Survivor Motivated by Family, Mesothelioma Survivors Treatment Journey Continues, A Post-Cancer Letter to Pre-Cancer Tamron. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Orphan drug designation is not the same as FDA approval, but it does help pharmaceutical companies move a drug designed to treat rare diseases through the approval process. Specialists suggest that both medications in combination may interfere with the ability of malignant tumor cells to grow and spread. More than 30 contributors, including mesothelioma doctors, survivors, health care professionals and other experts, have peer-reviewed our website and written unique research-driven articles to ensure you get the highest-quality medical and health information. A medical doctor who specializes in mesothelioma or cancer treatment reviewed the content on this page to ensure it meets current medical standards and accuracy. Assisting mesothelioma patients and their loved ones since 2006. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in a single-dose vial. Current clinical trials are testing the drug on multiple types of cancer. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms, In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in 20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%), In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Further research has been done to test the drug as a treatment for metastatic renal cell carcinoma, malignant pleural mesothelioma, metastatic colorectal cancer, and advanced gastric and esophageal adenocarcinoma. (n.d.). 2. 322 0 obj <>/Filter/FlateDecode/ID[<2567B33F55498047B5C633564638CC02>]/Index[301 165]/Info 300 0 R/Length 115/Prev 474568/Root 302 0 R/Size 466/Type/XRef/W[1 3 1]>>stream Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Request free informational, treatment, financial or support resources to help you and your loved one after a mesothelioma diagnosis. Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. (2015). AHFSfirstRelease. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO. Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab based on the severity. Several clinical trials continue to test the drug in mesothelioma patients, including Dr. David Sugarbakers trial that combines tremelimumab with durvalumab and surgery. For non-prescription products, read the label or package ingredients carefully. Tremelimumab for the treatment of malignant mesothelioma. Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. 5 WARNINGS AND PRECAUTIONS These immune cells kill cancer cells. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). (n.d.). Massard C, Gordon MS, Sharma S, et al. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Immune-Mediated Nephritis with Renal Dysfunction: Tremelimumab-actl in combination with durvalumab can cause immune-mediated nephritis. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. New clinical trials are testing it in combination with several anti-cancer drugs with the hope of finding a magic combination. Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. Copyright 2023, Selected Revisions November 29, 2022. See USPI Dosing and Administration for specific details. (2016). The site is secure. (2019). Immune-Mediated Dermatology Reactions: Tremelimumab-actl in combination with durvalumab can cause immune-mediated rash or dermatitis. Tremelimumab which has no brand name yet has not been approved by the U.S. Food and Drug Administration (FDA) to treat any cancer or disease. (2018, January 4). Retrieved from, ClinicalTrials.gov. The drugs stopped his tumor growth for months. Learn everything you need to know about this rare disease. Events resolved in 15 of the 18 patients. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Tremelimumab. IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Most common adverse reactions ( 20%) of patients with uHCC receiving tremelimumab-actl are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Thyroid Disorders: Tremelimumab-actl in combination with durvalumab can cause immune-mediated thyroid disorders. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Immune-mediated nephritis occurred in 1% (4/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.5%) adverse reactions. Imfinzi [package insert]. Fatal adverse reactions occurred in 8% of patients who received IMJUDO in combination with durvalumab, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). Of the 393 patients with uHCC treated with tremelimumab-actl in combination with durvalumab, 50% of patients were 65 years or older and 13% of patients were 75 years or older. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of tremelimumab-actl in combination with durvalumab. Systemic corticosteroids were required in 2 patients (2/6) with immune-mediated thyroiditis, of these 1 patient required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath. WebCyramza: EPAR Product Information - European Medicines Agency Tremelimumab. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Since then, multiple studies have tested the drug on several types of cancer. Written by Medications like tremelimumab are designed to fight cancer cells by increasing the amount of activated killer T cells. See USPI Dosing and Administration for specific details. IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. "Tremelimumab." 1 Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood Mated genetically engineered mice heterozygous for CTLA-4 (CTLA-4+/-) gave birth to CTLA-4+/- offspring and offspring deficient in CTLA-4 (homozygous negative, CTLA-4-/-) that appeared healthy at birth.