(2009, November 19). It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. Other immune-mediated adverse reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of aseptic meningitis, immune thrombocytopenia, myocarditis, hemolytic anemia, myositis, uveitis, keratitis, and myasthenia gravis. Seventeen patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker). In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. This study used the drug alone rather than in combination with other drugs. 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. WebIMJUDO (tremelimumab-actl) injection, for intravenous use Initial U.S. Approval: 2022----- INDICATIONS AND USAGE -----IMJUDOis a cytotoxic T-lymphocyte-associated Monitor for signs and symptoms of infusion-related reactions. This phase 2 trial conducted by the Dana-Farber Cancer Institute studies how well durvalumab with or without tremelimumab works in treating pleural mesothelioma patients who are eligible for tumor-removing surgery. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. (n.d.). (2021, September). Based on its mechanism of action, fetal exposure to tremelimumab-actl may increase the risk of developing immune-mediated disorders or altering the normal immune response. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. For more information about any of the below clinical trials, they can be found at ClinicalTrials.gov. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. (2018, January 4). Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Three patients also required endocrine therapy. Tremelimumab Immunotherapy Mesothelioma Medication Option Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 and CTLA-4 blocking antibodies. The trial was suspended in late 2019 after criteria were not met, but doctors and researchers estimate completion in 2024. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Drug class: anti-CTLA-4 monoclonal antibodies. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Two patients (2/18) required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). 2023 AstraZeneca. Access free resources to help you or a loved one after a mesothelioma diagnosis. 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. 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. Copyright 2023, Selected Revisions November 29, 2022. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Cleviprex Full Prescribing Information - Chiesi USA Connect with mesothelioma patients around the country who are battling the disease. IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). Nearly 37 percent of participants survived at least two years in one of the studies. Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. Immediate treatment of side effects helps keep them in control. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. Dermatological reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. For non-prescription products, read the label or package ingredients carefully. 5-star reviewed mesothelioma and support organization. No overall differences in safety or efficacy of tremelimumab-actl have been observed between patients 65 years or older and younger adult patients. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. (2017). Tremelimumab is a cancer treatment drug manufactured by AstraZeneca. 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. Helps more than 50% of mesothelioma patients diagnosed annually in the U.S. A+ rating from the Better Business Bureau. IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Events resolved in 6 of the 9 patients. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Our pipeline. Immune-mediated pancreatitis occurred in 2.3% (9/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. IMFINZI and IMJUDO can cause immune-mediated nephritis. 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 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 Journal of Clinical Oncology,34, No. However, combining tremelimumab and durvalumab has proven more effective against lung cancer than tremelimumab alone. "Tremelimumab." IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. IMFINZI (durvalumab) plus tremelimumab demonstrated Tremelimumab for the treatment of malignant mesothelioma. This website information is proprietary, protected, and not a substitute for professional medical advice, diagnosis or treatment. All patients received systemic corticosteroids, and 20 of the 23 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of tremelimumab-actl in combination with durvalumab. Imfinzi [package insert]. Tremelimumab is a human antibody that helps the immune system fight cancer. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Immunotherapy for BTC, uHCC, NSCLC & ES-SCLC IMFINZI For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. WebUse in Cancer. Retrieved from, Maio, M. et al. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Both durvalumab and tremelimumab have been tested for mesothelioma alone, but not in combination. The drug usually stops cancer growth for several months before it stops working altogether, a reason why it hasnt been FDA approved to treat mesothelioma. AstraZeneca stopped the trial in 2016 when they realized it was not working well enough. 5 WARNINGS AND PRECAUTIONS Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/record/NCT02592551?view=record. Feature: The FDA Accelerated Approval Program: A Double-Edged WebOn October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with 2. WebTremelimumab is a fully human monoclonal antibody that binds to the CTLA-4 molecule. Dosage summary: Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution. We will help you find the best mesothelioma doctor in your area. We comply with the HONcode standard for trustworthy health information. Last Modified: September 22, 2022, Created: July 6, 2022. A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1). Events resolved in 5 of the 42 patients. (n.d.). Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 1 patient. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tremelimumab-actl are unknown. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO in combination with platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions. 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. The results led the researchers to conclude that the treatment combination was associated with long-term survival. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey. All rights reserved. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with tremelimumab-actl and for 3 months after the last dose. An official website of the United States government, : CONTRAINDICATIONS . One patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Retrieved March 4, 2023, from https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. Selby, Karen. Tremelimumab-actl is a monoclonal antibody that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, thereby removing inhibition of the immune response. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. Please read our privacy policy and disclaimer for more information about our website. Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Retrieved from, Pfizer. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Systemic corticosteroids were required in all patients with immune-mediated pancreatitis, of these 7 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). In 2017, mesothelioma survivor and Navy veteran Jim McWhorter joined a clinical trial testing tremelimumab and durvalumab, another immunotherapy drug. Brand name: Imjudo US-63354; US-65135; US-65136; US-71396 Last Updated 1/23, WITH IMFINZI ALONE OR IN COMBINATION WITH IMJUDO, IMFINZI with IMJUDO and Platinum-Based Chemotherapy, Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism), Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis, Musculoskeletal and connective tissue disorders. et al. Tremelimumab The information on this website is proprietary and protected. Thyroiditis can present with or without endocrinopathy. Expert Review of Anticancer Therapy, 16(7), 673675. Initial studies of the drug produced impressive results that havent been replicated in larger clinical trials. The sources on all content featured in The Mesothelioma Center at Asbestos.com include medical and scientific studies, peer-reviewed studies and other research documents from reputable organizations. Patients were randomized to one of three arms: tremelimumab 300 mg as a one-time single intravenous (IV) infusion plus durvalumab 1500 mg IV on the same day, followed by durvalumab 1500 mg IV every 4 weeks; durvalumab 1500 mg IV every 4 weeks; or sorafenib 400 mg orally twice daily until disease progression or unacceptable toxicity. Additional efficacy outcomes included investigator-assessed progression-free survival (PFS) and overall response rate (ORR) according to RECIST v1.1.

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