Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Previous studies have shown both mild and serious side effects in mesothelioma patients who receive tremelimumab as treatment. Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Institute medical management promptly, including specialty consultation as appropriate. Several landmark trials have shown tremelimumab can stop mesothelioma tumors from growing for periods of time. Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 1 patient. Dermatological reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions. 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. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. We comply with the HONcode standard for trustworthy health information. Definition of tremelimumab. Drug class: Antineoplastic Agents This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDAs assessment. Antibodies are proteins produced by plasma cells that the immune system by attaching themselves to molecules on the surface of problematic cells. Tremelimumab Dosage and Administration General. 5 WARNINGS AND PRECAUTIONS The CTLA-4-/- homozygous negative offspring developed signs of a lymphoproliferative disorder and died by 3 to 4 weeks of age with multiorgan tissue destruction. Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving tremelimumab-actl in combination with durvalumab, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Tremelimumab, which has no brand name yet, has not been approved by the United States Food and Drug Administration (FDA) to treat any cancer or disease. Tremelimumab. 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. 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%). Update your browser for more security, speed and compatibility. Interaction highlights: Please see product labeling for drug interaction information. There are therapies and medications to treat every side effect. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. (n.d.). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey. Events resolved in 2 of the 6 patients. 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. Retrieved on November 14, 2019, from https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808, National Cancer Institute. hbbd```b``y"3@$>K mX d g0"Y$C,@m!X2ZqX%(9JR;BI:@ s About tremelimumab Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions. See USPI Dosing and Administration for specific details. Before sharing sensitive information, make sure you're on a federal government site. Tremelimumab may help people live longer with mesothelioma, but the drug may also cause side effects. Selby, K. (2023, February 24). Type 1 Diabetes Mellitus: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. None. Tremelimumab. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/NCT01843374, United States National Library of Medicine. Immune-Mediated Pneumonitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated pneumonitis, which may be fatal. 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. 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). Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain. Assisting mesothelioma patients and their loved ones since 2006. 0 2023 AstraZeneca. 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. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). New clinical trials are testing it in combination with several anti-cancer drugs with the hope of finding a magic combination. Events resolved in 2 of the 5 patients. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 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. Clinical Trials Using Tremelimumab. Nerve inflammation (peripheral neuropathy), Renowned mesothelioma center Dana-Farber Cancer Institute in 2017 opened a phase II trial. It might be most effective when combined with other immunotherapy drugs. Available for Android and iOS devices. Selby, Karen. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Request a free legal case evaluation today. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Karen Selby, RN But these trials have yet to provide impressive enough results to warrant an FDA approval. Interrupt, slow the rate of, or permanently discontinue tremelimumab-actl and durvalumab based on the severity. 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. 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. Our fact-checking process begins with a thorough review of all sources to ensure they are high quality. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Would you like to speak with a Patient Advocate? Tremelimumab has been tested on a variety of cancers including mesothelioma, lung cancer, melanoma, liver cancer, bladder cancer and head and neck cancer. You may report side effects related to AstraZeneca products by clicking here. 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. Retrieved from, ClinicalTrials.gov. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. Prior results do not predict a similar outcome. 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. (2016). 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. Current clinical trials are testing the drug on multiple types of cancer. Our Patient Advocates have relationships with top doctors and cancer centers and can help you schedule and expedite appointments. While immune-mediated adverse reactions usually manifest during treatment, immune-mediated adverse reactions can also manifest after discontinuation of tremelimumab-actl and/or durvalumab. Thyroid Disorders: Tremelimumab-actl in combination with durvalumab can cause immune-mediated thyroid disorders. Tremelimumab-actl is a monoclonal antibody that binds to CTLA-4 and blocks the interaction with its ligands CD80 and CD86, releasing CTLA-4-mediated inhibition of T-cell activation. 1 Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood So far, research has proven the drug helps some people with mesothelioma. While smaller trials have shown success, more research on the drug is needed to treat future patients. An official website of the United States government, : Dont try to tough it out, even with mild side effects. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not. Advise females of reproductive potential to use effective contraception during treatment with tremelimumab-actl and for 3 months after the last dose. Since then, multiple studies have tested the drug on several types of cancer. Massard C, Gordon MS, Sharma S, et al. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. This website and its content may be deemed attorney advertising. Events resolved in 6 of the 9 patients. This study used the drug alone rather than in combination with other drugs. Request free informational, treatment, financial or support resources to help you and your loved one after a mesothelioma diagnosis. Results from a recent study at Rice University in Houston are exciting. Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica. Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. The Mesothelioma Center at Asbestos.com has provided patients and their loved ones the most updated and reliable information on mesothelioma and asbestos exposure since 2006. Pediatric . (2017, December 13). The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients. 15_suppl, 8502-8502. doi: 10.1200/JCO.2016.34.15_suppl.8502, AstraZeneca. It binds to CTLA-4, which is primarily expressed on the surface of T lymphocytes, and thus enhances T-cell activation That research is underway at several U.S. mesothelioma specialty centers and internationally.