tremelimumab package insert tremelimumab package insert

Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. (2006). by Asbestos.com and The Mesothelioma Center. This study used the drug alone rather than in combination with other drugs. Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. Several clinical trials continue to test the drug in mesothelioma patients, including Dr. David Sugarbakers trial that combines tremelimumab with durvalumab and surgery. Asbestos.com is sponsored by law firms. Serious adverse reactions in >1% of patients included hemorrhage (6%), diarrhea (4%), sepsis (2.1%), pneumonia (2.1%), rash (1.5%), vomiting (1.3%), acute kidney injury (1.3%), and anemia (1.3%). Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. (2016). There are no available data on the use of tremelimumab-actl in pregnant women. WebIMJUDO (tremelimumab-actl) injection, for intravenous use Initial U.S. Approval: 2022----- INDICATIONS AND USAGE -----IMJUDOis a cytotoxic T-lymphocyte-associated Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. %PDF-1.7 % WebTREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. 2023 AstraZeneca. Tremelimumab, manufactured by AstraZeneca, is an immunotherapy treatment that helps the immune system recognize and attack cancer cells. 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. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. The most frequent serious adverse reactions reported in at least 2% of patients were cholangitis (7%), pyrexia (3.8%), anemia (3.6%), sepsis (3.3%) and acute kidney injury (2.4%). Systemic corticosteroids were required in 4 patients (4/5) with hypophysitis, of these 1 of the 4 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Weve gathered all of our resources into one guide with one purpose: helping you navigate mesothelioma. 4 . 301 0 obj <> endobj Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. 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%). Events resolved in 6 of the 9 patients. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions. In general, if combination of tremelimumab-actl and durvalumab requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Accessed November 2022. 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. Would you like to speak with a Patient Advocate? Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Initial early phase studies of the drug often showed promising results, in which the drug stopped tumors from growing for periods of time. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/NCT01843374, United States National Library of Medicine. Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Refer to the prescribing information for the agents administered in combination with tremelimumab-actl for recommended contraception duration, as appropriate. Tremelimumab AstraZeneca will be available as a 20 mg/ml concentrate for solution for infusion. 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. Tremelimumab. 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. See USPI Dosing and Administration for specific details. Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Most common adverse reactions ( 20%) of patients with uHCC receiving tremelimumab-actl are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. It also does not guarantee FDA approval. The most common Grade 3 or 4 adverse reaction (3%) was fatigue/asthenia (3.4%), In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. While immune-mediated adverse reactions usually manifest during treatment, immune-mediated adverse reactions can also manifest after discontinuation of tremelimumab-actl and/or durvalumab. Tremelimumab may help people live longer with mesothelioma, but the drug may also cause side effects. Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. 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). This is a staff of compassionate and knowledgeable individuals who respect what your family is experiencing and who go the extra mile to make an unfortunate diagnosis less stressful. Researchers estimate the study will be completed in late 2019. Lancet Respir Med, 3(4), 301-309. doi: 10.1016/S2213-2600(15)00092-2, Ceresoli, G.L., Bonomi, M., & Sauta, M.G. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. Verify pregnancy status of females of reproductive potential prior to initiating treatment with tremelimumab-actl. Retrieved from, Calabro, L. et al. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Available for Android and iOS devices. Clinical trials on tremelimumab have been conducted on cancer patients in an attempt to study the prevention, detection, or treatment of multiple diseases. Immune-Mediated Hepatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hepatitis, which may be fatal. Three patients also received other immunosuppressants. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. 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). Good research has proven it isnt effective enough on its own to use as a single therapy against mesothelioma. Please read our privacy policy and disclaimer for more information about our website. WebThe most common side effects of IMFINZI when used with other anticancer medicines in people with biliary tract cancer (BTC) include feeling tired, nausea, constipation, decreased appetite, stomach (abdominal) pain, rash, and fever. Events resolved in 15 of the 18 patients. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Read more about the latest news and research on mesothelioma, asbestos regulations, and emerging treatments. Infusion-related reactions occurred in 2.9% (17/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions. No overall differences in safety or efficacy of tremelimumab-actl have been observed between patients 65 years or older and younger adult patients. Medications like tremelimumab are designed to fight cancer cells by increasing the amount of activated killer T cells. WebThe STRIDE Regimen (Single Tremelimumab Regular Interval Durvalumab): A single priming dose of IMJUDO 300 mg followed by IMFINZI 1500 mg on Day 1 of Cycle 1; 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. Tremelimumab-actl, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody, is an antineoplastic agent. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. He initially responded quite well. Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. Retrieved from, Guazzelli, A. The medication was first studied as a treatment for metastatic melanoma. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2022. Tremelimumab Dosage and Administration General. Advise female patients not to breastfeed while taking tremelimumab-actl and for at least 3 months after the last dose. (2015). doi: 10.1080/14737140.2016.1191951, AstraZeneca. Interrupt, slow the rate of, or permanently discontinue tremelimumab-actl and durvalumab based on the severity. Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. "Tremelimumab." Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions. 15_suppl, 8502-8502. doi: 10.1200/JCO.2016.34.15_suppl.8502, AstraZeneca. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. Calling this number connects you with a Patient Advocate at The Mesothelioma Center, the nation's most trusted mesothelioma resource. 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. Most common laboratory abnormalities ( 40%) of patients with uHCC receiving tremelimumab-actl are increased AST, increased ALT, decreased hemoglobin, decreased sodium, increased bilirubin, increased alkaline phosphatase, and decreased lymphocytes. Human immunoglobulin G2 (IgG2) is known to cross the placental barrier; therefore, tremelimumab-actl has the potential to be transmitted from the mother to the developing fetus. 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. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tremelimumab-actl are unknown. Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. 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. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors. Treatment / Immunotherapy / Immunotherapy Medications / Tremelimumab. Immune-Mediated Hypophysitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hypophysitis. Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled DETERMINE study. AHFSfirstRelease. Mesothelioma Center - Vital Services for Cancer Patients & Families doesnt believe in selling customer information. Early results in the Phase 2b study have suggested that the drug fails to improve lifespan. Events resolved in 2 of the 6 patients. Tremelimumab is an immunotherapy drug that helps the immune system block cancerous cells. Brand name: Imjudo Tremelimumab is considered an immune checkpoint blocker because it blocks a protein called CTLA-4, which deactivates killer T 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%). Inform patients of the risk of immune-mediated adverse reactions that may require corticosteroid treatment and interruption or discontinuation of tremelimumab-actl in combination with durvalumab. This approval is based on a comparison of the 782 patients randomized to tremelimumab plus durvalumab to sorafenib. MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma. Cardiac/vascular: Myocarditis, pericarditis, vasculitis. Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. 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). Retrieved from, ClinicalTrials.gov. Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). The problem is tremelimumab seems to work well for only a little while. 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 Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Thank you for your feedback. Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. This Both durvalumab and tremelimumab have been tested for mesothelioma alone, but not in combination. Dont try to tough it out, even with mild side effects. Immune checkpoint inhibitors in malignant pleural mesothelioma: promises and challenges. Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Selby, Karen. Tremelimumab plus durvalumab retreatment and 4-year outcomes in patients with mesothelioma: a follow-up of the open label, non-randomised, phase 2 NIBIT-MESO-1 study. Antibodies are proteins in the immune system that recognize and attack foreign Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. If youre still feeling overwhelmed, let us help you seek the advice you need. Any unauthorized or illegal use, copying or dissemination will be prosecuted. However, combining tremelimumab and durvalumab has proven more effective against lung cancer than tremelimumab alone. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Institute medical management promptly, including specialty consultation as appropriate. Mechanism of action. Tremelimumab aims to stimulate an immune system attack on tumors. Cytotoxic T lymphocytes (CTLs) can recognize and destroy cancer cells. However, there is also an inhibitory mechanism (immune checkpoint) that interrupts this destruction. Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Resources for Information | Approved Drugs, Recalls, Market Withdrawals and Safety Alerts, Resources for Information | Approved Drugs, Oncology (Cancer) / Hematologic Malignancies Approval Notifications, Verified Clinical Benefit | Cancer Accelerated Approvals, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description, FDA approves tremelimumab in combination with durvalumab for unresectable hepatocellular carcinoma, View full prescribing information for Imjudo, NCI: Coronavirus: What People WithCancer Should Know. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in 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 Medically reviewed by Drugs.com on Nov 29, 2022. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDAs assessment. The treatment helps the immune system to find and eliminate cancer cells. People see immunotherapy as a more natural approach to fighting cancer because it activates the immune system, but this does not mean serious side effects arent a possibility. Monitor for signs and symptoms of infusion-related reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Tremelimumab-actl works as a form of immunotherapy and blocks the activity of T-lymphocyte-associated- antigen 4 (CTLA-4) a molecule found on T cells that 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. Fatal adverse reactions occurred in a total of 4.2% of patients, In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). IMFINZI and IMJUDO can cause immune-mediated nephritis. Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab depending on severity. In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.5%) adverse reactions. In animal studies, CTLA-4 blockade is associated with increased risk of immune-mediated rejection of the developing fetus and fetal death. Refer to the prescribing information for agents administered in combination with tremelimumab-actl for breastfeeding recommendations, as appropriate. Retrieved on November 14, 2019, from https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, National Cancer Institute. 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. Drug class: anti-CTLA-4 monoclonal antibodies. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. WebUse in Cancer. Karen Selby, RN All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. 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. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. Immune-mediated adverse reactions can occur at any time after starting tremelimumab-actl in combination with durvalumab. Retrieved from, Pfizer. All rights reserved. It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. For non-prescription products, read the label or package ingredients carefully. Tremelimumab-actl can cause fetal harm when administered to a pregnant woman. (n.d.). Tremelimumab succeeds by activating immune cells, called cytotoxic T lymphocytes (CTLs), or killer T cells, which kill cancer cells. Get help paying for treatment, lost wages & more. Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (3.6%) adverse reactions. Selby, Karen. Systemic corticosteroids were required in all 6 patients and of these, 1 patient required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). An increase in activated killer T cells helps a persons immune system fight cancer. The trial was suspended in late 2019 after criteria were not met, but doctors and researchers estimate completion in 2024. This website and its content may be deemed attorney advertising. 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. 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. Assisting mesothelioma patients and their loved ones since 2006. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Retrieved from, ClinicalTrials.gov. 1 Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood CONTRAINDICATIONS . (n.d.). Expert Opin Biol Ther, 15(12), 1819-29. doi: 10.1517/14712598.2015.1116515, ClinicalTrials.gov. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). The tremelimumab antibody activates an immune cell known as cytotoxic T lymphocytes (CTLs), or killer T cells. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses.