Immune-Mediated Colitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated colitis that is frequently associated with diarrhea. 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). Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. It is not a substitute for professional medical advice, diagnosis or treatment. "Tremelimumab." Tremelimumab. (2006). 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. Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. 15_suppl, 8502-8502. doi: 10.1200/JCO.2016.34.15_suppl.8502, AstraZeneca. Tremelimumab plus durvalumab demonstrated a statistically significant and clinically meaningful improvement in OS compared to sorafenib (stratified hazard ratio [HR] of 0.78 [95% CI: 0.66, 0.92], 2-sided p value = 0.0035); median OS was 16.4 months (95% CI: 14.2, 19.6) versus 13.8 months (95% CI: 12.3, 16.1). For platinum-based chemotherapy or pemetrexed, refer to Prescribing Information for administration information Observe for 60 minutes following completion of infusion; then administer durvalumab as a separate IV infusion over 60 minutes on same day Combination with durvalumab: Infuse tremelimumab, followed by durvalumab on same day of dosing 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). IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not. Medically Reviewed By Dr. Daniel A. Landau. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Hypophysitis can cause hypopituitarism. 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 2 of the 6 patients. Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, and immune thrombocytopenia. 5-Year Mesothelioma Survivor Motivated by Family, Mesothelioma Survivors Treatment Journey Continues, A Post-Cancer Letter to Pre-Cancer Tamron. Webof tremelimumab-actl* at Day 1 of Cycle 1, followed by a maintenance dose of 20 mg/kg as a single agent every 28 days thereafter, until disease 1. Karen has assisted surgeons with thoracic surgeries such as lung resections, lung transplants, pneumonectomies, pleurectomies and wedge resections. Institute medical management promptly, including specialty consultation as appropriate. A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma. 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. The most common Grade 3 or 4 adverse reactions (3%) were pneumonia (7%) and pneumonitis/radiation pneumonitis (3.4%), In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled DETERMINE study. Retrieved from, Pfizer. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Maternal IgG is known to be present in human milk. IMFINZI and IMJUDO can cause immune-mediated nephritis. 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. Immune-Mediated Hypophysitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hypophysitis. 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. Eventually, the cancer returned and McWhorter had to leave that trial in search of other options to control his cancer. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. IMFINZI and IMJUDO can cause severe or life-threatening infusion-related reactions. Institute medical management promptly, including specialty consultation as appropriate. Systemic corticosteroids were required in all patients, of these 4 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Eight patients (8/29) required other immunosuppressants. After several months, the drug seems to stop working altogether, which is why the FDA hasnt improved it. Advise the patient to read the FDA-approved patient labeling (Medication Guide). For more information about any of the below clinical trials, they can be found at ClinicalTrials.gov. 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. In addition to being investigated as a monotherapy treatment for patients with mesothelioma, tremelimumab is currently being studied in combination with Efficacy was evaluated in HIMALAYA (NCT03298451), a randomized (1:1:1), open-label, multicenter study in patients with confirmed uHCC who had not received prior systemic treatment for HCC. Orphan designation does not mean the drug is safe or effective. Advise females of reproductive potential to use effective contraception during treatment with tremelimumab-actl and for 3 months after the last dose of the drug. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Mesothelioma Center - Vital Services for Cancer Patients & Families doesnt believe in selling customer information. WebTremelimumab 1 mg/kg IV Durvalumab: 20 mg/kg IV Cycles 1-4 Dose interval every 3 weeks Administer tremelimumab, durvalumab and chemotherapy Cycle 5 (week 12) There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). This website information is proprietary, protected, and not a substitute for professional medical advice, diagnosis or treatment. 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 hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. 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. 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. AstraZeneca stopped the trial in 2016 when they realized it was not working well enough. WebCleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. 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. (2019). The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child to tremelimumab-actl are unknown. Cardiac/vascular: Myocarditis, pericarditis, vasculitis. 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. Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. 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. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. 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. For more information, visit our sponsor page. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. Refer to the prescribing information for agents administered in combination with tremelimumab-actl for breastfeeding recommendations, as appropriate. Previous studies have shown both mild and serious side effects in mesothelioma patients who receive tremelimumab as treatment. Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. WebIMJUDO (tremelimumab-actl) injection, for intravenous use Initial U.S. Approval: 2022----- INDICATIONS AND USAGE -----IMJUDOis a cytotoxic T-lymphocyte-associated One cycle is defined as every 4 weeks. Retrieved on November 14, 2019, from https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, National Cancer Institute. Imfinzi: Package Insert / Prescribing Information - Drugs.com Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. 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. This optimistic outcome has researchers hopeful for similar results for mesothelioma patients. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. Immune-mediated Hypothyroidism: Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving tremelimumab-actl in combination with durvalumab. Verify pregnancy status of females of reproductive potential prior to initiating treatment with tremelimumab-actl. CONTRAINDICATIONS . In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Connect with mesothelioma patients around the country who are battling the disease. Tremelimumab is a monoclonal antibody drug, which is a type of treatment that helps the immune system fight cancer. Systemic corticosteroids were required in all 9 patients and of these, 7 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Tremelimumab. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. None. (2009, November 19). Dosage summary: Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution. AHFSfirstRelease. (2015). Various grades of visual impairment to include blindness can occur. Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab depending on severity Immune-mediated hypophysitis/hypopituitarism occurred in 1.1% (5/462) of patients receiving the STRIDE regimen (combination of tremelimumab-actl with durvalumab). (2015, April 15). In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. (2016). 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. 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. There are therapies and medications to treat every side effect. Immune-mediated Thyroiditis: Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab. 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. In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. The safety and effectiveness of tremelimumab-actl have not been established in pediatric patients. An official website of the United States government, : Monoclonal antibody drugs for cancer: How they work. Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). The results led the researchers to conclude that the treatment combination was associated with long-term survival. Around half of the patients lived at least a year in both studies. Initial studies of the drug produced impressive results that havent been replicated in larger clinical trials. Medications like tremelimumab are designed to fight cancer cells by increasing the amount of activated killer T cells. WebOut of more than 180 oncology approvals, less than half of the approvals were successfully converted to full FDA approvals so far. Tremelimumab-actl, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody, is an antineoplastic agent. Would you like to speak with a Patient Advocate? Events resolved in 15 of the 18 patients. Tremelimumab may help people live longer with mesothelioma, but the drug may also cause side effects. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCEs Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. In April 2015, tremelimumab received orphan drug designation by the FDA to treat mesothelioma. For patients with mesothelioma cancer, immunotherapy is a promising new field. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). The recommended dosage of tremelimumab-actl for the treatment of uHCC in adults is based on body weight as follows: Body weight 30 kg and more: tremelimumab-actl 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab 1,500 mg as a single agent every 4 weeks. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Events resolved in 2 of the 6 patients. Material safety data sheet: Tremelimumab. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. (2016). Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. We will help you find the best mesothelioma doctor in your area. Initiate symptomatic treatment including hormone replacement as clinically indicated. Systemic corticosteroids were required in all 29 patients and all 29 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions. Information and assistance were provided by The Mesothelioma Center at no cost to our family.". Tremelimumab-actl, a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking human IgG2 monoclonal antibody, is produced by recombinant DNA 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. 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. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. Before sharing sensitive information, make sure you're on a federal government site. "Tremelimumab." Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. In animal studies, CTLA-4 blockade is associated with higher incidence of pregnancy loss. All rights reserved. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors. For those weighing less than 30 kg, the recommended tremelimumab dose is 4 mg/kg IV as a single dose in combination with durvalumab 20 mg/kg IV, followed by durvalumab 20 mg/kg IV every 4 weeks. There is no information regarding the presence of IMFINZI and IMJUDO in human milk; however, because of the potential for serious adverse reactions in breastfed infants from IMFINZI and IMJUDO, advise women not to breastfeed during treatment and for 3 months after the last dose. Clinical trials began testing tremelimumab on mesothelioma in 2013. Clinical Trials Using Tremelimumab. IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal. Massard C, Gordon MS, Sharma S, et al. The drugs stopped his tumor growth for months. 0 It also does not guarantee FDA approval. Tremelimumab-actl can cause fetal harm when administered to a pregnant woman. Current clinical trials are testing the drug on multiple types of cancer. Pancreatitis: Advise patients to contact their healthcare provider immediately for signs or symptoms of pancreatitis. Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 1 patient. All patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker). Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. 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. Immune-Mediated Hepatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hepatitis, which may be fatal. 465 0 obj <>stream 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. (2018, January 4). Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. Tremelimumab is a human antibody that helps the immune system fight cancer. Tremelimumab has been tested on a variety of cancers including mesothelioma, lung cancer, melanoma, liver cancer, bladder cancer and head and neck cancer. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. Tremelimumab, manufactured by AstraZeneca, is an immunotherapy treatment that helps the immune system recognize and attack cancer cells. Several clinical trials continue to test the drug in mesothelioma patients, including Dr. David Sugarbakers trial that combines tremelimumab with durvalumab and surgery. Accessed November 2022. One patient received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). 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. IMJUDO (tremelimumab) in combination with IMFINZI (durvalumab) approved in the US for patients with unresectable liver cancer PUBLISHED 24 October The .gov means its official.Federal government websites often end in .gov or .mil. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. 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). 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. IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. 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. (2017, December 13). Asbestos.com. Webc. All rights reserved. After Cycle 1 of combination therapy, administer durvalumab as a single agent every 4 weeks until disease progression or unacceptable toxicity occurs. Body weight less than 30 kg: tremelimumab-actl 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab 20 mg/kg as a single agent every 4 weeks. (n.d.). WebIMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not IMPORTANT SAFETY INFORMATION There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Good research has proven it isnt effective enough on its own to use as a single therapy against mesothelioma. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. This A study called DETERMINE assesses tremelimumab as a second or third-line treatment for malignant mesothelioma patients who ineligible for tumor-removing surgery in a randomized, double-blind study. One patient (1/5) required other immunosuppressants. Two patients (2/18) required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). endstream endobj startxref Get help paying for treatment, lost wages & more. Thyroid Disorders: Tremelimumab-actl in combination with durvalumab can cause immune-mediated thyroid disorders. (2019). 5-star reviewed mesothelioma and support organization. Tremelimumab succeeds by activating immune cells, called cytotoxic T lymphocytes (CTLs), or killer T cells, which kill cancer cells. The tremelimumab antibody activates an immune cell known as cytotoxic T lymphocytes (CTLs), or killer T cells. View full prescribing information for Imjudo. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. Type 1 Diabetes Mellitus: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. 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. 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. It has been shown to induce durable tumor responses in patients with metastatic melanoma Immune checkpoint inhibitors in malignant pleural mesothelioma: promises and challenges. 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. 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 Retrieved on November 14, 2019, from https://www.clinicaltrials.gov/ct2/show/NCT03075527, United States National Library of Medicine. Learn everything you need to know about this rare disease. Antibodies are proteins in the immune system that recognize and attack foreign invaders such as bacteria, viruses and cancer cells. 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. In a murine model of pregnancy, CTLA-4 blockade resulted in increased resorptions and reduced live fetuses. Tremelimumab. Monitor for signs and symptoms of infusion-related reactions. Tremelimumab (CP-675,206), a Cytotoxic T LymphocyteAssociated Antigen 4 Blocking Monoclonal Antibody in Clinical Development for Patients with Cancer. Exfoliative dermatitis, including Stevens Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with CTLA-4 and PD-1/L-1 blocking antibodies. Retrieved on November 14, 2019, from http://theoncologist.alphamedpress.org/content/12/7/873.full, United States National Library of Medicine. 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. Our Patient Advocates can help guide you or your loved one through the steps to take after a mesothelioma diagnosis. Learn how to access mesothelioma clinical trials utilizing immunotherapy. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.5%) adverse reactions. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in

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