tremelimumab package insert

Download Guide. Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled DETERMINE study. This study used the drug alone rather than in combination with other drugs. Initial studies of the drug produced impressive results that havent been replicated in larger clinical trials. The problem is tremelimumab seems to work well for only a little while. It also does not guarantee FDA approval. IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. 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. For information on the COVID-19 pandemic, see the following resources: Follow the Oncology Center of Excellence on Twitter@FDAOncology. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. Tremelimumab-actl in combination with durvalumab can cause severe or life-threatening infusion-related reactions. She is also a member of the Academy of Oncology Nurse & Patient Navigators. Pharmacodynamics. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Cardiac/vascular: Myocarditis, pericarditis, vasculitis. Advise females of reproductive potential to use effective contraception during treatment with tremelimumab-actl and for 3 months after the last dose. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. 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. Medically Reviewed By Dr. Daniel A. Landau. Positive results from the HIMALAYA Phase III trial showed a single priming dose of tremelimumab added to Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus sorafenib as a 1st-line treatment for patients with unresectable hepatocellular carcinoma (HCC) who had not 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; For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. 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. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Several landmark trials have shown tremelimumab can stop mesothelioma tumors from growing for periods of time. 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). Material safety data sheet: Tremelimumab. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Each page includes all sources for full transparency. Dont try to tough it out, even with mild side effects. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. (2018, January 4). Treatment / Immunotherapy / Immunotherapy Medications / Tremelimumab. CTLA-4 is a negative regulator of T-cell activity. Tremelimumab succeeds by activating immune cells, called cytotoxic T lymphocytes (CTLs), or killer T cells, which kill cancer cells. Invert vial gently several times before use to ensure uniformity of the emulsion prior to This optimistic outcome has researchers hopeful for similar results for mesothelioma patients. 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. Selby, Karen. Would you like to speak with a Patient Advocate? Retrieved from, Calabro, L. et al. Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 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. Edited By Walter Pacheco IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. Based on their mechanism of action and data from animal studies, IMFINZI and IMJUDO can cause fetal harm when administered to a pregnant woman. 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%). IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Drug class: Antineoplastic Agents 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). 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. Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Our team has a combined experience of more than 30 years in assisting cancer patients, and includes a medical doctor, an oncology registered nurse and a U.S. Navy veteran. 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 Immune-mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. Selby, K. (2023, February 24). Retrieved from, Guazzelli, A. IMFINZI and IMJUDO are registered trademarks and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. 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. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2022. The safety and effectiveness of tremelimumab-actl have not been established in pediatric patients. 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. by Asbestos.com and The Mesothelioma Center. Mesothelioma Hub is dedicated to helping you find information, support, and advice. (n.d.). Expert Opin Biol Ther, 15(12), 1819-29. doi: 10.1517/14712598.2015.1116515, ClinicalTrials.gov. He initially responded quite well. 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. Support and resources for HCPs and patients. (2006). Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. There are therapies and medications to treat every side effect. Retrieved on November 14, 2019, from https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, National Cancer Institute. 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. In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. Tremelimumab, manufactured by AstraZeneca, is an immunotherapy treatment that helps the immune system recognize and attack cancer 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; 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. After Cycle 1 of combination therapy, administer durvalumab as a single agent every 4 weeks until disease progression or unacceptable toxicity occurs. Learn everything you need to know about this rare disease. 1 Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood 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. Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Events resolved in 22 of the 23 patients and resulted in permanent discontinuation in 5 patients. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. 465 0 obj <>stream Pediatric . Three patients also received other immunosuppressants. Connect with mesothelioma patients around the country who are battling the disease. In a murine model of pregnancy, CTLA-4 blockade resulted in increased resorptions and reduced live fetuses. 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. WebOut of more than 180 oncology approvals, less than half of the approvals were successfully converted to full FDA approvals so far. 2023 AstraZeneca. By blocking CTLA-4, tremelimumab activates killer T cells so they can get to work fighting cancer. Any unauthorized or illegal use, copying or dissemination will be prosecuted. Tremelimumab granted Orphan Drug Designation by US FDA for treatment of malignant mesothelioma. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Tremelimumab. AstraZenecas Biologics License Application (BLA) for tremelimumab has been accepted for Priority Review in the US, supporting the indication of a single priming dose of the anti-CTLA4 antibody added to Imfinzi (durvalumab) for the treatment of patients with unresectable hepatocellular carcinoma (HCC).A supplemental BLA (sBLA) has also 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. 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). Information and assistance were provided by The Mesothelioma Center at no cost to our family.". Advise the patient to read the FDA-approved patient labeling (Medication Guide). 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. WebUse in Cancer. Copyright 2023, Selected Revisions November 29, 2022. (2009, November 19). Access free resources to help you or a loved one after a mesothelioma diagnosis. Tremelimumab-actl can cause fetal harm when administered to a pregnant woman. One patient (1/5) required other immunosuppressants. 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. MEDI4736 or MEDI4736 + Tremelimumab in Surgically Resectable Malignant Pleural Mesothelioma, https://www.sciencedirect.com/science/article/abs/pii/S2213260021000436, https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=448620, https://www.astrazeneca.com/media-centre/press-releases/2015/tremelimumab-orphan-drug-designation-us-fda-malignant-mesothelioma-treatment-15042015.html, https://www.astrazeneca.com/our-science/pipeline.html, https://web.archive.org/web/20150905112429/https://www.pfizer.com/system/files/products/material_safety_data/PZ00158.pdf, https://clinicaltrials.gov/ct2/show/NCT02592551, https://www.clinicaltrials.gov/ct2/show/NCT02588131, https://clinicaltrials.gov/ct2/show/study/NCT01843374, https://www.clinicaltrials.gov/ct2/show/NCT03075527, Immune checkpoint blocker, monoclonal antibody, Ticilimumab, anti-CTLA 4 monoclonal antibody-Pfizer, CP-675, CP-675206, Skin reaction, skin rash, itching sensation, diarrhea, nausea, fatigue and immune-mediated disorders. New clinical trials are testing it in combination with several anti-cancer drugs with the hope of finding a magic combination. Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. Retrieved from, Maio, M. et al. Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. 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. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Hepatitis: Advise patients to contact their healthcare provider immediately for jaundice, severe nausea or vomiting, pain on the right side of abdomen, lethargy, or easy bruising or bleeding. Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. Events resolved in 5 of the 42 patients. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Retrieved from, National Cancer Institute. 0 Immune-mediated adverse reactions can occur at any time after starting tremelimumab-actl in combination with durvalumab. An official website of the United States government, : Immune-mediated pancreatitis occurred in 1.9% (9/462) of patients receiving the STRIDE regimen (combination of tremelimumab-actl with durvalumab), including Grade 4 (0.2%) and Grade 3 (1.3%) adverse reactions. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss. The side effects range from mild to severe. 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 The information on this website is proprietary and protected. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Tremelimumab. Tremelimumab is a cancer treatment drug manufactured by AstraZeneca. Tremelimumab is considered an immune checkpoint blocker because it blocks a protein called CTLA-4, which deactivates killer T cells. Permanent discontinuation of treatment regimen due to an adverse reaction occurred in 14% of patients. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey. If youre still feeling overwhelmed, let us help you seek the advice you need. Interrupt, slow the rate of, or permanently discontinue tremelimumab-actl and durvalumab based on the severity. In 2021, a clinical research study followed up with mesothelioma patients four years after they received tremelimumab and durvalumab. Eight patients (8/29) required other immunosuppressants. AHFS Drug Information. There are no available data on the use of tremelimumab-actl in pregnant women. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. 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. "My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. Retrieved on November 14, 2019, from https://www.clinicaltrials.gov/ct2/show/NCT03075527, United States National Library of Medicine. 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%). It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. 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%). 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. 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.

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