tremelimumab package insert

Expert Review of Anticancer Therapy, 16(7), 673675. 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. Imjudo blocks the Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. By blocking CTLA-4, tremelimumab activates killer T cells so they can get to work fighting cancer. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. It might be most effective when combined with other immunotherapy drugs. The purpose of tremelimumab is to blog receptors on immune cells that normally suppress immune attacks. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Small studies indicate about half of mesothelioma patients respond to tremelimumab and about half live at least one year on the drug. For patients with mesothelioma cancer, immunotherapy is a promising new field. Update your browser for more security, speed and compatibility. Retrieved on November 14, 2019, from https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808, National Cancer Institute. %PDF-1.7 % Antibodies are proteins in the immune system that recognize and attack foreign invaders such as bacteria, viruses and cancer cells. Three patients also received other immunosuppressants. 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. Borrie, A., & Vareki, M. (2018). Karen Selby joined Asbestos.com in 2009. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Additional efficacy outcomes included investigator-assessed progression-free survival (PFS) and overall response rate (ORR) according to RECIST v1.1. Tremelimumab for the treatment of malignant mesothelioma. 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. Tremelimumab may help people live longer with mesothelioma, but the drug may also cause side effects. All rights reserved. Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/NCT01843374, United States National Library of Medicine. Before sharing sensitive information, make sure you're on a federal government site. Retrieved on November 14, 2019, from https://www.sciencedirect.com/topics/neuroscience/tremelimumab, Mayo Clinic. Tremelimumab was granted orphan drug designation. Last Modified: September 22, 2022, Created: July 6, 2022. Lancet, 18(9), 1261-1273. doi: 10.1016/S1470-2045(17)30446-1, Kindler, H.L. 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. Immune-Mediated Dermatology Reactions: Tremelimumab-actl in combination with durvalumab can cause immune-mediated rash or dermatitis. Immune-Mediated Adrenal Insufficiency: Tremelimumab-actl in combination with durvalumab can cause primary or secondary adrenal insufficiency. Dosage summary: Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution. This study used the drug alone rather than in combination with other drugs. If receiving both durvalumab and tremelimumab for the first 4 cycles, they will be given on the same day. It is used with She is also a member of the Academy of Oncology Nurse & Patient Navigators. For example, two small Italian studies reported tremelimumab stopped cancer growth in about half of the mesothelioma participants. Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. Events resolved in 22 of the 23 patients and resulted in permanent discontinuation in 5 patients. Immune-Mediated Hypophysitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hypophysitis. These include ischemic or hemorrhagic stroke (4 patients), sepsis (2 patients), and upper gastrointestinal hemorrhage (2 patients), In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO, the most common adverse reactions (occurring in 20% of patients) were rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain, In patients with unresectable HCC in the HIMALAYA study receiving IMFINZI and IMJUDO, serious adverse reactions occurred in 41% of patients. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Imfinzi: Package Insert / Prescribing Information - Drugs.com Tremelimumab-actl injection is used in combination with durvalumab to treat liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC). 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). Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Immune-mediated hepatitis occurred in 7.5% (29/388) of patients receiving tremelimumab-actl in combination with durvalumab, including fatal (0.8%), Grade 4 (0.3%), and Grade 3 (4.1%) adverse reactions. 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. These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. 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. Your web browser is no longer supported by Microsoft. Multiple clinical trials have found that the medication works for a short time by stopping cancer growth. Material safety data sheet: Tremelimumab. endstream endobj startxref Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. 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. The jury is still out on whether tremelimumab will prove to be an effective mesothelioma treatment. However, combining tremelimumab and durvalumab has proven more effective against lung cancer than tremelimumab alone. In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. Tremelimumab as second- or third-line treatment of unresectable malignant mesothelioma (MM): Results from the global, double-blind, placebo-controlled DETERMINE study. Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. 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%). IMFINZI and IMJUDO can cause immune-mediated nephritis. In reproduction studies, administration of tremelimumab-actl to pregnant cynomolgus monkeys during the period of organogenesis through delivery was not associated with maternal toxicity or effects on embryo-fetal development at exposure levels approximately 31-times higher than those observed at a recommended dose of 300 mg (based on AUC). Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. (n.d.). Clinical trials are testing the drug on several different cancers including mesothelioma. The FDA designated the drug as an orphan drug in April 2015. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. 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. Nerve inflammation (peripheral neuropathy), Renowned mesothelioma center Dana-Farber Cancer Institute in 2017 opened a phase II trial. For more information about any of the below clinical trials, they can be found at ClinicalTrials.gov. None. 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 Thyroid Disorders: Tremelimumab-actl in combination with durvalumab can cause immune-mediated thyroid disorders. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. Our Patient Advocates have relationships with top doctors and cancer centers and can help you schedule and expedite appointments. Withhold or permanently discontinue tremelimumab-actl and durvalumab depending on severity. In 2021, a clinical research study followed up with mesothelioma patients four years after they received tremelimumab and durvalumab. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of tremelimumab-actl. Tremelimumab succeeds by activating immune cells, called cytotoxic T lymphocytes (CTLs), or killer T cells, which kill cancer cells. 2023 AstraZeneca. Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 1 patient. View full prescribing information for Imjudo. Specialists suggest that both medications in combination may interfere with the ability of malignant tumor cells to grow and spread. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in Early results in the Phase 2b study have suggested that the drug fails to improve lifespan. The purpose of tremelimumab is to blog receptors on immune cells that 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. Pediatric . 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. Hypophysitis can cause hypopituitarism. Events resolved in 2 of the 6 patients. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Events resolved in 6 of the 9 patients. Tremelimumab has been tested on a variety of cancers including mesothelioma, lung cancer, melanoma, liver cancer, bladder cancer and head and neck cancer. Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. It also does not guarantee FDA approval. (2015, April 15). Edited By Walter Pacheco Our pipeline. Selby, Karen. Medications like tremelimumab are designed to fight cancer cells by increasing the amount of activated killer T cells. Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. 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. Clinical trials often combine the medication with another immunotherapy drug called durvalumab. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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). 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.