Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab depending on severity. Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. Our Patient Advocates have relationships with top doctors and cancer centers and can help you schedule and expedite appointments. and tremelimumab with chemotherapy demonstrated overall 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. "My family has only the highest compliment for the assistance and support that we received from The Mesothelioma Center. Monitor for signs and symptoms of infusion-related reactions. Researchers suggested more trials that combine drugs are necessary to see how well tremelimumab may work against mesothelioma. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. An orphan drug typically treats uncommon illnesses, and cannot make much of a profit. 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. Immune-Mediated Colitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated colitis that is frequently associated with diarrhea. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. She hopes to create public awareness about cancer through her writing. 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%). 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 hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. (2017, December 13). Asbestos.com. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 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 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, 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). 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. 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; 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 The jury is still out on whether tremelimumab will prove to be an effective mesothelioma treatment. Calling this number connects you with a Patient Advocate at The Mesothelioma Center, the nation's most trusted mesothelioma resource. Events resolved in 5 of the 42 patients. Antibodies are proteins in the immune system that recognize and attack foreign invaders such as bacteria, viruses and cancer cells. 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. Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. 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 Withhold or permanently discontinue tremelimumab-actl in combination with durvalumab based on the severity Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.3%) adverse reactions. Karen Selby, RN Both durvalumab and tremelimumab have been tested for mesothelioma alone, but not in combination. This Drug class: Antineoplastic Agents One cycle is defined as every 4 weeks. Thank you for your feedback. 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). Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. Dermatological reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions. For more information, visit our sponsors page. CTLA-4 plays a role in maintaining maternal immune tolerance to the fetus to preserve pregnancy and in immune regulation of the newborn. (n.d.). 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. Prior results do not predict a similar outcome. Journal of Clinical Oncology,34, No. Durvalumab, Tremelimumab + Radiotherapy in Gynecologic Cancer Immune-Mediated Nephritis with Renal Dysfunction: Tremelimumab-actl in combination with durvalumab can cause immune-mediated nephritis. These immune cells kill cancer cells. In a murine model of pregnancy, CTLA-4 blockade resulted in increased resorptions and reduced live fetuses. Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. Retrieved from, ClinicalTrials.gov. This optimistic outcome has researchers hopeful for similar results for mesothelioma patients. The purpose of tremelimumab is to blog receptors on immune cells that 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). Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Tremelimumab 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. Before sharing sensitive information, make sure you're on a federal government site. Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy. Rachel Ernst is a content writer at Mesothelioma Hub. The active substance of Tremelimumab AstraZeneca is tremelimumab, a monoclonal antibody ( ATC code: L01FX20). Infusion-related reactions occurred in 10 (2.6%) patients receiving tremelimumab-actl in combination with durvalumab. Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis. (2018, January 4). Support and resources for HCPs and patients. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Connect with mesothelioma patients around the country who are battling the disease. 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. Request free informational, treatment, financial or support resources to help you and your loved one after a mesothelioma diagnosis. Tremelimumab. But these trials have yet to provide impressive enough results to warrant an FDA approval. For more information about any of the below clinical trials, they can be found at ClinicalTrials.gov. Tremelimumab has produced promising anticancer responses in early clinical trials. Tremelimumab is a human antibody that helps the immune system fight cancer. This is a randomized, open-label, multi-center, global, Phase II study to determine the efficacy and safety of MEDI4736 + tremelimumab combination therapy, MEDI4736 monotherapy and tremelimumab monotherapy in the treatment of patients with recurrent or metastatic PD-L1-negative squamous cell carcinoma of the head and neck 2. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. CAS number: 745013-59-6. Would you like to speak with a Patient Advocate? 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. IMFINZI and IMJUDO are registered trademarks and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. Imfinzi: Package Insert / Prescribing Information - Drugs.com Intestinal perforation and large intestine perforation were reported in 0.1% of patients. Advise females of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose of tremelimumab-actl. Read more about the latest news and research on mesothelioma, asbestos regulations, and emerging treatments. product information is intended for US Healthcare Professionals only. 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. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Tremelimumab-actl - NCI Interrupt, slow the rate of, or permanently discontinue IMFINZI and IMJUDO based on the severity. The largest study to date of tremelimumab in mesothelioma patients did not reach its goal of extending overall survival. Immune-mediated Hypothyroidism: Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving tremelimumab-actl in combination with durvalumab. The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI and IMJUDO or were reported with the use of other immune-checkpoint inhibitors. 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. (2016). Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. 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. Tremelimumab Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. Clinical Trials Using Tremelimumab. Written by ASHP. Available for Android and iOS devices. See USPI Dosing and Administration for specific details. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of tremelimumab-actl in combination with durvalumab. Immune-mediated adverse reactions can occur at any time after starting tremelimumab-actl in combination with durvalumab. 0 Refer to the prescribing information for agents administered in combination with tremelimumab-actl for breastfeeding recommendations, as appropriate. Immune-mediated Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.3%) adverse reactions. 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. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. 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. Massard C, Gordon MS, Sharma S, et al. Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy, In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), the most common adverse reactions (occurring in 20% of patients) were fatigue, nausea, constipation, decreased appetite, abdominal pain, rash, and pyrexia, In patients with locally advanced or metastatic BTC in the TOPAZ-1 study receiving IMFINZI (n=338), discontinuation due to adverse reactions occurred in 6% of the patients receiving IMFINZI plus chemotherapy. HIGHLIGHTS OF PRESCRIBING INFORMATION immune Edited By Walter Pacheco Imfinzi combinations have also demonstrated clinical benefit in metastatic NSCLC in the POSEIDON Phase III trial. Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. 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. Institute medical management promptly, including specialty consultation as appropriate. WebOut of more than 180 oncology approvals, less than half of the approvals were successfully converted to full FDA approvals so far. A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma. After Cycle 1 of combination therapy, administer durvalumab as a single agent every 4 weeks until disease progression or unacceptable toxicity occurs. Specialists suggest that both medications in combination may interfere with the ability of malignant tumor cells to grow and spread. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. The treatment helps the immune system to find and eliminate cancer cells. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Pharmacodynamics. Retrieved on November 14, 2019, from https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, National Cancer Institute. Advise pregnant women of the potential risk to a fetus. Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. 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. Events resolved in 2 of the 5 patients. This website information is proprietary, protected, and not a substitute for professional medical advice, diagnosis or treatment. Since then, multiple studies have tested the drug on several types of cancer. 15_suppl, 8502-8502. doi: 10.1200/JCO.2016.34.15_suppl.8502, AstraZeneca. Brand name: Imjudo Retrieved on November 14, 2019, from http://theoncologist.alphamedpress.org/content/12/7/873.full, United States National Library of Medicine. 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. (2017). 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. 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. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Immune-mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). For more information, visit our sponsor page. IMJUDO (tremelimumab) in combination with IMFINZI (durvalumab) approved in the US for patients with unresectable liver cancer PUBLISHED 24 October Fatal adverse reactions occurred in 3.6% of patients receiving IMFINZI plus chemotherapy. et al. IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. Our Patient Advocates can help guide you or your loved one through the steps to take after a mesothelioma diagnosis. Last Modified: September 22, 2022, Created: July 6, 2022. All patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker). Serious adverse reactions occurred in 29% of patients receiving IMFINZI. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. dyes, preservatives, or animals. 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. Karen Selby joined Asbestos.com in 2009. (n.d.). Initial early phase studies of the drug often showed promising results, in which the drug stopped tumors from growing for periods of time. 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%). If receiving both durvalumab and tremelimumab for the first 4 cycles, they will be given on the same day. Antibodies are proteins in the immune system that recognize and attack foreign The most frequent serious adverse reactions (2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). For patients with mesothelioma cancer, immunotherapy is a promising new field. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Oncologist and Hematologist & Contributing Writer. Events resolved in 3 of the 5 patients and resulted in permanent discontinuation in 1 patient. 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. IMFINZI (durvalumab) & IMJUDO (tremelimumab-actl) Dosing 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. Serious adverse reactions occurred in 47% of patients receiving IMFINZI plus chemotherapy. 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. 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. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. Karen has assisted surgeons with thoracic surgeries such as lung resections, lung transplants, pneumonectomies, pleurectomies and wedge resections. Would you like to speak with a Patient Advocate? Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Medically reviewed by Drugs.com on Nov 29, 2022. Request a free legal case evaluation today. Tremelimumab AstraZeneca will be available as a 20 mg/ml concentrate for solution for infusion. For non-prescription products, read the label or package ingredients carefully. One patient (1/5) required other immunosuppressants. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Early results in the Phase 2b study have suggested that the drug fails to improve lifespan. Get help paying for treatment, lost wages & more. Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. (2021, September). 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 .gov means its official.Federal government websites often end in .gov or .mil. (2015, October 27). Tremelimumab Asbestos.com. 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. Monoclonal antibody drugs for cancer: How they work. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. "Tremelimumab." It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. 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 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. Weve gathered all of our resources into one guide with one purpose: helping you navigate mesothelioma. Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO in combination with platinum-based chemotherapy, including Grade 3 (0.3%) adverse reactions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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. Access free resources to help you or a loved one after a mesothelioma diagnosis. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. (2019). 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. Events resolved in 2 of the 6 patients. 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. MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma. 20% of patients were alive at 36 months, and 15% of patients survived for 48 months or longer. Eight patients (8/29) required other immunosuppressants. 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

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