tremelimumab package insert

Our pipeline. Journal of Clinical Oncology,34, No. 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). Karen Selby joined Asbestos.com in 2009. 2023 AstraZeneca. Support and resources for HCPs and patients. Severe and Fatal Immune-Mediated Adverse Reactions Refer to the prescribing information for the agents administered in combination with tremelimumab-actl for recommended contraception duration, as appropriate. Hypophysitis can cause hypopituitarism. 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. Infusion-related reactions occurred in 10 (2.6%) patients receiving tremelimumab-actl in combination with durvalumab. Small studies indicate about half of mesothelioma patients respond to tremelimumab and about half live at least one year on the drug. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. 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 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. (2015). Institute medical management promptly, including specialty consultation as appropriate. A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma. (2015, October 27). Other Immune-Mediated Pancreatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated pancreatitis. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. In animal studies, CTLA-4 blockade is associated with increased risk of immune-mediated rejection of the developing fetus and fetal death. Webc. This website information is proprietary, protected, and not a substitute for professional medical advice, diagnosis or treatment. 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%). Researchers estimate the study will be completed in late 2019. For patients with mesothelioma cancer, immunotherapy is a promising new field. Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain. Similar clinical trials are underway in Italy and in 104 study locations worldwide. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. The safety and effectiveness of tremelimumab-actl have not been established in pediatric patients. (2019). Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. 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. Initiate symptomatic treatment including hormone replacement as clinically indicated. Immune-mediated Thyroiditis: Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab. Retrieved from, ClinicalTrials.gov. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. 0 Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. 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. 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. 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. 4 . The drugs stopped his tumor growth for months. 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. 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. Both durvalumab and tremelimumab have been tested for mesothelioma alone, but not in combination. Immune-mediated Hypothyroidism: Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving tremelimumab-actl in combination with durvalumab. The pharmaceutical companies Pfizer and Medarex licensed and patented the drug in 2004. Access free resources to help you or a loved one after a mesothelioma diagnosis. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. 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). 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. %PDF-1.7 % We will help you find the best mesothelioma doctor in your area. Retrieved from, Calabro, L. et al. 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. (2019). 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. All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. AstraZeneca stopped the trial in 2016 when they realized it was not working well enough. She hopes to create public awareness about cancer through her writing. Information and assistance were provided by The Mesothelioma Center at no cost to our family.". Advise pregnant women and females of reproductive potential of the potential risk to a fetus. So far, research has proven the drug helps some people with mesothelioma. Tremelimumab. 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. Borrie, A., & Vareki, M. (2018). Pediatric . 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). Institute medical management promptly, including specialty consultation as appropriate. Tremelimumab (CP-675,206), a Cytotoxic T LymphocyteAssociated Antigen 4 Blocking Monoclonal Antibody in Clinical Development for Patients with Cancer. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. 20% of patients were alive at 36 months, and 15% of patients survived for 48 months or longer. WebCleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. 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. 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. 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. CTLA-4 is a negative regulator of T-cell activity. Tremelimumab-actl is indicated, in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). Thank you for your feedback. 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 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. 8 It binds to its target, human CTLA-4, with high selectivity 2 and subnanomolar affinity. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not. No overall differences in safety or efficacy of tremelimumab-actl have been observed between patients 65 years or older and younger adult patients. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. It might be most effective when combined with other immunotherapy drugs. Eventually, the cancer returned and McWhorter had to leave that trial in search of other options to control his cancer. View full prescribing information for Imjudo. However, combining tremelimumab and durvalumab has proven more effective against lung cancer than tremelimumab alone. Tremelimumab-actl in combination with durvalumab can cause severe or life-threatening infusion-related reactions. In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. He initially responded quite well. "Tremelimumab." Retrieved from. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. Orphan drug designation is not the same as FDA approval, but it does help pharmaceutical companies move a drug designed to treat rare diseases through the approval process. 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). 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 on November 14, 2019, from http://theoncologist.alphamedpress.org/content/12/7/873.full, United States National Library of Medicine. AHFS Drug Information. Helps more than 50% of mesothelioma patients diagnosed annually in the U.S. A+ rating from the Better Business Bureau. If you have been diagnosed with mesothelioma, you are likely entitled to financial compensation. Download our guide to get the latest information about mesothelioma treatments, clinical trials, complementary and emerging therapies. After several months, the drug seems to stop working altogether, which is why the FDA hasnt improved it. Systemic corticosteroids were required in all patients with immune-mediated pancreatitis, of these 7 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). She graduated with a Bachelor of Arts degree from the University of Illinois at Chicago, where she majored in communication and minored in sociology. Immediate treatment of side effects helps keep them in control. Events resolved in 5 of the 42 patients. 15_suppl, 8502-8502. doi: 10.1200/JCO.2016.34.15_suppl.8502, AstraZeneca. Immune checkpoint inhibitors in malignant pleural mesothelioma: promises and challenges. Interaction highlights: Please see product labeling for drug interaction information. Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy. Tremelimumab granted Orphan Drug Designation by US FDA for treatment of malignant mesothelioma. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Results from a recent study at Rice University in Houston are exciting. 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. Last Modified: September 22, 2022, Created: July 6, 2022. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in Events resolved in 2 of the 5 patients. IMFINZI and IMJUDO are registered trademarks and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. 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. Advise the patient to read the FDA-approved patient labeling (Medication Guide). The Mesotheliomahub.com website and its content are sponsored by a law firm and may be deemed attorney advertising. The results led the researchers to conclude that the treatment combination was associated with long-term survival. Material safety data sheet: Tremelimumab. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. This approval is based on a comparison of the 782 patients randomized to tremelimumab plus durvalumab to sorafenib. AHFSfirstRelease. An increase in activated killer T cells helps a persons immune system fight cancer. This optimistic outcome has researchers hopeful for similar results for mesothelioma patients. Initial early phase studies of the drug often showed promising results, in which the drug stopped tumors from growing for periods of time. Retrieved from, National Cancer Institute. About tremelimumab Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated by Asbestos.com and The Mesothelioma Center. doi: 10.1080/14737140.2016.1191951, AstraZeneca. Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. Global Health Status/QoL and Functioning Scales, Adverse Reactions and Discontinuation Rates. 2. One patient (1/5) required other immunosuppressants. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. These more serious side effects include holes in the intestines, obstruction of the small intestine, inflammation of the colon and skin ulcers. Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. WebOn October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with Each infusion will take approximately 1 hour. Study participants with malignant pleural mesothelioma either received MEDI4736, known as durvalumab, or durvalumab and tremelimumab in this phase 2 trial. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Imjudo blocks the For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. (2018, January 4). Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO. Retrieved from, Pfizer. 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. Asbestos.com. 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. There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). hb```e``>' @1V x/6RVj. Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Eight patients (8/29) required other immunosuppressants. The tremelimumab antibody activates an immune cell known as cytotoxic T lymphocytes (CTLs), or killer T cells. Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. IMFINZI and IMJUDO can cause immune-mediated nephritis. See USPI Dosing and Administration for specific details. The study concluded is estimated to be completed in late 2019. After Cycle 1 of combination therapy, administer durvalumab as a single agent every 4 weeks until disease progression or unacceptable toxicity occurs. Invert vial gently several times before use to ensure uniformity of the emulsion prior to Research is ongoing to determine which mesothelioma patients may benefit the most from this drug. 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 hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. (2015, April 15). Imfinzi: Package Insert / Prescribing Information - Drugs.com Calling this number connects you with a Patient Advocate at The Mesothelioma Center, the nation's most trusted mesothelioma resource. Events resolved in 6 of the 9 patients. IMJUDO (tremelimumab) in combination with IMFINZI (durvalumab) approved in the US for patients with unresectable liver cancer PUBLISHED 24 October 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. 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. 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. Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. We comply with the HONcode standard for trustworthy health information. Would you like to speak with a Patient Advocate? Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. 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). (n.d.). Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis. 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. 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. See USPI Dosing and Administration for specific details. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. Oncologist and Hematologist & Contributing Writer. Dont try to tough it out, even with mild side effects. Medically reviewed by Drugs.com on Nov 29, 2022. WebCyramza: EPAR Product Information - European Medicines Agency Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. Monoclonal antibody drugs for cancer: How they work. Our team of Patient Advocates includes a medical doctor, a registered nurse, health services administrators, veterans, VA-accredited Claims Agents, an oncology patient navigator and hospice care expert. Assisting mesothelioma patients and their loved ones since 2006. Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. Your web browser is no longer supported by Microsoft. Call your doctor right away if you notice any mild or serious side effects. Tremelimumab has been tested on a variety of cancers including mesothelioma, lung cancer, melanoma, liver cancer, bladder cancer and head and neck cancer. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. The FDA designated the drug as an orphan drug in April 2015. Seventeen patients required other therapy (thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker). In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. 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. Various grades of visual impairment to include blindness can occur. Retrieved on November 14, 2019, from https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tremelimumab, Ribas, A., et. Since then, multiple studies have tested the drug on several types of cancer. Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. 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 These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Events resolved in 15 of the 18 patients. 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. 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; This Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts.

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