tremelimumab package insert
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%). Monitor for signs and symptoms of infusion-related reactions. Available for Android and iOS devices. IMJUDO (tremelimumab) in combination with IMFINZI (durvalumab) approved in the US for patients with unresectable liver cancer PUBLISHED 24 October Initial early phase studies of the drug often showed promising results, in which the drug stopped tumors from growing for periods of time. Borrie, A., & Vareki, M. (2018). One patient (1/5) required other immunosuppressants. Your web browser is no longer supported by Microsoft. This website and its content may be deemed attorney advertising. 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. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. (2015). WebTREMFYA is a clear and colorless to light yellow solution that may contain small translucent particles. He initially responded quite well. Learn how to access mesothelioma clinical trials utilizing immunotherapy. Last modified February 24, 2023. https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. 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. Immune-Mediated Colitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated colitis that is frequently associated with diarrhea. IMFINZI and IMJUDO can cause immune-mediated nephritis. Tremelimumab is a human antibody that helps the immune system fight cancer. Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. al. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. Connect with mesothelioma patients around the country who are battling the disease. In synergistic mouse tumor models, blocking CTLA-4 activity resulted in decreased tumor growth and increased proliferation of T cells in tumors. 301 0 obj <> endobj Tremelimumab-actl can cause fetal harm when administered to a pregnant woman. The purpose of tremelimumab is to blog receptors on immune cells that normally suppress immune attacks. 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. Medically reviewed by Drugs.com on Nov 29, 2022. Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Initiate symptomatic treatment including hormone replacement as clinically indicated. Dosage summary: Administer tremelimumab-actl as an intravenous infusion over 60 minutes after dilution. This website information is proprietary, protected, and not a substitute for professional medical advice, diagnosis or treatment. Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. Events resolved in 15 of the 18 patients. 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 chemotherapy for 4 cycles, then durvalumab 1500 mg with maintenance chemotherapy every 4 weeks. A fifth tremelimumab dose (75 mg) should be given at week 16. Events resolved in 6 of the 9 patients. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. 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. Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. %%EOF Hypothyroidism can follow hyperthyroidism. (2017). 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. Retrieved from, Pfizer. An official website of the United States government, : 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. By blocking CTLA-4, tremelimumab activates killer T cells so they can get to work fighting cancer. Retrieved on November 14, 2019, from http://theoncologist.alphamedpress.org/content/12/7/873.full, United States National Library of Medicine. Immune-Mediated Hepatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hepatitis, which may be fatal. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. The site is secure. WebTremelimumab is an investigational, fully human IgG monoclonal antibody directed against CTLA-4, a coinhibitory receptor that represses effector T-cell activity in cancer. ORR was 20.1% (95% CI: 16.3, 24.4) in the tremelimumab plus durvalumab arm and 5.1% (95% CI: 3.2, 7.8) for those treated with sorafenib. Most common adverse reactions ( 20%) of patients with uHCC receiving tremelimumab-actl are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. The treatment helps the immune system to find and eliminate cancer cells. 465 0 obj <>stream Tremelimumab-actl injection is used in combination with durvalumab to treat liver cancer that cannot be removed by surgery (unresectable hepatocellular carcinoma or uHCC). 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. %PDF-1.7 % Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. (n.d.). WebCleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. Three patients also required endocrine therapy. Once an antibody attaches to an antigen on a molecule, receptors signal the immune system to fight back. Karen Selby joined Asbestos.com in 2009. The medication was first studied as a treatment for metastatic melanoma. Orphan designation does not mean the drug is safe or effective. Fatal adverse reactions occurred in 8% of patients who received IMJUDO in combination with durvalumab, including death (1%), hemorrhage intracranial (0.5%), cardiac arrest (0.5%), pneumonitis (0.5%), hepatic failure (0.5%), and immune-mediated hepatitis (0.5%). 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%). It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Written by ASHP. Study participants with malignant pleural mesothelioma either received MEDI4736, known as durvalumab, or durvalumab and tremelimumab in this phase 2 trial. Several landmark trials have shown tremelimumab can stop mesothelioma tumors from growing for periods of time. See full Prescribing Information for preparation and administration instructions and dosage modifications for adverse reactions. (2015, April 15). 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. AHFS Drug Information. Withhold or discontinue tremelimumab-actl in combination with durvalumab based on the severity. Type 1 Diabetes Mellitus: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. 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). Calling this number connects you with a Patient Advocate at The Mesothelioma Center, the nation's most trusted mesothelioma resource. WebUse in Cancer. Thyroiditis can present with or without endocrinopathy. 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 Before sharing sensitive information, make sure you're on a federal government site. 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%). 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. WebIMJUDO (tremelimumab-actl) injection, for intravenous use Initial U.S. Approval: 2022----- INDICATIONS AND USAGE -----IMJUDOis a cytotoxic T-lymphocyte-associated IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). The active substance of Tremelimumab AstraZeneca is tremelimumab, a monoclonal antibody ( ATC code: L01FX20). The safety and effectiveness of IMFINZI and IMJUDO have not been established in pediatric patients. 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. 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) 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. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Retrieved from, Guazzelli, A. (2015, October 27). 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 is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Eventually, the cancer returned and McWhorter had to leave that trial in search of other options to control his cancer. 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. Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms, In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in 20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%), In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. No overall differences in safety or efficacy of tremelimumab-actl have been observed between patients 65 years or older and younger adult patients. 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.