Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of tremelimumab-actl in combination with durvalumab. In 2021, a clinical research study followed up with mesothelioma patients four years after they received tremelimumab and durvalumab. Hypophysitis can cause hypopituitarism. Tremelimumab | Has The FDA Approved It? - asbestos In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. (2015, April 15). Infusion-related reactions occurred in 10 (2.6%) patients receiving IMFINZI and IMJUDO. Systemic corticosteroids were required in 4 patients (4/5) with hypophysitis, of these 1 of the 4 patients received high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Immune mediated pneumonitis occurred in 1.3% (5/388) of patients receiving tremelimumab-actl in combination with durvalumab, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. Cleviprex Full Prescribing Information - Chiesi USA Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Severe and Fatal Immune-Mediated Adverse Reactions The pharmaceutical companies Pfizer and Medarex licensed and patented the drug in 2004. Verify pregnancy status of females of reproductive potential prior to initiating treatment with tremelimumab-actl. (n.d.). Any unauthorized or illegal use, copying or dissemination will be prosecuted. 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. Tremelimumab. After several months, the drug seems to stop working altogether, which is why the FDA hasnt improved it. Tremelimumab-actl is approved to treat adults with: Hepatocellular carcinoma (a type of liver cancer) that cannot be removed by surgery. Systemic corticosteroids were required in all patients with immune-mediated nephritis, of these 3 patients required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Assisting mesothelioma patients and their loved ones since 2006. 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. 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 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%). Retrieved from. FDA approves tremelimumab in combination with durvalumab New clinical trials are testing it in combination with several anti-cancer drugs with the hope of finding a magic combination. Study participants with malignant pleural mesothelioma either received MEDI4736, known as durvalumab, or durvalumab and tremelimumab in this phase 2 trial. 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. A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma. Advise females of reproductive potential to use effective contraception during treatment with tremelimumab-actl and for 3 months after the last dose. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. Antibodies are proteins in the immune system that recognize and attack foreign invaders such as bacteria, viruses and cancer cells. Asbestos.com is sponsored by law firms. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Both durvalumab and tremelimumab have been tested for mesothelioma alone, but not in combination. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below. Learn everything you need to know about this rare disease. Two patients (2/18) required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Each page includes all sources for full transparency. Karen Selby joined Asbestos.com in 2009. 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. 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. One cycle is defined as every 4 weeks. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. 15_suppl, 8502-8502. doi: 10.1200/JCO.2016.34.15_suppl.8502, AstraZeneca. Advise pregnant women of the potential risk to a fetus. Nephritis: Advise patients to contact their healthcare provider immediately for signs or symptoms of nephritis. 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. 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. Request free informational, treatment, financial or support resources to help you and your loved one after a mesothelioma diagnosis. Accessed November 2022. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Pediatric . Prior results do not predict a similar outcome. Tremelimumab was granted orphan drug designation. Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis. It is used with Dont try to tough it out, even with mild side effects. 5-Year Mesothelioma Survivor Motivated by Family, Mesothelioma Survivors Treatment Journey Continues, A Post-Cancer Letter to Pre-Cancer Tamron. Dermatological reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions. The safety and effectiveness of tremelimumab-actl have not been established in pediatric patients. There are no available data on the use of tremelimumab-actl in pregnant women. Systemic corticosteroids were required in all 6 patients and of these, 1 patient required high-dose corticosteroid treatment (at least 40 mg prednisone or equivalent per day). Events resolved in 12 of the 29 patients and resulted in permanent discontinuation in 9 patients. 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 Cyramza: EPAR Product Information - European Medicines Agency There are no contraindications for IMFINZI (durvalumab) or IMJUDO (tremelimumab-actl). Reach out any time! Imjudo (tremelimumab) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). 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. Tremelimumab-actl can cause fetal harm when administered to a pregnant woman. Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. Thyroid Disorders: Tremelimumab-actl in combination with durvalumab can cause immune-mediated thyroid disorders. Tremelimumab, manufactured by AstraZeneca, is an immunotherapy treatment that helps the immune system recognize and attack cancer cells. Similar clinical trials are underway in Italy and in 104 study locations worldwide. Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. CTLA-4 is a negative regulator of T-cell activity. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. 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. There are no data on the presence of tremelimumab-actl in human milk, its effects on a breastfed child, or on milk production. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. 1 Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood Immune-Mediated Nephritis with Renal Dysfunction: Tremelimumab-actl in combination with durvalumab can cause immune-mediated nephritis. Tremelimumab Immunotherapy Mesothelioma Medication Option But these trials have yet to provide impressive enough results to warrant an FDA approval. Then we cross-check the facts with original medical or scientific reports published by those sources, or we validate the facts with reputable news organizations, medical and scientific experts and other health experts. In April 2015, tremelimumab received orphan drug designation by the FDA to treat mesothelioma. Immune-mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions. It binds to CTLA-4, which is primarily expressed on the surface of T lymphocytes, and thus enhances T-cell activation IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Tremelimumab is a monoclonal antibody drug, which is a type of treatment that helps the immune system fight cancer. AHFSfirstRelease. 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%). Imjudo blocks the WebOut of more than 180 oncology approvals, less than half of the approvals were successfully converted to full FDA approvals so far. (2006). 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. Tremelimumab-actl in combination with durvalumab can cause severe or life-threatening infusion-related reactions. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. 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. This website and its content may be deemed attorney advertising. We will help you find the best mesothelioma doctor in your area. DailyMed - IMJUDO- tremelimumab injection, solution Tremelimumab is a cancer treatment drug manufactured by AstraZeneca. Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Tremelimumab succeeds by activating immune cells, called cytotoxic T lymphocytes (CTLs), or killer T cells, which kill cancer cells. Refer to the prescribing information for the agents administered in combination with tremelimumab-actl for recommended contraception duration, as appropriate. Antibodies are proteins produced by plasma cells that the immune system by attaching themselves to molecules on the surface of problematic cells. There are therapies and medications to treat every side effect. Their combined expertise means we help any mesothelioma patient or loved one through every step of their cancer journey. Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain. MRxM Imfinzi (E) 01 23 Before sharing sensitive information, make sure you're on a federal government site. Small studies indicate about half of mesothelioma patients respond to tremelimumab and about half live at least one year on the drug. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Tremelimumab (CP-675,206), a Cytotoxic T LymphocyteAssociated Antigen 4 Blocking Monoclonal Antibody in Clinical Development for Patients with Cancer. "Tremelimumab." 5 WARNINGS AND PRECAUTIONS 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). et al. We comply with the HONcode standard for trustworthy health information. 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. Good research has proven it isnt effective enough on its own to use as a single therapy against mesothelioma. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. Events resolved in 2 of the 6 patients. Specialists suggest that both medications in combination may interfere with the ability of malignant tumor cells to grow and spread. In a murine model of pregnancy, CTLA-4 blockade resulted in increased resorptions and reduced live fetuses. Borrie, A., & Vareki, M. (2018). Tremelimumab Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. 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). 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. Most common adverse reactions ( 20%) of patients with uHCC receiving tremelimumab-actl are rash, diarrhea, fatigue, pruritus, musculoskeletal pain, and abdominal pain. Tremelimumab-actl - NCI Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. The largest study to date of tremelimumab in mesothelioma patients did not reach its goal of extending overall survival. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.5%) adverse reactions. Tremelimumab is a cytotoxic agent that works to decrease tumour growth. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 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. Tremelimumab is considered an immune checkpoint blocker because it blocks a protein called CTLA-4, which deactivates killer T cells. Read more about the latest news and research on mesothelioma, asbestos regulations, and emerging treatments. Immunotherapy for NSCLC & ES-SCLC - IMFINZI (durvalumab) Immune-Mediated Colitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated colitis that is frequently associated with diarrhea. Immune-mediated Thyroiditis: Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab. It is not a substitute for professional medical advice, diagnosis or treatment. Asbestos.com, 24 Feb 2023, https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. 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). (2019). Immune-Mediated Hepatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hepatitis, which may be fatal. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. CTLA-4 plays a role in maintaining maternal immune tolerance to the fetus to preserve pregnancy and in immune regulation of the newborn. It might be most effective when combined with other immunotherapy drugs. WebTremelimumab is an investigational, fully human IgG monoclonal antibody directed against CTLA-4, a coinhibitory receptor that represses effector T-cell activity in cancer. Researchers suggested more trials that combine drugs are necessary to see how well tremelimumab may work against mesothelioma. None. Get help paying for treatment, lost wages & more. 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. Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. Thank you for your feedback. Written by ASHP. Drug class: anti-CTLA-4 monoclonal antibodies. IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal. WebTremelimumab is a fully human monoclonal antibody that binds to the CTLA-4 molecule. (2017, December 13). Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. 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. 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. Our Patient Advocates can help guide you or your loved one through the steps to take after a mesothelioma diagnosis. 465 0 obj <>stream Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barr syndrome, nerve paresis, autoimmune neuropathy. Monitor for signs and symptoms of infusion-related reactions. 4 . 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). An increase in activated killer T cells helps a persons immune system fight cancer. Medically reviewed by Drugs.com on Nov 29, 2022. Receptors interpret and respond to signals from multiple factors, such as cancerous cells. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. 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. These immune cells kill cancer cells. Edited By Walter Pacheco 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). Please read our privacy policy and disclaimer for more information about our website. 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. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Download Guide. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not. If you have been diagnosed with mesothelioma, you are likely entitled to financial compensation. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. Wilmington, DE; AstraZeneca Pharmaceuticals LP; November 2022. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. Based on findings from animal studies and its mechanism of action, tremelimumab-actl can cause fetal harm when administered to a pregnant woman. 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. For more information, visit our sponsor page. 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. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCEs Project Facilitate at 240-402-0004 or email [email protected]. These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. 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. Retrieved on November 14, 2019, from https://www.sciencedirect.com/topics/neuroscience/tremelimumab, Mayo Clinic. IMFINZI and IMJUDO are registered trademarks and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies. Selby, K. (2023, February 24). %PDF-1.7 % Previous studies have shown both mild and serious side effects in mesothelioma patients who receive tremelimumab as treatment. In addition to being investigated as a monotherapy treatment for patients with mesothelioma, tremelimumab is currently being studied in combination with Fatal adverse reactions occurred in a total of 4.2% of patients, In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). Orphan designation does not mean the drug is safe or effective. MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma. Would you like to speak with a Patient Advocate? The trial was suspended in late 2019 after criteria were not met, but doctors and researchers estimate completion in 2024. 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. FULL PRESCRIBING INFORMATION: CONTENTS* 8 USE IN Retrieved from, Pfizer. 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. 20% of patients were alive at 36 months, and 15% of patients survived for 48 months or longer. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. 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. Retrieved on November 14, 2019, from https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tremelimumab, Ribas, A., et. 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. Retrieved from, Maio, M. et al. Advise the patient to read the FDA-approved patient labeling (Medication Guide). Tremelimumab as second-line or third-line treatment in relapsed malignant mesothelioma (DETERMINE): a multicentre, international, randomised, double-blind, placebo-controlled phase 2b trial. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Tremelimumab WebIMJUDO (tremelimumab-actl) injection, for intravenous use Initial U.S. Approval: 2022----- INDICATIONS AND USAGE -----IMJUDOis a cytotoxic T-lymphocyte-associated Once an antibody attaches to an antigen on a molecule, receptors signal the immune system to fight back. Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO.
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