Events resolved in 6 of the 9 patients. Download Guide. Three patients also received other immunosuppressants. Immune-mediated adverse reactions can occur at any time after starting tremelimumab-actl in combination with durvalumab. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. More than 30 contributors, including mesothelioma doctors, survivors, health care professionals and other experts, have peer-reviewed our website and written unique research-driven articles to ensure you get the highest-quality medical and health information. Research in mesothelioma patients shows tremelimumab has the potential to cause life-threatening side effects. Tremelimumab may help people live longer with mesothelioma, but the drug may also cause side effects. Retrieved from, ClinicalTrials.gov. 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. Update your browser for more security, speed and compatibility. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. 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. (2009, November 19). Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Asbestos.com, 24 Feb 2023, https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. Refer to the prescribing information for the agents administered in combination with tremelimumab-actl for recommended contraception duration, as appropriate. Events resolved in 2 of the 5 patients. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated reactions. The most common (20%) adverse reactions occurring in patients were rash, diarrhea, fatigue, pruritis, musculoskeletal pain and abdominal pain. Immune-Mediated Dermatology Reactions: Tremelimumab-actl in combination with durvalumab can cause immune-mediated rash or dermatitis. Medications like tremelimumab are designed to fight cancer cells by increasing the amount of activated killer T cells. CTLA-4 plays a role in maintaining maternal immune tolerance to the fetus to preserve pregnancy and in immune regulation of the newborn. Retrieved from, ClinicalTrials.gov. For non-prescription products, read the label or package ingredients carefully. A Study of Tremelimumab Combined With the Anti-PD-L1 MEDI4736 Antibody in Malignant Mesothelioma (NIBIT-MESO-1). The largest study to date of tremelimumab in mesothelioma patients did not reach its goal of extending overall survival. Each page includes all sources for full transparency. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Orphan designation does not mean the drug is safe or effective. 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). 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. 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 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. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. 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 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. 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. Maternal IgG is known to be present in human milk. Brand name: Imjudo 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). CAS number: 745013-59-6. 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. Tremelimumab-actl is available in the following dosage form(s) and strength(s): Injection: 25 mg/1.25 mL (20 mg/mL) solution in 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. 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). Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Clinical trials often combine the medication with another immunotherapy drug called durvalumab. Mesothelioma Hub is dedicated to helping you find information, support, and advice. WebTremelimumab is an investigational, fully human IgG monoclonal antibody directed against CTLA-4, a coinhibitory receptor that represses effector T-cell activity in cancer. Colitis: Advise patients to contact their healthcare provider immediately for diarrhea, blood or mucus in stools, or severe abdominal pain. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. MEDI4736 Or MEDI4736 + Tremelimumab In Surgically Resectable Malignant Pleural Mesothelioma. In her free time, Rachel likes to be outdoors, watch movies, and spend time with her animals. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. For more information, visit our sponsors page. Tremelimumab is a cytotoxic agent that works to decrease tumour growth. The Mesotheliomahub.com website and its content are sponsored by a law firm and may be deemed attorney advertising. 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 Tremelimumab is a human antibody that helps the immune system fight cancer. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. The FDA designated the drug as an orphan drug in April 2015. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. The purpose of tremelimumab is to blog receptors on immune cells that normally suppress immune attacks. Interrupt, slow the rate of, or permanently discontinue tremelimumab-actl and durvalumab based on the severity. Retrieved on November 14, 2019, from https://www.clinicaltrials.gov/ct2/show/NCT03075527, United States National Library of Medicine. endstream
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Support and resources for HCPs and patients. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. Karen has assisted surgeons with thoracic surgeries such as lung resections, lung transplants, pneumonectomies, pleurectomies and wedge resections. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT. Immune-Mediated Hypophysitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated hypophysitis. "Tremelimumab." Three patients also required endocrine therapy. Initiate treatment with insulin as clinically indicated. 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. 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. Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. Tremelimumab is a human antibody that helps the immune system fight cancer. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. Our fact-checking process begins with a thorough review of all sources to ensure they are high quality. There are no available data on the use of tremelimumab-actl in pregnant women. Retrieved on November 14, 2019, from https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/monoclonal-antibody/art-20047808, National Cancer Institute. Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Tremelimumab which has no brand name yet has not been approved by the U.S. Food and Drug Administration (FDA) to treat any cancer or disease. This optimistic outcome has researchers hopeful for similar results for mesothelioma patients. Hypophysitis can cause hypopituitarism. Tremelimumab, which has no brand name yet, has not been approved by the United States Food and Drug Administration (FDA) to treat any cancer or disease. Retrieved from, Pfizer. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving tremelimumab-actl in combination with durvalumab, including Grade 3 (0.5%) adverse reactions. 1 Tremelimumab caused increased IL-2 production in a dose-dependent manner in ex-vivo blood stimulation assays using peripheral blood In 2017, mesothelioma survivor and Navy veteran Jim McWhorter joined a clinical trial testing tremelimumab and durvalumab, another immunotherapy drug. Clinical trials are testing the drug on several different cancers including mesothelioma. Medically Reviewed By Dr. Daniel A. Landau. View full prescribing information for Imjudo. Advise females of reproductive potential to use effective contraception during treatment with tremelimumab-actl and for 3 months after the last dose. It might be most effective when combined with other immunotherapy drugs. Stay up-to-date on treatment, research, clinical trials, doctors and survivors. 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. Advise patients to contact their healthcare provider immediately for signs or symptoms of infusion-related reactions. 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. The side effects range from mild to severe. (2021, September). (2019). Oncologist and Hematologist & Contributing Writer. 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. 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. dyes, preservatives, or animals. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. In females of reproductive potential, verify pregnancy status prior to initiating IMFINZI and IMJUDO and advise them to use effective contraception during treatment with IMFINZI and IMJUDO and for 3 months after the last dose of IMFINZI and IMJUDO. If you are looking for mesothelioma support, please contact our Patient Advocates at (855) 404-4592. 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. 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. Type 1 Diabetes Mellitus: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. The drug usually stops cancer growth for several months before it stops working altogether, a reason why it hasnt been FDA approved to treat mesothelioma. WebOn October 21, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of tremelimumab-actl in combination with durvalumab. Mesothelioma Center - Vital Services for Cancer Patients & Families doesnt believe in selling customer information. Imfinzi: Package Insert / Prescribing Information - Drugs.com Retrieved on November 14, 2019, from https://www.sciencedirect.com/topics/neuroscience/tremelimumab, Mayo Clinic. Retrieved on November 14, 2019, from https://clinicaltrials.gov/ct2/show/NCT01843374, United States National Library of Medicine. Dermatological reactions: Advise patients to contact their healthcare provider immediately for signs or symptoms of severe dermatological reactions. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Retrieved on November 14, 2019, from https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tremelimumab, Ribas, A., et. Tremelimumab (CP-675,206), a Cytotoxic T LymphocyteAssociated Antigen 4 Blocking Monoclonal Antibody in Clinical Development for Patients with Cancer. The treatment helps the immune system to find and eliminate cancer cells. The purpose of tremelimumab is to blog receptors on immune cells that WebUse in Cancer. Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. It binds to CTLA-4, which is primarily expressed on the surface of T lymphocytes, and thus enhances T-cell activation If you have been diagnosed with mesothelioma, you are likely entitled to financial compensation. Monitor for signs and symptoms of infusion-related reactions. Additional efficacy outcomes included investigator-assessed progression-free survival (PFS) and overall response rate (ORR) according to RECIST v1.1. Definition of tremelimumab. Patients taking the medication can receive medications or therapies to treat each side effect or keep them under control. (2016). 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. About tremelimumab Tremelimumab is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated hbbd```b``y"3@$>K mX
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Similar clinical trials are underway in Italy and in 104 study locations worldwide. 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. 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. If receiving both durvalumab and tremelimumab for the first 4 cycles, they will be given on the same day. Specialists suggest that both medications in combination may interfere with the ability of malignant tumor cells to grow and spread. Monitor for signs and symptoms of infusion-related reactions. Data sources include IBM Watson Micromedex (updated 5 Feb 2023), Cerner Multum (updated 22 Feb 2023), ASHP (updated 12 Feb 2023) and others. Retrieved on November 14, 2019, from http://theoncologist.alphamedpress.org/content/12/7/873.full, United States National Library of Medicine. Pediatric . The pharmaceutical companies Pfizer and Medarex licensed and patented the drug in 2004. Drug class: anti-CTLA-4 monoclonal antibodies. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Clinical trials of tremelimumab have shown it may help control several different types of cancer including lung cancer and mesothelioma. In combination with durvalumab, a PD-L1 inhibitor, these drugs have the potential for induction of immune-mediated adverse reactions. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Access free resources to help you or a loved one after a mesothelioma diagnosis. Verify pregnancy status of females of reproductive potential prior to initiating treatment with tremelimumab-actl. 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. 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). 5-star reviewed mesothelioma and support organization. Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions. This Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial. Other Immune-Mediated Pancreatitis: Tremelimumab-actl in combination with durvalumab can cause immune-mediated pancreatitis. 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 Serious adverse reactions occurred in 29% of patients receiving IMFINZI. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Retrieved on November 14, 2019, from https://www.cancer.gov/about-cancer/treatment/clinical-trials/intervention/tremelimumab?redirect=true, National Cancer Institute. 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. IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). Pneumonitis: Advise patients to contact their healthcare provider immediately for any new or worsening cough, chest pain, or shortness of breath. However, a phase III trial of tremelimumab mo WebCyramza: EPAR Product Information - European Medicines Agency You may report side effects related to AstraZeneca products by clicking here. Last modified February 24, 2023. https://www.asbestos.com/treatment/immunotherapy/tremelimumab/. So far, research has proven the drug helps some people with mesothelioma. 5-Year Mesothelioma Survivor Motivated by Family, Mesothelioma Survivors Treatment Journey Continues, A Post-Cancer Letter to Pre-Cancer Tamron. Institute medical management promptly, including specialty consultation as appropriate. Lancet Respir Med, 3(4), 301-309. doi: 10.1016/S2213-2600(15)00092-2, Ceresoli, G.L., Bonomi, M., & Sauta, M.G. 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. Institute medical management promptly, including specialty consultation as appropriate. IMFINZI in combination with IMJUDO can cause immune-mediated pancreatitis. These more serious side effects include holes in the intestines, obstruction of the small intestine, inflammation of the colon and skin ulcers. 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). product information is intended for US Healthcare Professionals only. 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. Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma (Tremelimumab). Please read our privacy policy and disclaimer for more information about our website. WebCleviprex is supplied in sterile, pre-mixed, ready-to-use 50 mL or 100 mL vials. Events resolved in 2 of the 6 patients. Invert vial gently several times before use to ensure uniformity of the emulsion prior to Tremelimumab for the treatment of malignant mesothelioma. Retrieved from, Maio, M. et al. 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). Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. 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. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. Current clinical trials are testing the drug on multiple types of cancer. 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. (2015, April 15). All patients required other therapy including hormone replacement therapy, thiamazole, carbimazole, propylthiouracil, perchlorate, calcium channel blocker, or beta-blocker. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity. Early results in the Phase 2b study have suggested that the drug fails to improve lifespan. The most common Grade 3 or 4 adverse reaction (3%) was fatigue/asthenia (3.4%), In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. (2019). 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. %PDF-1.7
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Download our guide to get the latest information about mesothelioma treatments, clinical trials, complementary and emerging therapies. Immune-mediated Thyroiditis: Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving tremelimumab-actl in combination with durvalumab. Request a free legal case evaluation today. Endocrinopathies: Advise patients to contact their healthcare provider immediately for signs or symptoms of hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus, or hypophysitis. Advise females of reproductive potential that tremelimumab-actl can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy.