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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].
Show detailsOVERVIEW
Monoclonal antibodies are immunoglobulins that have a high degree of specificity (mono-specificity) for an antigen or epitope. Monoclonal antibodies are typically derived from a clonal expansion of antibody producing malignant human plasma cells. The initial monoclonal antibodies were created by fusing spleen cells from an immunized mouse with human or mouse myeloma cells (malignant self-perpetuating antibody producing cells), and selecting out and cloning the hybrid cells (hybridomas) that produced the desired antibody reactivity. These initial monoclonal products were mouse antibodies and were very valuable in laboratory and animal research and diagnostic assays, but were problematic as therapeutic agents because of immune reactions to the foreign mouse protein. Subsequently, production of chimeric mouse-human monoclonal antibodies and means of further “humanizing” them and producing fully human recombinant monoclonal antibodies were developed. The conventions used in nomenclature of monoclonal antibodies indicate whether they are mouse dervied (-omab), chimeric (-ximab), humanized (-zumab) or fully human (-umab).
Monoclonal antibodies have broad clinical and experimental medical uses. Many of the initial monoclonal antibodies used in clinical medicine were immunomodulatory agents with activity against specific immune cells, such as CD4 or CD3 lymphocytes, which are important in the pathogenesis of rejection after solid organ transplantation. Subsequently, monoclonal antibodies were prepared against specific cytokines (anti-cytokines), which were believed to play a role in cell and tissue damage in immunologically mediated diseases such as rheumatoid arthritis, alkylosing spondylitis, inflammatory bowel disease, multiple sclerosis and psoriasis, among others. In addition, therapeutic monoclonal antibodies were developed, aimed at blocking or inhibiting the activity of specific enzymes, cell surface transporters or signaling molecules and have been used in cancer chemotherapy and to treat severe viral infections. Use of monoclonal antibodies is currently broadening to therapy of other severe, nonmalignant conditions including asthma, atopic dermatitis, migraine headaches, hypercholesterolemia, osteoporosis, bacterial diseases (such as anthrax) and viral infections (such as COVID-19). Thus, the therapeutic monoclonal antibodies do not fall into a single class and have broad therapeutic uses. As of 2022, more than 80 therapeutic monoclonal antibodies have been approved for use in the United States.
Monoclonal antibodies are generally well tolerated. Because they are large proteins (typically 150-200,000 daltons in size) they require parenteral, often intravenous, administration. Circulating proteins are metabolized by many cells, but particularly by hepatocytes. Proteins undergo hepatic uptake by endocytosis and are either degraded or recycled to the cell surface for secretion. The hepatic metabolism of antibodies often determines their half-life. Proteins are broken down by cellular proteases into small peptides and amino acids that can used to synthesize other proteins. Metabolism of proteins does not generate toxic intermediates and, therefore, monoclonal antibodies are unlikely to induce drug induced liver injury via production of toxic metabolites. On the other hand, the peptides that are generated by the metabolism of the exogenously administered protein may ultimately be presented as foreign epitopes and generate an immune response. In addition, the primary effect of the monoclonal antibody may generate a response, either immune or otherwise, that leads to an immune mediate hepatic injury. Finally, monoclonal antibodies that suppress the immune system may cause reactivation of latent infections, including tuberculosis, herpes simplex, varicella zoster (shingles) and hepatitis B.
Among the monoclonal antibodies that have been used in clinical medicine, only a few have been linked to drug induced liver injury and, in many situations, the cause of the hepatic adverse event is often unclear. The monoclonal antibodies most clearly linked to drug induced liver injury include the antibodies to tumor necrosis factor (anti-TNF such as infliximab, adalimumab, certolizumab and golimumab) and antibodies to checkpoint proteins (anti-CTLA4 such as ipilimumab; anti-PD1 such as cemiplimab, dostarlimab, nivolumab and pembrolizumab; and anti-PD-L1 such as atezolizumab, avelumab and durvalumab) and to antibodies to B cell markers and activation signals (anti-CD20 such as rituximab, ofatumumab and tositumomab). The liver injury caused by these products is usually attributed to induction of autoimmunity or to immune modulation and reactivation of hepatitis B.
Because of their fine specificity, monoclonal antibodies can also be used to direct more conventional therapeutic agents to specific organs, tissues or cells. Several monoclonal antibody conjugates have been developed, largely in the therapy of cancer, the conjugated drug being an antineoplastic or cytotoxic agent. Five such agents are gemtuzumab ozogamicin, brentuximab vedotin, trastuzumab emtansine, inotuzumab ozogamicin and moxetumomab pasudotox. These products combine a monoclonal antibody (anti-CD33, anti-CD30, anti-HER2, anti-CD22) to a microtubule inhibitor (ozogamicin, vedotin, emtansine, pasudotox). These agents have been associated with serum enzyme elevations during therapy, and several have been linked to hepatic vascular damage, sinusoidal obstruction syndrome and nodular regenerative hyperplasia. These forms of hepatotoxicity are likely due to the conjugate (the "payload") rather than the monoclonal antibody (the targeting vehicle).
Monoclonal antibodies approved for clinical use in the United States are listed below with their brand name followed by the type of monoclonal and specific antigen targeted, the year of initial approval, likelihood score of causing liver injury, and major uses. Those monoclonal antibodies with specific chapters in LiverTox are underlined and have a link to the corresponding record. COVID-19-related monoclonal antibodies, which are typically granted Emergency Use Authorization (EUA) and are often subsequently withdrawn because of antiviral resistance, are not listed in this table but can be found in the chapter “COVID-19 Monoclonal Antibodies.”
MONOCLONAL ANTIBODIES
Underlined Generic Names link to a LiverTox chapter.
CANCER | ||||
Generic Name Brand Name |
Type Antigenic Target | Year of Initial Approval |
Likelihood Score† | Major Uses |
Alemtuzumab Campath | Humanized CD52 | 2001 | C | Chronic lymphocytic leukemia |
Atezolizumab Tecentriq | Humanized PD-L1 | 2016 | B | Urothelial carcinoma Non-small cell lung cancer Small cell lung cancer Hepatocellular carcinoma |
Avelumab Bavencio | Human PD-L1 | 2017 | B | Merkel cell carcinoma Urothelial carcinoma Renal cell carcinoma |
Belantamab Blenrep | Humanized BCMA | 2020 Withdrawn In 2022 | D | Multiple myeloma |
Bevacizumab Avastin | Humanized VEGF | 2004 | E | Colorectal cancer Renal, Ovarian, and Non-small cell lung cancer Macular degeneration (off lbl) |
Blinatumomab Blincyto | Mouse CD3, CD19 | 2014 | E* | Acute lymphoblastic leukemia |
Brentuximab Adcetris | Chimeric CD30 | 2011 | B | Hodgkin lymphoma Anaplastic large cell lymphoma |
Cemiplimab Libtayo | Human PD-1 | 2018 | C | Squamous cell carcinoma Basal cell carcinoma Non-small cell lung cancer |
Cetuximab Erbitux | Chimeric EGFR | 2004 | E | Head and neck cancer Colorectal cancer |
Daratumumab Darzalex | Human CD38 | 2015 | E | Multiple myeloma |
Dinutuximab Unituxin | Chimeric GD2 | 2015 | E* | Neuroblastoma |
Dostarlimab Jemperli | Human PD-1 | 2021 | C | Endometrial carcinoma |
Durvalumab Imfinzi | Human PD-L1 | 2017 | B | Non-small cell lung cancer Small cell lung cancer |
Elotuzumab Empliciti | Humanized SLAMF7 | 2015 | D | Multiple myeloma |
Enfortumab Padcev | Nectin-4 | 2019 | E* | Metastatic urothelial cancer |
Gemtuzumab Mylotarg | Humanized CD33 | 2000 2017 | A | Acute myelogenous leukemia |
Inotuzumab Besponsa | Humanized CD22 | 2017 | A | Acute lymphoblastic leukemia |
Ipilimumab Yervoy | Human CTLA4 | 2009 | A | Malignant melanoma Colorectal, Esophageal, Hepato-cellular and Renal cell cancer Non-small cell lung cancer |
Isatuximab Sarclisa | Chimeric CD38 | 2020 | E | Multiple myeloma |
Margetuximab Margenza | Chimeric HER2 | 2020 | E | Breast cancer |
Mogamulizumab Poteligeo | Humanized CCR4 | 2018 | C | Mycosis fungoides Sézary syndrome |
Moxetumomab Lumoxiti | Mouse CD22 | 2018 | E* | Hairy cell leukemia |
Naxitamab Danyelza | Humanized GD2 | 2020 | E | Neuroblastoma |
Necitumumab Portrazza | Human EGFR | 2015 | E | Non-small cell lung cancer |
Nivolumab Opdivo | Human PD-1 | 2015 | A | Malignant melanoma Colorectal, Esophageal, Hepato-cellular and Renal cell cancer Non-small cell lung cancer |
Ofatumumab Arzerra | Human CD20 | 2009 | E* | Chronic lymphocytic leukemia |
Olaratumab Lartruvo | Human PDGF | 2016 | E | Soft tissue sarcoma |
Panitumumab Vectibix | Human EGFR | 2006 | E | Colorectal cancer |
Pembrolizumab Keytruda | Humanized PD-1 | 2014 | A | Malignant melanoma Non-small cell lung cancer Advanced cervical cancer |
Pertuzumab Perjeta | Humanized HER2 | 2012 | E | Breast cancer |
Polatuzumab Vedotin Polivy | Human CD79b | 2019 | E* | B cell lymphomas |
Ramucirumab Cyramza | Human VEGF | 2014 | E* | Gastric, non-small cell lung cancer Colorectal cancer |
Rituximab Rituxan | Chimeric CD20 | 1997 | A | Chronic lymphocytic leukemia Non-Hodgkin lymphoma Rheumatoid arthritis |
Sacituzumab Govitecan Trodelvy | Humanized Trop-2 | 2020 2021 2023 | E* | Triple-negative breast cancer Urothelial cancer Hormone receptor positive breast cancer |
Tafasitamab Monjuvi | Humanized CD19 | 2020 | E | B cell malignancies, including B cell lymphoma |
Teclistamab Tecvayli | Human BCMA, CD3 | 2022 | D | Multiple myeloma |
Tisotumab Vedotin Tivdak | Human TF | 2021 | E | Cervical cancer |
Tositumomab Bexxar | Mouse CD20 | 2003 Withdrawn | E* | Non-Hodgkin lymphoma |
Trastuzumab Herceptin | Humanized HER2 | 1998 | C | Breast and gastric cancer |
Trastuzumab Deruxtecam Enhertu | Humanized HER2 | 2019 | E* | Breast, gastric, and non-small cell lung cancers |
Trastuzumab Emtansine Kadcyla | Humanized HER2 | 2013 | B | Breast cancer |
Tremelimumab Imjudo | Human CTLA4 | 2022 | C | Hepatocellular carcinoma Non-small cell lung cancer |
AUTOIMMUNE DISEASES | ||||
Generic Name Brand Name |
Type Antigenic Target |
Initial
Approval |
Likelihood Score† | Major Uses |
Adalimumab Humira | Human TNFα | 2002 | B | Inflammatory bowel disease Rheumatoid, Psoriatic arthritis Severe psoriasis |
Alemtuzumab Lemtrada | Humanized CD52 | 2014 | C | Multiple sclerosis |
Anifrolumab Saphnelo | Human Type 1 IFN | 2021 | E | Systemic lupus erythematosus |
Axatilimab Niktimvo | Humanized CSF-1R | 2024 | E | Graft-versus-host disease |
Belimumab Benlysta | Human B cell activity factor | 2011 2020 | E | Systemic lupus erythematosus Lupus nephritis |
Brodalumab Siliq | Human IL-17A | 2017 | E | Plaque psoriasis |
Canakinumab Ilaris | Human IL1β | 2009 | E* | Autoinflammatory diseases |
Certolizumab Cimzia | Humanized TNFα | 2008 | E* | Inflammatory bowel disease Rheumatoid arthritis |
Daclizumab Zinbryta | Humanized CD25 | 2016 | C | Multiple sclerosis |
Dupilumab Dupixent | Human IL-4α | 2017 | E | Atopic dermatitis |
Efalizumab Raptiva | Humanized CD11a | 2003 Withdrawn | D | Plaque psoriasis |
Golimumab Simponi | Human TNFα | 2009 | E* | Inflammatory bowel disease Rheumatoid, Psoriatic arthritis |
Guselkumab Tremfya | Human IL-23 | 2017 | E* | Plaque psoriasis |
Infliximab Remicade | Chimeric TNFα | 1998 | A | Inflammatory bowel disease Rheumatoid arthritis Severe psoriasis |
Ixekizumab Taltz | Humanized IL-17A | 2016 | E | Plaque psoriasis Psoriatic arthritis |
Ocrelizumab Ocrevus | Humanized CD20 | 2017 | D | Multiple sclerosis |
Omalizumab Xolair | Humanized IgE | 2003 | E | Eosinophilic asthma Chronic idiopathic urticaria |
Risankizumab Skyrizi | Humanized IL-23 | 2019 | E | Plaque psoriasis |
Rituximab Rituxan | Chimeric CD20 | 1997 | A | Chronic lymphocytic leukemia Non-Hodgkin lymphoma Rheumatoid arthritis |
Sarilumab Kevzara | Human IL6R | 2017 | E* | Rheumatoid arthritis |
Satralizumab Enspryng | Humanized IL-6r | 2020 | E* | Neuromyelitis optica spectrum disorder |
Secukinumab Cosentyx | Human IL-17A | 2015 | E* | Plaque psoriasis Psoriatic arthritis, Ankylosing spondylitis, Scalp psoriasis Axial spondylarthritis |
Siltuximab Sylvant | Chimeric IL6 | 2014 | E | Castleman disease |
Tildrakizumab Ilumya | Humanized IL-23 | 2018 | E* | Plaque psoriasis |
Tocilizumab Actemra | Humanized IL6R | 2010 | C | Rheumatoid arthritis Juvenile idiopathic arthritis Giant cell arteritis |
Tralokinumab Adbry | Human IL-13 | 2021 | E | Atopic dermatitis |
Ustekinumab Stelara | Human IL-12, IL-23 | 2010 | E* | Plaque psoriasis Psoriatic arthritis |
Vedolizumab Entyvio | Humanized Integrin α4β7 | 2014 | D | Inflammatory bowel disease |
LIVER TRANSPLANTATION | ||||
Generic Name Brand Name |
Type Antigenic Target |
Initial
Approval |
Likelihood Score† | Major Uses |
Basiliximab Simulect | Chimeric IL-2Rα | 1998 | E | Prevention of transplant rejection |
Daclizumab Zenapax | Humanized IL-2 | 1997 Withdrawn | C | Prevention of transplant rejection |
Muromonab-CD3 OKT3 | Mouse CD3 T cells | 1985 Withdrawn | E | Prevention of transplant rejection |
MISCELLANEOUS | ||||
Generic Name Brand Name |
Type Antigenic Target |
Initial
Approval |
Likelihood Score† | Major Uses |
Abciximab Reopro | Chimeric GpIIb/IIIa | 1993 | Inhibition of platelet aggregation | |
Aducanumab Aduhelm | Human Amyloid β | 2021 | E | Alzheimer disease |
Alirocumab Praluent | Human PCSK9 | 2015 | E | Hypercholesterolemia |
Benralizumab Fasenra | Humanized IL5 | 2017 | E | Eosinophilic asthma |
Bezlotoxumab Zinplava | Human C. difficile toxin B | 2016 | E | Prevention of recurrence of C. difficile infection |
Burosumab Crysvita | Human FGF 23 | 2018 | E | X-linked Hypophosphatemia |
Caplacizumab Cablivi | Humanized vWF | 2019 | E | Acquired thrombotic thrombocytopenic purpura |
Crizanlizumab Adakveo | Humanized P-selectin | 2019 | E | Sickle cell disease |
Donanemab Kisunla | Humanized Amyloid β | 2024 | E | Alzheimer disease |
Denosumab Prolia, Zgeva | Human RANKL | 2010 | E* | Osteoporosis Bone metastases |
Eculizumab Soliris | Humanized C5 | 2007 | D | Paroxysmal nocturnal hemoglobinuria |
Emapalumab Gamifant | Human Interferon Gamma | 2018 | E | Hemophagocytic lymphohistiocytosis |
Emicizumab Hemlibra | Humanized Factor IXa & X | 2017 | E | Hemophilia A |
Eptinezumab Vyepti | Humanized CGRP | 2019 | E | Migraine headache |
Erenumab Aimovig | Human CGRP | 2018 | E | Migraine headache |
Evinacumab Evkeeza | Human ANGPTL3 | 2021 | E | Hypercholesterolemia |
Evolocumab Repatha | Human PCSK9 | 2015 | E | Hypercholesterolemia |
Fremanezumab Ajovy | Humanized CGRP | 2018 | E | Migraine headache |
Galcanezumab Emgality | Humanized CGRP | 2018 | E | Migraine headache |
Ibalizumab Trogarzo | Humanized CD4 | 2018 | E | HIV infection |
Inebilizumab Uplizna | Humanized CD19 | 2020 | E | Neuromyelitis optica spectrum disorder |
Lanadelumab Takhzyro | Human Kallikrein | 2018 | E | Hereditary angioneurotic edema |
Lecanemab Leqembi | Human Amyloid β | 2023 | E | Alzheimer disease |
Mepolizumab Nucala | Humanized IL15 | 2015 | E | Eosinophilic asthma Hypereosinophilic syndrome |
Natalizumab Tysabri | Humanized Integrin α4β7 | 2004 | B | Multiple sclerosis Inflammatory bowel disease |
Obiltoxaximab Anthim | Chimeric Anthrax toxin | 2016 | E | Inhalational anthrax |
Omalizumab Xolair | Humanized IgE | 2003 | E | Eosinophilic asthma Chronic idiopathic urticaria |
Palivizumab Synagis | Humanized RSV fusion protein | 1998 | E | Respiratory syncytial virus infection |
Ranibizumab Lucentis | Humanized VEGF-A | 2006 | E | Macular degeneration |
Ravulizumab Ultomiris | Humanized Complement C5 | 2018 | E* | Paroxysmal noctural hemoglobinuria |
Raxibacumab | Human Anthrax toxin | 2012 | E | Inhalational anthrax |
REGN-EB3 [Atoltivimab, Maftivimab, Odesivimab] Inmazeb | Human Ebolavirus glycoprotein | 2020 | E | Ebolavirus infection |
Reslizumab Cinqair | Humanized IL5 | 2016 | E | Eosinophilic asthma |
Romosozumab Evenity | Humanized Sclerostin | 2019 | E | Osteoporosis |
Teplizumab Tzield | Humanized CD3 | 2022 | E | Diabetes |
Teprotumumab Tepezza | Human IGF1R | 2019 | E | Graves ophthalmopathy |
Tezepelumab Tezspire | Human TSLP | 2021 | E | Asthma |
† Likelihood Score indicates the likelihood of association with drug induced liver injury,
based upon the known potential of the drug to cause such injury.
Updated: December 10, 2024
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