Table 4.
Adverse events associated with approved 1 monoclonal antibodies used for non-cancer therapies (as at December 2021).
| Monoclonal Antibody 2 INN and Trade Names | Target 3 | Warnings, Precautions, Risks and Safety Concerns | Other Adverse Events 4, Serious and Common |
|---|---|---|---|
| Abciximab (ReoPro®) | Glycoprotein IIb/IIIa | Increased risk of bleeding; thrombocytopenia |
Systemic: Bleeding; intracranial hemorrhage or stroke; GI; CV; anemia; NS; respiratory; urinary disorders Cutaneous: Pruritus; generalized exanthema |
| Adalimumab (Humira®) | TNF |
Boxed warning: Serious infections; malignancy Other: Anaphylaxis, serious allergic reactions; hepatitis B reactivation; demyelinating disease; cytopenias; heart failure; lupus-like syndrome |
Systemic: Infections; isr; ILD; sarcoidosis; liver failure Cutaneous: SJS; EM; psoriasis; cutaneous vasculitis; alopecia |
| Aducanumab-avwa (Aduhelm®) | Amyloid beta | Amyloid-related imaging abnormalities (ARIA); hypersensitivity |
Systemic: Headache; ARIA-oedema, -headache, -H microhemorrhage, -H superficial siderosis, fall |
| Alemtuzumab (Lemtrada®) | CD52 |
Boxed warning: Autoimmunity; IRs; malignancies Other: Other immune cytopenias; glomerular nephropathies; thyroid disorders; delay therapy in cases of infections; pneumonitis |
Systemic: Headache; pyrexia; nausea; UTI; herpes virus infection; extremity and back pain; dizziness; flushing; cough; chills; vomiting; dyspnea Cutaneous: Rash; urticaria; pruritus; dermatitis |
| Alirocumab (Praluent®) | PCSK9 | Allergic reactions (pruritus, urticaria, rash) including some serious (including hypersensitivity vasculitis) |
Systemic: Nasopharyngitis; isr; influenza; URTI; cough; sinusitis; bronchitis; diarrhea; myalgia; muscle spasms; musculoskeletal pain; liver enzyme abnormalities |
| Anifrolumab-fnia (Saphnelo®) | IFNAR | Serious infections; hypersensitivity; malignancy; avoid live attenuated vaccines and other biological therapies | Systemic: Nasopharyngitis; URTI; IR; bronchitis; herpes zoster; cough |
| Ansuvimab-zykl (Ebanga®) | EBOV GP1 | Hypersensitivity; IR | Systemic: Pyrexia; tachycardia; diarrhea; vomiting; hypotension; tachypnoea; chills |
| Atoltivimab, Maftivimab, and Odesivimab-ebgn (Inmazeb®) |
EBOV GP1 | Hypersensitivity; IR |
Systemic: Pyrexia; chills; tachycardia; tachypnoea; vomiting |
| Basiliximab (Simulect®) | IL-2 receptor α-chain (CD25) |
Boxed warning: General risk of immunosuppressive therapy Other: Immunogenicity; hypersensitivity |
Systemic: GI; viral infection; peripheral oedema; UTI; URTI; dyspnea; wound complications; hypertension; anemia; hypo- and hyperkalemia and hyperuricemia; headache; tremor Cutaneous: Rash; pruritus; hypertrichosis |
| Belimumab (Benlysta®) | BLyS | Mortality; serious infection; malignancy; hypersensitivity including anaphylaxis; IR; depression; immunization |
Systemic: Nausea; diarrhea; pyrexia; pain in extremity; bronchitis; depression; migraine Cutaneous: Rash; pruritus |
| Benralizumab (Frasenra®) | IL-5Rα | Hypersensitivity; helminth infections—treat prior; decrease steroids gradually |
Systemic: Headache; pharyngitis |
| Bezlotoxumab (Zinplava®) | Clostridium difficile toxin B | Heart failure | Systemic: Nausea; pyrexia; headache |
| Bimekizumab (Bimzelx®) | IL-17A, IL-17F, IL-17AF | Infections; pre-evaluation for tuberculosis; IBD; avoid live vaccines; hypersensitivity |
Systemic: Infections and infestations, nervous system disorders; isr Cutaneous: Dermatitis; acne; eczema |
| Brodalumab (Siliq®; Kyntheum®; Lumicef®) | IL-17RA |
Boxed warning: Suicidal ideation and behavior. Other: TB; infections; Crohn’s disease; avoid live vaccines |
Systemic: Arthralgia; headache; fatigue; diarrhea; oropharyngeal pain; nausea; myalgia; isr, influenza; neutropenia; tinea infections |
| Brolucizumab-dbll (Beovu®) | VEGF-A | Endophthalmitis and retinal detachment; risk of arterial thromboembolic events; increase in intraocular pressure |
Systemic: Conjunctival hemorrhage; eye pain; vitreous floaters; cataracts; blurred vision |
| Burosumab-twza (Crysvita®) | FGF23 | Hypersensitivity; isr; hyperphosphatemia and risk of nephrocalcinosis |
Systemic: Headache; isr; vomiting; pyrexia; pain in extremity; decreased vitamin D |
| Canakinumab (Ilaris®) |
IL-1β | Increased risk of serious infections; immunization; MAS; hypersensitivity; immunosuppression |
Systemic: CAPS—Nasopharyngitis; diarrhea; influenza; headache; nausea; dizziness/vertigo; SJIA, URTI, isr, abdominal pain |
| Caplacizumab-yhdp (Cablivi®) | von Willibrand factor | Bleeding | Systemic: Epistaxis; gingival bleeding; headache; isr |
| Casirivimab + Imdevimab (REGEN-COV®; Ronapreve®) |
mAbs bind to SARS-CoV-2 spike protein RBD preventing binding to the ACE2 receptor | Hypersensitivity including anaphylaxis; IR | - |
| Certolizumab pegol (Cimzia®) |
TNF |
Boxed warning: Serious infections; lymphoma and other malignancies Other: Heart failure; serious allergic reactions; hepatitis B reactivation; demyelinating disease; cytopenias; lupus-like syndrome |
Systemic: URTI; cardiac disorders; eye disorders; isr; hepatitis and ↑ liver enzymes; nephrotic syndrome; renal failure; thrombophlebitis; vasculitis Cutaneous: Dermatitis; erythema nodosum; urticaria |
| Crizanlizumab-tmca (Adakveo®) | P-selectin | IR | Systemic: Nausea; arthralgia; back pain; pyrexia |
| Daclizumab (Zinbryta®) | IL-2 receptor α-chain (CD25) |
Boxed warning: Hepatic injury including autoimmune hepatitis and other immune-mediated disorders Other: Hypersensitivity; infections; depression and suicide |
Systemic: Nasopharyngitis; URTI; oropharyngeal pain; bronchitis; eczema; depression; influenza. Cutaneous: Dermatitis, rash |
| Denosumab (Prolia®) | RANKL | Hypersensitivity; hypocalcemia; serious infections; osteonecrosis of jaw; atypical femoral fractures; severe bone, joint, muscle pain; suppression of bone turnover; dermatologic reactions |
Systemic: Post-menopausal osteoporosis—back, extremity and musculoskeletal pain; hypercholesterolemia; cystitis; male osteoporosis—back pain; arthralgia; nasopharyngitis Cutaneous: Rash; pruritus; dermatitis; eczema |
| Dupilumab (Dupixent®) | IL-4Rα | Hypersensitivity; conjunctivitis and keratitis; eosinophilic conditions; helminth infections—treat prior; decrease steroids gradually |
Systemic: Conjunctivitis; blepharitis; eye pruritus; herpes infections; keratitis; dry eye; oropharyngeal pain; isr; eosinophilia |
| Eculizumab (Soliris®) | Complement C5 | Boxed warning: Serious meningococcal infection |
Systemic: PNH—headache; nasopharyngitis; back pain; nausea; AHUS—hypertension; URTI; GI; abdominal pain; anemia; cough; pyrexia; peripheral edema Cutaneous: Rash; pruritus |
| Efgartigimod-alfa-fcab (Vyvgart®) 5 |
Neonatal Fc receptor FcRn | See reference below 5 | See reference below 5 |
| Emapalumab-lzsg (Gamifant®) | IFNγ | Infections; IR; avoid live vaccines |
Systemic: Infections; pyrexia; hypertension; IR |
| Emicizumab-kxwh (Hemlibra®) | Factors IXa & X |
Boxed warning: Thrombotic microangiopathy and thromboembolism. Other: mAb interference with coagulation tests |
Systemic: Arthralgia; isr; headache |
| Eptinezumab-jjmr (Vyepti®) | CGRP | Hypersensitivity | Systemic: Nasopharyngitis; hypersensitivity |
| Erenumab-zooe (Aimoig®) | CGRP Receptor | - | Systemic: Constipation; isr |
| Evinacumab-dgnb (Evkeeza®) | ANGPTL3 | Serious hypersensitivity; embryo-fetal toxicity |
Systemic: Nasopharyngitis; influenza-like illness; dizziness; rhinorrhea; nausea |
| Evolocumab (Repatha®) | PCSK9 | Patients with renal and hepatic impairments have not yet been adequately studied; cover of prefilled syringe and pen contain latex which may cause allergic reactions |
Systemic: Nasopharyngitis; isr; influenza; URTI; back pain; arthralgia; hypertension; nausea Cutaneous: Rash; hives |
| Fremanezumab-vfrm (Ajovy®) | CGRP | Hypersensitivity | Systemic: isr |
| Galcanezumab-gnlm (Emgality®) | CGRP | Hypersensitivity | Systemic: isr |
| Golimumab (Simponi®) | TNF |
Boxed warning: Serious infections; lymphoma, and other malignancies Other: Invasive fungal infections; heart failure; hepatitis B reactivation; demyelinating disease; hypersensitivity |
Systemic: URTI; viral infections; bronchitis; ↑ liver enzymes; sarcoidosis; ILD; paresthesia Cutaneous: Skin exfoliation; rash |
| Guselkumab (Tremfya®) | IL-23 | Infections; prior evaluation for TB |
Systemic: URTI; isr; arthralgia; headache; diarrhea; tinea; gastroenteritis; herpes simplex infections |
| Ibalizumab-uiyk (Trogarzo®) | CD4 | IRIS |
Systemic: Diarrhea, nausea; dizziness. Cutaneous: Rash |
| Idarucizumab (Praxbind®) | Dabigatran | Thromboembolic risk; hypersensitivity; risk of adverse reaction in patients with hereditary fructose intolerance; reappearance of bleeding |
Systemic: Headache; hypokalemia; delirium; pneumonia; constipation; pyrexia |
| Inebilizumab-cdon (Uplizna®) | CD19 | IR; infections; monitor immunoglobulin levels; fetal risk |
Systemic: Urinary tract infection; arthralgia |
| Infliximab (Remicade®) | TNF |
Boxed warning: Serious infections; malignancy Other: Hepatitis B reactivation; hepatotoxicity; cytopenias; demyelinating disease; lupus-like syndrome |
Systemic: Infections; pancytopenia; anemia; cellulitis; serum sickness; thrombophlebitis; intestinal obstruction; ILD; anaphylaxis; IRs Cutaneous: Cutaneous vasculitis; SJS; EM; psoriasis; |
| Ixekizumab (Taltz®) | IL-17A | Infections: TB—evaluate prior; hypersensitivity; inflammatory bowel disease | Systemic: URTI; isr; nausea; tinea infections |
| Lanadelumab-flyo (Takhzyro®) | Plasma kallikrein | Hypersensitivity |
Systemic: URTI; isr; headache; diarrhea; dizziness; myalgia Cutaneous: Rash |
| Mepolizumab (Nucala®) | IL-5 | Hypersensitivity; helminth infections—treat prior; herpes zoster infections—consider prior vaccination; decrease steroids gradually; not to be used for bronchospasm or status asthmaticus |
Systemic: Headache; isr; back pain; fatigue |
| Natalizumab (Tysabri®) | α4 integrin (binds to α4β1 and α4β7 integrins) |
Boxed warning: PML Other: Hypersensitivity; hepatotoxicity; immunosuppression/infections; IRIS |
Systemic: MS—headache; fatigue; arthralgia; urinary tract infection; URTI; gastroenteritis; vaginitis; diarrhea. CD—headache; URTI; nausea Cutaneous: Rash; urticaria |
| Obiltoxaximab (Anthim®) | Bacillus anthracis PA | Boxed warning: Hypersensitivity and anaphylaxis |
Systemic: URTI; headache; pruritus; IR pain, swelling, bruise Cutaneous: Urticaria |
| Ocrelizumab (Ocrevus®) | CD20 | Infections; IR; increased risk of malignancy |
Systemic: Respiratory tract infections; IR; PML Cutaneous: Skin infections |
| Omalizumab (Xolair®) | IgE | Anaphylaxis; malignancy; acute asthma; decrease CSs gradually; eosinophilia; serum sickness-like reaction; parasitic infection |
Systemic: Allergic asthma— arthralgia; pain; dizziness; fracture; earache. CIU—nausea; pharyngitis; URTI; sinusitis; arthralgia; headache; cough; virus infections Cutaneous: Pruritus; dermatitis. |
| Palivisumab (Synagis®) | RSVF | Anaphylaxis; delay administration during moderate–severe infections; give with caution in cases of thrombocytopenia or coagulation disorders |
Systemic: isr; pyrexia; apnea; cough; dizziness thrombocytopenia Cutaneous: Rash; itching; erythema |
| Ranibizumab (Lucentis®) | VEGF-A | Endophthalmitis and retinal detachment, increase in intraocular pressure and risk of arterial thromboembolic events after intravitreal injection |
Systemic: Conjunctival hemorrhage; eye pain; vitreous floaters; cataracts |
| Ravulizumab-cwvz (Ultomiris®) |
Complement C5 |
Boxed warning: Serious meningococcal infections |
Systemic: URTI; headache; diarrhea; nausea |
| Raxibacumab (ABthrax®) | Bacillus anthracis PA | IR |
Systemic: Pain in extremity; somnolence; headache; URTI; nausea; cough; arthralgias. Cutaneous: Rash; pruritus; urticaria |
| Regdanvirimab (Regkirona®) | Binds to SARS-CoV-2 spike protein RBD preventing binding to ACE2 receptor |
Hypersensitivity including anaphylaxis; IR |
-- |
| Reslizumab (Cinqair®) | IL-5 |
Boxed warning: Anaphylaxis Other: Helminth infections—treat prior; decrease steroids gradually; malignancy |
Systemic: Oropharyngeal pain |
| Risankizumab-rzaa (Skyrizi®) | IL-23 p19 | Infections; prior evaluation for TB; hypersensensitivity | Systemic: URTI; isr; diarrhea |
| Romosozumab-aqqg (Evenity®) | Sclerostin |
Boxed warning: Potential risk of myocardial infarction, stroke, and cardiovascular death Other: Cardiac events; hypersensitivity; hypocalemia; atypical femoral fracture |
Systemic: Arthralgia; headache |
| Satralizumab-mwge (Enspryng®) | IL-6R | Infections; elevated liver enzymes (ALT, AST); decreased neutrophils |
Systemic: Nasopharyngitis; headache; URTI; gastritis; arthralgia; extremity pain; fatigue; nausea Cutaneous: Rash |
| Sarilumab (Kevzara®) | IL-6R |
Boxed warning: Risk of serious infection Other: GI perforation; avoid live vaccines; hypersensitivity; neutropenia; thrombocytopenia |
Systemic: increased ALT; isr; URTI; urinary tract infections |
| Secukinumab (Cosentyx®) | IL-17A | Infections; tuberculosis activation; exacerbation of Crohn’s disease; hypersensitivity; avoid live vaccines |
Systemic: Nasopharyngitis; diarrhea; URTI; rhinitis Cutaneous: Urticaria |
| Sotrovimab (Xevudy®) 6 | Spike protein RBD of SARS-CoV-2 | Hypersensitivity reactions including anaphylaxis |
-- |
| Teprotumumab-trbw (Tepezza®) |
IGF-1R | IR; exacerbation of pre-existing inflammatory bowel disease; hyperglycemia |
Systemic: Muscle spasm; nausea; alopecia; diarrhea; fatigue; hyperglycemia; hearing impairment; dry skin; dysgeusia; headache |
| Tezepelumab-ekko (Tezspire®) 7 | Thymic stromal lymphopoietin | Hypersensitivity; acute asthma and deteriorating disease; reduction of corticosteroid dosage; parasite infection; live attenuated virus vaccines 7 |
Systemic: Pharyngitis; arthralgia; back pain 7 |
| Tildrakizumab-asmn (Ilumetri®; Ilumya®) | IL-23 p19 | Infections; prior evaluation for TB; hypersensensitivity | Systemic: URTI; isr; diarrhea |
| Tocilizumab (Actemra®; RoActemra®) | IL-6R |
Boxed warning: Serious infections Other: GI perforation; avoid live vaccines; hypersensitivity; laboratory monitoring |
Systemic: Nasophraryngitis; nausea; ↑ liver enzymes; IR; hypertension; thrombocytopenia; neutropenia; headache Cutaneous: Dermatologic reactions |
| Tralokinumab (Adtralza®) | IL-13 | Hypersensitivity; conjunctivitis; helminth infection; avoid live and live attenuated vaccines | Systemic: URTI; conjunctivitis; eosinophilia; isr |
| Ustekinumab (Stelara®) | IL-12 IL-23 |
Infections; tuberculosis; RPLS; malignancies; anaphylaxis; avoid live vaccines |
Systemic: Nasopharyngitis; headache; dental infections; URTI; isr; arthralgia; GI Cutaneous: Pruritus |
| Vedolizumab (Entyvio®) | α4β7 integrin | Hypersensitivity/IR; infections; PML; liver injury |
Systemic: Headache; arthralgia; nausea; pyrexia; URTI; cough; bronchitis; influenza; back pain; pain in extremities; nasopharyngitis Cutaneous: Rash; pruritus |
ACE2—angiotensin-converting enzyme 2; AHUS—atypical hemolytic uremic syndrome; ANGPTL3—angiopoietin-like 3; BLyS—B lymphocyte stimulator, also known as B cell-activating factor, BAFF; C5—complement component 5; CAPS—cryopyrin-associated periodic syndrome; CD—Crohn’s disease; CIU—chronic idiopathic urticaria; COVID—Coronavirus disease; CSs—corticosteroids; CV—cardiovascular; EBOV—Zaire ebolavirus; EM—erythema multiforme; GI—gastrointestinal; GP1—glycoprotein 1 of EBOV; HSTC—hematopoietic stem cell transplantation; IBD—inflammatory bowel disease; IFNAR—subunit I type I interferon receptor; IGF-1R—insulin-like growth factor receptor-1; ILD—interstitial lung disease; IR—infusion reaction; IRIS—immune reconstitution inflammatory syndrome; isr—injection site reaction; MAS—macrophage activation syndrome; MS—multiple sclerosis; NS—nervous system; PA—protective antigen of B. anthracis toxin; PCSK9—proprotein convertase subtilisin/kexin type 9; PML—progressive multifocal leukoencephalopathy; PNH—paroxysmal nocturnal hemoglobinuria; RANKL—receptor activator of nuclear factor kappa-B ligand (CD254); RBD—receptor binding domain; REMS—Risk Evaluation Mitigation Strategy; RSVF—human respiratory syncytial virus (F protein coat antigen); SARS-CoV-2—severe acute respiratory syndrome coronavirus 2; SJIA—active systemic juvenile idiopathic arthritis; SJS—Stevens–Johnson syndrome; URTI—upper respiratory tract infection; UTI—urinary tract infection; VEGF-A—vascular endothelial growth factor A. 1 Approved by the FDA or EMA or both. 2 Monoclonal antibodies are listed in alphabetical order. 3 Specificity of antibody. 4 Adverse events in addition to those mentioned as occurring, or potentially likely to occur, and shown in column 3. 5 Approved by the FDA on 17 December 2021. For safety data and adverse events, see Howard, J.F; Bril, V.; Vu, T.; et al. [21]. 6 Note added in press: Approved by the EMA on 17 December 2021. 7 Approved by the FDA on 17 December 2021. For safety data and adverse events, see Menzies-Gow, A.; Colice G, Griffiths, J.M.; et al. [22] and Menzies-Gow, A.; Corren, J.; Bourdin, A.; et al. [23]. ↑ increase.