Table 5.
Adverse events associated with approved 1 monoclonal antibodies used for cancer therapy (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 |
|---|---|---|---|
| Ado-trastuzumab emtansine (Kadcyla®) | HER2 |
Boxed warning: Hepatotoxicity; cardiac toxicity; embryo-fetal toxicity Other: IR; pulmonary toxicity; extravasation; hemorrhage; thrombocytopenia; neurotoxicity |
Systemic: Pulmonary events; fetal harm; LVD; hypersensitivity/IR; nausea; fatigue; anemia; headache; musculoskeletal pain; increased transaminases; constipation Cutaneous: Rash; pruritus |
| Alemtuzumab (Campath®; MabCampath®) |
CD52 |
Boxed warning: Cytopenias; IR; immunosuppression/infections Other: Immunization |
Systemic: Pulmonary events; immunogenicity; cardiac events; diarrhea; nausea; emesis; insomnia Cutaneous: Rash; urticaria; erythema; pruritus |
| Amivantamab-vmjw (Rybrevant®) |
EGFR and c-MET receptors | ILD/pneumonitis; IR; dermatologic (including acneiform dermatitis and TEN); ocular toxicity; embryo-fetal toxicity |
Systemic: IR; paronychia; musculoskeletal pain; dyspnea; nausea; fatigue; edema; stomatitis; cough; constipation; vomiting Cutaneous: Rash |
| Atezolizumab (Tecentriq®) |
PD-L1 | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies (hypophysitis, thyroid disorders, adrenal insufficiency, diabetes mellitus); embryo-fetal toxicity |
Systemic: IR; fatigue; nausea; infections; urinary tract infections; decreased appetite; diarrhea; pyrexia; constipation; dyspnea. Cutaneous: Rash; pruritus |
| Avelumab (Bavencio®) |
PD-L1 | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction; IR |
Systemic: Fatigue; musculoskeletal pain; diarrhea; nausea; decreased appetite; peripheral edema; urinary tract infection Cutaneous: Rash; pruritus |
| Belantamab mafodoton-blmf (Blenrep®) |
BCMA with MMAF microtubule inhibitor |
Boxed warning: Ocular toxicity Other: Thrombocytopenia; IR; embryo-fetal toxicity |
Systemic: Keratopathy; decreased visual acuity, nausea; blurred vision; pyrexia; IR; fatigue; decreased platelets, lymphocytes, hemoglobin; increased creatinine, GGT |
| Bevacizumab (Avastin®) |
VEGF-A |
Boxed warning: GI perforation; surgery/wound healing; hemorrhage Other: Non-GI fistula; RPLS; IR; CHF; hypertension; arterial/venous thromboembolism; eye disorders; proteinurea; neutropenia/infections; ONJ |
Systemic: Pulmonary events; epistaxis; headache; rectal hemorrhage; dry skin; necrotizing fasciitis; taste alteration; lacrimation disorder; ovarian failure Cutaneous: Exfoliative dermatitis; alopecia |
| Blinatumomab (Blincyto®) | CD19/CD3 epsilon |
Boxed warning: CRS; neurological toxicities Other: Infections; neutropenia and febrile neutropenia; TLS; elevated liver enzymes; leukoencephalopathy |
Systemic: HLH; pyrexia; lymphopenia; leukopenia; chills; headache; CNS symptoms (disorientation, confusion, tremor, speech disorders); hypokalemia; pneumonia; sepsis, constipation, peripheral edema Cutaneous: Rash |
| Brentuximab vedotin(Adcetris®) | CD-30 |
Boxed warning: PML Other: Peripheral neuropathy; IR and anaphylaxis; neutropenia; infections; fetal harm; hepatotoxicity; TLS; SJS |
Systemic: Cytopenias; immunogenicity; URTI; pyrexia; nausea; vomiting; fatigue; cough; anaphylaxis Cutaneous: Rash; pruritus; SJS; alopecia |
| Catumaxomab (Removab®) |
EpCAM/CD3 | Monitor and evaluate for: CRS; SIRS; HAMA/HARA; GI hemorrhage; hepatic disorders; abdominal infection; ileus/intestinal perforation; decreased lymphocyte count |
Systemic: Cytopenias; hepatotoxicity; abdominal disorders; pyrexia; chills; nausea; vomiting; infections; immunogenicity; dyspnea Cutaneous: Rash; erythema; allergic dermatitis; hyperhidrosis; pruritus |
| Cemiplimab-rwlc (Libtayo®) |
PD-1 | Immune-mediated pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions; IR; embryo-fetal toxicity |
Systemic: Diarrhea; fatigue; nausea; constipation; musculoskeletal pain Cutaneous: Rash; pruritus |
| Cetuximab (Erbitux®) |
EFGR |
Boxed warning: Serious IR and cardiopulmonary arrest. Other: Pulmonary toxicity; dermatologic toxicity; hypomagnesemia |
Systemic: Electrolyte imbalance; infection; GI; anaphylaxis; headache; diarrhea Cutaneous: Acneiform rash; nail changes; xeroderma; paronychial inflammation; pruritus |
| Daratumumab (Darzalex®) |
CD38 | IR; interference with serological testing; neutropenia; thrombocytopenia |
Systemic: Neutropenia; thrombocytopenia; fatigue; nausea; diarrhea; constipation; vomiting; muscle spasms; arthralgia; back pain; pyrexia; chills; dizziness; insomnia; cough; dyspnea; peripheral edema; peripheral sensory neuropathy; URTI |
| Denosumab (Prolia®; Xgeva®) | RANKL | Hypocalcemia; ONJ; embryo-fetal toxicity |
Systemic: Osteomyelitis; hypophosphatemia; dyspnea; fatigue/asthenia; back pain; nausea; extremity pain Cutaneous: Rash; pruritus; dermatitis; eczema |
| Dinutuximab (Unituxin®) |
GD2 |
Boxed warning: Serious IR; neuropathy Other: CLS and hypotension; infection; RPLS; neurological disorders of eye; BMS; electrolyte abnormalities; AHUS; embryo-fetal toxicity |
Systemic: Hypokalemia; pain; fever; hypocalcemia; hyponatremia; anemia; thrombocytopenia; lymphopenia; neutropenia; increased AST, ALT; GI Cutaneous: Urticaria |
| Dostarlimab-gxly (Jemperli®) | PD-1 | Immune-mediated colitis, pneumonitis, hepatitis, endocrinopathies, nephritis, dermatologic adverse reactions; IR; complications of allogeneic HSCT after PD-1/L-1–blocking antibody; embryo-fetal toxicity |
Systemic: Fatigue/asthenia; nausea; diarrhea; anemia |
| Durvalumab (Imfinzi®) |
PD-L1 | Immune-mediated pneumonitis, colitis, hepatitis, nephritis, endocrinopathies; dermatologic reactions; embryo-fetal toxicity; infections; IR |
Systemic: Fatigue; musculoskeletal pain; diarrhea; nausea; decreased appetite; peripheral edema; urinary tract infection; pneumonitis; dyspnea; URTI; cough Cutaneous: Rash; pruritus |
| Elotuzumab (Empliciti®) |
SLAMF7 | IR; infections; second primary malignancies; hepatotoxicity; interference in monitoring M-protein impacting determination of complete response in patients with IgGκ myeloma protein |
Systemic: Fatigue; diarrhea; pyrexia; constipation; cough; peripheral neuropathy; nasopharyngitis; URTI; decreased appetite; pneumonia |
| Enfortumab-vedotin-ejfv (Padcev®) |
Nectin-4 with MMAE microtubule inhibitor |
Hyperglycemia; peripheral neuropathy; ocular disorders; skin reactions; infusion site extravasation; embryo-fetal toxicity |
Systemic: Fatigue; peripheral neuropathy; decreased appetite; rash; alopecia; nausea; dysgeusia; diarrhea; dry eye Cutaneous: Pruritus; dry skin |
| Fam-trastuzumab deruxtecan-nxki (Enhertu®) |
HER2 |
Boxed warning: ILD and pneumonitis; embryo-fetal toxicity Other: Neutropenia; LVD |
Systemic: Decreased hemoglobin, white blood cells, neutrophils, lymphocytes, platelets; nausea; vomiting; constipation; fatigue; decreased appetite; anemia; diarrhea; hypokalemia; pyrexia; alopecia; increased blood bilirubin, aspartate aminotransferase, AP, alanine aminotransferase |
| Gemtuzumab ozogamicin (Mylotarg®) |
CD33 |
Boxed warning: Hepatotoxicity including severe or fatal hepatic veno-occlusive disease Other: IR including anaphylaxis; hemorrhage; embryo-fetal toxicity |
Systemic: Hemorrhage; infection; fever; nausea; vomiting; constipation; headache; increased ALT, AST; mucositis Cutaneous: Rash |
| Ibritumomab tiuxetan (Zevalin®) | CD20 |
Boxed warning: Serious IR; severe cytopenias; severe mucocutaneous and cutaneous reactions Other: MDS and AML; extravasation; immunization |
Systemic: Infections; asthenia; musculoskeletal symptoms; GI; hemorrhage; hypersensitivity Cutaneous: Exfoliative dermatitis; bullous dermatitis; EM; SJS; TEN |
| Inotuzumab ozogamicin (Besponsa®) |
CD22 |
Boxed warning: Hepatotoxicity including hepatic veno-occlusive disease; increased risk of post- transplant non-relapse mortality Other: myelosuppression; embryo- fetal toxicity; QT interval prolongation |
Systemic: IR; cytopenias; nausea; fatigue; hemorrhage; pyrexia; infection; headache; febrile neutropenia; increased transaminases; hyperbilirubinemia |
| Ipilimumab (Yervoy®) |
CTLA-4 |
Boxed warning: Immune-mediated adverse reactions |
Systemic: Diarrhea; fatigue; colitis Cutaneous: Rash; pruritus; dermatitis |
| Isatuximab-irfc (Sarclisa®) |
CD38 | IR; neutropenia; second primary malignancies; indirect antiglobulin test and interference with serum electrophoresis and immunofixation tests |
Systemic: Neutropenia; IR; pneumonia; URTI; diarrhea; anemia; lymphopenia; thrombocytopenia |
| Loncastumab tesirine-lpyl (Zynlonta®) |
CD19 with teserine cytotoxic agent | Effusions (pericardial, pleural, ascites); embryo-fetal toxicity; myelosuppression; infections; cutaneous reactions (including photosensitivity) |
Systemic: Thrombocytopenia; increased gamma-glutamyltransferase; neutropenia; nausea; anemia; hyperglycemia; transaminase elevation; fatigue; hypoalbuminemia; edema; musculoskeletal pain Cutaneous: Rash |
| Margetuximab-cmkb (Margenza®) |
HER2 |
Boxed warning: LVD; embryo-fetal toxicity |
Systemic: Fatigue/asthenia; nausea; diarrhea; vomiting; constipation; IR; headache; pyrexia; alopecia; abdominal pain; peripheral neuropathy; arthralgia/myalgia; cough; decreased appetite; dyspnea; extremity pain Cutaneous: PPE |
| Mogamulizumab-kpkc (Poteligeo®) | CCR4 | Dermatologic toxicity; IR; infections; autoimmune reactions; HSCT complications |
Systemic: IR; diarrhea; fatigue; URTI; musculoskeletal pain Cutaneous: Rash |
| Moxetumomab pasudox- tdfk (Lumoxiti®) |
CD22 |
Boxed warning: CLS; hemolytic uremic syndrome Other: Renal toxicity; electrolyte abnormalities; IR |
Systemic: Edema; nausea; fatigue; headache; pyrexia; constipation; diarrhea; anemia; increased creatinine, ALT, AST; hypophosphatemia; hypocalcemia |
| Naxitamab-gqgk (Danyelza®) |
GD2 |
Boxed warning: Serious IR; neurotoxicity including RPLS |
Systemic: IR; isr; pain; tachycardia; vomiting; cough; nausea; diarrhea; decreased appetite; hypertension; fatigue; peripheral neuropathy; edema; urticaria; pyrexia; headache; anxiety; irritability; decreased lymphocytes; neutrophils, hemoglobin, platelets, K, Ca, Na, glucose, albumin, phosphate; increased alanine aminotransferase Cutaneous: EM |
| Necitumumab (Portrazza®) |
EGFR |
Boxed warning: Cardiopulmonary arrest; hypo-magnesemia Other: Venous, arterial thromboembolic events; dermatologic toxicities; embryo-fetal toxicity; ↑ toxicity, mortality in patients with non- squamous NSCLC; IR |
Systemic: Diarrhea; vomiting Cutaneous: Rash; dermatitis acneiform |
| Nivolumab (OPDIVO®) |
PD-1 | Immune-mediated adverse reactions; embryo-fetal toxicity |
Systemic: Increased ALT, AST, AP; hyponatremia; hyper- and hypokalemia; hyper- and hypocalcemia; lymphopenia; fatigue; asthenia; musculoskeletal and abdominal pain; dyspnea; cough; GI. Cutaneous: Rash; pruritus |
| Obinutuzumab (Gazyva®; Gazyvaro®) | CD20 |
Boxed warning: Hepatitis B virus reactivation; PML. Other: IR; TLS; neutropenia; thrombocytopeia; infections; immunization |
Systemic: Anemia; pyrexia; musculoskeletal disorders; headache; cough |
| Ofatumumab (Arzerra®) | CD20 | IR; Hepatitis B virus reactivation; PML; cytopenias intestinal obstruction; immunization |
Systemic: Infections; pneumonia; neutropenia; pyrexia; dyspnea; cough; diarrhea; URTI; nausea; fatigue; bronchitis Cutaneous: Rash; urticaria; hyperhidrosis. |
| Olaratumab (Lartruvo®) | PDGFR-α | IR; embryo-fetal toxicity |
Systemic: Olaratumab + doxorubicin: fatigue; musculoskeletal pain; diarrhea; decreased appetite; headache; neuropathy; cytopenias; hyperglycemia; elevated aPTT; hypokalemia; hypophosphatemia Cutaneous: Alopecia |
| Panitumumab (Vectibix®) |
EGFR |
Boxed warning: Dermatologic toxicity; IR Other: Increased toxicity with bevacizumab and chemotherapy; pulmonary toxicities; electrolyte depletion; ocular events |
Systemic: Pulmonary events; pulmonary embolism; GI; fatigue; abdominal pain; hypomagnesemia Cutaneous: Rash; dermatitis ‘acneiform’; erythema; exfoliation; paronychia; skin fissures; photosensitivity; xerosis; pruritus |
| Pembrolizumab (Keytruda®) | PD-1 | Immune-mediated adverse reactions; embryo-fetal toxicity |
Systemic: Fatigue; peripheral edema; chills; pyrexia; renal failure; cellulitis; decreased appetite; dyspnea; arthralgia; nausea; diarrhea; cough Cutaneous: Rash; pruritus; vitiligo |
| Pertuzumab (Perjeta®) |
HER2 |
Boxed warning: Cardiomyopathy; embryo-fetal toxicity. Other: IR; hypersensitivity/anaphylaxis |
Systemic: Neutropenias; LVD; peripheral neuropathy; fatigue; GI; asthenia Cutaneous: Rash; paronychia; pruritus; alopecia; PPE (in combination therapy) |
| Polatuzumab vedotin-piiq (Polivy®) | CD79b | Peripheral neuropathy; myelosuppression and related reactions; infections; IR; TLS; PML; hepatotoxicity; embryo-fetal toxicity |
Systemic: Cytopenia; fatigue; decreased appetite; diarrhea; pyrexia; pneumonia |
| Ramucirumab (Cyramza®) |
VEGFR2 |
Boxed warning: Hemorrhage; GI perforation; impaired wound healing. Other: A rterial thromboembolic events; IR; RPLS; hypertension; deterioration in patients with cirrhosis; proteinuria including nephrotic syndrome; thyroid dysfunction; embryo-fetal risk |
Systemic: Hypertension; diarrhea; headache; hytremia; neutropenia; epistaxis; stomatitis; immunogenicity |
| Rituximab (Rituxan®; MabThera®) | CD20 |
Boxed warning: Fatal IRs; TLS; potentially fatal PML and severe mucocutaneous reactions Other: hepatitis B virus reactivation; infections; cardiac arrhythmias; bowel obstruction and perforation |
Systemic: Pulmonary events; renal toxicity; neutropenias; serum sickness; anaphylaxis; fever; lymphopenia; chills; asthenia Cutaneous: Paraneoplastic pemphigus; lichenoid dermatitis; vesicullobullous dermatitis; SJS; TEN |
| Sacituzumab govitecan-hziy (Trodelvy®) |
Trop-2 with topoisomerase inhibitor |
Boxed warning: Severe neutropenia; severe diarrhea Other: Hypersensitivity; nausea/vomiting; risk of neutropenia increased in individuals with reduced uridine diphosphate-glucuronosyl transferase 1A1; embryo-fetal toxicity |
Systemic: Nausea; neutropenia; diarrhea; fatigue; anemia; vomiting; alopecia; constipation; decreased appetite; abdominal pain Cutaneous: Rash |
| Siltuximab (Sylvant®) |
IL-6 | Not for patients with severe infections or live vaccines; IR; cautionary use in patients with GI perforation risk |
Systemic: Hyperuricemia; URTI; increased weight Cutaneous: Rash; pruritus |
| Tafasitamab-cxix (Monjuvi®) |
D19 | IR; myelosuppression; infections; embryo-fetal toxicity |
Systemic: Neutropenia; fatigue; anemia; diarrhea; thrombocytopenia; cough; pyrexia; peripheral edema; URTI; decreased appetite |
| Tisotumab vedotin-tftv (Tivdak®) |
TF with MMAE microtubule inhibitor |
Boxed warning: Ocular toxicity Other: Ocular adverse reactions, e.g., conjunctival reactions, dry eyes, corneal reactions, blepharitis; ulcerative keratitis; peripheral neuropathy; pneumonitis; embryo- fetal toxicity |
Systemic: Most serious: ileus; hemorrhage; pneumonia; sepsis; pyrexia; peripheral neuropathy; constipation. Most common: diarrhea; peripheral neuropathy; conjunctival and corneal reactions; fatigue; alopecia; epistaxis; decreased hemoglobin, lymphocytes, and leukocytes; increased creatinine; dry eye; prothrombin international normalized ratio; aPTT prolonged Cutaneous: Rash |
| Trastuzumab (Herceptin®) |
HER2 |
Boxed warning: Cardiomyopathy; IR; pulmonary toxicity Other: Exacerbation of chemotherapy-induced neutropenia; embryo-fetal toxicity |
Systemic: Neutropenia; anemia; thrombocytopenia; pulmonary events; LVD; GI; chills; fever; URTI; anaphylaxis/angioedema; headache; cough; stomatitis; mucosal inflammation Cutaneous: Rash; nail disorders; pruritus |
AHUS—atypical hemolytic syndrome; ALT—alanine transaminase; AML—acute myelogenous leukemia; AP—alkaline phosphatase; aPTT—activated partial thromboplastin time; AST—aspartate transaminase; BCMA—B cell maturation antigen; BMS—bone marrow suppression; CHF—congestive heart failure; CLS—capillary leak syndrome; c-MET—mesenchymal-epithelial transition factor, a tyrosine kinase receptor; CNS—central nervous system; CRS—cytokine release syndrome; CTLA-4—cytotoxic T lymphocyte-associated antigen 4; DLBCL—diffuse large B cell lymphoma; EGFR—epidermal growth factor receptor (HER1, ErbB-1); EM—erythema multiforme; EpCAM—epithelial cell adhesion molecule; GD2—disialoganglioside expressed on tumors of neuroectodermal origin; GGT—gamma-glutamyl transferase; GI—gastrointestine/gastrointestinal symptoms, e.g., nausea, diarrhea, vomiting, constipation; GM-CSF—granulocyte-macrophage colony-stimulating factor; HAMA—human antimouse antibody; HARA—human antirat antibody; HER2—human epidermal growth factor 2, also known as Neu, ErbB2, CD340, or p185; HLH—hemophagocytic lymphohistiocytosis; IR—infusion reactions; isr—injection site reaction; ILD—interstitial lung disease; LBCL—large B cell lymphoma; LVD—left ventricular dysfunction; MMAE—monomethyl auristatin E; MMAF—monomethyl auristatin F; MDS—myelodysplastic syndrome; mTNBC—metastatic triple-negative breast cancer; ONJ—osteonecrosis of the jaw; PD-1—programmed cell death protein 1; PD-L1; PDGFRA—platelet-derived growth factor receptor A; PML—progressive multifocal leucoencephalopathy; PPE—palmar plantar erythrodysaesthesia; RANKL—receptor activator of nuclear factor kappa-B ligand (CD254); RPLS—reversible posterior leukoencephalopathy syndrome; SIRS—systemic inflammatory response syndrome; SJS—Stevens–Johnson syndrome; TEN—toxic epidermal necrolysis; teserine—also known as SG3249, a pyrrolobenzodiazepine dimer; TF—tissue factor, platelet tissue factor, factor III, CD142; TLS—tumor lysis syndrome; Trop-2—trophoblast cell surface antigen-2; URTI—upper respiratory tract infection; VEGF—vascular endothelial growth factor; VEGFR-2—vascular endothelial growth factor receptor 2. 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 warnings and precautions in column 3. ↑ increase.