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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1) ] Neutropenia [see Warnings and Precautions (5.2) ] Left Ventricular Dysfunction [see Warnings and Precautions (5.3) ] The most common adverse reactions (≥20%), including laboratory abnormalities, in patients with: HER2-Positive, HER2-Low, and HER2-Ultralow Breast Cancer, HER2-Mutant NSCLC, and HER2-Positive (including IHC 3+) Solid Tumors are decreased white blood cell count, nausea, decreased hemoglobin, decreased neutrophil count, decreased lymphocyte count, fatigue, decreased platelet count, increased aspartate aminotransferase, increased alanine aminotransferase, increased blood alkaline phosphatase, vomiting, alopecia, constipation, decreased blood potassium, decreased appetite, diarrhea, and musculoskeletal pain. ( 6.1 ) HER2-Positive Early Breast Cancer are decreased hemoglobin, increased alanine aminotransferase, increased aspartate aminotransferase, decreased white blood cell count, nausea, peripheral neuropathy, diarrhea, decreased neutrophil count, alopecia, fatigue, decreased lymphocyte count, rash, musculoskeletal pain, decreased blood potassium, constipation, vomiting, stomatitis, and decreased appetite. ( 6.1 ) HER2-Positive Metastatic Breast Cancer in Combination with Pertuzumab are decreased white blood cell count, decreased hemoglobin, decreased neutrophil count, nausea, increased alanine aminotransferase, diarrhea, increased aspartate aminotransferase, decreased lymphocyte count, decreased platelet count, increased blood alkaline phosphatase, decreased blood potassium, fatigue, alopecia, vomiting, upper respiratory tract infection, constipation, decreased appetite, decreased weight, COVID-19, musculoskeletal pain, increased blood bilirubin, and abdominal pain. ( 6.1 ) HER2-Positive Gastric Cancer are decreased hemoglobin, decreased white blood cell count, decreased neutrophil count, decreased lymphocyte count, decreased platelet count, nausea, decreased appetite, increased aspartate aminotransferase, fatigue, increased blood alkaline phosphatase, increased alanine aminotransferase, diarrhea, decreased blood potassium, vomiting, constipation, increased blood bilirubin, pyrexia, and alopecia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Daii...
adverse reactions table
Table 4: Common Adverse Reactions (≥10% All Grades or ≥2% Grades 3 or 4) Patients in DESTINY-Breast11Adverse ReactionsENHERTU 5.4 mg/kg followed by THP N = 320ddAC followed by THP N = 312All Grades %Grade 3 or 4 %All Grades %Grade 3 or 4 %THP= paclitaxel, trastuzumab, and pertuzumab; ddAC=dose dense doxorubicin and cyclophosphamide; Events were graded using NCI CTCAE version 5.0.Gastrointestinal DisordersNausea651.9520.3Diarrhea596543.2Constipation290.3240Vomiting290.9210.6Stomatitis Including aphthous ulcer, cheilitis, glossitis, mouth ulceration, mucosal inflammation, and stomatitis.230.3361.0Abdominal painIncluding abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, and gastrointestinal pain.160120Nervous System DisordersPeripheral neuropathyIncluding dysesthesia, hypoesthesia, neuropathy peripheral, paresthesia, peripheral motor neuropathy, peripheral sensory neuropathy, and polyneuropathy.592.5472.2HeadacheIncluding headache, migraine, and sinus headache. 180160Skin and Subcutaneous Tissue DisordersAlopecia480490RashIncluding dermatitis, dermatitis acneiform, dermatitis bullous, eczema, palmar-plantar erythrodysesthesia syndrome, rash, rash erythematous, rash macular, rash maculo-papular, rash papular, rash pruritic, rash pustular, skin exfoliation, and urticarial dermatitis.310.9251.0General Disorders and Administration Site ConditionsFatigueIncluding asthenia, fatigue, and malaise.410.6552.2Musculoskeletal and Connective Tissue DisordersMusculoskeletal painIncluding arthralgia, back pain, bone pain, muscle spasms, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, and pain in extremity.300280.3Metabolism and Nutrition DisordersDecreased appetite200180.3Respiratory, Thoracic and Mediastinal DisordersEpistaxis150100Cough100140Infections and InfestationsUpper respiratory tract infectionIncluding influenza, influenza-like illness, laryngitis, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection.130.6200.3COVID-19100.9110.3