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adverse reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Cardiac Toxicities [see Warnings and Precautions (5.1) ] Acute Renal Failure [see Warnings and Precautions (5.2) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.3) ] Pulmonary Toxicity [see Warnings and Precautions (5.4) ] Pulmonary Hypertension [see Warnings and Precautions (5.5) ] Dyspnea [see Warnings and Precautions (5.6) ] Hypertension [see Warnings and Precautions (5.7) ] Venous Thrombosis [see Warnings and Precautions (5.8) ] Infusion-Related Reactions [see Warnings and Precautions (5.9) ] Hemorrhage [see Warnings and Precautions (5.10) ] Thrombocytopenia [see Warnings and Precautions (5.11) ] Hepatic Toxicity and Hepatic Failure [see Warnings and Precautions (5.12) ] Thrombotic Microangiopathy [see Warnings and Precautions (5.13) ] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.14) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.15) ] The most common adverse reactions occurring in at least 20% of patients treated with Kyprolis in monotherapy trials: anemia, fatigue, thrombocytopenia, nausea, pyrexia, dyspnea, diarrhea, headache, cough, edema peripheral. ( 6 ) The most common adverse reactions occurring in at least 20% of patients treated with Kyprolis in the combination therapy trials: anemia, diarrhea, hypertension, fatigue, upper respiratory tract infection, thrombocytopenia, pyrexia, cough, dyspnea, and insomnia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The pooled safety population described in the Warnings and Precautions reflect exposure to Kyprolis in 2,239 patients administered in combination with other drugs in ASPIRE, ENDEAVOR, A.R.R.O.W., CANDOR, IKEMA, EQUULEUS, and PLEIADES. The most common adverse reactions occurring in at least 20% of patients who received Kyprolis in combination were anemia, diarrhea, hypertension, fatigue, upper respirato...
adverse reactions table
Table 8: Adverse Reactions (≥ 10%) Occurring in Cycles 1–12 in Patients Who Received KRd (20/27 mg/m2 Regimen) in ASPIREAdverse ReactionsKRd (N = 392) n (%)Rd (N = 389) n (%)Any Grade≥ Grade 3Any Grade≥ Grade 3KRd = Kyprolis, lenalidomide, and dexamethasone; Rd = lenalidomide and dexamethasoneBlood and Lymphatic System Disorders Anemia138 (35)53 (14)127 (33)47 (12) Neutropenia124 (32)104 (27)115 (30)89 (23) Thrombocytopenia100 (26)58 (15)75 (19)39 (10)Gastrointestinal Disorders Diarrhea119 (30)8 (2)106 (27)12 (3) Constipation68 (17)0 (0)55 (14)1 (0) Nausea63 (16)1 (0)43 (11)3 (1)General Disorders and Administration Site Conditions Fatigue113 (29)23 (6)107 (28)20 (5) Pyrexia93 (24)5 (1)64 (17)1 (0) Edema peripheral59 (15)3 (1)48 (12)2 (1) Asthenia54 (14)11 (3)49 (13)7 (2)Infections Upper respiratory tract infection87 (22)7 (2)54 (14)4 (1) Bronchitis55 (14)5 (1)40 (10)2 (1) Viral upper respiratory tract infection55 (14)0 (0)44 (11)0 (0) PneumoniaPneumonia includes pneumonia and bronchopneumonia.54 (14)35 (9)43 (11)27 (7)Metabolism and Nutrition Disorders Hypokalemia78 (20)22 (6)35 (9)12 (3) Hypocalcemia55 (14)10 (3)39 (10)5 (1) Hyperglycemia43 (11)18 (5)33 (9)15 (4)Musculoskeletal and Connective Tissue Disorders Muscle spasms92 (24)3 (1)75 (19)3 (1) Back pain41 (11)4 (1)54 (14)6 (2)Nervous System Disorders Peripheral neuropathiesPeripheral neuropathies includes peripheral neuropathy, peripheral sensory neuropathy, and peripheral motor neuropathy.43 (11)7 (2)39 (10)4 (1)Psychiatric Disorders Insomnia64 (16)6 (2)51 (13)8 (2)Respiratory, Thoracic and Mediastinal Disorders CoughCough includes cough and productive cough.93 (24)2 (1)54 (14)0 (0) DyspneaDyspnea includes dyspnea and dyspnea exertional.71 (18)8 (2)61 (16)6 (2)Skin and Subcutaneous Tissue Disorders Rash45 (12)5 (1)54 (14)5 (1)Vascular Disorders Embolic and thrombotic eventsEmbolic and thrombotic events, venous includes deep vein thrombosis, pulmonary embolism, thrombophlebitis superficial, thrombophlebitis, venous thrombosis limb, post thrombotic syndrome, venous thrombosis.49 (13)16 (4)23 (6)9 (2) HypertensionHypertension includes hypertension, hypertensive crisis.41 (11)12 (3)15 (4)4 (1)