Side Effects, Interactions, Warning, Dosage Uses. Sail Simulator 5 Full Version. SIDE EFFECTSThe following adverse reactions are discussed in greater detail in other sections of the label The most common adverse reactions in patients receiving Herceptin in the adjuvant and metastatic breast cancer setting are fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia. Adverse reactions requiring interruption or discontinuation of Herceptin treatment include CHF, significant decline in left ventricular cardiac function, severe infusion reactions, and pulmonary toxicity see DOSAGE AND ADMINISTRATION. In the metastatic gastric cancer setting, the most common adverse reactions 1. Herceptin arm as compared to the chemotherapy alone arm were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia. US Military Abbreviations, Acronyms, Terms and Organizations, US Military Ranks. Serial Vs Parallel Dilution' title='Serial Vs Parallel Dilution' />The most common adverse reactions which resulted in discontinuation of treatment on the Herceptin containing arm in the absence of disease progression were infection, diarrhea, and febrile neutropenia. 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adjuvant Breast Cancer Studies. The data below reflect exposure to one year Herceptin therapy across three randomized,open label studies, Studies 1, 2, and 3, with n 3. The data summarized in Table 3 below, from Study 3, reflect exposure to Herceptin in 1. Among the 3. 38. 6 patients enrolled in the observation and one year Herceptin arms of Study 3 at a median duration of follow up of 1. Titration, also known as titrimetry, is a common laboratory method of quantitative chemical analysis that is used to determine the unknown concentration of an. Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Easily share your publications and get. Herceptin arm, the median age was 4. Caucasian, and 1. Asian. Table 3 Adverse Reactions for Study 3a, All Gradesb. Adverse Reaction. One Year Herceptinn 1. Observationn 1. Cardiac. Hypertension. Dizziness. Ejection Fraction Decreased. Palpitations. 48 31. Cardiac Arrhythmiasc. Cardiac Failure Congestive. Cardiac Failure. 9 0. Cardiac Disorder. Ventricular Dysfunction. Respiratory Thoracic Mediastinal Disorders. Cough. 81 53. 4 2Influenza. Dyspnea. 57 32. URI4. Rhinitis. Pharyngolaryngeal Pain. Sinusitis. 26 25 0. Epistaxis. 25 21 0. Pulmonary Hypertension. Interstitial Pneumonitis. Gastrointestinal Disorders. Diarrhea. 12. 3 71. Nausea. 10. 8 61. Vomiting. 58 3. 51. Constipation. 33 21. Dyspepsia. 30 29 0. Upper Abdominal Pain. Musculoskeletal Connective Tissue Disorders. Arthralgia. 13. 7 89. Back Pain. 91 55. Myalgia. 63 41. Bone Pain. Muscle Spasm. 46 33 0. Nervous System Disorders. Headache. 16. 2 1. Paraesthesia. 29 21. Skin Subcutaneous Tissue Disorders. Rash. 70 41. 0 0. Nail Disorders. 43 20 0Pruritus. General Disorders. Pyrexia. 10. 0 66 0. Edema Peripheral. Chills. 85 50 0Asthenia. Influenza like Illness. Sudden Death. 1 0. Infections. Nasopharyngitis. UTI3. 9 31. 3 0. Immune System Disorders. Hypersensitivity. Autoimmune Thyroiditis. Median follow up duration of 1. Herceptin treatment arm. The incidence of Grade 3 or higher adverse reactions was lt 1 in both arms for each listed term. Higher level grouping term. In Study 3, a comparison of 3 weekly Herceptin treatment for two years versus one year was also performed. The rate of asymptomatic cardiac dysfunction was increased in the 2 year Herceptin treatment arm 8. Herceptin treatment arm. More patients experienced at least one adverse reaction of Grade 3 or higher in the 2 year Herceptin treatment arm 3. Herceptin treatment arm 1. The safety data from Studies 1 and 2 were obtained from 3. Herceptin the median treatment duration was 5. Milton Nascimento 320 on this page. The median age was 4. White, 7 Black, 4 Hispanic, and 3 Asian. In Study 1, only Grade 35 adverse events, treatment related Grade 2 events, and Grade 25 dyspnea were collected during and for up to 3 months following protocol specified treatment. The following non cardiac adverse reactions of Grade 25 occurred at an incidence of at least 2 greater among patients receiving Herceptin plus chemotherapy as compared to chemotherapy alone fatigue2. The majority of these events were Grade 2 in severity. In Study 2, data collection was limited to the following investigator attributed treatment related adverse reactions NCI CTC Grade 4 and 5 hematologic toxicities, Grade 35 non hematologic toxicities, selected Grade 25 toxicities associated with taxanes myalgia, arthralgias, nail changes, motor neuropathy, and sensory neuropathy and Grade 15 cardiac toxicities occurring during chemotherapy andor Herceptin treatment. The following non cardiac adverse reactions of Grade 25 occurred at an incidence of at least 2 greater among patients receiving Herceptin plus chemotherapy as compared to chemotherapy alone arthralgia 1. The majority of these events were Grade 2 in severity. Safety data from Study 4 reflect exposure to Herceptin as part of an adjuvant treatment regimen from 2. AC TH n 1. 06. TCH n 1. The overall median treatment duration was 5. AC TH and TCH arms. The median number of infusions was 2. AC TH arm and 3. TCH arm, including weekly infusions during the chemotherapy phase and every three week dosing in the monotherapy period. Among these patients, the median age was 4. In Study 4, the toxicity profile was similar to that reported in Studies 1, 2, and 3 with the exception of a low 3. CHF in the TCH arm. Metastatic Breast Cancer Studies. The data below reflect exposure to Herceptin in one randomized, open label study, Study 5, of 3. Study 6 n 2. 22 in patients with metastatic breast cancer. Data in Table 4 are based on Studies 5 and 6. Among the 4. 64 patients treated in Study 5, the median age was 5. Eighty nine percent were White, 5 Black, 1 Asian, and 5 other racialethnic groups. All patients received 4 mgkg initial dose of Herceptin followed by 2 mgkg weekly. The percentages of patients who received Herceptin treatment for 6 months and 1. Among the 3. 52 patients treated in single agent studies 2. Study 6, the median age was 5. White, 3 were Black, 3 were Asian, and 8 in other racialethnic groups. Most of the patients received 4 mgkg initial dose of Herceptin followed by 2 mgkg weekly. The percentages of patients who received Herceptin treatment for 6 months 3. Table 4 Per Patient Incidence of Adverse Reactions Occurring in 5 of Patients in Uncontrolled Studies or at Increased Incidence in the Herceptin Arm Studies 5 and 6 Single Agentan 3. Herceptin Paclitaxeln 9. Paclitaxel Alonen 9. Herceptin ACbn 1. ACb Alonen 1. 35. Body as a Whole  Pain. Asthenia. 426. 25. Fever. 364. 92. Chills. Headache. 263. 62. Abdominal pain. 223. Back pain. 223. 43. Infection. 204. 72. Flu syndrome. 101. Accidental injury. Allergic reaction. Cardiovascular  Tachycardia. Congestive heart failure. Digestive  Nausea. Diarrhea. 254. 52. Vomiting. 233. 72. Nausea and vomiting. Anorexia. 142. 41. Heme Lymphatic  Anemia. Leukopenia. 32. 41. Metabolic  Peripheral edema. Edema. 81. 081. Musculoskeletal  Bone pain. Arthralgia. 63. 72. Nervous  Insomnia. Dizziness. 132. 22. Paresthesia. 94. Depression. Peripheral neuritis. Neuropathy. 11. 3544Respiratory  Cough increased. Dyspnea. 222. 72.