Daily. Med - AVASTIN- bevacizumab injection, solution. The following serious adverse reactions are discussed in greater detail in other sections of the label: The most common adverse reactions observed in Avastin patients at a rate > 1. Some of the adverse reactions are commonly seen with chemotherapy; however, Avastin may exacerbate these reactions when combined with chemotherapeutic agents. Examples include palmar- plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine peripheral sensory neuropathy with paclitaxel or oxaliplatin, and nail disorders or alopecia with paclitaxel. Across all studies, Avastin was discontinued in 8. Clinical Trial 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. The data below reflect exposure to Avastin in 4. CRC, non- squamous NSCLC, glioblastoma, m. RCC, or cervical cancer or platinum- resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer including controlled (Studies 1, 2, 4, 5, 8 9 and 1. Study 6) treated at the recommended dose and schedule for a median of 6 to 2. Avastin. The population included 2. CRC patients who received a median of 1. Avastin, 4. 80 first- line metastatic NSCLC patients who received a median of 8 doses of Avastin, 1. Avastin, 3. 37 m. RCC patients who received a median of 1. Bevacizumab Package Insert Pdf In ExcelBevacizumab is FDA approved in metastatic. Cardiotoxicity in Patients Treated With Bevacizumab Is. Avastin, 2. 18 cervical cancer patients who received a median of 6 doses of Avastin and 1. Avastin. These data also reflect exposure to Avastin in 3. MBC) who received a median of 9. Avastin, 1. 33. 8 adjuvant CRC patients, including 6. Avastin, and 4. 03 previously untreated patients with diffuse large B- cell lymphoma (DLBCL) who received a median of 8 doses of Avastin. Avastin is not approved for use in MBC, adjuvant CRC, or DLBCL. Surgery and Wound Healing Complications. The incidence of post- operative wound healing and/or bleeding complications was increased in patients with m. CRC receiving Avastin as compared to patients receiving only chemotherapy. Among patients requiring surgery on or within 6. IFL plus Avastin as compared to 4% (1/2. Avastin 12/12/14 Page 3 Adapted from the Avastin (bevacizumab) package insert. Genentech Oncology, November 2014 KCA disclaimer statement: you should rely primarily upon your doctor for medical information. IFL alone. In Study 6, events of post- operative wound healing complications (craniotomy site wound dehiscence and cerebrospinal fluid leak) occurred in patients with previously treated glioblastoma: 3/8. Avastin alone arm and 1/7. Avastin plus irinotecan arm. CRC receiving bolus- IFL plus Avastin compared with patients receiving bolus- IFL plus placebo. All but one of these events were Grade 1 in severity and resolved without medical intervention. Grade 1 or 2 hemorrhagic events were more frequent in patients receiving bolus- IFL plus Avastin when compared to those receiving bolus- IFL plus placebo and included gastrointestinal hemorrhage (2. In Study 1, more patients in the Avastin containing arm experienced deep venous thrombosis (3. The risk of developing a second thromboembolic event while on Avastin and oral anticoagulants was evaluated in two randomized studies. In Study 1, 5. 3 patients (1. IFL plus Avastin arm and 3.
IFL plus placebo arm received full dose warfarin following a venous thromboembolic event (VTE). Among these patients, an additional thromboembolic event occurred in 2. IFL plus Avastin and 3% (1/3. IFL alone. In a second, randomized, 4- arm study in 1. CRC, prospectively evaluating the incidence of VTE (all grades), the overall incidence of first VTE was higher in the Avastin containing arms (1. Among the 1. 16 patients treated with anticoagulants following an initial VTE event (7. Avastin plus chemotherapy arms and 4. VTEs was also higher among the Avastin treated patients (3. In this subgroup of patients treated with anticoagulants, the overall incidence of bleeding, the majority of which were Grade 1, was higher in the Avastin treated arms than the chemotherapy arms (2. From a clinical trial in patients with persistent, recurrent, or metastatic cervical cancer (Study 9), Grade 3 or 4 VTE have been reported in 1. Avastin compared with 5. There were no patients with Grade 5 VTE. In Study 1, the incidence of Grade 3 or 4 neutropenia was increased in m. CRC patients receiving IFL plus Avastin (2. IFL alone (1. 4%). In Study 5, the incidence of Grade 4 neutropenia was increased in NSCLC patients receiving paclitaxel/carboplatin (PC) plus Avastin (2. PC alone (1. 7. 2%). Febrile neutropenia was also increased (5. PC plus Avastin vs. There were 1. 9 (4. Grade 3 or 4 neutropenia in the PC plus Avastin arm of which 3 were fatal compared to 9 (2%) neutropenic infections in patients receiving PC alone, of which none were fatal. During the first 6 cycles of treatment, the incidence of serious infections including pneumonia, febrile neutropenia, catheter infections and wound infections was increased in the PC plus Avastin arm . The incidence of any grade of infection in patients receiving Avastin alone was 5. Grade 3. The overall incidence of proteinuria (all grades) was only adequately assessed in Study 8, in which the incidence was 2. Median onset of proteinuria was 5. Avastin. Median time to resolution was 6. CI 2. 8 months, 1. Proteinuria did not resolve in 4. Avastin in 3. 0% of the patients who developed proteinuria (Study 8). In an exploratory, pooled analysis of 8,2. Avastin in combination with chemotherapy experienced Grade . Avastin was re- initiated in 4. Of the 1. 13 patients who re- initiated Avastin, 4. Grade . Creatinine levels did not return to baseline in approximately one- third of patients who received Avastin. Congestive Heart Failure (CHF)The incidence of Grade . In patients with metastatic breast cancer (MBC), an indication for which Avastin is not approved, the incidence of Grade 3. Among patients receiving prior anthracyclines for MBC, the rate of CHF was 3. Avastin as compared to 0. The safety of continuation or resumption of Avastin in patients with cardiac dysfunction has not been studied. In previously untreated patients with diffuse large B- cell lymphoma (DLBCL), an indication for which Avastin is not approved, the incidence of CHF and decline in left- ventricular ejection fraction (LVEF) were significantly increased in the Avastin plus R- CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) arm (n=4. R- CHOP arm (n=3. At the completion of R- CHOP therapy, the incidence of CHF was 1. Avastin plus R- CHOP arm compared to 5. R- CHOP alone arm . The incidence of a LVEF event, defined as a decline from baseline of 2. LVEF or a decline from baseline of 1. LVEF value of less than 5. Avastin plus R- CHOP arm (1. R- CHOP alone arm (5. Time to onset of left- ventricular dysfunction or CHF was 1- 6 months after initiation of therapy in at least 8. CHF in the Avastin arm compared to 8. Ovarian Failure. The incidence of new cases of ovarian failure (defined as amenorrhoea lasting 3 or more months, FSH level . New cases of ovarian failure were identified in 3. Avastin in combination with chemotherapy compared with 2% (2/8. After discontinuation of Avastin treatment, recovery of ovarian function at all time points during the post- treatment period was demonstrated in 2. Avastin- treated women. Recovery of ovarian function is defined as resumption of menses, a positive serum . Long term effects of Avastin exposure on fertility are unknown. Post- treatment vascular events included arterial and venous thromboembolic events, ischemic events, and vascular aneurysms. Metastatic Colorectal Cancer (m. CRC) The data in Table 1 and Table 2 were obtained in Study 1, a randomized, double- blind, controlled trial comparing chemotherapy plus Avastin with chemotherapy plus placebo. Avastin was administered at 5 mg/kg every 2 weeks. Severe and life- threatening (Grade 3. The most frequent adverse events (selected Grade 3. These data are likely to under- estimate the true adverse event rates due to the reporting mechanisms used in Study 2. Avastin in Combination with Fluoropyrimidine- Irinotecan or Fluoropyrimidine- Oxaliplatin Based Chemotherapy in Second- line m. CRC Patients who have Progressed on an Avastin Containing Regimen in First- line m. CRC: No new safety signals were observed in Study 4 when Avastin was administered in second line m. CRC patients who progressed on an Avastin containing regimen in first line m. CRC. The safety data was consistent with the known safety profile established in first and second line m. CRC. Unresectable Non- Squamous Non- Small Cell Lung Cancer (NSCLC)Only Grade 3- 5 non- hematologic and Grade 4- 5 hematologic adverse events were collected in Study 5. Grade 3 or 4 neutropenia (4% vs. Glioblastoma. All adverse events were collected in 1. Study 6 who either received Avastin alone or Avastin plus irinotecan. All patients received prior radiotherapy and temozolomide. Avastin was administered at 1. Avastin was discontinued due to adverse events in 4. Avastin alone. In patients receiving Avastin alone (N = 8. Of these, the incidence of Grade . Two deaths on study were possibly related to Avastin: one retroperitoneal hemorrhage and one neutropenic infection. In patients receiving Avastin alone or Avastin plus irinotecan (N = 1. Avastin- related adverse events (Grade 1. The incidence of Grade 3. Grade 1. 1 patient); rhinitis (9 vs. Persistent, Recurrent, or Metastatic Carcinoma of the Cervix. All grade adverse reactions were collected in Study 9. Grade 1- 4 adverse reactions occurring where the incidence difference is . There were no Grade 5 adverse reactions occurring at a higher incidence ( . There were no Grade 5 events occurring at a higher incidence ( . Among these 1. 4 patients, three tested positive for neutralizing antibodies against bevacizumab using an enzyme- linked immunosorbent assay (ELISA). The clinical significance of these anti- product antibody responses to bevacizumab is unknown.
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