WARNINGS
GASTROINTESTINAL PERFORATIONS
AVASTIN administration can result in the development of gastrointestinal perforation, in some instances resulting in fatality. Gastrointestinal perforation, sometimes associated with intra‑abdominal abscess, occurred throughout treatment with AVASTIN (i.e., was not correlated to duration of exposure). The incidence of gastrointestinal perforation (gastrointestinal perforation, fistula formation, and/or intra‑abdominal abscess) in patients with colorectal cancer and in patients with non‑small cell lung cancer (NSCLC) receiving AVASTIN was 2.4% and 0.9%, respectively. The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting. Gastrointestinal perforation should be included in the differential diagnosis of patients presenting with abdominal pain on AVASTIN. AVASTIN therapy should be permanently discontinued in patients with gastrointestinal perforation. (See WARNINGS: Gastrointestinal Perforations and DOSAGE AND ADMINISTRATION: Dose Modifications.)
WOUND HEALING COMPLICATIONS
AVASTIN administration can result in the development of wound dehiscence, in some instances resulting in fatality. AVASTIN therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention. The appropriate interval between termination of AVASTIN and subsequent elective surgery required to avoid the risks of impaired wound healing⁄wound dehiscence has not been determined. (See WARNINGS: Wound Healing Complications and DOSAGE AND ADMINISTRATION: Dose Modifications.)
Hemorrhage
Fatal pulmonary hemorrhage can occur in patients with NSCLC treated with chemotherapy and AVASTIN. The incidence of severe or fatal hemoptysis was 31% in patients with squamous histology and 2.3% in patients with NSCLC excluding predominant squamous histology. Patients with recent hemoptysis (≥1⁄2 tsp of red blood) should not receive AVASTIN. (See WARNINGS: Hemorrhage, ADVERSE REACTIONS: Hemorrhage, and DOSAGE AND ADMINISTRATION: Dose Modifications.)
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AVASTIN SUMMARY
AVASTIN® (Bevacizumab) is a recombinant humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF) in in vitro and in vivo assay systems. Bevacizumab contains human framework regions and the complementarity‑determining regions of a murine antibody that binds to VEGF (1).
AVASTIN®, in combination with intravenous 5‑fluorouracil‑based chemotherapy, is indicated for first- or second‑line treatment of patients with metastatic carcinoma of the colon or rectum.
AVASTIN®, in combination with carboplatin and paclitaxel, is indicated for first‑line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer.
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NEWS HIGHLIGHTS
Published Studies Related to Avastin (Bevacizumab)
Randomized phase III trial of gemcitabine plus docetaxel plus bevacizumab or
placebo as first-line treatment for metastatic uterine leiomyosarcoma: an NRG
Oncology/Gynecologic Oncology Group study. [2015] progression-free survival (PFS) in uLMS... CONCLUSION: The addition of bevacizumab to gemcitabine-docetaxel for first-line
Bevacizumab plus capecitabine and cisplatin in Chinese patients with inoperable
locally advanced or metastatic gastric or gastroesophageal junction cancer:
randomized, double-blind, phase III study (AVATAR study). [2015] cancer... CONCLUSIONS: Addition of bevacizumab to capecitabine-cisplatin in Chinese
A randomized trial of bevacizumab for newly diagnosed glioblastoma. [2014] patients with newly diagnosed glioblastoma is not known... CONCLUSIONS: First-line use of bevacizumab did not improve overall survival in
Can bevacizumab prolong survival for glioblastoma patients through multiple lines
of therapy? [2014] Glioblastoma has a poor prognosis accompanied by debilitating neurological
symptoms and impaired quality of life... The bevacizumab
mechanism of action suggests a rationale for continuing bevacizumab treatment
through multiple lines of therapy, strengthened by longer progression-free and
overall survival observed with bevacizumab continuation beyond progression in a
Phase III study in metastatic colorectal cancer and in pooled analyses of Phase
II trials in glioblastoma.
TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for
first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2
trial. [2013] specifically activates death receptor 5 (DR5)... CONCLUSIONS: Conatumumab with mFOLFOX6/bev did not offer improved efficacy over
Clinical Trials Related to Avastin (Bevacizumab)
A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin) [Completed]
This study will provide preliminary data on the dose and dose interval related effects of
intravitreally administered Avastin on retinal thickness and visual acuity in subjects with
Diabetic Macular Edema (DME) to aid in planning a phase 3 trial.
In addition, this study will provide preliminary data on the safety of intravitreally
administered Avastin in subjects with DME.
Safety Study Of Avastin And Pelvic Radiation In Women With Recurrent Gynecological Cancers [Completed]
This research study is evaluating a drug called avastin in combination with standard
radiation as a possible treatment for treatment for recurrent pelvic-confined gynecological
cancer (i. e. endometrial, cervical, vulvar, ovarian or vaginal cancers).
Safety/Biomarker Study of CNTO 95 and Avastin in Solid Tumors [Completed]
The purpose of this research study is to find out what side effects the combination of the
two study drugs, bevacizumab (Avastin) and CNTO 95 have on the body and to determine the
highest dose of CNTO 95 that can be given with bevacizumab that is safe and well tolerated.
Dose-Escalation Study of TPI 287 + Avastin Followed by Randomized Study of the Same Versus Avastin for Glioblastoma [Recruiting]
This trial is divided into two parts, a dose-escalation study (phase 1) and a randomized
study (phase 2).
The purpose of the dose-escalation study (phase 1) is to determine the safety, maximum
tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in
subjects who have glioblastoma multiforme (GBM) that has progressed following prior
radiation therapy and temozolomide (TMZ).
The purpose of the randomized study (phase 2) is to determine the safety and efficacy of the
phase 1 MTD of TPI 287 in combination with bevacizumab versus bevacizumab alone in subjects
who have GBM that has progressed following prior radiation therapy and TMZ.
Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer [Active, not recruiting]
The purpose of this study is to evaluate the tolerability of intraperitoneal cisplatin with
intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete
6 cycles of treatment.
Reports of Suspected Avastin (Bevacizumab) Side Effects
Death (741),
Disease Progression (373),
Diarrhoea (250),
Nausea (230),
Hypertension (209),
Vomiting (207),
Fatigue (156),
General Physical Health Deterioration (149),
Anaemia (139),
Decreased Appetite (132), more >>
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Page last updated: 2015-08-10
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