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Avastin (Bevacizumab) - Summary

 
 



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.)

 

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.


See all Avastin indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Avastin (Bevacizumab)

Regeneron's Eylea Works Better vs Avastin and Lucentis in Study
Source: Medscape Ophthalmology Headlines [2014.10.20]
Regeneron Pharmaceuticals said its drug Eylea (aflibercept) for diabetic macular edema produced significantly greater improvement in visual acuity from baseline to 52 weeks compared with Genentech's Avastin (bevacizumab) and Lucentis (ranibizumab).
Reuters Health Information

Avastin Approved for Late-Stage Cervical Cancer
Source: MedicineNet Cervical Cancer Specialty [2014.08.18]
Title: Avastin Approved for Late-Stage Cervical Cancer
Category: Health News
Created: 8/15/2014 12:35:00 PM
Last Editorial Review: 8/18/2014 12:00:00 AM

Avastin May Help Fight Early Breast Cancer
Source: MedicineNet capecitabine Specialty [2012.01.26]
Title: Avastin May Help Fight Early Breast Cancer
Category: Health News
Created: 1/26/2012 11:00:00 AM
Last Editorial Review: 1/26/2012 12:00:00 AM

more news >>

Published Studies Related to Avastin (Bevacizumab)

Cediranib with mFOLFOX6 versus bevacizumab with mFOLFOX6 as first-line treatment for patients with advanced colorectal cancer: a double-blind, randomized phase III study (HORIZON III). [2012]
treatment for advanced metastatic colorectal cancer (mCRC)... CONCLUSION: Cediranib activity, in terms of PFS and OS, was comparable to that of

Effect of the Honan intraocular pressure reducer to prevent vitreous reflux after intravitreal bevacizumab injection. [2012]
on vitreous reflux during intravitreal (IVT) injection... CONCLUSIONS: The HIPR prevents vitreous reflux after IVT through a reduction in

A double-blind, randomized, placebo-controlled, phase 2 study of maintenance enzastaurin with 5-fluorouracil/leucovorin plus bevacizumab after first-line therapy for metastatic colorectal cancer. [2012]
maintenance therapy for metastatic colorectal cancer (MCRC)... CONCLUSIONS: Enzastaurin combined with bevacizumab-based therapy is tolerable,

BEAM: a randomized phase II study evaluating the activity of bevacizumab in combination with carboplatin plus paclitaxel in patients with previously untreated advanced melanoma. [2012]
metastatic melanoma... CONCLUSION: The study did not meet the primary objective of statistically

Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium: A Pilot Study. [2011.11.10]
PURPOSE:: To investigate the efficacy and safety of subconjunctival bevacizumab injection for the treatment of impending recurrent pterygium... CONCLUSIONS:: A single subconjunctival bevacizumab injection seems to only partially and transiently decrease conjunctival vascularization in impending recurrent pterygium in a dose-dependent manner. This treatment does not cause regression or reduce the recurrent rate of impending recurrent pterygium.

more studies >>

Clinical Trials Related to Avastin (Bevacizumab)

MAAM Study: Avastin and Macugen Versus Avastin Versus Macugen [Recruiting]
The first results of Anti Vascular Endothelial Growth Factor (VEGF) therapy were very promising and superior to established therapies. Three different substances all of them applied intravitreally are available, but comparative studies have not yet been conducted. In this pilot study the safety (number of adverse events)and efficacy (distance acuity testing retinal thickness measurement)of Avastin and Macugen applied as monotherapy should be compared to a combined treatment of Avastin followed by macugen used for retreatment.

At least equal results of the combined therapy are expected.

A Phase 2 Evaluation of Anti-VEGF Therapy for Diabetic Macular Edema: Bevacizumab (Avastin) [Active, not recruiting]
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.

Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma [Active, not recruiting]
The purpose of this study is to determine whether the combination of the investigational drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously been treated with chemotherapy.

A Study Evaluating Tarceva in Combination With Avastin Versus Avastin Alone in Treating Metastatic Renal Cell Carcinoma [Completed]
The primary purpose of the study is to assess the potential benefit of combining two targeted therapies (an anti-EGF inhibitor along with an anti-VEGF inhibitor). The goal will be to determine whether the addition of Erlotinib to Avastin will improve the benefit in metastatic renal cell carcinoma (RCC) with regard to time to progression, response rate, duration of response, and survival compared with Avastin alone. Since Avastin has been shown to be active in renal cancer, the goal will be to assess whether this activity can be enhanced with Erlotinib.

A Study to Compare Two Avastin-Based Treatment Regimens for the Treatment of Metastatic Colorectal Cancer [Terminated]
This is a randomized, open-label, active-control, multicenter trial comparing two oxaliplatin/Avastin-based treatment sequences as first-line therapy for metastatic colorectal cancer. The study is designed to compare the efficacy of these two treatment sequences with respect to progression free survival (PFS) and overall survival.

more trials >>

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 >>


Page last updated: 2014-10-20

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