What Is Bevacizumab?

Avastin (Bevacizumab, Avastin) is a recombinant humanized monoclonal antibody. It was approved by the FDA on February 26, 2004, and is the first drug in the United States to be approved for marketing to inhibit tumor angiogenesis. It was confirmed by in vivo and in vitro detection systems that the IgG1 antibody can bind to human vascular endothelial growth factor (VEGF) and block its biological activity. Avastin contains the structural region of human antibody and the complementarity determining region of mouse monoclonal antibody that can bind VEGF. Avastin is produced by the Chinese Hamster Ovary Cell Expression System and has a molecular weight of approximately 149,000 Daltons. Avastin is a colorless, transparent, light milky or gray-brown sterile liquid with a pH value of 6.2. Avastin is available in 100mg and 400mg specifications, with corresponding volumes of 4ml and 16ml (25mg / ml) without preservatives.

Bevacizumab

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Avastin (Bevacizumab, Avastin) is a recombinant humanized monoclonal antibody. It was approved by the FDA on February 26, 2004, and is the first drug in the United States to be approved for marketing to inhibit tumor angiogenesis. In vivo and in vitro detection systems confirm that IgG1 antibodies can interact with humans

Some Avastin prescription data in Chinese (for reference only)

Country of origin English name: Avastin

Country of origin English drug name: Bevacizumab BEVACIZUMAB Chinese reference product translation name: Avastin Avastin

Molecular structure name: Bevacizumab

Avastin Bevacizumab (brand name Avastin) Chinese manual

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Dosage form: water. Dosage: two, 100mg / 4ml or 400mg / 16ml.

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Gastrointestinal perforation / wound healing complications (see "Dosage and Administration: Dose Adjustment")

Gastrointestinal perforation / wound healing complications with intra-abdominal abscesses were higher in patients receiving Avastin compared to controls. In preclinical animal models, Avastin can affect wound healing.

In Study 1, 1 of 396 patients (0.3%) in the IFL + placebo group, 6 of 392 patients (2%) in the IFL + Avastin group, and the 5-FU / LV + Avastin group Of the 109 patients, 4 (4%) had gastrointestinal perforations, and some were fatal. These complications can be with or without intra-abdominal abscesses and can occur at any time during treatment. According to reports, the typical manifestation is abdominal pain with some symptoms such as constipation or vomiting.

In addition, in the IFL + placebo group, 2 of the 396 patients (0.5%), in the IFL + Avastin group, 4 of the 392 patients (1%), and in the 5-FU / LV + Avastin group, One of the 109 patients (1%) developed a wound crack during treatment. How long it takes before surgery to start Avastin treatment to avoid the effects on wound healing is still inconclusive. In Study 1, the study protocol did not allow patients to use Avastin within 28 days of surgery. One patient (a total of 501 patients treated with Avastin in Study 1) received Avastin treatment more than 2 months after surgery and had anastomotic fissures.

Similarly, in order to avoid the effect of Avastin treatment on wound healing, it is not yet clear how long it takes to perform selective surgery after Avastin treatment. Of the study's 1,190 patients treated with IFL + Avastin, 39 received surgery after Avastin treatment was completed, and 6 of these patients (15%) had wound healing / bleeding complications.

In the same study, 25 of the 193 patients treated with IFL underwent surgery after treatment, and only 1 (4%) of these patients had wound healing / bleeding complications. The longest interval between the end of treatment and the appearance of wound dehiscence occurred in patients receiving IFL + Avastin, with an interval of 56 days. The interval between Avastin treatment and subsequent elective surgery should consider Avastin's half-life (approximately 20 days). Avastin will be permanently discontinued if the patient experiences gastrointestinal perforation or a wound that requires medical intervention during the application of Avastin.

Bleeding (see "Dosage and Administration: Dosage Adjustment").

In patients receiving Avastin, two different bleeding episodes occurred. The most common is minor bleeding, which is mainly manifested as Grade 1 nosebleeds; the second condition is severe, sometimes even fatal, major bleeding. Severe bleeding event first appeared in treatment

Overview

Patients who are allergic to Avastin or any of its products should be used with caution.

While patients are receiving Avastin, their blood pressure should be monitored every 2 to 3 weeks. Patients with hypertension should monitor their blood pressure more frequently. Patients discontinued due to hypertension induced or exacerbated by Avastin should continue to monitor their blood pressure regularly.

Patients receiving Avastin should undergo a systematic urine test to monitor whether proteinuria is induced or exacerbated. Patients with 2+ or more severe proteinuria should be examined for 24-hour urine for further evaluation. (See warning: "Proteinuria and Dosage and Usage: Dose Adjustment")

Avastin and antitumor have not yet been performed

In mg / kg, malformations occur when rabbits are given twice the recommended dose of Avastin. Observed effects include reduced maternal and fetal weight, increased fetal abortion, and increased incidence of fetal body and bone changes. Fetal effects were observed in all dose groups.

Angiogenesis is crucial for fetal development. Caused by Avastin treatment

The most serious side effects associated with Avastin are:

Gastrointestinal perforation / wound dehiscence syndrome (see warning)

Bleeding (see warning)

The following serious side effects were considered uncommon in tumor patients receiving cytotoxic chemotherapy, and at least one of them occurred in a clinical study of Avastin.

Body: Serositis

Avastin should only be infused after dilution with sterile techniques by a health professional. The required Avastin was extracted at a dose of 5 mg / kg and diluted to a total volume of 0.9% of 100 mL

First application

Avastin should be stored in a refrigerator at 2-8 °, and kept in the original carton until protected from light until use.

Packaging: Available in 4ml and 16ml, sterile solutions in disposable glass bottles, each containing 100 and 400 mg of Bevacizumab. Single 100 mg package: contains a 4ml bottle of Avastin. (25 mg / mL). NDC 50242-060-01 606 Single 400 mg package: contains a 16ml bottle of Avastin. (25 mg / mL). NDC 50242-060-02 608.

Shelf life: 3 years

Manufacturer: Roche Group

References: 1. Presta LG, Chen H, O \ 'Connor SJ, Chisholm V, Meng YG, Krummen L, et al. Humanized antibodies

Onvatine, the only anti-tumor molecular targeted drug listed in China in 2010, was approved by the State Food and Drug Administration for advanced colorectal and rectal cancer. However, Avidin has been listed in many countries around the world as early as 2004. In October 2006, it was updated with indications for non-small cell lung cancer. In 2007, EU countries approved it for breast cancer.

In recent years, some doctors in the United States have clinically found that because of the anti-vascular endothelial growth factor (VEGF) effect of Avastin, it can neutralize abnormal high-level eye disease VEGF in the macular region, thereby inhibiting AMD (age-related macular degeneration) Deterioration, used to treat this elderly eye disease that is common in the elderly and can cause severe visual impairment is highly successful. The efficacy of Avatin has spread to doctor circles. Over time, almost all doctors treating macular degeneration in the world have used or recommended the use of Avatin. In 2009, some large hospitals in China also started to use it for clinical treatment of AMD. So far, more than 100,000 injections have been made. This is the reason why the anti-cancer drug Avastin (Bevacizumab) staged the "Shanghai Eye Medicine Gate" in China.

It s no secret that the cancer drug Avrin is used to treat fundus disease in China. It has even been proven by clinical practice of ophthalmologists around the world to have the effect of treating fundus disease and is inexpensive. It has been active in the private prescription of ophthalmologists. The medical infection accident made it appear in people's focus as a scapegoat, and caused controversy such as "counterfeit medicine" and "pour medicine."

So why has Avastin (bevacizumab) been used globally for many years, and only now pays attention to the side effects of drugs? According to the investigation after the "Shanghai Eye Medicine Gate" incident, the problem stems from the "smuggling" nature of the batch of Avastin used by patients. Avastin (Bevacizumab) is a biological agent and a monoclonal antibody protein. Once the transportation and storage conditions are not good enough, it will cause protein denaturation, and then allergic reactions will occur, leading to immunogenic inflammation. Therefore, Avatin must be refrigerated. However, those who come in through various smuggling channels are clearly outside the supervision of the Good Manufacturing Practices.

At the Beijing launch conference of Roche Pharma's Avastin (Bevacizumab) this year, domestic experts said in an interview that Avastin is the world's leading anti-tumor angiogenesis drug and will become the future development direction of cancer treatment Based on this, the "anti-tumor angiogenesis + anti-tumor cell proliferation" treatment strategy is becoming the core strategy of tumor treatment internationally. ^[1]

Avastin revokes approval for breast cancer treatment by FDA

Avastin is a drug approved by the US Food and Drug Administration for the treatment of a range of cancers on February 22, 2008. Roche failed to provide data on its safety assessment and did not significantly improve the survival of cancer patients. Time, on November 18, 2011, the FDA revoked its permission for breast cancer treatment, but it can still be used for colon cancer, lung cancer, kidney cancer and brain cancer treatment. ^[2]