Avastin® (Bevacizumab)

Avastin is the first of a new class of drugs, called anti-angiogenic for cancer therapy

What is Avastin?

Avastin is the first of a new class of drugs, called anti-angiogenic therapy, which is used to treat cancer of the colon or rectum. Avastin is not chemotherapy; it is a monoclonal antibody which has a very specific target. While chemotherapy attacks the tumor, Avastin attacks the blood vessels that surround the tumor. Avastin is usually given in combination with chemotherapy.

How does Avastin work?

In order to grow and spread, tumors need a constant supply of oxygen and other nutrients. Tumors get this supply by creating their own network of blood vessels. This process is called angiogenesis. To start angiogenesis, a tumor sends out signals to nearby blood vessels. These signals cause new blood vessels to "sprout" toward the tumor. Once these new vessels reach the tumor, they provide the supply of blood that "feeds" the tumor.

Avastin: an anti-angiogenic agent

Avastin works by blocking angiogenesis. Because of this, it is often referred to as anti-angiogenic therapy. By preventing the growth of new blood vessels, Avastin helps "starve" the tumor. This makes it hard for the tumor to grow. Avastin is the first anti-angiogenic therapy proven to help people with metastatic colorectal cancer live longer. Metastatic colorectal cancer is a very advanced stage of cancer when the cancer has already spread elsewhere in the body from the original tumour in the colon or rectum. On average, people taking Avastin in combination with chemotherapy were more likely to have their tumors become smaller in size, have a longer period of time before their tumors grew, and live longer. Avastin plus chemotherapy may work better than chemotherapy alone.

Avastin has been approved in USA & European countries to treat patients with metastatic colorectal cancer in the first line setting when given with chemotherapy.

What have studies with Avastin found?

Avastin has been studied in a large clinical trial in people who have metastatic colorectal cancer. Some people received chemotherapy plus Avastin, while others received just chemotherapy. People who received Avastin plus chemotherapy benefited in important ways. While results may vary, on average

• Their tumors shrank in size more often than those who received chemotherapy alone
• Cancer growth was stopped for a longer time, approximately a 70% increase, compared with those who received chemotherapy alone
• People who received Avastin lived approximately 30% longer than those who received chemotherapy alone

Avastin does have possible side effects. In clinical trials, some people receiving Avastin in combination with chemotherapy experienced side effects.

What are the common side effects of Avastin?

In clinical trials for colorectal cancer, the following side effects occurred more often in people receiving Avastin plus chemotherapy than in people receiving only chemotherapy:

• Nosebleeds
• Some people receiving Avastin experienced minor nosebleeds
• Nosebleeds usually stopped on their own or by holding a tissue to the nose
• If you experience a nosebleed, sit with your head tipped slightly forward and apply pressure by lightly "pinching" the bridge of your nose with your thumb and forefinger
• If you feel dizzy or faint, or if the bleeding doesn't stop after 10 to 15 minutes, call your doctor
• Hypertension (high blood pressure)
• Standard oral medications were used to manage high blood pressure
• Tell your doctor if you've had high blood pressure in the past
• Proteinuria (too much protein in the urine)
• Other side effects include weakness, pain, diarrhea, nausea and leucopenia (a reduced white blood cell count)

Serious side effects you should know about:

In clinical trials for colorectal cancer, a small percentage of people treated with Avastin in combination with chemotherapy experienced serious side effects, including gastrointestinal perforation (2%) and slow or incomplete wound healing (1%). In rare cases, these side effects have been fatal.

Patients taking Avastin with chemotherapy had a higher risk of stroke or heart problems compared with people taking chemotherapy alone. Talk to your doctor about these potential problems, especially if you are over 65 years old.

For more information, please speak to your doctor about the common and serious side effects observed in Avastin clinical trials.

How Avastin administered?

Avastin is given by infusion, which means it is given through a needle placed in a vein in the arm or hand. Another way to give the infusion is through a central line.

Avastin is given in combination with chemotherapy every 14 days for as long as the doctor recommends therapy.

The first time you receive Avastin, the infusion will take about 90 minutes. If you have no problems with the first infusion, the second should take 60 minutes, and the third will take only 30 minutes. All the remaining infusions will take 30 minutes.

In clinical studies, infusion reactions with the first dose of Avastin were uncommon (<3%), and severe reactions occurred in 0.2% of patients. Avastin infusion should be interrupted in all patients with severe infusion reactions and appropriate medical therapy administered. No pretreatment is required.

How should Avastin be stored?

Avastin vials should be refrigerated at 2-8 C (36-46 F). Protect from light. Store in the original carton until time of use. DO NOT SHAKE. DO NOT FREEZE.

Further information

For more information about this medicinal product, please contact your doctor or pharmacist.