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Fact Sheet for AVASTIN

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Contact : Office of Regulatory Affairs, Biologics and Genetic Therapies Directorate

Authorization with Conditions of AVASTIN« (bevacizumab)

For Use in the Treatment of People Diagnosed with a Particular Type of Brain Cancer [Glioblastoma]

Fact Sheet

What is AVASTIN and how does it work?

AVASTIN (pronounced ah-'va-stin) is a monoclonal antibody. AVASTIN is not chemotherapy and therefore works differently. While chemotherapy attacks the tumour directly, AVASTIN attacks the blood vessels that surround the tumour.

In order to grow and spread, tumours need a constant supply of oxygen and other nutrients. Tumours get this supply by creating their own network of blood vessels. This process is called angiogenesis (an'-gee-o-jen'-i-sis). AVASTIN works by blocking angiogenesis. By preventing the growth of new blood vessels, AVASTIN helps starve the tumour of oxygen and other nutrients. This makes it hard for the tumour to grow.

AVASTIN is given intravenously (through a needle placed in a vein in the arm, hand, or through a central line).

Health Canada has authorized AVASTIN with conditions, under the Notice of Compliance with Conditions (NOC/c) Policy. This authorization reflects the promising nature of the clinical evidence which must be verified and/or extended with further studies. Products authorized under Health Canada's NOC/c Policy have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment.

What is AVASTIN used for?

AVASTIN is authorized with conditions, under the NOC/c Policy, based on the benefit/risk assessment of two studies, for use in the treatment of people diagnosed with a particular type of brain cancer called glioblastoma. AVASTIN is used when brain cancer comes back or gets worse after having been treated before.

What is glioblastoma?

Glioblastoma is a fast-growing type of central nervous system tumour that forms from glial [supportive] tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma usually occurs in adults and affects the brain more often than the spinal cord. It is also called GBM, glioblastoma multiforme, and grade IV astrocytoma. It is the most common type of malignant primary brain tumour and can spread, but rarely spreads to area outside of the central nervous system [brain or spinal cord].

What other treatments have been used to treat glioblastoma?

The choice of treatment for glioblastoma depends upon many individual factors.

Whatever treatment plan you and your doctor choose, it will usually consist of some of the following components:

  • Surgery
  • Radiation
  • Chemotherapy
  • Supportive therapy, for example, anticonvulsants, corticosteroids

There are no other currently authorised treatments that target angiogenesis.

What are the advantages of AVASTIN over other therapies?

AVASTIN belongs to an innovative class of drugs called "targeted" therapy. It is a term used to describe a drug that "targets" specific properties of cancer cells: their production of protein, their use of enzymes, or in the case of AVASTIN, their ability to form new blood vessels to support growth.

What do patients need to know about using AVASTIN?

AVASTIN treatment can cause gastrointestinal perforation (holes in the stomach or bowel) and wound dehiscence (wounds opening and not healing), which can be fatal. AVASTIN treatment should be stopped if these happen, and within one month of having surgery. Gastrointestinal perforation can happen at any time during treatment: symptoms include abdominal pain, constipation and vomiting.

When AVASTIN should not be used?

AVASTIN should not be used by people who are allergic to it or any of its ingredients or given to patients whose cancer [in an organ other than the brain] has spread to their central nervous system [brain or spinal cord] because of the risk of bleeding. AVASTIN should not be taken for at least 28 days following surgery because of problems with wound healing.

Can AVASTIN be taken with other drugs?

AVASTIN may interact with sunitinib malate. The safety and effectiveness of AVASTIN in combination with sunitinib malate has not been established, therefore this combination is not recommended.

What are the side effects and how serious are they?

Unwanted effects are possible with all medicines. Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are taking AVASTIN.

The most serious side effects across all clinical trials include:

  • Fistula (abnormal tube like connection between internal parts of the body that are not normally connected) such as tracheoesophageal fistula (abnormal connection between the windpipe and esophagus) and gastrointestinal perforation (holes in the stomach or bowels);
  • Bleeding associated with the tumour;
  • Problems with wound healing, especially surgical wounds;
  • Blood clots in arteries or veins, including stroke and heart attack;
  • High blood pressure;
  • Reversible posterior leukoencephalopathy syndrome [RPLS symptoms include headache, vision problems, dizziness, or change in mental status (for example, confusion));
  • A decrease in the number of certain white blood cells in the blood that help fight off infection;
  • Kidney damage;
  • Heart failure;
  • Risk of birth defects.

The most common side effects in more than 10% of patients in all clinical trials were fatigue (lack of energy or strength), diarrhea, high blood pressure, stomach pain and nosebleeds.

The most common serious side effects in glioblastoma were infection, fatigue (lack of energy or strength), headache, high blood pressure, diarrhea and nosebleeds.

Frequent monitoring of blood pressure (for example, every 2-3 weeks) and testing for protein in the urine is recommended during AVASTIN treatment to detect potential complications including severe hypertension and brain disorders such as RPLS.

This is not a complete list of side effects. For any unexpected effects while taking AVASTIN, contact your doctor or pharmacist.

What should you tell your doctor before you start AVASTIN treatment?

Before you start AVASTIN talk to your doctor or pharmacist if you:

  • have high blood pressure;
  • have had surgery in the last 28 days;
  • have ever had a heart attack or stroke;
  • are pregnant or plan to become pregnant;
  • are breast feeding;
  • have any allergies to this drug or its ingredients;
  • have any illnesses or diseases affecting your kidneys;
  • have heart failure or weakened heart muscles;
  • have ever coughed up blood.

If you develop headache, vision problems, dizziness, or change in mental status (for example, confusion) contact your doctor immediately.

This information will help your doctor and you decide whether you should be treated with AVASTIN and what extra care may need to be taken while you are on treatment.

How should AVASTIN be given for the treatment of glioblastoma?

The usual dose of AVASTIN is based on your weight in kg. The recommended dose of AVASTIN for glioblastoma treatment is 10 milligrams/kilograms of body weight given once every 2 weeks for as long as your physician recommends therapy.

The first time AVASTIN is given, it will take about 90 minutes. After the first or second time, once your doctor makes sure you have no problems with the infusion, treatments with AVASTIN may require less time, usually about 30-60 minutes.

What should you do if you miss a dose of AVASTIN?

If you miss a dose of AVASTIN, your doctor will decide when you should receive your next dose.

What should you do in case of an overdose or AVASTIN is taken accidentally?

Call your doctor or the Poison Control Centre immediately if you think you have taken an overdose or someone has accidentally taken your AVASTIN. If you are not able to contact them, go to the nearest hospital emergency department for medical help. In addition to the possible side-effects listed above an overdose may cause a severe headache.

What are the other uses of AVASTIN?

AVASTIN is authorized for use in combination with a specific type of chemotherapy (intravenous 5-fluorouracil [5-FU]-based chemotherapy) for treatment of people diagnosed with metastatic colorectal cancer for the first time. Metastatic colorectal cancer is cancer of the colon or rectum that has spread to other organs in the body.

AVASTIN is used in combination with a specific type of chemotherapy (carboplatin and paclitaxel) for the treatment of people diagnosed with metastatic non-small cell lung cancer. Metastatic non-small cell lung cancer is cancer of the lungs that has spread to other organs in the body.

AVASTIN, for use in combination with a specific type of chemotherapy (paclitaxel) for the treatment of people diagnosed with a common type of metastatic breast cancer [HER-2 negative mBC] and who are in good general health, has been authorized with conditions, pending the results of confirmatory studies to verify its clinical benefit. Metastatic breast cancer is cancer of the breast that has spread to other organs in the body.

Where can I learn more about AVASTIN?

Contact the Drug Information Department at Hoffmann-La Roche Limited at 1-888-762-4388 from 8:30 a.m. to 4:30 p.m. Monday to Friday Eastern Standard Time. Full Part III (Consumer Information) for AVASTIN is available at Next link will take you to another Web site rochecanada.