Avastin

The recommended adult dose of Avastin (Bevacizumab) is based on body weight and given as an intravenous infusion by your doctor. The dose and frequency depend on the type of cancer that the medication is being used to treat. The first dose should be given slowly over 90 minutes, and if the side effects are acceptable, the second dose can be given over 60 minutes. If the side effects are still acceptable, future infusions can be given over 30 minutes.

Very careful handling of Avastin (Bevacizumab) is required, and it is always given in a hospital or similar setting with access to sterile equipment for preparation.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. It is important Avastin (Bevacizumab) be given exactly as recommended by your doctor. If you miss an appointment to receive Avastin (Bevacizumab), contact your doctor as soon as possible to reschedule your appointment.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each vial contains Avastin (Bevacizumab) 25 mg/mL as either Avastin (Bevacizumab) 100 mg in 4 mL or Avastin (Bevacizumab) 400 mg in 16 mL. Nonmedicinal ingredients: α,α-trehalose dihydrate, polysorbate 20, sodium phosphate and water for injection. Preservative-free.

Do not use Avastin (Bevacizumab) if you:

• are allergic to Avastin (Bevacizumab) or any ingredients of the medication
• are allergic to Chinese hamster ovary cell products or other recombinant human or humanised antibodies
• have untreated cancer that has spread to the central nervous system

There may be an interaction between Avastin (Bevacizumab) and any of the following:

• bacillus Calmette-Guérin (BCG)
• Belimumab
• bisphosphonates (e.g., alendronate, etidronate)
• cancer medications (e.g., Carboplatin, Cyclophosphamide, doxorubicin, Ifosfamide)
• Clozapine
• dipyrone
• Sunitinib

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Avastin (Bevacizumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Avastin (Bevacizumab).

HEALTH CANADA ADVISORY

May 2, 2013

Health Canada has issued new information concerning the use of Avastin® (Avastin (Bevacizumab)). To read the full report, visit Health Canada's website at www.hc-sc.gc.ca.

A previous advisory on Avastin® was issued on December 7, 2011.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
A previous advisory on Avastin® was issued on November 28, 2011.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
A previous advisory on Avastin® was issued on November 14, 2011.

To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.

Blood clotting: Treatment with Avastin (Bevacizumab) should be stopped for people who develop clots that block their blood vessels. Tell your doctor if you have a history of clotting or are over 65 years of age, as you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, Stroke, or clots in the deep veins of your leg.

Gastrointestinal perforations: Avastin (Bevacizumab) can cause gastrointestinal perforations (holes in the wall of the stomach or intestine). Treatment with Avastin (Bevacizumab) should be stopped for people who develop perforations, as they can lead to bacterial contamination and an infection of the stomach area. Symptoms include severe stomach pain that gets worse during movement, along with nausea, constipation, and vomiting, followed by fever and chills.

Heart failure: Tell your doctor if you have had chemotherapy in the past with a class of medications called anthracyclines (e.g., Daunorubicin, Doxorubicin, Mitoxantrone) or have had radiation therapy to your chest area, as you may be at higher risk of experiencing heart failure.

Hemorrhage:There have been reports of severe and sometimes fatal bleeding in people receiving this medication. The most serious bleeding may occur in the stomach and the brain. Your doctor will stop treatment with Avastin (Bevacizumab) if you develop serious bleeding. If you notice signs of serious bleeding, such as vomiting blood or coffee grounds-like substance, or bleeding from the rectum, get immediate medical attention.

High blood pressure and hypertensive encephalopathy: Avastin (Bevacizumab) can cause high blood pressure. People with uncontrolled high blood pressure should be closely monitored by their doctor. Your blood pressure should be monitored every 2 to 3 weeks during treatment with Avastin (Bevacizumab). If you develop high blood pressure that requires treatment, this medication should be stopped until your blood pressure is controlled. If you develop severe high blood pressure known as hypertensive crisis, this medication should be permanently stopped.

In some cases, a complication of high blood pressure that affects the brain called hypertensive encephalopathy can occur. Signs and symptoms of this complication include very high blood pressure, headache, nausea, vomiting, vision problems, and seizures or confusion. Get immediate medical attention if you experience any of these signs and symptoms.

Infection: Avastin (Bevacizumab) may increase the risk of infection. If you have a fever, sore throat, or other signs of infection (such as redness, pus, or swelling near a cut), contact your doctor.

Jaw problems: Rarely, Avastin (Bevacizumab) may cause severe jaw problems, especially in people who have had invasive dental procedures or are taking bisphosphonates (e.g., Alendronate, Risedronate). If you experience any pain in the jaw, contact your doctor immediately. Invasive dental procedures should be avoided if possible.

Kidney damage: People with a history of high blood pressure may have an increased risk of proteinuria (high levels of protein in urine) when treated with Avastin (Bevacizumab). If you have high blood pressure, you will need to have regular urine tests before starting and while taking Avastin (Bevacizumab). If the tests show protein in the urine, your doctor may recommend stopping the medication.

Kidney and liver disease: The safety and effectiveness of using Avastin (Bevacizumab) has not been established for people who have kidney or liver disease.

Neurological problems: This medication can cause a rare neurological disorder called posterior reversible encephalopathy syndrome (PRES). Signs and symptoms of PRES include seizures, headache, confusion, vision problems or blindness, dizziness, and high blood pressure. If you experience any of these signs and symptoms, get medical attention immediately.

Wound healing: This medication may slow the healing of wounds. Treatment should not be started for at least 28 days after major surgery or until the wound is fully healed. If you will be having surgery, treatment with Avastin (Bevacizumab) will be stopped during this time. There have been rare reports of necrotizing fasciitis (flesh-eating disease) in people who have received Avastin (Bevacizumab).

Pregnancy: Avastin (Bevacizumab) may affect a baby's development in the womb and should not be used during pregnancy. It is strongly recommended that women who may become pregnant take proper contraceptive measures (e.g., use of a condom) for at least 6 months after the last dose of Avastin (Bevacizumab).

Breast-feeding: It is not known if Avastin (Bevacizumab) passes into breast milk. Women should avoid breast-feeding while taking Avastin (Bevacizumab) and should not breast-feed for 6 months after stopping treatment.

Children: The safety and effectiveness of using Avastin (Bevacizumab) have not been established for children.

Seniors: Tell your doctor if you are over 65 years of age with a history of blood clotting, as you may be at risk of experiencing related problems, such as heart attack and stroke.