Vegzelma

This medication is a man-made antibody (IgG1) used to treat various types of cancer. This drug works by blocking a certain protein (vascular endothelial growth factor-VEGF) thereby decreasing the blood supply to the tumor and slowing tumor growth.

This monograph is about the following bevacizumab products: bevacizumab, bevacizumab-awwb, and bevacizumab-bvzr.

This medication is given by infusion into a vein by a health care professional. The first dose is usually given over 90 minutes. If you tolerate the first dose well, then later infusions may be given over a shorter time (60 or 30 minutes).

The dosage is based on your medical condition, response to previous therapy, and your weight. Tell your doctor if your weight changes.

Use this medication regularly in order to get the most benefit from it. Try not to miss any doses.

Dry mouth, cough, voice changes, loss of appetite, diarrhea, vomiting, constipation, mouth sores, nausea, or headache may occur. If any of these effects persist or worsen, notify your doctor or pharmacist right away.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fast heartbeat, symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), signs of infection (such as fever, persistent sore throat), muscle cramps, muscle loss, yellowing eyes/skin, dark urine, difficulty urinating, signs of kidney problems (such as change in the amount of urine, frothy urine).

Symptoms of a severe infusion reaction that may occur during bevacizumab treatment include difficulty breathing, flushing, severe dizziness, nausea/vomiting, shaking, or chest pain. Tell your healthcare professional if you have any of these symptoms during your treatment. Your doctor will monitor you closely and will temporarily stop your treatment if a reaction occurs.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Bevacizumab may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, heart/blood vessel disease, or if you are immobile (such as on very long plane flights or being bedridden). If you use estrogen-containing products, these may also increase your risk. Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur: shortness of breath/rapid breathing, chest/jaw/left arm pain, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in groin/calf, sudden/severe headaches, slurred speech, weakness on one side of the body, sudden vision changes.

This medication can cause bleeding. Some episodes may be minor including nosebleeds, minor gum bleeding, and vaginal bleeding. If these persist or worsen, tell your doctor or pharmacist promptly.

This medication can also cause serious (possibly fatal) bleeding, such as bleeding from the stomach/intestines or in the brain. You should not receive this medication if you have any serious bleeding problems. In addition, this medication can rarely cause a tear in the stomach/intestines (gastrointestinal perforation). Get medical help right away if you have any signs of these serious side effects, including bloody or black/tarry stools, persistent or severe stomach/abdominal pain, constipation with vomiting, vomit that is bloody or looks like coffee grounds, coughing up blood, shortness of breath, dizziness/fainting, unusual or persistent tiredness/weakness, severe headache, fever.

This medication may also cause wounds to heal slowly or poorly or cause the wounds to break open. It can also rarely cause very serious (possibly fatal) skin and tissue infections that spread quickly. Get medical help right away if you have wounds that are not healing well, a fever, severe pain/redness/heat/swelling at the surgery site or other areas on the skin, fluid-filled blisters in the skin, discolored/scaling/peeling skin, confusion, dizziness, or fainting. You should not receive this medication for at least 4 weeks before and after a major surgery and until the wound from the surgery is fully healed.

Rarely, bevacizumab may cause a condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop persistent headache, seizures, sudden vision changes, mental/mood changes (such as confusion).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

See also Side Effects section.

Before using bevacizumab, tell your doctor or pharmacist if you are allergic to it; or to any bevacizumab products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal ulcers, bleeding problems (such as recent bloody vomiting or coughing up blood), recent major surgery, recent injuries/wounds, high blood pressure, kidney disease, diabetes.

Before having surgery or any medical procedure, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Bevacizumab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Older adults may be at greater risk for side effects (e.g., blood clots, kidney effects such as protein in the urine). See also Side Effects section.

This medication can affect fertility in females. Ask your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. Discuss the risks and benefits with your doctor. Women of child-bearing age should use reliable forms of birth control while using this medication and for 6 months after stopping treatment. If you become pregnant or think you may be pregnant, tell your doctor right away.

Based on information from related drugs, this medication may pass into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this medication and for 6 months after stopping treatment. Consult your doctor before breast-feeding.

Not applicable. This medication is given in a clinic and will not be stored at home.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: sunitinib.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe headache.

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Laboratory and/or medical tests (e.g., blood pressure monitoring, urine tests for protein, kidney function tests, bilirubin levels, complete blood counts-CBC) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.