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Description

Bevacizumab is given along with other medicines to treat patients with metastatic (a cancer that has spread) carcinoma of the colon or rectum. This medicine is also used to treat a certain type of metastatic lung cancer called non-squamous, non-small cell lung cancer.

Bevacizumab is a substance that helps the body fight cancer. It prevents the growth of certain types of blood vessels to cancer cells. This helps to decrease the growth of cancer cells by starving the cells of nutrients needed to grow.

Bevacizumab is also used in combination with paclitaxel (Taxol®) to treat a certain type of breast cancer called metastatic HER2 negative breast cancer. This medicine should not be used to treat breast cancer that has worsened after receiving other cancer medicines such as anthracycline (e.g., doxorubicin [Adriamycin®, Rubex®]) or taxane (e.g., docetaxel [Taxotere®]).

Bevacizumab is to be administered only by or under the immediate supervision of your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, bevacizumab is used in certain patients with the following medical conditions:

• Glioblastoma multiforme, recurrent, following prior treatment with temozolomide.

This product is available in the following dosage forms:

• Solution

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Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bevacizumab in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bevacizumab in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel problems, which may require caution in patients receiving bevacizumab.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Angina or
• Bleeding problems or
• Blood clots or
• Esophageal/Stomach/Intestinal problems or
• High blood pressure or
• Heart attack or
• Heart failure or
• Hypersensitivity to bevacizumab or
• Kidney problems or
• Liver problems or
• Protein in the urine or
• Stroke or
• Wound healing problems—May make these conditions worse.

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Proper Use

Bevacizumab is often given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right times.

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Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Other medicines: Do not take other medicines unless they have been discussed with your doctor.

Surgery: This medicine should not be taken within several weeks before or after surgery.

Call your doctor right away if you start to have headaches, seizures, unusual drowsiness, confusion, any changes in vision, or any other unusual medical conditions.

Tell your doctor right away if you are having severe stomach pain accompanied by other symptoms such as constipation and vomiting. These could be symptoms of a serious medical condition.

This medicine may also increase your risk of having a serious condition called tracheoesophageal fistula (an abnormal connection in one or more places between the esophagus and the trachea). Tell your doctor right away if you start having trouble swallowing, coughing, or choking while eating, trouble breathing, or chest pain or discomfort while you are using this medicine.

Bevacizumab can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you start to cough up blood or if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Black, tarry stools
• Bleeding gums
• Body aches or pain
• Chest pain or discomfort
• Chills
• Cloudy urine
• Convulsions
• Cough
• Cracks in the skin
• Decreased urine output
• Dilated neck veins
• Ear congestion
• Extreme fatigue
• Fever
• High blood pressure
• Irregular breathing
• Irregular heartbeat
• Lack or loss of strength
• Loss of appetite
• Loss of heat from the body
• Loss of voice
• Mood changes
• Nasal congestion
• Pain
• Painful or difficult urination
• Pinpoint red spots on the skin
• Redness
• Runny nose
• Shortness of breath
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swelling of the face, fingers, feet, or lower legs
• Swollen glands
• Tightness in the chest
• Troubled breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting of blood or material that looks like coffee grounds
• Watery or bloody diarrhea
• Weight gain
• Wheezing
• Yellow skin

• Difficulty having a bowel movement (stool)
• Difficulty swallowing
• Fainting
• Stomach tenderness

• Back pain
• Blisters
• Blurred vision
• Coma
• Confusion
• Dizziness
• Drowsiness
• Headache
• Increased thirst
• Muscle pain or cramps
• Open sores
• Pale skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Belching
• Bloody nose
• Change in walking and balance
• Clumsiness or unsteadiness
• Excess flow of tears
• Hair loss
• Heartburn
• Indigestion
• Low blood pressure
• Thinning of hair
• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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