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Generic Name: bevacizumab (Intravenous route)

be-va-SIZ-yoo-mab

Intravenous route(Solution)

Gastrointestinal perforation, some cases fatal, has occurred in up to 2.4% of bevacizumab-treated patients. Discontinue bevacizumab if gastrointestinal perforation or wound dehiscence occurs. Discontinue at least 28 days prior to elective surgery. Do not initiate bevacizumab for at least 28 days after surgery and until the surgical wound is fully healed. Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, CNS hemorrhage, and vaginal bleeding, has occurred up to 5-fold more frequently in bevacizumab-treated patients. Do not administer bevacizumab to patients with serious hemorrhage or recent hemoptysis .

Commonly used brand name(s)

In the U.S.

  • Avastin

Available Dosage Forms:

  • Solution

Therapeutic Class: Immunological Agent

Pharmacologic Class: Monoclonal Antibody

Uses For Avastin

Bevacizumab injection is given 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 nonsquamous, non-small cell lung cancer, and a certain type of brain tumor called glioblastoma.

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 that are needed to grow.

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Bevacizumab is also used in combination with other medicines (eg, interferon alfa) to treat patients with cancer of the kidney that has spread to other areas of the body.

This medicine 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:

  • Diabetic macular edema (swelling of the back of the eye in diabetic patients).
  • Glioblastoma multiforme, recurrent, after therapy with temozolomide (a type of brain cancer that is getting worse or not responding to therapy).
  • Metastatic colorectal cancer, first-line therapy, in combination with capecitabine and oxaliplatin (cancer of the colon or rectum that has spread to other areas of the body).

Before Using Avastin

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 injection 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 injection 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 injection.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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 (severe chest pain) or
  • Bleeding problems or
  • Blood clots or
  • Esophagus problems or
  • Heart attack, history of or
  • Heart failure or
  • Hypertension (high blood pressure) or
  • Kidney problems or
  • Liver problems or
  • Protein in the urine or
  • Stomach or intestinal problems or
  • Stroke, history of or
  • Wound healing problems—Use with caution. May make these conditions worse.
  • Hemoptysis (coughing up blood), recent history of—Should not be used in patients with this condition.

Proper Use of Avastin

You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Bevacizumab is often given together with other cancer 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.

Precautions While Using Avastin

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. Your doctor will need to check your urine and blood pressure at regular visits while you are receiving this medicine. Be sure to keep all appointments. You may be taught how to check your blood pressure at home.

Using this medicine while you are pregnant can harm your unborn baby. Use two forms of birth control to keep from getting pregnant. Keep using two forms of birth control for at least 6 months after your treatment ends. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several weeks before and after having surgery.

This medicine may increase your chance of having bleeding problems. Stop using this medicine and tell your doctor right away if you start to notice any signs of bleeding.

This medicine may increase your chance of having blood clots or a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using this medicine and tell your doctor right away if you develop chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are using this medicine.

Tell your doctor right away if you are having severe stomach pain accompanied by other symptoms such as constipation, fever, nausea, 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 opening 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 the 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.

Bevacizumab may cause a serious side effect called an infusion reaction. This can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, or chest pain within a few hours after you receive it.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

Avastin 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 or nurse immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bleeding gums
  • body aches or pain
  • burning, tingling, numbness, or pain in the hands, arms, feet, or legs
  • chest pain or discomfort
  • chills
  • cloudy urine
  • convulsions
  • cough
  • cracks in the skin
  • decreased urine output
  • difficult or labored breathing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • ear congestion
  • extreme fatigue
  • fever
  • high blood pressure
  • irregular breathing
  • irregular heartbeat
  • lack or loss of strength
  • lightheadedness
  • loss of appetite
  • loss of heat from the body
  • loss of voice
  • mood changes
  • nasal congestion
  • nervousness
  • pain
  • pain, redness, or swelling in the arm or leg
  • painful or difficult urination
  • pinpoint red spots on the skin
  • pounding in the ears
  • rapid breathing
  • redness
  • runny nose
  • sensation of pins and needles
  • shortness of breath
  • slow or fast heartbeat
  • sore throat
  • sores on the skin
  • sores, ulcers, or white spots on the lips or in the mouth
  • stabbing pain
  • sunken eyes
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swelling or inflammation of the mouth
  • swollen glands
  • thirst
  • tightness in the chest
  • trouble with 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
  • wrinkled skin
  • yellow skin
Less common
  • Abdominal or stomach pain
  • bone pain
  • difficulty having a bowel movement (stool)
  • difficulty with swallowing
  • fainting
  • severe constipation
  • severe vomiting
  • stomach tenderness
Rare
  • Back pain
  • blisters
  • blurred vision
  • coma
  • confusion
  • dizziness
  • drowsiness
  • headache
  • increased thirst
  • muscle pain or cramps
  • open sores
  • pale skin
Incidence not known
  • Bloody mucus or unexplained nosebleeds
  • hoarseness
  • sudden weakness in the arms or legs
  • sudden, severe chest pain
  • voice changes

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:

More common
  • Acid or sour stomach
  • belching
  • bloody nose
  • change in taste or bad unusual or unpleasant (after) taste
  • change in walking and balance
  • clumsiness or unsteadiness
  • diarrhea
  • dry mouth
  • excess flow of tears
  • hair loss
  • heartburn
  • indigestion
  • low blood pressure
  • stomach discomfort, upset, or pain
  • thinning of the 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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