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Bevacizumab (Intravenous route)

Pronunciation:

be-va-SIZ-yoo-mab

Brand Names:

  • Avastin

Dosage Forms:

  • Solution

Warnings:

Intravenous route(Solution)

Gastrointestinal perforation, some cases fatal, has occurred in up to 3.2% of bevacizumab-treated patients. Bevacizumab is also associated with an increased incidence of surgical and wound healing complications, including serious and fatal complications. 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, epistaxis, 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 .

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Monoclonal Antibody

Uses of This Medicine:

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.

Bevacizumab injection 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. It is also used in combination with other medicines (eg, paclitaxel and cisplatin, or paclitaxel and topotecan) to treat patients with cancer of the cervix that has spread to other areas of the body. This medicine is also used in combination with other medicines (eg, paclitaxel, pegylated liposomal doxorubicin, or topotecan) to treat patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

This medicine is to be given 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).
  • Malignant mesothelioma of pleura, unresectable, first-line therapy, in combination with pemetrexed and cisplatin (malignant cancer of the protective lining of the lungs that cannot be removed by surgery).
  • 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 This Medicine:

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.

Children

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.

Older adults

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.

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.

Other 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.

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 (severe chest pain) or
  • Bleeding problems or
  • Blood clots or
  • Diabetes 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 (eg, fistula, perforation) 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 This Medicine:

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 This Medicine:

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 an effective form of birth control to prevent pregnancy while you are using this medicine and 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. 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 posterior reversible encephalopathy syndrome (PRES). 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 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).

Using this medicine may increase risk of ovarian failure. Talk with your doctor about this risk.

Side Effects of This Medicine:

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
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
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 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
wrinkled skin
yellow skin
Less common
Abdominal or stomach pain or tenderness
bone pain
difficulty with swallowing
fainting
severe constipation
severe vomiting
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
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.


Last Updated: 10/12/2016
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