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 .
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:
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:
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.
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.
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.
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.
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.
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:
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.
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:
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.
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:
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:
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.