Severely compromised wound healing may occur; discontinuation is required. Suspend therapy for at least 4 weeks prior to elective surgery, and do not resume for at least 4 weeks following major surgery and until the surgical wound is fully healed. Severe and sometimes fatal hemorrhage, including gastrointestinal hemorrhage, has been reported; monitoring is required. Do not administer if severe hemorrhage. Gastrointestinal perforation including fatalities may occur; discontinuation is required .
Ziv-aflibercept injection is given together with other medicines to treat advanced cancer of the colon or rectum. It is used in patients who have already been treated with other cancer medicines that did not work well. Ziv-aflibercept works by changing the amount of blood that gets to the tumor.
This medicine is to be administered only by or under the direct supervision of your doctor.
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 ziv-aflibercept 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 ziv-aflibercept injection in the elderly. However, elderly patients are more likely to have unwanted effects (eg, diarrhea, dehydration), which may require caution in patients receiving ziv-aflibercept injection.
|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.|
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:
A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in a vein and is given together with other cancer medicines.
Your doctor will want to check your progress at regular visits to see if the medicine is working properly and to decide if you should continue to receive it.
Your doctor will check your blood, urine, and blood pressure on a regular basis while you are receiving this medicine. You may also need to monitor your blood pressure at home. If you notice any changes to your normal blood pressure, call your doctor right away.
Make sure your doctor knows if you or your partner are planning to become pregnant. This medicine may cause fertility problems for men and women. You must use an effective form of birth control while you are receiving the medicine and for at least 3 months after the last dose. Talk to your doctor about effective birth control.
This medicine may increase your chance of having bleeding problems. Call your doctor right away if you notice any signs of bleeding, such as bloody or black, tarry stools, blood in the urine, lightheadedness, shortness of breath, or vomiting of blood that looks like coffee grounds.
Call your doctor right away if you have severe diarrhea, nausea, vomiting, or stomach pain. These may be symptoms of a serious stomach problem.
This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several weeks before having surgery.
Check with your doctor right away if you have a headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious brain condition called reversible posterior leukoencephalopathy syndrome (RPLS).
Ziv-aflibercept 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:
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.