Ziv-aflibercept (Intravenous route)
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 .
Uses of This Medicine:
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.
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:
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:
- Angina (severe chest pain) or
- Bleeding problems or
- Heart attack, history of or
- Hypertension (high blood pressure) or
- Kidney disease or
- Neutropenia (low white blood cells) or
- Proteinuria (protein in the urine), history of or
- Stomach or intestinal problems (eg, diarrhea, bleeding), history of or
- Transient ischemic attacks (TIA or small strokes), history of or
- Wound healing problems—Use with caution. May make these conditions worse.
Proper Use of This Medicine:
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.
Precautions While Using This Medicine:
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:
- 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.
Side Effects of This Medicine:
- More common
- black, tarry stools
- bladder pain
- bleeding gums
- blood in the urine or stools
- bloody nose
- blurred vision
- chest pain
- cough or hoarseness
- decreased urination
- difficult, burning, or painful urination
- dizziness or lightheadedness
- dry mouth
- excessive thirst
- fever or chills
- frequent urge to urinate
- lower back or side pain
- pain or swelling around the rectum
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- sudden shortness of breath or troubled breathing
- sunken eyes
- swollen glands
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- wrinkled skin
- Less common
- Abdominal or stomach pain
- decreased appetite
- lack or loss of strength
- redness, swelling, or pain of the skin
- runny nose
- scaling of the skin on the hands and feet
- swelling or inflammation of the mouth
- tingling of the hands and feet
- ulceration of the skin
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.
Last Updated: 11/4/2014