Pronunciation:

ziv a-FLIB-er-sept

Brand Names:

• Zaltrap

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Uses of This Medicine:

Ziv-aflibercept injection is given together with other medicines (eg, fluorouracil, irinotecan, leucovorin) 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 given 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:

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 ziv-aflibercept 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 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.

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 clotting 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, fistula, perforation), 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 for at least 1 hour and is given together with other cancer medicines every 2 weeks.

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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 month after the last dose. If you think you have become pregnant, tell your doctor right away.

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.

This medicine may increase your risk of having blood clots. Check with your doctor right away if you have severe headaches of sudden onset, sudden loss of coordination, pains in the chest, groin, or legs, especially calves of legs, sudden onset of shortness of breath for no apparent reason, sudden onset of slurred speech, or sudden vision changes.

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.

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

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

Anxiety

black, tarry stools

bladder pain

bleeding gums

blood in the urine or stools

bloody nose

blurred vision

chest pain

confusion

cough or hoarseness

decreased urination

difficult, burning, or painful urination

dizziness or lightheadedness

dry mouth

excessive thirst

fainting

fever or chills

frequent urge to urinate

headache

hoarseness

lower back or side pain

nervousness

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

Pains in the chest, groin, or legs, especially calves of the legs

severe headaches of sudden onset

sudden loss of coordination

sudden onset of shortness of breath for no apparent reason

sudden onset of slurred speech

sudden vision changes

troubled breathing

Rare

Heartburn

indigestion

nausea

severe abdominal or stomach pain, cramping, or burning

vomiting of material that looks like coffee grounds, severe and continuing

Incidence not known

Dilated neck veins

extreme fatigue

irregular breathing

irregular heartbeat

swelling of the face, fingers, feet, or lower legs

tightness in the chest

weight gain

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:

Less common

Abdominal or stomach pain

decreased appetite

diarrhea

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

Incidence not known

Heavy jaw feeling

loosening of a tooth

pain, swelling, or numbness in the mouth or jaw

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.