Ziv-Aflibercept, Infusion

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KEY POINTS

• This medicine is given by IV to treat colorectal cancer.
• You may get infections more easily when you are taking this medicine.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause brain problems, severe bleeding, or holes in the stomach or intestines. This medicine may cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: ziv-aflibercept, infusion; Zaltrap

What is this medicine used for?

This medicine is given by IV infusion (slow drip through a needle into a large vein) to treat advanced colorectal (bowel and rectal) cancer. It is used with other anticancer drugs.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Bleeding or blood clotting problems, a blood disorder, or if you are taking blood thinners
• High blood pressure
• Kidney disease

Tell your provider if you have had surgery or dental surgery in the past 4 weeks, or if you are planning to have a surgery, dental, or other medical procedure in the next 4 weeks.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not become pregnant while you are receiving this medicine and for 3 months after you stop treatment. Talk to your healthcare provider if you need birth control. If you do become pregnant while receiving this medicine, contact your healthcare provider right away. Do not breast-feed during this treatment.

Males: Use an effective birth control method while you are receiving this medicine and for 3 months after stopping it. Talk to your healthcare provider about effective forms of birth control.

How do I use it?

Infusions are given by a healthcare provider, usually every 2 weeks. The infusions are given over a 1-hour period. Keep all appointments for the infusions.

What should I watch out for?

Warning: Occasionally, this medicine may cause severe bleeding, or perforation of the stomach, small intestine, or large intestine. You may have these problems with or without warning symptoms. If you have abdominal pain, a black tarry bowel movement, a bloody bowel movement, or any unusual bruising or bleeding, contact your healthcare provider right away.

Use a soft brush to brush your teeth. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects. Avoid sports and activities that may cause injuries.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. This medicine can slow wound healing.

You need to have blood and urine tests regularly to see how this medicine affects you. Keep all appointments.

This medicine can increase your blood pressure. Your blood pressure needs to be checked regularly while you are taking this medicine. Talk with your healthcare provider about this.

You may get infections more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Also, do not have any vaccines without getting your healthcare provider's approval first. Contact your healthcare provider right away if you have any signs of infection, such as fever, sore throat, mouth sores, or cough. Also, contact your healthcare provider if you have severe diarrhea, vomiting, or severe abdominal pain.

This medicine increases the risk for reversible posterior leukoencephalopathy syndrome (RPLS). Call your healthcare provider right away if you have:

• Headache
• Seizures
• Weakness
• Confusion
• Trouble seeing or changes in vision
• Problems thinking

Adults over the age of 65 may be at greater risk for side effects, including diarrhea and dehydration. Talk with your healthcare provider about this.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Fever or chills; unusual tiredness or weakness; unusual bruising or bleeding; black or tarry bowel movements; chest pain; trouble breathing; coughing up blood; severe muscle cramps; blood in the urine; trouble urinating or decreased urine; ongoing sore throat or mouth sores; cough; severe dizziness; pain, redness, or swelling in a leg or arm; unexplained swelling in legs, hands, or feet; severe stomach pain, nausea, vomiting, or diarrhea; a wound that does not heal; confusion; severe skin rash or blisters; seizures.

Other: Mild diarrhea; constipation; headache; nausea; vomiting; loss of appetite; weight loss; hoarseness; redness, swelling, or pain where you had the infusion.

What products might interact with this medicine?

No significant drug interactions have been reported.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.