Zaltrap is made from a human antibody fragment. It works by keeping new blood vessels from forming in a fast-growing tumor.

Zaltrap is used in combination with other medications to treat colorectal cancer that has spread to other parts of the body (metastatic).

Zaltrap is usually given after other medications did not work or have stopped working.

You should not use Zaltrap if you have severe bleeding or uncontrolled hypertension (high blood pressure).

Before you receive Zaltrap, tell your doctor if you have high blood pressure, open sores or skin wounds, or if you have had surgery or dental work within the past 4 weeks.

If you need surgery, tell the surgeon ahead of time that you are using this medicine.

Zaltrap may cause serious and sometimes fatal bleeding. Call your doctor at once if you have any signs of unusual bleeding, including easy bruising, bloody stools, coughing up blood, or feeling light-headed or short of breath.

If you need surgery or dental work, tell the surgeon or dentist ahead of time that you are using Zaltrap. You may need to stop using the medicine at least 4 weeks before your surgery.

Before taking this medicine

To make sure Zaltrap is safe for you, tell your doctor if you have:

• bleeding problems;

• heart problems, high blood pressure;

• open sores or skin wounds; or

• surgery or dental work within the past 4 weeks.

Ziv-aflibercept may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while using this medicine and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

You should not breastfeed while you are using Zaltrap, and for at least 1 month after your last dose.

Zaltrap is given as an infusion into a vein, usually every other week. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 1 hour to complete.

You will need frequent medical tests and blood pressure checks.

Zaltrap can cause problems with wound healing, which could result in bleeding or infection. You will need to stop receiving Zaltrap at least 4 weeks before having any surgery or dental work. Do not start using the medicine for at least 4 weeks after surgery, or until your surgical incision heals.

Usual Adult Dose for Colorectal Cancer:

4 mg/kg IV over 1 hour every 2 weeks; administer this drug prior to any component of the FOLFIRI regimen on the day of treatment
-Duration of therapy: until disease progression or unacceptable toxicity.

Use: This drug in combination with 5-fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen.

To make sure Zaltrap is safe for you, tell your doctor if you have:

• bleeding problems;

• heart problems, high blood pressure;

• open sores or skin wounds; or

• surgery or dental work within the past 4 weeks.

Ziv-aflibercept may harm an unborn baby. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while using this medicine and for at least 1 month after your last dose. Tell your doctor if you become pregnant.

Pregnancy may be less likely to occur while the mother or the father is using this medicine. Women should still use birth control to prevent pregnancy because the medicine can harm an unborn baby.

You should not breastfeed while you are using Zaltrap, and for at least 1 month after your last dose.

Call your doctor for instructions if you miss an appointment for your Zaltrap injection.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Zaltrap: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Zaltrap can make it easier for you to bleed. Call your doctor or seek emergency medical attention if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, rectum), or any bleeding that will not stop;

• signs of bleeding inside your body - feeling light-headed; pink or brown urine; bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or

• signs of bleeding in the brain - sudden weakness (especially on one side of the body), severe headache, problems with speech or vision.

Call your doctor at once if you have:

• severe or ongoing vomiting or diarrhea;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• any wound that will not heal;

• headache, confusion, thinking problems, vision loss, seizure;

• signs of a blood clot - chest pain, sudden numbness or weakness;

• signs of perforation (a hole or tear) in your stomach or intestines - fever, ongoing stomach pain, change in bowel habits;

• signs of a fistula (abnormal passageway) in your lower body - rectal pain, foul-smelling vaginal discharge, pain or swelling in your lower stomach, problems with urination or bowel movements.

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• signs of a kidney disorder - puffy eyes, swelling in your ankles or feet, weight gain, urine that looks foamy; or

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Older adults may be more likely to have severe diarrhea or get dehydrated.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Zaltrap side effects may include:

• increased blood pressure;

• low white blood cells;

• bruising or bleeding, nosebleeds;

• stomach pain, diarrhea;

• mouth sores, loss of appetite, weight loss;

• headache, feeling tired;

• hoarse voice; or

• abnormal kidney or liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with ziv-aflibercept, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.