For U.S. Residents Only
Important Safety Information
Including Boxed WARNING

Your Guide to
ZALTRAP® (ziv-aflibercept)

ZALTRAP (ziv-aflibercept) is a prescription anti-cancer medicine used in combination with the chemotherapy regimen 5-fluorouracil, leucovorin, and irinotecan-(FOLFIRI) to treat metastatic colorectal cancer that has progressed during or after treatment with other anti-cancer medicines that include oxaliplatin.

You or a loved one may be considering therapy with ZALTRAP, also known as ziv-aflibercept, which is an FDA-approved anti-cancer medicine given in combination with a chemotherapy regimen called FOLFIRI (foal-feer-ee) to treat colorectal cancer that has spread. FOLFIRI combines the drugs 5-fluorouracil, leucovorin, and irinotecan. ZALTRAP is an option for people who have had their cancer worsen or have become resistant to the initial therapy used to treat their metastatic colorectal cancer (mCRC).

Those who receive ZALTRAP have been previously treated with a chemotherapy called oxaliplatin (ox-alley-plaht-in).

IMPORTANT SAFETY INFORMATION FOR ZALTRAP® (ziv-aflibercept) INJECTION FOR INTRAVENOUS INFUSION

WARNING: Patients treated with ZALTRAP have experienced serious and sometimes fatal side effects. Your doctor may adjust or stop your ZALTRAP treatment if you have these or other side effects. Tell your doctor right away if you experience any of the following:

Severe bleeding. ZALTRAP can cause severe internal bleeding including bleeding of the digestive system, brain, or lungs. Signs and symptoms may include blood in the stool or urine, abdominal pain or lightheadedness. Patients with severe bleeding should not take ZALTRAP.

Gastrointestinal perforation. ZALTRAP can also cause a hole in the stomach, esophagus, or intestines. Symptoms may include abdominal pain, vomiting, fever, and chills.

Wounds that don’t heal. ZALTRAP can interfere with wound healing. Do not undergo surgery or medical procedures (including tooth extractions) without discussing first with your doctors, as ZALTRAP should not be used at least 4 weeks before or 4 weeks after surgery and until the wound is fully healed.

Patients treated with ZALTRAP have experienced serious side effects. Your doctor may adjust or stop your ZALTRAP treatment if you have these or other side effects:

Before receiving ZALTRAP, tell your doctor if you:

The most common side effects of ZALTRAP include:

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of ZALTRAP. For more information, ask your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088.

Please see full Prescribing Information, including Boxed WARNING.

In the U.S., ZALTRAP is a registered trademark of Regeneron Pharmaceuticals, Inc.

US.AFL.13.05.001 Last Update: May 2013

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