Generic Name: ziv-aflibercept (ziv-a-FLIB-er-sept)
Brand Name: Zaltrap
The risk of severe and sometimes fatal bleeding is increased with Zaltrap. Patients who have severe bleeding should not use Zaltrap. Tell your doctor right away if you experience dark, tarry, or bloody stools; bloody or dark urine; confusion; coughing up blood; light-headedness; nosebleeds; one-sided weakness; severe stomach pain; slurred speech; unusual bruising or bleeding; vision problems; or vomit that looks like coffee grounds.
Serious and possibly fatal stomach or bowel problems (eg, perforation or a hole in the stomach or bowel) may occur with Zaltrap. Tell your doctor right away if you develop severe stomach pain, fever, nausea, or vomiting.
Zaltrap may delay wound healing. Tell your doctor immediately if you notice any wounds that do not heal. Tell your doctor if you are scheduled to have surgery, including tooth extractions, or if you have had surgery within in the past 28 days. Talk with your doctor for more information.
Zaltrap is used for:
Treating colorectal cancer that has spread to other parts of the body in certain patients. It is used in combination with other medicines.
Zaltrap is a recombinant fusion protein. It works by blocking certain growth factors that are involved in the formation of new blood vessels in tumors to prevent tumor growth.
Do NOT use Zaltrap if:
- you are allergic to any ingredient in Zaltrap
- you have severe bleeding or uncontrolled high blood pressure
- you have a wound (including a surgical wound) that has not healed
Contact your doctor or health care provider right away if any of these apply to you.
Before using Zaltrap:
Some medical conditions may interact with Zaltrap. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of bleeding problems, blood clots, blood vessel problems, stroke or transient ischemic attack (TIA) (mini-stroke), chest pain, high blood pressure, heart problems (eg, heart failure), kidney problems, low levels of neutrophils (white blood cells), or stomach or bowel problems (eg, fistula, perforation)
- if you have protein in your urine or diarrhea or vomiting, or you are dehydrated
- if you have a wound that has not fully healed
- if you have had recent surgery or if you will be having surgery (including tooth extraction)
Some MEDICINES MAY INTERACT with Zaltrap. However, no specific interactions with Zaltrap are known at this time.
Ask your health care provider if Zaltrap may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Zaltrap:
Use Zaltrap as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Zaltrap is given as an injection at your doctor's office, hospital, or clinic.
- Do not use Zaltrap if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- If you miss a dose of Zaltrap, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Zaltrap.
Important safety information:
- Zaltrap may cause or worsen high blood pressure. Your doctor will monitor your blood pressure while you are taking Zaltrap. Tell your doctor if you experience severe or persistent headache or dizziness.
- Zaltrap may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if notice signs of infection like fever, sore throat, rash, or chills.
- If vomiting or diarrhea occurs, you will need to take care not to become dehydrated. Contact your doctor for instructions.
- A serious and sometimes fatal brain problem called reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in patients taking Zaltrap. Contact your doctor right away if you experience severe headaches, seizures, sluggishness, confusion, problems thinking, or vision changes (eg, loss of vision).
- Zaltrap may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Women who may become pregnant should use effective birth control while they are taking Zaltrap and for at least 3 months after the last dose. Check with your doctor if you have questions about effective birth control.
- Men who may father a child should use effective birth control while taking Zaltrap and for at least 3 months after the last dose. Check with your doctor if you have questions about effective birth control. If your partner becomes pregnant, contact your doctor right away.
- Tell your doctor or dentist that you take Zaltrap before you receive any medical or dental care, emergency care, or surgery. Zaltrap may need to be stopped at least 28 days before having surgery.
- Lab tests, including complete blood cell counts and urine protein levels, may be performed while you use Zaltrap. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Zaltrap with caution in the ELDERLY; they may be more sensitive to its effects, especially dehydration, diarrhea, dizziness, weakness, and weight loss.
- Zaltrap should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor right away. You will need to discuss the benefits and risks of using Zaltrap while you are pregnant. It is not known if Zaltrap is found in breast milk. Do not breast-feed while using Zaltrap.
Possible side effects of Zaltrap:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Dark skin patches; diarrhea; hemorrhoids; loss of appetite; mild headache or stomach pain; runny nose; tiredness; weakness; weight loss.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or dark urine; calf or leg pain, swelling, redness, or tenderness; chest pain; confusion; coughing up blood; dark, tarry, or bloody stools; decreased urination; dry mouth or eyes; light-headedness; nosebleeds; numbness, tingling, pain, redness, swelling, or peeling of the skin on the palms of the hands or soles of the feet; one-sided weakness; severe or persistent diarrhea or stomach pain; severe or persistent headache or dizziness; shortness of breath; sluggishness; speech problems (eg, slurred speech); swelling or soreness of the mouth or tongue; symptoms of infection (eg, fever, chills, or persistent cough or sore throat; difficult or painful urination; tooth pain); unusual bruising or bleeding; unusual tiredness or weakness; vision problems; vomit that looks like coffee grounds; wounds that do not heal.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Zaltrap:
Zaltrap is usually handled and stored by a health care provider. Keep Zaltrap out of the reach of children and away from pets.
- If you have any questions about Zaltrap, please talk with your doctor, pharmacist, or other health care provider.
- Zaltrap is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Zaltrap or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Zaltrap. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Zaltrap. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Zaltrap.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.