(ziv a FLIB er sept)

Trade Name: Zaltrap®

Ziv-aflibercept is the generic name for the trade name drug Zaltrap. In some cases, health care professionals may use the trade name Zaltrap when referring to the generic drug name ziv-aflibercept.

Drug Type:

Ziv-aflibercept is classified as an antineoplastic (anti-cancer) and ­­­­­­­­­vascular endothelial growth factor (VEGF) inhibitor. (For more detail, see “How Ziv-aflibercept Works” below)

What Ziv-aflibercept Is Used For:

• Treatment of patients with metastatic colorectal cancer. Ziv-aflibercept is used in combination with other chemotherapy agents.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Ziv-aflibercept Is Given:

• Ziv-aflibercept is given through a vein (intravenously, IV) over 1 hour. It is given before the other chemotherapy agents scheduled for the same treatment day.

The amount of ziv-aflibercept that you will receive depends on many factors, including your weight, your general health or other health problems, and the type of cancer or condition you have. Your doctor will determine your exact dosage and schedule.

Side Effects:

Important things to remember about the side effects of ziv-aflibercept:

• Side effects listed occurred when Ziv-afibercept was given with FOLFIRI
• Most people will not experience all of the ziv-aflibercept side effects listed.
• Ziv-aflibercept side effects will improve after therapy is complete.
• Side effects can be managed. Discuss options to minimize or prevent the side effects with your healthcare provider.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking ziv-aflibercept in combination therapy with fluorouracil, leucovorin and irinotecan (FOLFIRI):

• Low blood counts. Your white and red blood cells and platelets may temporarily decrease. This can put you at increased risk for infection, anemia and/or bleeding.
• Diarrhea
• Increase in blood liver enzyme tests
• Proteinuria (protein in urine)
• Mouth sores
• Fatigue
• Infection
• Hypertension (high blood pressure)
• Bleeding
• Decreased appetite
• Weight loss

The following side effects are uncommon (occurring in 10 to 29%) for patients taking ziv-aflibercept in combination therapy with fluorouracil, leucovorin and irinotecan (FOLFIRI):

• Dysphonia (difficulty with speech)
• Headaches
• Abdominal pain
• Increased creatinine (blood test for kidney function)
• Shortness of breath
• Hand -foot syndrome (swelling, redness, pain and/or peeling of the skin on the palms of hands and soles of feet)
• Eye discomfort and/or redness of eye

These are rare but serious complications of ziv-aflibercept:

• Perforation (holes) in the GI (gastrointestinal) tract
• Uncontrolled bleeding
• Impaired wound healing, fistulas

• Blood clots

Not all side effects are listed above. But you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately and notify your health care provider, if you experience the following symptoms:

• Chest pain, shortness of breath

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.5º F (38º C) or higher, chills (possible signs of infection)
• Unusual bleeding
• Severe headache, light headedness or other neurological symptoms (numbness, tingling, difficulty speaking, Change in thinking clearly and with logic).

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Yellowing of skin or eyes
• Pain or burning with urination
• Extreme fatigue (unable to carry on self-care activities)
• Mouth sores (painful redness, swelling or ulcers)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting ziv-aflibercept treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• Do not receive any kind of immunization or vaccination without your doctor’s approval.
• Do not undergo any procedures or surgery (including dental work) without discussing first with your doctor.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category C (use in pregnancy only when benefit to the mother outweighs risk to the fetus). Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.).
• For both men and women: Use contraceptives, and do not conceive a child (get pregnant) while taking ziv-aflibercept and for 3 months after the last dose. Barrier methods of contraception, such as condoms, are recommended.
• Do not breast feed while taking ziv-aflibercept.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• Monitor your blood pressure and notify your physician if blood pressure is elevated or if you develop severe headache, light headedness or other neurological symptoms (numbness, tingling, difficulty speaking).
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
• Follow regimen of anti-diarrhea medication as prescribed by your health care professional.
• Eat foods that may help reduce diarrhea (see managing side effects - diarrhea).

• Prevention of hand-foot syndrome. Modification of normal activities of daily living to reduce friction and heat exposure to hands and feet, for about a week after treatment.
• Keep palms of hands and soles of feet moist using emollients.

• Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition .
• Maintain physical activity as tolerated.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your doctor while you are taking ziv-aflibercept, to monitor side effects and check your response to therapy. Periodic blood work will be obtained to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.

How Ziv-aflibercept Works:

In normal tissue, new blood vessels are formed during tissue growth and repair (for example in a healing wound) and during the development of baby during pregnancy. Blood vessels carry oxygen and nutrients to tissue that are necessary for growth and survival. In cancer, tumors need blood vessels in order to grow and spread.

Through a complex process, endothelial cells (which line the blood vessels) are able to divide and grow and create new blood vessels. Vascular endothelial growth factor (VEGF) is a cytokine (a small protein released by cells that have specific behavior of cells) which when it interacts with its receptors in the cell leads to new blood vessel formation (angiogenesis).This process, (angiogenesis) occurs in both healthy tissue and in cancerous tissue.

Ziv-aflibercept (also known as VEGF-trap) works by interfering with the process of angiogenesis by targeting human vascular endothelial growth factor (VEGF). Ziv-aflibercept acts as a decoy receptor for VEGF-A, VEGF-B, and placental growth factor (PIGF) which prevent VEGF receptor binding activation to their receptors. This leads to antiangiogenesis and tumor regression.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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