Ziv-aflibercept Injection

WHY is this medicine prescribed?

Ziv-aflibercept injection is used in combination with other chemotherapy medications to treat cancer of the colon (large intestine) or rectum that has spread to other parts of the body. Ziv-aflibercept is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Ziv-aflibercept injection come as a solution to be injected intravenously (into a vein) over at least 1 hour by a doctor or nurse in a medical facility. Ziv-aflibercept is usually given once every 14 days.

Your doctor may need to decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with ziv-aflibercept injection.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ziv-aflibercept injection,

• tell your doctor and pharmacist if you are allergic to ziv-aflibercept, any other medications, or any of the ingredients in ziv-aflibercept injection. Ask your doctor or pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• tell your doctor if you have recently had any unusual or severe bleeding such as coughing up blood, vomiting blood, or bloody or black tarry stools. Also tell your doctor if you have an open or healing wound, if you have or have ever had high blood pressure; a stroke; transient ischemic attacks (TIA); angina (chest pain); a fistula (abnormal connection between 2 organs inside your body or between an organ and the outside of your body); a tear in the wall of your stomach or intestine; an aneurysm (swelling and weakening of part of a blood vessel) or artery dissection (tear in a blood vessel wall); or kidney or liver problems.

• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you start treatment with ziv-aflibercept. You should not become pregnant during your treatment and for 3 months after your last dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while using ziv-aflibercept, call your doctor. Ziv-aflibercept may harm the fetus.

• tell your doctor if you are breast-feeding. You should not breastfeed during your treatment with ziv-aflibercept and for 1 month after your last dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of receiving ziv-aflibercept injection.

• you should know that ziv-aflibercept may cause high blood pressure. Your blood pressure should be checked regularly while you are receiving ziv-aflibercept.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Ziv-aflibercept may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• loss of appetite
• weight loss
• sores in the mouth or throat
• tiredness
• voice changes
• hemorrhoids
• diarrhea
• dry mouth
• darkening of the skin

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• nosebleeds or bleeding from your gums; coughing up or vomiting blood or material that looks like coffee grounds; unusual bleeding or bruising; pink, red, or dark brown urine; red or tarry black bowel movements; dizziness; or weakness
• stomach pain, constipation, nausea, vomiting, or fever
• leakage of fluids through an opening in the skin
• slow or difficult speech
• headache
• dizziness or faintness
• weakness or numbness of an arm or leg
• chest pain
• shortness of breath
• seizures
• extreme tiredness
• confusion
• change in vision or loss of vision
• sore throat, fever, chills, ongoing cough and congestion, or other signs of infection
• swelling of the face, eyes, stomach, hands, feet, ankles, or lower legs
• unexplained weight gain
• foamy urine
• pain, tenderness, warmth, redness, or swelling in one leg only
• redness, pain, blisters, bleeding, or swelling on the palms of your hands or soles of your feet

Ziv-aflibercept may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ziv-aflibercept.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.