Ziv-aflibercept Injection

(ziv a flib' er sept)

Brand Name(s): , Zaltrap^®

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IMPORTANT WARNING:

Ziv-aflibercept may cause severe bleeding that can be life-threatening. Tell your doctor if you have recently noticed any unusual bruising or bleeding. Your doctor may not want you to receive ziv-aflibercept. If you experience any of the following symptoms at any time during your treatment, call your doctor immediately: 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.

Ziv-aflibercept may cause you to develop a hole in the wall of your stomach or intestine. This is a serious and possibly life-threatening condition. If you experience any of the following symptoms, call your doctor immediately: stomach pain, constipation, nausea, vomiting, or fever.

Ziv-aflibercept may slow the healing of wounds, such as cuts made by a doctor during surgery. In some cases, ziv-aflibercept may cause a wound that has closed to split open. This is a serious and possibly life-threatening condition. If you experience this problem, call your doctor immediately. Tell your doctor if you have recently had surgery or if you plan to have surgery, including dental surgery. If you have recently had surgery, you should not use ziv-aflibercept until at least 28 days have passed and until the area has completed healed. If you are scheduled to have surgery, your doctor will stop your treatment with ziv-aflibercept at least 28 days before the surgery.

Talk to your doctor about the risks of using ziv-aflibercept.

WHY is this medicine prescribed?

Ziv-aflibercept injection is used in combination with other 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 delay your treatment or adjust your dose 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.

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 or any other medications.
• 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 are pregnant, plan to become pregnant, or if you plan to father a child. You or your partner should use birth control to prevent pregnancy during your treatment with ziv-aflibercept and for at least 3 months after you stop using the medication. If you or your partner 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.
• 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
• dryness, thickness, cracking, or blistering of skin on the palms of the hands and the soles of the feet

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:

• 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

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 ([WEB]) 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 [WEB]. 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.

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This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2023. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: January 15, 2013.