Warnings:

Margetuximab may lead to serious heart problems, including heart failure. Your doctor will do heart exams before and during treatment with this medication. Tell your doctor right away if you have any symptoms of heart failure, such as new or worsening shortness of breath, swelling ankles/feet, swelling of the face, fast heartbeat, fainting, unusual tiredness, or unusual/sudden weight gain.

Margetuximab may cause serious (possibly fatal) harm to an unborn baby if used during pregnancy. Discuss reliable forms of birth control with your doctor. See also Precautions section.

How to use Margenza 25 Mg/Ml Intravenous Solution Antineoplast EGF Receptor Blocker Recomb Monoclonal Antibody

This medication is given by slow injection into a vein as directed by your doctor, usually once every 3 weeks. The injection is given by a health care professional. The first injection is given over at least 120 minutes. Later doses may be given over a shorter time (at least 30 minutes).

The dosage, the speed of your injection, and the length of time you receive margetuximab are based on your body weight, medical condition, and response to treatment.

To get the most benefit from this medication, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

Side Effects

See also Warning section.

Dizziness, diarrhea or constipation, abdominal pain, nausea, vomiting, headache, sweating, fast heartbeat, or shortness of breath may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Temporary hair loss may occur. Normal hair growth should return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: unusual tiredness, muscle/joint pain, numbness/tingling/pain in the arms/legs, pale skin, easy bruising/bleeding.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before using margetuximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent/current infection, heart disease.

Margetuximab can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using margetuximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication. You should not become pregnant while using margetuximab. Margetuximab may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 4 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consult your pharmacist or physician.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Lab and/or medical tests (such as heart exams, complete blood counts, liver function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage

Not applicable. This medication is given in a clinic or hospital and will not be stored at home.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.