Pronunciation:

mar-je-TUX-i-mab - cmkb

Brand Names:

• Margenza

Dosage Forms:

• Solution

Warnings:

Warning: Left Ventricular Dysfunction and Embryo-fetal ToxicityLeft Ventricular Dysfunction: Margetuximab-cmkb may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue margetuximab-cmkb treatment for a confirmed clinically significant decrease in left ventricular function.Embryo-fetal Toxicity: Exposure to margetuximab-cmkb during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Margetuximab

Uses of This Medicine:

Margetuximab-cmkb injection is used to treat metastatic (cancer that has spread) HER2-positive breast cancer in patients who have received two or more anti-HER2 breast cancer treatments, and at least one treatment for metastatic disease.

Margetuximab-cmkb is a monoclonal antibody that changes the immune system to help control the growth of cancer cells.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of margetuximab-cmkb injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of margetuximab-cmkb injection in the elderly. However, elderly patients are more likely to have serious unwanted effects (eg, heart problems), which may require caution in patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Daunorubicin
• Daunorubicin Citrate Liposome
• Daunorubicin Liposome
• Doxorubicin
• Epirubicin
• Idarubicin
• Pirarubicin
• Pixantrone
• Valrubicin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart disease—Use with caution. May make this condition worse.

Proper Use of This Medicine:

Medicines used to treat cancer are very strong and can have many unwanted effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be given slowly, so the needle will have to remain in place for at least 2 hours for the first dose and at least 30 minutes for the next doses. The injection is usually given every 3 weeks.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 4 months after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause heart problems (eg, left ventricular dysfunction). Check with your doctor right away if you have chest pain, decreased urine output, dilated neck veins, irregular breathing, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, tightness in the chest, trouble breathing, unusual tiredness or weakness, or weight gain.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

chest pain or tightness

chills

cough

decreased urine output

difficulty in moving

dilated neck veins

fever

flushing

headache

irregular breathing

irregular heartbeat

muscle aches, cramps, pain, or stiffness

nausea and vomiting

pain in the joints

redness, swelling, pain of the skin

scaling of the skin on the hands and feet

swelling of the face, fingers, feet, or lower legs

swollen joints

tingling of the hands and feet

trouble breathing

ulceration of the skin

unusual tiredness or weakness

weakness

weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Arm or leg pain

burning, numbness, tingling, or painful sensations

constipation

decreased appetite

diarrhea

hair loss, thinning of hair

stomach pain

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.