Pronunciation:

jem-TOOZ-oo-mab oh-zoe-ga-MYE-sin

Brand Names:

• Mylotarg

Dosage Forms:

• Powder for Solution

Warnings:

Hepatotoxicity, including severe or fatal hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), has been reported in association with the use of gemtuzumab ozogamicin as a single agent, and as part of a combination chemotherapy regimen. Monitor frequently for signs and symptoms of VOD after treatment with gemtuzumab ozogamicin

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antibody Drug Conjugate

Uses of This Medicine:

Gemtuzumab injection is used alone or together with other medicines (eg, cytarabine, daunorubicin) to treat newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults. It is also used alone to treat CD33-positive AML that has come back (relapsed) or after other medicines did not work well (refractory).

Gemtuzumab is an antineoplastic (cancer) medicine. It interferes with the growth of cancer cells, which are eventually destroyed by the body. Since the growth of normal cells may also be affected by gemtuzumab, other side effects can occur. Before you begin treatment, talk to your doctor about the benefits of this medicine as well as the possible risks of using it.

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gemtuzumab injection together with other medicines in children 1 month of age and older with newly-diagnosed AML. Safety and efficacy have not been established in children with newly-diagnosed AML to receive gemtuzumab injection alone.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of gemtuzumab injection in children 2 years of age and older with relapsed or refractory AML. Safety and efficacy have not been established children younger than 2 years of age with relapsed or refractory AML.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of gemtuzumab injection in the elderly. However, elderly patients are more likely to have high fever or serious infections, 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

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.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Levoketoconazole
• Methotrexate
• Pexidartinib
• Poliovirus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

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:

• Electrolyte imbalance or
• Liver disease, moderate or severe or
• Patients who have had hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

• Heart rhythm problems (including QT prolongation), history of—Use with caution. May make this condition worse.

• Hyperleukocytosis (blood problem)—Surgical removal of cancer cells is recommended before starting treatment with gemtuzumab.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 2 hours.

You may receive other medicines (eg, allergy medicine, fever medicine, steroids) before starting treatment with this medicine.

Precautions While Using This Medicine:

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

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. 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. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before receiving this medicine. Some men and women receiving this medicine have become infertile (unable to have children).

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem (eg, hepatic veno-occlusive disease or sinusoidal obstruction syndrome).

This medicine may cause infusion-related reactions, including anaphylaxis, 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, fast, slow, pounding, or irregular heartbeat, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed more easily, which can be life-threatening. Check with your doctor right away if you have any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, headache, dizziness, weakness, pain, swelling, or discomfort in a joint, pinpoint red spots on your skin, unusual nosebleeds, or unusual vaginal bleeding that is heavier than normal.

Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you had a heart rhythm problem, such as QT prolongation.

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

Bleeding gums

blood in the urine or stools

blurred vision

bone pain

chest pain

chills

confusion

cough

coughing up blood

decreased urine output

difficulty in breathing or swallowing

dizziness, lightheadedness, or fainting

dry mouth

fast or irregular heartbeat

fever

flushed, dry skin

fruit-like breath odor

headache

hoarseness

increased hunger

increased menstrual flow or vaginal bleeding

increased thirst

increased urination

irregular heartbeat

loss of appetite

loss of consciousness

lower back or side pain

mood changes

muscle pain or cramps

nausea

nosebleeds

numbness or tingling in the hands, feet, or lips

painful or difficult urination

paralysis

pinpoint red spots on the skin

prolonged bleeding from cuts

rapid, shallow breathing

rash

red or black, tarry stools

red or dark brown urine

seizures

sore throat

stomach pain and bloating

sweating

swelling of the face, ankles, or hands

tightness in the chest

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Less common

Blue lips and fingernails

coughing that sometimes produces a pink frothy sputum

difficult, fast, noisy breathing

fast, pounding, or irregular heartbeat or pulse

increased sweating

pale skin

ulcers, sores, or white spots in the mouth

Incidence not known

Stomach cramps

watery or bloody diarrhea

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

Constipation

Less common

Cracked lips

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.