Gemtuzumab (Intravenous)

Gemtuzumab injection is used by itself or with other medicines (like 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 returned (relapsed) or after other medicines did not work well (refractory).

Gemtuzumab is an antineoplastic (cancer) medicine. It stops cancer cells from growing, and the body eventually destroys them. Since gemtuzumab can also affect the growth of normal cells, other side effects may happen. Before starting treatment, talk to your doctor about the benefits of this medicine and the possible risks of using it.

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

It is very important that your doctor checks your progress at regular visits to ensure 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 get pregnant, 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 (for example, 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, a 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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.

Pediatric

Appropriate studies performed to date have not shown any pediatric-specific problems that would limit the usefulness of gemtuzumab injection with other medicines in children 1 month of age and older with newly-diagnosed AML. Safety and effectiveness have not been established for children with newly-diagnosed AML receiving gemtuzumab injection alone.

Appropriate studies performed to date have not shown any 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 effectiveness have not been established for children younger than 2 years of age with relapsed or refractory AML.

Geriatric

Appropriate studies performed to date have not shown any geriatric-specific problems that would limit the usefulness of gemtuzumab injection in elderly patients. However, elderly patients are more likely to experience high fever or serious infections, which may require caution in patients receiving this medicine.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might occur. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the following medicines. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Levoketoconazole
• Methotrexate
• Pexidartinib
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about 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 to inform your doctor if you have any other medical issues, especially:

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

• 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.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away 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 happen that usually do not require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Additionally, your healthcare professional may be able to tell you about ways to prevent or lessen some of these side effects. Check with your healthcare professional if any of the following side effects continue, 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.

In the U.S.

• Mylotarg

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Antibody Drug Conjugate

Find detailed information on biosimilars for this medication.

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.