Description
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.
This product is available in the following dosage forms:
- Powder for Solution
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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 Type 4, Live
- Adenovirus Vaccine Type 7, 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
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
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
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.
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