Mylotarg Side Effects

Some medical professionals may administer medications prior to the infusion of Mylotarg to diminish the allergic-type reactions the drug can cause.

Serious side effects

Mylosupression- cardiac and blood problems including low blood counts, white and red blood cells and platelets decrease, low potassium, high/low blood pressure, which all can cause infection (fever and chills) and septic shock
Liver problems including failure (hepatotoxicity) due to Tumor Lysis Syndrome which can cause abdominal and back pain. This occurs when cancer sells are rapidly being killed and the uric acid from the cells is released into the blood.
Veno-occlusive liver disease (VOD) which can happen after chemotherapy followed by bone marrow/stem cell transplants. Symptoms include enlarged liver, weight gain due to fluid retention and high bilirubin levels, which can lead to multiple organ failure.

Common side effects

Mostly occur after infusion and are known to diminish over time:

Poor appetite, diarrhea/constipation and nausea/vomiting which can lead to weakness, anemia and depression.
Common allergic-type reactions like shortness of breath, swelling of face/hands/feet, rashes, mouth sores (mucositis/stomatitis), and inflammation in the throat.
Pains, such as headaches and joint pains.

Warnings & Recalls for Mylotarg

[caption id="attachment_2419" align="alignnone" width="200"]

Mylotarg, as depicted in its vial, used for the treatment of bone marrow cancer.[/caption]

FDA withdrawal warning

In June 2010, Pfizer withdrew Mylotarg from the market at the request of the FDA after it was found that no benefit came from the drug, and that a larger number of patient deaths occurred in those who received Mylotarg as compared to those just receiving chemotherapy. After October 15, 2010, Mylotarg was not available to new patients. Although new evidence suggests that newly diagnosed patients who receive a small amount of Mylotarg combined with chemotherapy may prolong a patient's life, the relaunch of Mylotarg will have to be under a new drug application and resubmitted to the FDA. For more information click here.

Other warnings

Tumor Lysis Syndrome will present itself within 24-48 hours after therapy. Medical professionals must keep patients hydrated and monitor uric acid levels.
Patients should not take aspirin, or aspirin-containing products, and should not receive any vaccinations prior to receiving the infusion.
Mylotarg should be stopped for patients experiencing shortness of breath, drastic hypotension (acute respiratory distress syndrome), anaphylaxis, or fluid in the lungs.
Special caution should be given when Mylotarg is administered in patients with pre-existing liver problems.

Contraindications:

Mylotarg is contraindicated in patients with sensitivity to anti-CD33 antibody (hP67.6), calicheamicin derivatives, dextran 40, sucrose, sodium chloride, monobasic and dibasic sodium phosphate.

Family Planning:

Fertility in males and females may be affected from receiving Mylotarg. It also may cause fetal harm and abnormalities in pregnant women. Women should avoid becoming pregnant while taking Mylotarg. Nursing mothers should be advised that breast feeding is not recommended while receiving Mylotarg infusions.

Mylotarg Treatment and Use

Mylotarg | gemtuzumab ozogamicin is an antineoplastic agent injection used for the treatment of the bone marrow cancer CD33+ acute myeloid leukemia (AML) in patients who are 60 years of age or older and cannot continue other chemotherapy. It was first approved by the FDA in 2000, but later taken off the market by Pfizer in 2010.

How does Mylotarg work?

Mylotarg is a monoclonal antibody cancer therapy treatment. Antibodies are created in the body to defend against antigen proteins by attaching to the antigens so the immune system will attack it at a later time. Monoclonal means that the antigens and antibodies have been identified and the antigens can be specifically attacked. Mylotarg contains the bound form of calicheamicin and monoclonal antibody. This specific antibody targets the CD33+ antigen (which is found on leukemic cells in more than 80% of patients with AML) and destroys it.

Dosage information for Mylotarg

Mylotarg is given intravenously (into a vein) by a medical professional. The recommended dosage of Mylotarg is 9 mg/m2 infused over a 2-hour time span twice with 14 days between the doses but the amount that a patient receives will vary depending on height/weight, health factors, and the severity of the cancer.

Other Names for Mylotarg

Brand Name:

Mylotarg

Generic Name:

gemtuzumab ozogamicin