Gemtuzumab ozogamicin (Mylotarg®)

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Last Modified: January 22, 2006

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Gemtuzumab ozogamicin is a monoclonal antibody attached to chemotherapy. Monoclonal antibodies are designed to target a specific type of cell. In this case, the target is "CD 33", a receptor that is found on the outside of leukemia cells in 80% of patients with acute myelogenous leukemia (AML). The antibody finds its way to the leukemia cells, attaches itself, and enters the cell with the chemotherapy. This allows the chemotherapy to kill the cell.

Facts about gemtuzumab ozogamicin

  • Gemtuzumab ozogamicin is approved by the Food & Drug Administration to treat patients with acute myelogenous leukemia (AML) that is positive for the CD 33 receptor.
  • Gemtuzumab ozogamicin is generally used in patients who are over 60 years of age or those who cannot tolerate the standard treatment for AML.

How to take gemtuzumab ozogamicin: Gemtuzumab ozogamicin is given directly into a vein and the infusion generally takes 2 hours. Allergic reactions are common, so you will receive medications before the infusion to prevent this reaction. The actual dose is dependent upon your body size.

How long should you take gemtuzumab ozogamicin? It is not known how many times you can receive gemtuzumab ozogamicin. Patients in clinical trials received a maximum of 2 doses.

Side effects of gemtuzumab ozogamicin

Some of the possible side effects and suggestions for dealing with them include:

Infusion Reactions

Infusion reactions are common and can occur during the infusion or within 24 hours after the infusion. Reactions can include fever, shaking chills, low blood pressure, and shortness of breath. These reactions may be prevented or reduced with pre-medications (diphenhydramine and acetaminophen). In some cases, reactions can be more severe and require discontinuation of the drug. This reaction is called anaphylaxis (a life-threatening allergic reaction), and can include: difficulty breathing, wheezing, tightening of the throat, swelling of the face and hives.

Low White Blood Cell Count

White blood cells are important for fighting infection. While receiving treatment you are at a higher risk of getting infections. You should wash your hands frequently, avoid large crowds and people who are sick or have colds. Your doctor will prescribe some medications to prevent 2 particular infections; pneumocystis carinii pneumonia (PCP) and herpes zoster. You should let your doctor or nurse know right away if you have a fever (temperature greater than 100.4), sore throat or cold, or a sore that doesn't heal.

Low Platelet Count

Platelets help your blood clot, so when the count is low you are at a higher risk of bleeding. You should not use a razor (an electric razor is fine), play any contact sports, or take any aspirin or ibuprofen products (lease can also increase the risk of bleeding). Let your doctor or nurse know if you have any bleeding, including nose bleeds or bleeding gums. If the count becomes too low you may receive a transfusion of platelets.

Low Red Blood Cell Count (Anemia)

Your red blood cells are responsible for carrying oxygen to the tissues in your body. When the red cell count is low, you may feel tired or weak. You should let your doctor or nurse know if you experience any shortness of breath, difficulty breathing, or pain in your chest. If the count gets too low you may receive a blood transfusion.

Diarrhea

Your doctor or nurse can recommend medication to relieve diarrhea. Also, try eating low-fiber bland foods, such as white rice and boiled or baked chicken. Avoid raw fruits, vegetables, whole grain breads and cereals, and seeds. Soluble fiber is a type of fiber found in some foods. Soluble fiber absorbs fluid and can help relieve diarrhea. Foods high in soluble fiber include: applesauce, bananas (ripe), canned fruit, orange and grapefruit sections, boiled potatoes, white rice and products made with white flour, oatmeal, cream of rice, cream of wheat and farina. Drink 8-10 glasses of non-alcoholic fluid a day to prevent dehydration.

Nausea and/or Vomiting

In general, nausea and vomiting associated with gemtuzumab ozogamicin occurs during or shortly after the infusion. It is a good idea to have something light to eat before your treatment. There are many effective drugs that will prevent, eliminate, or lessen the severity of nausea and vomiting if you need them, just ask your doctor which is best for you. In addition, dietary adjustments may help. Avoid things that worsen the symptoms, try antacids like milk of magnesia and calcium tablets (like Tums), or have saltines or ginger ale to lessen symptoms.

Muscle or Joint Pain/Aches and Headache

Your doctor or nurse can recommend medication and other strategies to relieve pain.

Fatigue

See OncoLink's section on fatigue for helpful tips.

Decrease in Appetite

Gemtuzumab ozogamicin may affect your appetite. See OncoLink's section on Nutrition for tips on dealing with this side effect.

Tumor Lysis Syndrome

Tumor lysis syndrome occurs when large amounts of cancerous cells are rapidly killed by a treatment. The dying cells release uric acid, potassium, and phosphorus into the blood stream. Elevated levels of these can lead to kidney failure. Tumor lysis syndrome usually occurs within 24 - 48 hours of therapy. In order to prevent this from occurring, you will receive plenty of fluids to keep you hydrated and be given a drug called allopurinol that blocks uric acid production. If your white blood cell count is very high, you may have some other treatment to lower this count before receiving gemtuzumab ozogamicin.

Veno-Occlusive Disease

Veno-occlusive disease (VOD) is a rare, but very serious complication of this medication. VOD is a disease that causes severe damage to the liver and is characterized by a painful, enlarged liver, rapid weight gain from fluid retention, and rising bilirubin levels (a blood test). Two of these three must be present to establish the diagnosis. Once VOD occurs, the chances for other organs to fail increases dramatically and potentially fatal multi-organ failure may occur.


News
Concerns focus on recent data showing lack of clinical benefit, increased number of deaths

Jun 23, 2010 - Gemtuzumab ozogamicin (Mylotarg) -- used in treating acute myeloid leukemia -- has been voluntarily withdrawn from the U.S. market following concerns over a recent clinical trial, according to a June 21 news release from the U.S. Food and Drug Administration.



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