Mylotarg®

Posted on June 22nd, 2010 by

Class: Biologic therapy

Generic Name: Gemtuzumab ozogamicin (jem-TOO-zoo-mab oh-zoe ga-MY-sin)
Trade Name: Mylotarg®

For which conditions is this drug approved? Gemtuzumab ozogamicin is FDA-approved for the treatment of patients who are 60 years or older, are not suitable candidates for chemotherapy, and have CD 33-positive acute myeloid leukemia in first relapse. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Gemtuzumab ozogamicin is classified as a monoclonal antibody. Gemtuzumab ozogamicin is comprised of two separate components, a monoclonal antibody and a toxin from the bacteria Micromonospora echinospora. The monoclonal antibody portion of gemtuzumab ozogamicin binds to a receptor, called the CD 33 receptor, on myeloid cells. Once gemtuzumab ozogamicin is bound, the toxin is delivered to the inside of the cell and attaches to the DNA of the cell. This results in cellular death.

How is gemtuzumab ozogamicin typically given (administered)? Gemtuzumab ozogamicin is given intravenously (into a vein) and the dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient.

Reactions with gemtuzumab ozogamicin are common and may occur during or immediately following administration of the agent. Infusion-related reactions may be severe. Patients are typically treated with medication prior to administration of gemtuzumab ozogamicin in order to reduce the incidence or severity of reactions during administration. Although patients will be closely monitored for this reaction, they should notify their healthcare provider if they experience difficulty breathing, lightheadedness, fever, chills and/or closing of the throat.

How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with gemtuzumab ozogamicin.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver, and levels of electrolytes.  Temperature and blood pressure will be monitored during and after infusion.  Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.

Patients are also monitored for an uncommon, but serious condition called veno-occlusive disease (VOD) of the liver.  Liver function tests will be abnormal if a patient has VOD.  In addition, patients may experience an enlarged liver, rising bilirubin levels, and rapid fluid retention causing swelling or weight gain.  Patients should notify their healthcare provider if they experience right upper quadrant abdominal pain, rapid swelling or weight gain, or enlargement of the abdomen, as these may be symptoms of VOD.

In addition, patients will be monitored for a condition called tumor lysis syndrome in which electrolyte and metabolic disturbances occur.  Tumor lysis syndrome can be prevented if treated at an early stage.  Blood tests will measure levels of electrolyte and metabolic products, and patients should contact their healthcare provider if they experience symptoms such as nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.

What are the common (occur in 30% or more of patients) side effects of treatment with gemtuzumab ozogamicin?

• Low levels of white blood cells – increases risk of infection
• Low levels of red blood cells – increases risk of anemia and blood transfusions
• Low levels of platelets – increases risk of bleeding
• Nausea and vomiting
• Diarrhea
• Loss of appetite
• Generalized weakness
• Abnormalities in electrolyte levels as determined by blood tests
• Shortness of breath
• Fever
• Chills

What are the less common (occur in 10% to 29% of patients) side effects of treatment with gemtuzumab ozogamicin?

• Changes in blood pressure
• Swelling of hands, feet or face
• Headache
• Skin reactions, rash
• Abdominal pain
• Constipation
• Back pain
• Abnormalities in liver function tests as determined by blood tests
• Changes in heart beat
• Joint pain
• Tumor lysis syndrome
• Depression
• Dizziness
• Difficulty sleeping
• Mouth sores
• Inflammation of the nose or throat, sore throat
• Cough
• Blood in urine

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
• If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
• Wash hands often to reduce the risk of infection.
• Eat small meals frequently to help alleviate nausea.
• If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
• Avoid activities that may cause injury or bruising.
• Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
• For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.

When should patients notify their physician?

• Signs of tumor lysis syndrome: nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort
• Signs of VOD: right upper quadrant abdominal pain, rapid swelling or weight gain, or enlargement of the abdomen
• Signs of reaction with gemtuzumab ozogamicin: difficulty breathing, lightheadedness, fever, chills and/or closing of the throat
• Mouth sores
• Severe or prolonged depression
• Noticeable changes in heart beat or rhythm
• Swelling of hands, feet or face
• Yellowing of skin or eyes
• Difficulty breathing
• Muscle cramping or twitching
• Lightheadedness or dizziness
• Fever, chills, cough, sore throat, flu or cold-like symptoms
• Signs of infection – redness, swelling, pus, tenderness
• Persistent or severe fatigue
• Unexplained or excessive bleeding (nosebleeds, bruising, black tarry stools, blood in the urine, etc.)
• Persistent or extreme diarrhea

What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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Tags: Biological Therapy, M

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