Generic name: Gemtuzumab Ozogamicin

Chemocare.com uses generic names in all descriptions of drugs. Mylotarg is the trade name for Gemtuzumab Ozogamicin. In some cases, health care professionals may use the trade name Mylotarg when referring to the generic drug name Gemtuzumab Ozogamicin.

Drug type:  Mylotarg is a monoclonal antibody. (For more detail, see "How this drug works" section below).

What This Drug Is Used For:

• Treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults and pediatric patients 1 month and older
• Treatment of relapsed or refractory CC33-positive AL in adults and pediatric patients 2 years and older.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How This Drug Is Given:

• Gemtuzumab ozogamicin is given through intravenous injection into a vein (IV).
• You may receive medications before the infusion to reduce allergic reactions.
• The amount of gemtuzumab ozogamicin that you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer or condition being treated.  Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of gemtuzumab ozogamicin:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration. 
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

Infusion-related side effects (symptoms which may occur as a result of the actual treatment) include:

• Infusion-related reaction: Occur within the first 24 hours after the infusion and most commonly during the first week of treatment.  Symptoms include: fever and chills, low blood pressure, and/or shortness of breath.
• Premedication is given to reduce the incidence of infusion-related reactions.
• Occasionally, infusion-related reactions can be severe including shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, and/or hives.  Patients will be carefully monitored for this type of allergic reaction (anaphylaxis). 

The following side effects are common (occurring in greater than 30%) for patients taking gemtuzumab ozogamicin:

• Low blood counts.  Your white and red blood cells and platelets may temporarily decrease.  This can put you at increased risk for infection, anemia and/or bleeding.
• Nausea and vomiting
• Diarrhea
• Fever
• Chills
• Poor appetite
• Weakness
• Shortness of breath. (see lung problems)
• Blood test abnormalities (low potassium)

These side effects are less common side effects (occurring in about 29%) of patients receiving gemtuzumab ozogamicin:

• Swelling of the face, hands, or feet
• Headache
• Pain
• Rash, petechiae, or bruising (see skin reactions)
• Abdominal pain
• Mouth sores
• Constipation
• High blood pressure or low blood pressure
• Back pain
• Increases in blood tests measuring liver function (increased bilirubin, lactate dehydrogenase, and transaminase).  These return to normal once treatment is discontinued (see liver problems).
• Rapid heartbeat (see heart problems)
• Depression
• Joint pain
• Inflammation of the nose or throat (see cold symptoms)
• Tumor lysis syndrome may occur as a result of leukemia treatment.  Tumor lysis syndrome occurs when large amounts of cancerous cells are rapidly killed by the therapy.  These cells release uric acid, potassium and phosphorus into the blood stream.  Tumor lysis syndrome can lead to kidney failure.  Tumor lysis syndrome usually occurs within 24 - 48 hours of therapy.  Care must be taken to prevent the development of tumor lysis syndrome.  Your health care provider will prescribe plenty of fluids to keep you hydrated.  You may be given a drug called allopurinol that blocks uric acid production.  In some cases, your health care provider may prescribe other measures to lower your white blood count before therapy.  Let your health care provider know immediately if you are unable to urinate.  Your health care provider will monitor your progress carefully during therapy.

A serious, but uncommon side effect of gemtuzumab ozogamicin is veno-occlusive liver disease (VOD).  VOD is most common in patients who have been treated with high dose chemotherapy followed by bone marrow or stem cell transplant.VOD is characterized by painful enlarged liver, rapid weight gain from fluid retention, and rising bilirubin levels.  Two of the three in a post-treatment setting must be present to establish the diagnosis.  Additional testing will reveal elevated liver enzymes (Alkaline phosphatase and GGT); as well as a reversal of blood flow in the veins of the liver on ultrasound.  Once VOD occurs, the chances for other organs to fail increases dramatically and potentially fatal multi-organ failure may occur.

Your fertility, meaning your ability to conceive or father a child, may be affected by gemtuzumab ozogamicin.  Please discuss this issue with your health care provider.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here.  However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Seek emergency help immediately and notify your health care provider, it you experience the following symptoms:

• Shortness of breath, wheezing, difficulty breathing, closing up of the throat, swelling of facial features, hives (possible allergic reaction).

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° C) or higher, chills (possible signs of infection)
• Shortness of breath

The following symptoms require medical attention, but are not an emergency.  Contact your health care provider within 24 hours of noticing any of the following:

• Nausea (interferes with ability to eat and unrelieved with prescribed medication)
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Diarrhea (4-6 episodes in a 24-hour period)
• Unusual bleeding or bruising
• Black or tarry stools, or blood in your stools
• Blood in the urine
• Rapid heartbeat
• Extreme fatigue (unable to carry on self-care activities)
• Mouth sores (painful redness, swelling or ulcers)
• Yellowing of the skin or eyes
• Swelling of the feet or ankles.  Sudden weight gain
• Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination.
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
• Depressed (interfering with your ability to carry on your regular activities)

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting gemtuzumab ozogamicin treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).   Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking gemtuzumab ozogamicin.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (gemtuzumab ozogamicin may be hazardous to the fetus.  Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus).
• For both men and women: Do not conceive a child (get pregnant) while taking gemtuzumab ozogamicin. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds and those not feeling well, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1/2 to 1 teaspoon of baking soda and/or 1/2 to 1 teaspoon of salt mixed with 8 ounces of water.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• Avoid contact sports or activities that could cause injury.
• To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals. 
• Acetaminophen (Tylenol^®) may help relieve discomfort.  However, be sure to talk with your doctor before taking it.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely.  You should discuss this with your doctor.
• Get plenty of rest. 
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team.  They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking gemtuzumab ozogamicin, to monitor side effects and check your response to therapy.  Periodic blood work to monitor your complete blood count (CBC) as well as the function of other organs (such as your kidneys and liver) will also be ordered by your doctor.   

How This Drug Works:

Monoclonal antibodies are a relatively new type of "targeted" cancer therapy.  Antibodies are part of the immune system.  Normally, the body creates antibodies in response to an antigen (such as a protein in a germ) entering the body.  The antibodies attach to the antigen in order to mark it for destruction by the body's immune system.  In the laboratory, scientists analyze specific antigens on the surface of cancer cells (target) to determine a protein to match the antigen.  Then, using animal and human proteins, scientists work to create a special antibody that will attach to the target antigen.  Antibodies will attach to matching antigens like a key fits a lock.  This technology allows treatment to target specific cells, causing less toxicity to healthy cells.   Monoclonal antibody therapy can be done only for cancers in which antigens (and the respective antibodies) have been identified.

Gemtuzumab ozogamicin Consists of a chemotherapy drug, calicheamicin, attached to a monoclonal antibody that targets the CD33 antigen, found on leukemic blast cells in more than 80% of patients with acute myelogenous leukemia (AML), as well as normal myeloid cells.  When the gemtuzumab ozogamicin binds to the CD33 antigen, the antigen-antibody complex moves to the inside of the cell.  Once inside, the calicheamicin derivative is released.  The calicheamicin derivative attaches to the DNA, resulting in the death of the myeloid cell.  This process does not affect pluripotent stem cells (cells that will ultimately become new blood cells - including myeloid cells).

Note:  We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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