Care During Chemotherapy and Beyond
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.
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
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
- Nausea and vomiting
- Poor appetite
- 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
- Rash, petechiae, or bruising (see skin reactions)
- Abdominal pain
- Mouth sores
- 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)
- 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
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
- 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.
- 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
- Do not breast feed while taking this medication.
- Drink at least two to three quarts of fluid every 24 hours, unless you are instructed
- 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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