Mylotarg® | |
Brand Name: | Mylotarg® |
Active Ingredient: | gemtuzumab ozogamicin |
Strength(s): | 5mg per 20mL vial |
Dosage Form(s): | Intravenous injection |
Company Name: | Wyeth Ayerst |
Availability: | Prescription only, hospital use only |
*Date Approved by FDA: | May 17, 2000 |
*Approval by FDA does not mean that the drug is available for consumers at this time. |
What
is Mylotarg used for? Mylotarg is used
to treat a form of bone marrow cancer (CD33 positive acute myeloid
leukemia) in patients who are:
The safety and
effectiveness of Mylotarg in patients with poor performance status and
organ dysfunction is not known and has not been tested. In
addition, the effectiveness of Mylotarg in improving symptoms, keeping
the disease from getting worse, or helping patients live longer
compared with standard treatments is not known. Special Warnings Concerning Mylotarg:
Mylotarg
should only be given by doctors who are experienced in the treatment
of acute leukemia and in facilities equipped to monitor and treat
leukemia patients.
Mylotarg causes a
severe decrease in the body’s ability to produce bone marrow.
Patients will be monitored by their doctor for the signs and
symptoms of this condition.
Severe
liver toxicity has been reported in patients taking Mylotarg.
Symptoms of this condition may include rapid weight gain,
right-sided pain, and elevated liver function tests.
Extra caution should be used in patients with liver disease.
General Precautions with Mylotarg: When large numbers
of leukemic cancer cells are being destroyed quickly, you may
experience side effects which may cause pain in the joints (gout) or
even kidney problems. What should I tell my doctor or health care provider? Tell your doctor
or health care provider if you have a history of liver problems. Serious
problems such as liver failure have occurred in people treated with
Mylotarg. Mylotarg can cause
harm to an unborn baby when given to a pregnant woman. Tell
your health care provider if you are trying to become pregnant, are
already pregnant, or are breast-feeding. What are some possible side effects of Mylotarg? (This
is not a complete list of side effects reported with Mylotarg.
Your health care provider can discuss with you a more complete list of
side effects.) Common side
effects include:
If the following
side effects occur, they will be soon after treatment with Mylotarg.
Other medicines can be prescribed to improve these conditions:
Posted: 12/27/01 Updated: 5/26/04 |