Brand Name: Mylotarg®
Active Ingredient: gemifloxacin mesylate
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

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:

• experiencing a return of the disease after the first treatment

• 60 years of age or older, and

• not considered able to take standard leukemia chemotherapy.

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.

1. 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:

• decrease in bone marrow production (see Special Warnings)

• low red blood cell counts (anemia)

• low blood platelets

• infection

• bleeding

• transfusions

• swelling of the membrane inside the mouth

• liver problems

• rash

If the following side effects occur, they will be soon after treatment with Mylotarg.  Other medicines can be prescribed to improve these conditions:

• chills

• fever

• nausea

• vomiting

• headache

• changes in blood pressure

• low levels of oxygen in the body

Posted: 12/27/01

Updated:  5/26/04