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.

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.