What is Mylotarg®?

Mylotarg® is a brand name for the anti-cancer medication, gemtuzumab ozogamicin. In 2010, the manufacturer withdrew Mylotarg® from the United States (US) market following concerns raised by an investigation from the US Food and Drug Administration (FDA). The investigation concluded that Mylotarg® failed to provide sufficient benefit for cancer patients, and that there are concerns about the drug's safety. This medication may still be available in other countries. Patients who were still undergoing treatment at the time of the US market withdrawal may be allowed to finish the course of treatment, following a consultation with their doctors.

This drug is intended to treat acute myeloid leukemia (AML). It is used specifically for patients who are unable to use other cancer treatments and who are at least 60 years old or older. Mylotarg® is classified as an antineoplastic agent, and binds to cancer cells and destroys essential components of them, causing cancer cell death.

Mylotarg® is given as an injection into a vein by a health care professional. Patients should expect each injection to take about two hours to complete. Typically, the doctor will prescribe two doses of the medicine to be given 14 days apart. Cancer patients may be given other medications along with this chemotherapy drug, in order to lower the risk of some side effects. They may also take diphenhydramine or acetaminophen.

Certain side effects from Mylotarg® are considered common, such as nausea, constipation, or diarrhea. Patients may experience dizziness, back pain, fatigue, mouth sores, loss of appetite, and stomach pain. Insomnia, joint pain, and pain or inflammation at the injection site have been reported. Others may suffer from general weakness and depression.

More serious side effects require a doctor's immediate care. Patients should get help if they suffer from seizures, loss of muscle control, or irregular heartbeat. Severe joint or muscle pain, as well as cloudy urine may also occur. Fever and chills may be signs of an infection. Shortness of breath, swelling of the limbs, and sudden weight gain have also been reported.

While undergoing treatment with Mylotarg®, patients can expect their physicians to monitor them regularly. Blood tests and liver function tests will likely be ordered, which allow the doctor to evaluate the body's response to the drug.

Mylotarg® can suppress the immune system, so patients should avoid contact with sick people. Patients should be careful to avoid injury because it can also reduce the ability of the blood to clot. Since one potential side effect is dizziness, it is strongly recommended that patients use caution while driving.