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Mylotarg

"Pfizer Inc. today announced the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer. The company took the action at the request of the U.S. Fo"...

Mylotarg

Mylotarg

Mylotarg Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking gemtuzumab (Mylotarg)?

You should not receive this medication if you are allergic to gemtuzumab

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • any type of infection;
  • lung or breathing problems;
  • liver disease;
  • kidney disease;
  • if you have ever received a stem cell transplant; or
  • if you being treated with other cancer medications.

FDA pregnancy category D. Gemtuzumab can cause harm to an unborn baby or cause birth defects. Before you receive gemtuzumab, tell your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether gemtuzumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is gemtuzumab given (Mylotarg)?

Gemtuzumab is given as an injection through a needle placed into a vein. You will receive this injection in a clinic or hospital setting. The medicine must be given slowly through an IV infusion, and can take at least 2 hours to complete.

Gemtuzumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Do not miss any follow-up visits to your doctor.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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