Enable JavaScript to visit this website.

Welcome to Mylotarg

MYLOTARG (gemtuzumab ozogamicin) is a prescription medicine used to treat a certain type of acute myeloid leukemia (AML) in adults and children over the age of 2.

No front page content has been created yet.

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNING: RISK OF LIVER PROBLEMS

MYLOTARG can cause liver problems that can be severe, life-threatening, or lead to death, including a condition called veno-occlusive disease (VOD). If you’ve previously had or will receive a stem cell transplant, or have a history of liver problems, you may be at an increased risk. Tell your doctor about any signs or symptoms of liver problems, including rapid weight gain, abdominal swelling (which may be painful), or yellowing of the whites of your eyes. Your doctor should do blood tests to check for liver problems before and regularly during your treatment. Liver problems may require dosing interruption or permanent discontinuation of MYLOTARG.

Infusion Reactions: You may experience reactions to MYLOTARG during or within 24 hours following your infusion. Reactions can be severe or life-threatening. Your doctor may give you medicines before you receive MYLOTARG to decrease your chance of having a severe reaction. Tell your doctor or get medical help right away if you have fever, chills, rash, or breathing problems while receiving or after receiving MYLOTARG. Do not take MYLOTARG if you have a history of hypersensitivity to it or any of its ingredients.

Bleeding: Bleeding, which may be life-threatening or fatal, can occur with MYLOTARG. Call your doctor right away if you have unexpected bleeding, bruising, or blood in your urine or stools. Your doctor should do blood tests to check your blood cell counts frequently after your treatment. If you have low blood cell counts with MYLOTARG, your treatment may be interrupted, your dose may be reduced, or MYLOTARG may be permanently discontinued.

Pregnancy and Breastfeeding: Avoid becoming pregnant during treatment with MYLOTARG. MYLOTARG can cause harm to an unborn baby. If you are able to become pregnant, you should use effective contraception during treatment with MYLOTARG and for at least 6 months after the last dose. If you are male and your partner is able to become pregnant, use effective contraception during treatment with MYLOTARG and for at least 3 months after the last dose. Avoid breastfeeding during treatment with MYLOTARG and for at least 1 month after the final dose.

Common Side Effects: The most common side effects are bleeding, infection, fever, nausea, vomiting, constipation, rash, headache, mouth sores, and increases in lab tests measuring liver function.

Indication

MYLOTARG (gemtuzumab ozogamicin) is a prescription medicine used to treat a certain type of acute myeloid leukemia (AML) in adults and children over the age of 2.

Please see full Prescribing Information, including BOXED WARNING.

Patients should ask their doctors for medical advice about adverse events.

You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.