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Welcome to Mylotarg

MYLOTARG (gemtuzumab ozogamicin) is a prescription medicine used to treat adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) or patients over the age of 2 with CD33-positive AML whose disease returned or did not respond to previous treatment.

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IMPORTANT SAFETY INFORMATION

WARNING: RISK OF LIVER PROBLEMS: MYLOTARG can cause liver problems that can be severe or life-threatening or lead to death, including a condition called veno-occlusive disease (VOD). If you have previously received or will be receiving a stem cell transplant, or you have a history of liver problems, you may be at an increased risk for VOD. 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.

Contraindications: Do not take MYLOTARG if you have a history of hypersensitivity to MYLOTARG or any of its ingredients.

Infusion Reactions: You may experience reactions to MYLOTARG during or within 24 hours following your infusion. Reactions can be life-threatening or fatal. 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, low blood pressure, rapid heartbeat, rash, or breathing problems while receiving or after receiving MYLOTARG.

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 or MYLOTARG may be permanently discontinued.

Pregnancy: 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.

Heart Problems: Call your doctor right away if you feel dizzy, lightheaded, or faint or have very slow, very fast, or abnormal heartbeats. Your healthcare provider may check your heart during treatment with MYLOTARG. Tell your healthcare provider about all the medicines you take.

Chromosomal Testing: Your healthcare provider may order tests (known as cytogenetic analyses) for chromosomal abnormalities that may be associated with your AML. Patients with certain chromosomal abnormalities may not benefit from adding MYLOTARG to chemotherapy. Based on your cytogenetic analysis, your healthcare provider may decide to stop treatment with MYLOTARG because its risks may outweigh its benefits.

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.

Breastfeeding: Avoid breastfeeding during treatment with MYLOTARG and for at least 1 month after the final dose.

INDICATIONS

MYLOTARG (gemtuzumab ozogamicin) is a prescription medicine used to treat adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) or patients over the age of 2 with CD33-positive AML whose disease returned or did not respond to previous treatment.

Please see full Prescribing Information, including BOXED WARNING.

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.