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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

OVERDOSE

No cases of overdose with Mylotarg (gemtuzumab ozogamicin for injection) were reported in clinical experience. Single doses higher than 9 mg/m² in adults were not tested. When a single dose of Mylotarg (gemtuzumab ozogamicin for injection) was administered to animals, mortality was observed in rats at the dose of 2 mg/kg (approximately 1.3-times the recommended human dose on a mg/m² basis), and in male monkeys at the dose of 4.5 mg/kg (approximately 6-times the recommended human dose on a mg/m² basis).

Signs and Symptoms: Signs of overdose with Mylotarg (gemtuzumab ozogamicin for injection) are unknown.

Recommended Treatment: General supportive measures should be followed in case of overdose. Blood pressure and blood counts should be carefully monitored. Gemtuzumab ozogamicin is not dialyzable.

CONTRAINDICATIONS

Mylotarg (gemtuzumab ozogamicin for injection) is contraindicated in patients with a known hypersensitivity to gemtuzumab ozogamicin or any of its components: anti-CD33 antibody (hP67.6), calicheamicin derivatives, or inactive ingredients.

Mylotarg is contraindicated in lactating mothers (see PRECAUTIONS, Nursing Mothers).

Last reviewed on RxList: 6/24/2008
This monograph has been modified to include the generic and brand name in many instances.

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