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Basic Drug Info
Drug Name:Mylotarg
Manufacturer:Wyeth Pharmaceuticals Inc.
Other Info:

DO NOT ADMINISTER AS AN INTRAVENOUS (IV) PUSH OR BOLUSOnce the reconstituted Mylotarg is diluted into the IV bag containing normal saline, the resulting solution should be infused over a 2-hour period. See Table 11 for infusion times. Mylotarg may be given peripherally or through a central line.

During the infusion, only the IV bag needs to be protected from light.

An in-line, low protein binding filter must be used for the infusion of Mylotarg.

The following filter membranes are qualified: 0.22 ?m or 1.2 ?m polyether sulfone (PES) (Supor®); 1.2 ?m acrylic copolymer hydrophilic filter (Versapor®); 0.8 ?m cellulose mixed ester (acetate and nitrate) membrane; 0.2 ?m cellulose acetate membrane.

DO NOT CO?ADMINISTER OTHER DRUGS THROUGH THE SAME INFUSION LINE.

Premedication, consisting of acetaminophen and diphenhydramine, should be given before each infusion to reduce the incidence of a post-infusion symptom complex (see ADVERSE REACTIONS, Acute Infusion-Related Events).



Clinical Trials:


Indications and Usage

Mylotarg is indicated for the treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for other cytotoxic chemotherapy.

The safety and efficacy of Mylotarg in patients with poor performance status and organ dysfunction has not been established.

The effectiveness of Mylotarg is based on OR rates (see CLINICAL STUDIES section).

There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival, compared to any other treatment.
Leukemia, Myelocytic, Acute -- acute leukemia arising from myeloid tissue in which the granular, polymorphonuclear leukocytes and their precursors predominate.

Recurrent disease -- The return of signs and symptoms of cancer after a period of improvement.

poor performance status --

Functional disorder -- Disturbance, impairment or abnormality of function.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Contraindications
Mylotarg 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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

Mylotarg should be administered under the supervision of physicians experienced in the treatment of acute leukemia and in facilities equipped to monitor and treat leukemia patients.

There are no controlled trials demonstrating efficacy and safety using Mylotarg in combination with other chemotherapeutic agents.

Therefore, Mylotarg should only be used as single agent chemotherapy and not in combination chemotherapy regimens outside clinical trials.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.