|Manufacturer:||Wyeth Pharmaceuticals Inc.|
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).
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.
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.