Generic name: GEMTUZUMAB OZOGAMICIN 5mg in 5mL
Dosage form: injection, powder, lyophilized, for solution
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The recommended dose of Mylotarg is 9 mg/m2, infused over a 2-hour period. Physicians should consider leukoreduction with hydroxyurea or leukapheresis to reduce the peripheral white blood count to below 30,000/μL prior to administration of Mylotarg. Appropriate measures (e.g. hydration and allopurinol) must be taken to prevent hyperuricemia. Patients should receive the following prophylactic medications one hour before Mylotarg administration: diphenhydramine 50 mg po and acetaminophen 650-1000 mg po; thereafter, two additional doses of acetaminophen 650-1000 mg po, one every 4 hours as needed. Vital signs should be monitored during infusion and for four hours following infusion. The recommended treatment course with Mylotarg is a total of 2 doses with 14 days between the doses. Full recovery from hematologic toxicities is not a requirement for administration of the second dose.
Hepatic Insufficiency: Patients with hepatic impairment were not included in the clinical studies. (See WARNINGS section).
Instructions for Reconstitution
The drug product is light sensitive and must be protected from direct and indirect sunlight and unshielded fluorescent light during the preparation and administration of the infusion. All preparation should take place in a biologic safety hood with shielded fluorescent light. Reconstitute the contents of each vial with 5 mL Sterile Water for Injection, USP, using sterile syringes. Gently swirl each vial. Each vial should be inspected for complete dissolution of the drug. The final concentration of the reconstituted drug solution is 1 mg/mL. See Table 11 for storage conditions for reconstituted product.
Instructions for Dilution
Prepare an admixture corresponding to 9 mg/m2 dose of Mylotarg by injecting the reconstituted solution into a 100 mL 0.9% sodium chloride injection solution in either a polyvinyl chloride (PVC) or ethylene/polypropylene copolymer (non-PVC) IV bag covered by an ultraviolet (UV) light protector. Mylotarg should only be diluted with 0.9% sodium chloride solution. DO NOT DILUTE WITH ANY OTHER ELECTROLYTE SOLUTIONS or 5% DEXTROSE or MIX WITH OTHER DRUGS. See Table 11 for storage conditions for diluted product.
Once 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 μm or 1.2 μm polyether sulfone (PES) (Supor®); 1.2 μm acrylic copolymer hydrophilic filter (Versapor®); 0.8 μm cellulose mixed ester (acetate and nitrate) membrane; 0.2 μm 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).
Stability and Storage:
After Reconstitution: Follow the instructions for reconstitution, dilution, and administration in the section above. See Table 11 below for reconstitution, dilution, and administration storage conditions and time intervals.
The following time intervals for reconstitution, dilution, and administration should be followed for storage of the reconstituted solution.
|a: Total maximum time allowed for the storage of the reconstituted and diluted solutions and completion of infusion.|
|≤ 2 hours at room temperature or refrigeration||≤ 16 hours at room temperature||2 hour infusion||20|
Instructions for Use, Handling and for Disposal: Individuals who have contact with anti-cancer drugs or work in areas where these drugs are used may be exposed to these agents through direct contact with contaminated objects.1 Potential health effects may be reduced by adherence to institutional procedures, published guidelines and local regulations for preparation, administration, transportation and disposal of hazardous drugs. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.2,3,4
Mylotarg should be inspected visually for particulate matter and discoloration, once in the transfer syringe. Additionally, the diluted admixture solution should be inspected visually for particulate matter and discoloration. Mylotarg is light sensitive and must be protected from direct and indirect sunlight and unshielded fluorescent light during the preparation and administration of the infusion (using an ultraviolet [UV] protective bag over the IV bag during infusion). All preparation should take place in a biologic safety hood with shielded fluorescent light. Vials are for single use. Aseptic technique must be strictly observed throughout the handling of Mylotarg since no bacteriostatic agent or preservative is present.
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