"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"...
- Patient Information:
Details with Side Effects
Mylotarg (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) 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.
DOSAGE AND ADMINISTRATION
The recommended dose of Mylotarg (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) . Appropriate measures (e.g. hydration and allopurinol) must be taken to prevent hyperuricemia. Patients should receive the following prophylactic medications one hour before Mylotarg (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) 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.
Methylprednisolone given prior to Mylotarg (gemtuzumab ozogamicin for injection) infusion may ameliorate infusion-related symptoms.
Hepatic Insufficiency: Patients with hepatic impairment were not included in the clinical studies. (See WARNINGS section).
Renal Insufficiency: Patients with renal impairment were not included in the clinical studies.
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 (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) 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.
DO NOT ADMINISTER AS AN INTRAVENOUS (IV) PUSH OR BOLUS
Once the reconstituted Mylotarg (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) . 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
Prior to Reconstitution: Mylotarg (gemtuzumab ozogamicin for injection) should be stored refrigerated 2° to 8° C (36° to 46° F) and protected from light.
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.
TABLE 11: STORAGE CONDITION AND TIME FOR RECONSTITUTION,
DILUTION, AND ADMINISTRATION
|The following time intervals for reconstitution, dilution, and administration should be followed for storage of the reconstituted solution.|
|Time Intervals||Total Maximum Hours a|
|≤ 2 hours at room temperature or refrigeration||≤ 16 hours at room temperature||2 hour infusion||20|
|a: Total maximum time allowed for the storage of the reconstituted and diluted solutions and completion of infusion.|
Instructions for Use, Handling and for Disposal: Individuals who have contact with anticancer 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.2,3,4,5
Mylotarg (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) 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 (gemtuzumab ozogamicin for injection) since no bacteriostatic agent or preservative is present.
Mylotarg® (gemtuzumab ozogamicin for Injection) is supplied as a single-vial package with an amber glass vial containing 5 mg of Mylotarg (gemtuzumab ozogamicin for injection) lyophilized powder. Single-unit 5 mg package: each vial contains 5 mg of Mylotarg (gemtuzumab ozogamicin for injection) . NDC 0008-4510-01.
1. OSHA. Controlling Occupational Exposure to Hazardous Drugs. OSHA Technical Manual; Section VI, Chapter 2, 1999.
2. NIH. Recommendations for the Safe Handling of Cytotoxic Drugs. NIH: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, 1992. US Department of Health and Human Services, Public Health Service Publication NIH 92-2621.
3. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J Hosp Pharm. 1990;47:1033-1049.
4. Power LA, Anderson RW, Cortopassi R, Gera JR, Lewis RM. Update on Safe Handling of Hazardous Drugs: The Advice of Experts. Am J Hosp Pharm. 1990;47:1050-1060.
5. NIOSH. Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. DHHS (NIOSH) Publication Number 2004-165, September 2004.
Wyeth Pharmaceuticals Inc. Philadelphia, PA 19101. Rev 01/07. FDA revision date: 1/23/2006
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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