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DRUG INTERACTIONS
Drug Interactions: There have been no formal drug-interaction studies performed with Mylotarg. The potential for drug-drug interaction with drugs affected by cytochrome P450 enzymes may not be ruled out.
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OVERDOSAGE
No cases of overdose with Mylotarg were reported in clinical experience. Single doses higher than 9 mg/m2 in adults were not tested. When a single dose of Mylotarg 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 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.
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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.
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REFERENCES
- OSHA. Technical Manual. TED 1–0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
- American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. Am J Health-Syst Pharm. 2006;63:1172–1193.
- NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
- Polovich, M., White, J.M.,& Kelleher, L.O. (eds.) Chemotherapy and biotherapy guidelines and recommendations for practice. (2nd ed.) Pittsburgh, PA: Oncology Nursing Society.
 | This product's label may have been updated. For current package insert and further product information, please visit www.wyeth.com or call our medical communications department toll-free at 1-800-934-5556. |  |
Wyeth ®
Wyeth Pharmaceuticals Inc.
Philadelphia, PA 19101
W10477C014
ET01
Rev 09/08
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