Pharmacy and Therapeutics - January 2008 - (Page 57) Pharmaceutical Approval Update Re-treatment Criteria: At the start of a cycle, dose adjustments should be based on nonhematological toxicity or blood counts from the preceding cycle. Patients should not begin a new cycle of treatment unless the neutrophil count is at least 1,500 cells/mm 3 , the platelet count is at least 100,000 cells/mm3, and nonhematological toxicities have improved to grade 1 (mild) or have resolved. Dose Adjustments in Hepatic Impairment: Combination Therapy: Ixabepilone in combination with capecitabine must not be given to patients with elevations above 2.5 times the ULN or bilirubin levels above 1 times the ULN. Patients receiving combination treatment who have AST and ALT levels of 2.5 times the ULN or less and bilirubin levels of 1 times the ULN or less may receive the standard dose of ixabepilone (40 mg/m2). Monotherapy: Patients with moderate hepatic impairment should start with ixabepilone 20 mg/m2. The dosage in subsequent cycles may be escalated up to, but not exceeding, 30 mg/m2 if tolerated. Ixabepilone is not recommended for patients with AST or ALT levels greater than 10 times the ULN or with bilirubin levels above 3 times the ULN. Limited data are available for patients with baseline AST or ALT levels above 5 times the ULN. Caution should be used when treating these patients. Commentar y: Standard treatment for metastatic breast cancer typically includes chemotherapy with anthracycline or taxane agents, capecitabine, or other chemotherapy drugs. Unfortunately, some women with breast cancer do not respond to treatment with standard agents. Because long-term outcomes for patients with resistant metastatic breast cancer remain suboptimal, researchers continue to evaluate novel agents that may improve survival. Ixabepilone is the first in a new class of antineoplastic agents, the epothilones and their analogues. It is approved to treat advanced breast cancer; as a single agent, it is indicated for recurrent, advanced breast cancer in patients who have stopped responding to chemotherapy, including anthracyclines, taxanes, and capecitabine. Ixabepilone is also approved to treat advanced breast cancer in combination with capecitabine in patients whose cancer has stopped responding to anthracyclines and taxanes or who do not respond to a taxane and are not eligible to receive further treatment with anthracyclines. Source: http://packageinserts.bms.com I DRUG FORECAST continued from page 50 gram-positive pathogens. Diagn Microbiol Infect Dis 2005;53: 307–310. 27. Lopez S, Hackbarth, Romano G, et al. In vitro antistaphylococcal activity of dalbavancin, a novel glycopeptide. J Anti microb Chemother 2005;55(Suppl 2): ii21–ii24. 28. Jones RN, Fritsche TR, Sader HS, Goldstein BP. Antimicrobial spectrum and potency of dalbavancin tested against clinical isolates from Europe and North America (2003): Initial results from an international surveillance protocol. J Chemotherapy 2005;17: 593–600. 29. Biedenbach DJ, Ross JE, Fritsche TR, et al. Activity of dalbavancin tested against Staphylococcus spp. and beta-haemolytic Streptococcus spp. isolated from fifty-two geographically diverse medical centers in the United States. J Clin Microbiol 2007;45: 998–1004. 30. Goldstein EJ, Citron DM, Warren YA, et al. In vitro activities of dalbavancin and 12 other agents against 329 aerobic and anaerobic gram-positive isolates recovered from diabetic foot infections. Antimicrob Agents Chemother 2006;50:2875–2879. 31. Jones RN, Stilwell MG, Sader HS, et al. Spectrum and potency of dalbavancin tested against 3322 gram-positive cocci isolated in the United States Surveillance Program (2004). Diagn Microbiol Infect Dis 2006;54:149–153. 32. Goldstein BP, Jones RN, Fritsche TR, Biedenbach DJ. Microbiologic characterization of isolates from a dalbavancin clinical trial for catheter-related bloodstream infections. Diagn Microbiol Infect Dis 2006;54:83–87. 33. Lin G, Smith K, Ednie LM, Appelbaum PC. Antipneumococcal activity of dalbavancin compared to other agents. Antimicrob Agents Chemother 2005;49:5182–5184. 34. Mushtaq S, Warner M, Johnson AP, Livermore DM. Activity of dalbavancin against staphylococci and streptococci, assessed by BSAC and NCCLS agar dilution methods. J Antimicrob Chemother 2004;54:617–620. 35. Jones RN, Biedenbach DJ, Johnson DM, Pfaller MA. In vitro evaluation of BI 397, a novel glycopeptide antimicrobial agent. J Chemother 2001;13:244–254. 36. Seltzer E, Dorr MB, Goldstein BP, et al. Once-weekly dalbavancin versus standard of care antimicrobial regimens for treatment of skin and soft tissue infections. Clin Infect Dis 2003;37:1298–1303. 37. Jauregui LE, Babazadeh S, Seltzer E, et al. Randomized, doubleblind comparison of once-weekly dalbavancin versus twice-daily linezolid therapy for the treatment of complicated skin and skin structure infections. Clin Infect Dis 2005;41: 1407–1415. 38. Raad I, Darouiche R, Vazquez J, et al. Efficacy and safety of weekly dalbavancin therapy for catheter-related bloodstream infection caused by gram-positive pathogens. Clin Infect Dis 2005;40:374– 380. I Vol. 33 No. 1 • January 2008 • P&T® 57 http://packageinserts.bms.com
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