TY - JOUR AU - Traynor,, Kate AB - FDA and Durata Therapeutics on May 23 announced the approval of dalbavancin for the treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. The company plans to launch the drug under the brand name Dalvance during the third quarter of this year. Dalbavancin is a lipoglycopeptide that interferes with cell wall synthesis in certain bacteria, according to the drug’s labeling. The recommended dosage of dalbavancin is 1000 mg delivered by i.v. infusion over 30 minutes, followed by a 500-mg second dose one week later. No dosage reduction is recommended for patients undergoing regularly scheduled dialysis. In patients with kidney disease whose creatinine clearance is less than 30 mL/min and who are not undergoing regularly scheduled hemodialysis, the recommended dalbavancin dosage is 750 mg the first week and 375 the second week. According to FDA, dalbavancin was shown in clinical trials to be as effective as vancomycin for the treatment of acute bacterial skin and skin structure infections in adults. The most frequently reported adverse events among clinical trial participants who received dalbavancin included nausea, headache, and diarrhea. Abnormal liver-enzyme test results also occurred in patients treated with dalbavancin. Rare but serious hypersensitivity reactions, including anaphylaxis and skin reactions, have been associated with the use of dalbavancin and other glycopeptide agents, according to the labeling for dalbavancin. The labeling also states that rapid infusion of dalbavancin can cause reactions resembling red man syndrome. Dalbavancin will be supplied in 500-mg, single-use vials that should be stored at 25 °C. Before administration, the contents of each vial should be reconstituted with 25 mL of Sterile Water for Injection, USP, to produce a clear, colorless to yellow solution containing 500 mg of dalbavancin at a concentration of 20 mg/mL. Reconstituted dalbavancin should be diluted to a final concentration of 1–5 mg/mL in an i.v. bag or bottle containing 5% Dextrose Injection, USP. The diluted solution may be refrigerated at 2–8 °C or kept at controlled room temperature for no more than 48 hours after the initial reconstitution of the vial’s contents. Dalbavancin is the first drug approved through FDA’s Qualified Infectious Disease Product program, which was created through the FDA Safety and Innovation Act to speed the approval of antimicrobial drugs for the treatment of serious infections. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved. TI - Dalbavancin approved for acute skin infections JF - American Journal of Health-System Pharmacy DO - 10.2146/news140044 DA - 2014-07-01 UR - https://www.deepdyve.com/lp/oxford-university-press/dalbavancin-approved-for-acute-skin-infections-WqZerw22V0 SP - 1062 VL - 71 IS - 13 DP - DeepDyve ER -