News
N e ws Dalbavancin approved for acute skin infections
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DA 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
New drugs and dosage forms Testosterone nasal gel (Natesto, Trimel BioPharma): The androgen is indicated for replacement therapy in males for primary hypogonadism and hypogonadotropic hypogonadism. The drug is a Schedule III controlled substance. Travoprost ophthalmic solution (Izba, Alcon Laboratories): The prostaglandin analog, as a 0.003% solution, is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Vedolizumab for injection (Entyvio, Takeda Pharmaceuticals): The integrin-receptor antagonist is indicated for the second-line treatment of ulcerative colitis or Crohn’s disease in adults. The drug is subject to FDA Medication Guide requirements.
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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. —Kate Traynor DOI 10.2146/news140044
Standardize units for dosing liquid oral prescription medicines, task group says
A
n organization best known for setting standards for the electronic exchange of pharmacy data released recommendations in April calling for pharmacies to eliminate nonmetric units
Am J Health-Syst Pharm—Vol 71 Jul 1, 2014
of measure on the labels of prescription liquid oral medications. The recommendations, published by the National Council for Prescription Drug Programs (NCPDP), would also
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
N e ws Dalbavancin approved for acute skin infections
F
DA 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
New drugs and dosage forms Testosterone nasal gel (Natesto, Trimel BioPharma): The androgen is indicated for replacement therapy in males for primary hypogonadism and hypogonadotropic hypogonadism. The drug is a Schedule III controlled substance. Travoprost ophthalmic solution (Izba, Alcon Laboratories): The prostaglandin analog, as a 0.003% solution, is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. Vedolizumab for injection (Entyvio, Takeda Pharmaceuticals): The integrin-receptor antagonist is indicated for the second-line treatment of ulcerative colitis or Crohn’s disease in adults. The drug is subject to FDA Medication Guide requirements.
1062
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. —Kate Traynor DOI 10.2146/news140044
Standardize units for dosing liquid oral prescription medicines, task group says
A
n organization best known for setting standards for the electronic exchange of pharmacy data released recommendations in April calling for pharmacies to eliminate nonmetric units
Am J Health-Syst Pharm—Vol 71 Jul 1, 2014
of measure on the labels of prescription liquid oral medications. The recommendations, published by the National Council for Prescription Drug Programs (NCPDP), would also
Copyright of American Journal of Health-System Pharmacy is the property of American Society of Health System Pharmacists and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
