Dalvance Approved for Children With Acute Bacterial Skin/Skin Structure Infections - Monthly Prescribing Reference

The Food and Drug Administration (FDA) has expanded the approval of Dalvance® (dalbavancin) to include treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms in pediatric patients. Previously, the treatment was only approved for adults 18 years of age and older.

Dalvance is a second-generation, semi-synthetic lipoglycopeptide. The approval was based on data from a multicenter, open-label, actively controlled phase 3 trial (ClinicalTrials.gov Identifier: NCT02814916) that evaluated the efficacy and safety of dalbavancin in 183 patients from birth to less than 18 years of age with ABSSSI, along with 3 pharmacokinetic studies. Patients were randomly assigned 3:3:1 to receive dalbavancin as a single-dose or 2-doses intravenously (IV), or a comparator which included IV vancomycin (for methicillin-resistant Gram-positive infections), or IV oxacillin or flucloxacillin (for methicillin susceptible Gram-positive infections). 

The primary objective was to evaluate the safety and tolerability of dalbavancin. A key secondary endpoint was early clinical response at 48 to 72 hours post-randomization based on at least a 20% reduction in lesion size compared with baseline and no receipt of rescue antibacterial therapy for children 3 months and older.

Findings demonstrated that the safety profile of dalbavancin in pediatric patients was similar to that observed in adult patients. The proportion of patients with an early clinical response was 97.3% (n=73/75) in the dalbavancin single-dose arm, 93.6% (n=73/78) in the dalbavancin 2-dose arm, and 86.7% (n=26/30) in the comparator arm.

Continue Reading

Dalvance is supplied as a single-use vial containing 500mg of lyophilized powder for IV infusion after reconstitution and dilution. The recommended dosage for pediatric patients with a creatinine clearance of 30mL/min/1.73m2 and above is based on age and weight and is administered as a single dose.

Reference

Dalvance® (dalbavancin) receives FDA approval to treat acute bacterial skin and skin structure infections in pediatric patients. News release. AbbVie. July 23, 2021. Accessed July 26, 2021. https://www.prnewswire.com/news-releases/dalvance-dalbavancin-receives-fda-approval-to-treat-acute-bacterial-skin-and-skin-structure-infections-in-pediatric-patients-301340347.html. 

Topics:

Bacterial Infections Infectious Disease

Adblock test (Why?)

Comments

Post a Comment

Popular posts from this blog

Medical Review Board

Image
johns hopkins internal medicine :: Article Creator Thyrotoxicosis Linked To Risk For Incident Cognitive Disorder For older adults, exposure to a low thyrotropin (TSH) level from either endogenous or exogenous thyrotoxicosis is associated with an increased risk for incident cognitive disorder, according to a study recently published in JAMA Internal Medicine. Roy Adams, Ph.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues conducted a cohort study to examine whether thyrotoxicosis is associated with an increased risk for cognitive disorders. Patients aged 65 years and older with at least two visits to their primary care physicians 30 days apart were eligible; the analysis included 65,931 patients. The exposure variable was low TSH level, characterized based on the clinical context as due to endogenous thyrotoxicosis, exogenous thyrotoxicosis, or unknown cause. The researchers found that the incidence of cogn...
Read more

Top Doctors List 2021 | HOUR Detroit Magazine

Image
You are being redirected... Javascript is required. Please enable javascript before you are allowed to see this page. anup singh pediatric nephrology :: Article Creator Division Of Pediatric Nephrology Pediatric Nephrology is located within the UAB Department of Pediatrics at Children's of Alabama. The nephrology team, which includes specialized nurses, nutritionist, social workers, family counselors and faculty, evaluate and treat children with kidney disease from infancy to adolescence. They care for those with urinary tract infections, hypertension, hematuria, proteinuria, glomerulonephritis, and nephrotic syndrome, vasculitis, and systemic lupus erythematosis and chronic kidney disease, including those who require chronic dialysis or transplantation. The renal care center is one of the largest comprehensive pediatric dialysis units in the United States offering acute and chronic dialysis therapies. The specialized staff offers peritone...
Read more