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Authors

  1. Aschenbrenner, Diane S. MS, RN

Abstract

* Liraglutide (Victoza) is now approved for use in children 10 years and older with type 2 diabetes.

 

* Tezacaftor-ivacaftor (Symdeko) is now approved for children six years and older with cystic fibrosis and a specific genetic mutation. Previously, the combination drug was approved for children ages 12 and older.

 

* The combination antiinfective ceftolozane-tazobactam (Zerbaxa) is now approved to treat hospital-acquired and ventilator-associated bacterial pneumonia in patients 18 years and older. The dose of ceftolozane-tazobactam is higher for this indication than for others.

 

 

Article Content

The Food and Drug Administration (FDA) has recently approved new indications for several drugs.

 

Pediatric type 2 diabetes. Liraglutide (Victoza) is now approved for use in children; it is the second drug (metformin was the first) approved to manage type 2 diabetes in children ages 10 and older. The drug was approved to treat adults with type 2 diabetes in 2010. Although most patients with type 2 diabetes are middle aged or older, there is a growing number of children with this form of diabetes.

 

Liraglutide improves blood sugar levels by mimicking the work of the glucagon-like peptide receptor proteins in the pancreas. Liraglutide slows digestion, prevents the liver from making excess glucose, and increases the production of insulin in the pancreas. Although liraglutide is indicated to reduce the risk of major cardiovascular events in adults, it was not studied for this effect in children. In a clinical trial of 134 pediatric patients, 64% who received liraglutide had a reduction in glycated hemoglobin to below 7%, compared with 37% who received placebo. Adverse effects and warnings for the drug remain the same.

 

To read the FDA news release regarding the approval of liraglutide in children, see http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pe.

 

Cystic fibrosis. Tezacaftor-ivacaftor (Symdeko), previously approved for children 12 years and older with cystic fibrosis and certain genetic mutations, is now approved for children six years and older with the same genetic mutations. In clinical trials of 70 children with cystic fibrosis ages six to 12 years, the drug was found to be effective in reducing exacerbations of the disease and had a safety profile similar to that in studies of children 12 years and older. Drug warnings, adverse effects, and drug-food or drug-drug interactions remain the same.

 

To read the FDA news release regarding the approval of tezacaftor-ivacaftor tablets in children ages six and older, go to http://www.fda.gov/news-events/press-announcements/fda-expands-approval-treatmen.

 

Hospital-acquired and ventilator-associated bacterial pneumonia. The FDA has now approved the antiinfective combination ceftolozane-tazobactam (Zerbaxa) for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in patients 18 years and older. The ceftolozane-tazobactam combination was originally approved to treat complicated intraabdominal infections and complicated urinary tract infections in 2014. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia are common infections in the United States and produce significant morbidity and mortality when ICU patients are infected. Ceftolozane-tazobactam will treat the following susceptible gram-negative microorganisms: Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Serratia marcescens.

 

In a multinational, double-blind clinical trial, 726 adult patients hospitalized with hospital-acquired or ventilator-associated bacterial pneumonia received either ceftolozane 2 g plus tazobactam 1 g or meropenem 1 g intravenously every eight hours. Mortality and cure rates were similar between the two groups.

 

Warnings and adverse effects for ceftolozane-tazobactam remain unchanged with this new indication. However, the ceftolozane-tazobactam dose is larger when the medication is given to treat hospital-acquired or ventilator-associated bacterial pneumonia than when it's used for intraabdominal infections or complicated urinary tract infections; nurses should carefully check the dose ordered against the information in the drug label.

 

To read the FDA news release regarding the approval of ceftolozane-tazobactam for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia see http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-ho.