Inhaled Aztreonam Lysine for Cystic Fibrosis

Lindsay E Hoffman and Denise K Lowe

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Objectives: To review the mechanism of action, indication, pharmacokinetics, clinical efficacy, safety and tolerability, dosing, availability, and place in therapy for aztreonam lysine in the chronic management of cystic fibrosis (CF).

Data Sources: PubMed/MEDLINE (1966-December 2011) was searched to identify articles addressing aztreonam lysine use for CF using the terms aztreonam, cystic fibrosis, and inhaled antibiotics. Reference lists of review articles, guidelines, and unpublished data from the manufacturer were also utilized.

Study Selection and Data Extraction: Limits were set for the English language and humans. Three placebo-controlled trials and 1 active-comparator trial evaluating the efficacy and safety of aztreonam lysine were reviewed for inclusion. Data were also extracted from review articles and the manufacturer’s Web site.

Data Synthesis: Pseudomonas aeruginosa is associated with significant morbidity and mortality in patients with CF; therefore, treatment is imperative. Current guidelines for chronic maintenance therapy recommend using chronic inhaled anti-pseudomonal antibiotics. Tobramycin (Tobi) is the only inhaled antibiotic approved by the FDA for management of CF patients with P. aeruginosa. Tobramycin treatment failures in P. aeruginosa infection have been increasing over the past decade; therefore, other treatment options are needed. Aztreonam lysine (Cayston) was approved by the FDA on February 22, 2010, as an inhaled antibiotic to help improve respiratory symptoms in patients 7 years of age or older with CF and known P. aeruginosa infection.

CONCLUSIONS: Aztreonam lysine is a newer inhaled antibiotic that improves forced expiratory volume in 1 second, respiratory symptoms, and quality of life measures when used as maintenance therapy in patients with CF and chronic P. aeruginosa infection. Availability of aztreonam lysine only from specialty pharmacies may limit its use.

J Pharm Technol 2012;28:75-81