Manufacturer:

Gilead Sciences, Inc.

Pharmacological Class:

Antibiotic (monobactam)

Active Ingredient(s):

Aztreonam 75mg/vial; pwd for inhalation via nebulization after reconstitution; preservative-free.

Indication(s):

To improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa.

Pharmacology:

Aztreonam is a monobactam antibiotic that is bactericidal against gram (–) aerobes including Pseudomonas aeruginosa. Cross-resistance with other antibiotics such as aminoglycosides, quinolones, and beta-lactams has not been seen in studies with this product.

The monobactam antibiotics are structurally different from the beta-lactams, and, although cross-sensitivity is possible, aztreonam may be used with caution in patients with a penicillin allergy.

Clinical Trials:

A randomized, double-blind, placebo-controlled, multicenter trial was conducted in patients 7 years of age (mean age 30 years) and older and with FEV1 of 25% to 75% predicted. This trial, which was designed to evaluate improvement in respiratory symptoms following a 28-day course of treatment, enrolled 164 patients with CF and P. aeruginosa. All patients were required to use a bronchodilator first, and they were treated on an outpatient basis. Patients were randomized to either Cayston or placebo by inhalation three times daily for 28 days. Also, patients were required to have been off antibiotics for at least 28 days before treatment with study drug. The primary efficacy endpoint was the improvement in respiratory symptoms (by self-assessment) on the last day of treatment with either Cayston or placebo. Respiratory symptoms were also checked two weeks after the treatment period finished. Patients randomized to the study drug had statistically significant improvements in respiratory function. Pulmonary function, as assessed by FEV1, increased from baseline in patients using the study drug compared to the FEV1 in those given placebo. The treatment difference at day-28 between Cayston-treated and placebo-treated patients for percent change in FEV1 was statistically significant at 10% (95% CI: 6%, 14%). Two weeks after the completion of therapy, the difference in improvement in pulmonary function between Cayston and placebo groups had decreased to 6% (95% CI: 2%, 9%).

The safety and efficacy of this product have not been established in patients colonized with Burkholderia cepacia, in patients under the age of 7 years, or in those with FEV1<25% or >75% predicted.

Legal Classification:

Rx

Adults & Children:

<7yrs: not established. Use a short-acting bronchodilator 15 minutes to 4 hours before each dose; or a long-acting bronchodilator 30 minutes to 12 hours before starting therapy. >7yrs: 75mg (1 vial) by nebulization three times daily (at least 4 hours apart) for 28 days. Use Altera Nebulizer only.

Warnings/Precautions:

Monobactam or beta-lactam allergy. FEV<25% or >75% predicted: insufficient data. Pregnancy (Cat.B).

Interaction(s):

Do not mix with other drugs in nebulizer.

Adverse Reaction(s):

Cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain, vomiting, rash; chest tightness, bronchospasm, allergic reactions (discontinue if occurs).

Notes:

To support and assist patients with cystic fibrosis contact the Cayston Access Program at (877) 7CAYSTON.

Cayston should be administered immediately after reconstitution. Do not reconstitute Cayston until ready to administer a dose.

How Supplied:

Vials—84 (w. diluent)

Last Updated:

4/9/2010