CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa). Read MoreSafety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV₁ <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Active Comparator: Extension Phase

Important information about the Active Comparator Study

This study was designed and funded by Gilead Sciences, Inc. (GSI), with input from all authors on this publication. Some of the authors had consultancy with or were employees and/or shareholders of GSI
The results and conclusions of this single study should be interpreted in light of its limitations, including, but not limited to, the open-label design and inclusion of previously treated patients with inhaled tobramycin (TNS). A comparable study has not been conducted to verify these results
There are conflicting views regarding the validation of the Cystic Fibrosis Questionnaire-Revised (CFQ-R). The FDA determined that the CFQ-R was not validated in accordance with its final Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims⁴
All results from the extension phase of the Active Comparator Trial are exploratory and therefore caution should be taken when interpreting the results

Active Comparator Extension Phase: Study Design⁸

The open-label Active Comparator period of the study was followed by an optional 24-week, open-label, single-arm extension period of 3 CAYSTON treatment cycles.

All patients who participated in the extension phase of the Active Comparator Study were treated with CAYSTON*

CAYSTON Active Comparator Extension Phase chart

*Eligible patients for the extension phase were from European study sites only (n=133; patients continuing CAYSTON from active comparator phase: 68; patients starting CAYSTON after TNS in active comparator phase: 65).

Active Comparator Extension Phase: Efficacy Results⁸

Study Extension Phase: Percent Change in FEV₁% Predicted from Week 0

CAYSTON Active Comparator Extension Phase: Efficacy Results chart

In this open-label study, standard error bars are for graphical representation of variability, and inferences regarding statistical significance should not be made.

Active Comparator Extension Phase: Adverse Reactions⁸

Adverse events occurring during the extension period⁸

Severe adverse events were experienced by 15/133 (11.3%) patients, most commonly cough (n=7/133), productive cough (n=5/133), and pyrexia (n=5/133)
One life-threatening event was reported (lung infiltration unrelated to treatment)
Two patients died due to complications of CF disease; both deaths were considered unrelated to treatment
Adverse events considered by investigators as treatment-related were reported for 6.8% of patients (n=9/133), most commonly respiratory incidents (n=6/133)

Learn about the Mechanism of Action & Delivery of CAYSTON

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CAYSTON is contraindicated in patients with a known allergy to aztreonam.

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Important Safety Information and Indication

Contraindications

CAYSTON is contraindicated in patients with a known allergy to aztreonam.

INDICATION

CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa). Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV₁ <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CAYSTON and other antibacterial drugs, CAYSTON should be used only to treat patients with CF known to have Pa in the lungs.

Warnings and Precautions

Allergic Reactions: Severe allergic reactions have been reported following administration of aztreonam for injection to patients with no known history of exposure to aztreonam. In addition, allergic reaction with facial rash, facial swelling, and throat tightness was reported with CAYSTON in clinical trials. If an allergic reaction occurs, stop administration of CAYSTON and initiate treatment as appropriate. Caution is advised when administering CAYSTON to patients if they have a history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, since cross-reactivity may occur.
Bronchospasm: Bronchospasm is a complication associated with nebulized therapies, including CAYSTON. Reduction of 15% or more in forced expiratory volume in 1 second (FEV₁) immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with CAYSTON.
Decreases in FEV₁ After 28-Day Treatment Cycle: In clinical trials, patients with increases in FEV₁ during a 28-day course of CAYSTON were sometimes treated for pulmonary exacerbations when FEV₁ declined after the treatment period. Healthcare providers should consider a patient’s baseline FEV₁ measured prior to CAYSTON therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV₁ are caused by a pulmonary exacerbation.
Development of Drug-Resistant Bacteria: Prescribing CAYSTON in the absence of known Pa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.

Adverse Reactions

Adverse reactions (>5%) in CAYSTON patients were cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain, and vomiting. Adverse reactions reported (<5%) in CAYSTON patients were bronchospasm and rash.

Indication

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