PATIENT INFORMATION
The Patient Information provides the most important information about Cayston, including Patient Instructions for Use. Any questions or concerns should be discussed with a healthcare professional.
FDA-Approved Patient Labeling
Patient Instructions for Use Brochure
CONTRAINDICATIONS
CAYSTON is contraindicated in patients with a known allergy to aztreonam.
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 to CAYSTON occurs, stop administration of CAYSTON and initiate treatment as appropriate.
Caution is advised when administering CAYSTON to patients if they have a history of beta-lactam allergy, although patients with a known beta-lactam allergy have received CAYSTON in clinical trials and no severe allergic reactions were reported. A history of allergy to beta-lactam antibiotics, such as penicillins, cephalosporins, and/or carbapenems, may be a risk factor, 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 Pseudomonas aeruginosa infection in patients with CF is unlikely to provide benefit and increases the risk of development of drug-resistant bacteria.
ADVERSE REACTIONS
Adverse reactions reported in ≥5% of patients. Common adverse reactions occurring more frequently in CAYSTON-treated patients (n=146) than in placebo-treated patients (n=160) were cough (54% vs 51%), nasal congestion (16% vs 12%), wheezing (16% vs 10%), pharyngolaryngeal pain (12% vs 11%), pyrexia (13% vs 6%), chest discomfort (8% vs 6%), abdominal pain (7% vs 5%), and vomiting (6% vs 4%).
Adverse reactions reported in <5% of patients. Adverse reactions that occurred in less than 5% of patients treated with CAYSTON were bronchospasm (3%) and rash (2%).
Please see the Full Prescribing Information and the FDA-Approved Patient Labeling for complete details.
