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.

Systemic Exposure & Microbiology

CAYSTON has low systemic exposure

SPUTUM CONCENTRATIONS

Mean sputum concentrations of aztreonam 10 minutes after dose administration in patients receiving CAYSTON (75 mg) 3 times a day for 28 days are shown below*:

Day 0

984 mcg/g

Day 14

793 mcg/g

Day 28

715 mcg/g

*There was considerable variability observed between patients.

PLASMA CONCENTRATIONS

Mean peak plasma concentrations were reached 1 hour postdose in patients receiving CAYSTON (75 mg) 3 times a day. Values shown below^†:

Day 0

0.55 mcg/mL

Day 14

0.67 mcg/mL

Day 28

0.65 mcg/mL

^†There was considerable variability observed between patients.

In contrast, serum concentration following a one-time, 30-minute IV administration of aztreonam for injection (500 mg) was approximately 54 mcg/mL
There was no systemic accumulation of CAYSTON

ABSORPTION

Evaluation of plasma and urine aztreonam concentrations in patients following administration of CAYSTON indicated low systemic absorption of aztreonam
About 10% of the total CAYSTON dose was excreted in the urine as unchanged drug, as compared to 60%-65% following IV administration of aztreonam for injection

Microbiology

CAYSTON did not negatively affect the lung microbiology profile

Resistance to CAYSTON was not increased

No changes in susceptibility of Pseudomonas aeruginosa (Pa) to aztreonam were observed following a 28-day course of CAYSTON in the phase 3, placebo-controlled trials.

In the follow‑on study of up to 18 months, cross‑resistance did not increase

No cross-resistance to other classes of antibiotics including aminoglycosides, quinolones, and beta-lactams, was observed following a 28-day course of CAYSTON in the phase 3 placebo-controlled trials or in an open-label follow-on trial of up to nine 28-day courses of 75 mg CAYSTON 3 times a day.

No trends in the treatment‑emergent isolation of other bacterial respiratory pathogens were observed in clinical trials

Burkholderia cepacia, Stenotrophomonas maltophilia, Achromobacter xylosoxidans, and Staphylococcus aureus were not observed in clinical trials. There was a slight increase in the isolation of Candida spp. following up to nine 28-day courses of CAYSTON therapy.

Learn About Guidelines on 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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