CAYSTON use in specific populations

Pregnancy

For CF patients with Pa, CAYSTON is the only inhaled antibiotic with a pregnancy category B classification.

No reproductive toxicology studies have been conducted with CAYSTON. However, studies were conducted with aztreonam for injection. Aztreonam has been shown to cross the placenta and enter fetal circulation. No evidence of embryo or fetotoxicity or teratogenicity has been shown in studies with pregnant rats and rabbits. In rats receiving aztreonam for injection during late gestation and lactation, no drug-induced changes in maternal, fetal, or neonatal parameters were observed.

No adequate and well-controlled studies of aztreonam for injection or CAYSTON have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, CAYSTON should be used during pregnancy only if clearly needed.

Nursing Mothers

Use of CAYSTON during breastfeeding is unlikely to pose a risk to infants.

Following administration of aztreonam for injection, aztreonam is excreted in human milk at concentrations that are less than 1% of those determined in simultaneously obtained maternal serum. Peak plasma concentrations of aztreonam following administration of CAYSTON are approximately 1% of peak concentrations observed following IV aztreonam.

Renal Impairment

CAYSTON may be administered to patients with mild, moderate, and severe renal impairment with no dosage adjustment.

Aztreonam is known to be excreted by the kidneys. Placebo-controlled clinical trials with CAYSTON excluded patients with abnormal baseline renal function (defined as serum creatinine greater than 2 times the upper limit of normal range). Given the low systemic exposure of aztreonam following administration of CAYSTON, clinically relevant accumulation of aztreonam is unlikely to occur in patients with renal impairment. Therefore, CAYSTON may be administered to patients with mild, moderate, and severe renal impairment with no dosage adjustment.

Pediatric Use

Patients 7 years and older were included in clinical trials with CAYSTON.

Safety and effectiveness in pediatric patients below the age of 7 years have not been established. Fifty-five patients under 18 years of age received CAYSTON in placebo-controlled trials. No dose adjustments were made for pediatric patients in clinical trials. Pyrexia was more commonly reported in pediatric patients than in adult patients.