Monobactams

Cayston

Approved 22 Feb 2010InhalationFor solution

Indications

CAYSTON ® is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa . Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV 1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia [see Clinical Studies (14) ]. 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 Pseudomonas aeruginosa in the lungs.

CAYSTON is a monobactam antibacterial indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa . Safety and effectiveness have not been established in pediatric patients below the age of 7 years, patients with FEV 1 <25% or >75% predicted, or patients colonized with Burkholderia cepacia . ( 1 )

Contraindications

CAYSTON is contraindicated in patients with a known allergy to aztreonam. Contraindicated in patients with a known allergy to aztreonam. ( 4 )

Warnings and precautions

Allergic reaction to CAYSTON was seen in clinical trials. Stop treatment if an allergic reaction occurs. Use caution when CAYSTON is administered to patients with a known allergic reaction to beta-lactams. ( 5.1 ) Bronchospasm has been reported with CAYSTON. Stop treatment if chest tightness develops during nebulizer use. ( 5.2 )

5.1Allergic 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.

At a glance

Brand name: Cayston
Active substance: aztreonam
Drug class: Monobactams
Route: Inhalation
Dosage form: For solution
Applicant: Gilead
Status: Prescription
FDA approval: 22 Feb 2010
Application: NDA050814-001
RxCUI: 901611

Indications

Warnings and precautions

5.1Allergic Reactions

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.

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Available data on CAYSTON use in pregnant women is insufficient to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; however, systemic absorption of aztreonam following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ]. There are risks to the mother associated with cystic fibrosis in pregnancy (see Clinical Considerations ) . In animal reproduction studies with aztreonam for injection administered parenterally to pregnant rats and rabbits during organogenesis, there was no evidence of developmental toxicity.

A peri/postnatal study in rats revealed no drug-induced changes in maternal, fetal, or neonatal parameters. The estimated background risk of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Cystic fibrosis may increase the risk for preterm delivery. Data Animal Data No reproductive toxicity studies have been conducted with CAYSTON. However, studies were conducted with aztreonam for injection. No evidence of developmental toxicity has been shown in studies with pregnant rats and rabbits that received parenteral doses of aztreonam during organogenesis of up to 1800 and 1200 mg/kg/day, respectively.

In rats receiving aztreonam for injection during late gestation and lactation at up to 1800 mg/kg/day, no drug induced changes in maternal, fetal or neonatal parameters were observed. These animal reproduction and developmental toxicity studies used parenteral routes of administration that would provide systemic exposures significantly greater than the average peak plasma levels measured in humans following CAYSTON therapy.

Adverse reactions

Common adverse reactions (more than 5%) occurring more frequently in CAYSTON patients are cough, nasal congestion, wheezing, pharyngolaryngeal pain, pyrexia, chest discomfort, abdominal pain and vomiting. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD5, option 3 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of CAYSTON was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg CAYSTON 3 times a day for 28 days.

Table 1 displays adverse reactions reported in more than 5% of patients treated with CAYSTON 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in CAYSTON-treated patients than in placebo-treated patients. Table 1 Adverse Reactions Reported in more than 5% of Patients Treated with CAYSTON in the Placebo-Controlled Trials Event (Preferred Term) Placebo (N=160) n (%) CAYSTON 75 mg 3 times a day (N=146) n (%) Cough 82 (51%) 79 (54%) Nasal congestion 19 (12%) 23 (16%) Wheezing 16 (10%) 23 (16%) Pharyngolaryngeal pain 17 (11%) 18 (12%) Pyrexia 9 (6%) 19 (13%) Chest discomfort 10 (6%) 11 (8%) Abdominal Pain 8 (5%) 10 (7%) Vomiting 7 (4%) 9 (6%) Adverse reactions that occurred in less than 5% of patients treated with CAYSTON were bronchospasm (3%) [see Warnings and Precautions (5.2) ] and rash (2%).

6.2Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of CAYSTON. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made. MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia, joint swelling

Cayston

Indications

Contraindications

Warnings and precautions

5.1Allergic Reactions

At a glance

Two medicines in one question?

Cayston

Indications

Contraindications

Warnings and precautions

5.1Allergic Reactions

At a glance

Two medicines in one question?

5.3Decreases in FEV 1 After 28-Day Treatment Cycle

5.4Development of Drug-Resistant Bacteria Prescribing

Interactions

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Trials Experience

6.2Postmarketing Experience

Composition

Official product information