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Aztreonam (oral inhalation): Drug information

Aztreonam (oral inhalation): Drug information
(For additional information see "Aztreonam (oral inhalation): Patient drug information" and see "Aztreonam (oral inhalation): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Cayston
Brand Names: Canada
  • Cayston
Pharmacologic Category
  • Antibiotic, Monobactam
Dosing: Adult
Cystic fibrosis

Cystic fibrosis: Inhalation (nebulizer): 75 mg 3 times daily (at least 4 hours apart) for 28 days; administer in repeated cycles of 28 days on drug, followed by 28 days off drug. Note: Pretreatment with a bronchodilator is recommended.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

US labeling: There are no dosage adjustments provided in the manufacturer’s labeling.

Canadian labeling: No dosage adjustment is necessary; minimal systemic absorption following inhalation.

Dosing: Pediatric

(For additional information see "Aztreonam (oral inhalation): Pediatric drug information")

Cystic fibrosis

Cystic fibrosis (Pseudomonas aeruginosa) : Inhalation (nebulizer): Infants ≥3 months, Children, and Adolescents (limited data available in ages <7 years): 75 mg via nebulization 3 times daily (at least 4 hours apart) for 28 days; administer in repeated cycles of 28 days on drug, followed by 28 days off drug (Ref).

Dosing: Kidney Impairment: Pediatric

Children ≥7 years and Adolescents: No adjustment required with any level of renal impairment due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely necessary due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Gastrointestinal: Pharyngolaryngeal pain (12%)

Respiratory: Cough (54%), nasal congestion (16%), wheezing (16%)

Miscellaneous: Fever (13%; more common in children)

1% to 10%:

Cardiovascular: Chest discomfort (8%)

Dermatologic: Skin rash (2%)

Gastrointestinal: Abdominal pain (7%), vomiting (6%)

Respiratory: Bronchospasm (3%; patients experienced ≥15% reduction in FEV1)

<1%, postmarketing, and/or case reports: Arthralgia, facial rash, facial swelling, hypersensitivity reaction, joint swelling, pharyngeal edema

Contraindications

Hypersensitivity to aztreonam or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Beta-lactam allergy: Rare cross-allergenicity to penicillins, cephalosporins, or carbapenems may occur; use with caution in patients with a history of hypersensitivity to beta-lactams.

• Bronchospasm: May occur following nebulization; administer a bronchodilator prior to treatment.

Dosage form specific issues:

• Appropriate use: Compare patient's baseline FEV1 prior to therapy and the presence of other symptoms when deciding if post-treatment FEV1 changes (eg, decline) are caused by a pulmonary exacerbation. Reserve use for cystic fibrosis (CF) patients with known Pseudomonas aeruginosa.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Inhalation [preservative free]:

Cayston: 75 mg (1 mL) [arginine free]

Generic Equivalent Available: US

No

Pricing: US

Solution (reconstituted) (Cayston Inhalation)

75 mg (per mL): $171.18

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Inhalation:

Cayston: 75 mg (1 ea)

Prescribing and Access Restrictions

Cayston (aztreonam inhalation solution) is only available through a select group of specialty pharmacies and cannot be obtained through a retail pharmacy. Because Cayston may only be used with the Altera Nebulizer System, it can only be obtained from the following specialty pharmacies; IV Solutions/Maxor; Foundation Care; Pharmaceutical Specialties Inc; TLCRx/ModernHEALTH; and Walgreens Specialty Pharmacy. This network of specialty pharmacies ensures proper access to both the drug and device. To obtain the medication and proper nebulizer, contact the Cayston Access Program at 1-877-7CAYSTON (1-877-722-9786) or at www.cayston.com. In Canada, Cayston is distributed by Innomar Solutions specialty pharmacy; Canadian healthcare providers and patients may obtain additional information at http://cayston.ca/

Administration: Adult

Administer using only an Altera nebulizer system; administer alone; do not mix with other nebulizer medications. Administer a bronchodilator before administration of aztreonam (short-acting: 15 minutes to 4 hours before; long-acting: 30 minutes to 12 hours before). For patients on multiple inhaled therapies, administer bronchodilator first, then mucolytic, and lastly, aztreonam.

To administer Cayston, pour reconstituted solution into the handset of the nebulizer system, turn unit on. Place the mouthpiece in the patient’s mouth and encourage to breathe normally through the mouth. Administration time is usually 2 to 3 minutes. Administer doses ≥4 hours apart.

Administration: Pediatric

Inhalation: For inhalation only; not for IM or IV use. Reconstitute immediately prior to use. Administer only using an Altera nebulizer system; dose can be nebulized over 2 to 3 minutes. Administer alone; do not mix with other inhaled nebulizer medications. Administer doses ≥4 hours apart. Administer a bronchodilator before administration of aztreonam (short-acting: 15 minutes to 4 hours before; long-acting: 30 minutes to 12 hours before). For patients on multiple inhaled therapies, administer bronchodilator first, then mucolytic, and lastly, aztreonam.

Use: Labeled Indications

Cystic fibrosis: Improve respiratory symptoms in cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa infections.

Medication Safety Issues
Sound-alike/look-alike issues:

Aztreonam may be confused with azidothymidine

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Aztreonam crosses the placenta and reaches the fetal circulation following IV administration; however, peak plasma concentrations following inhalation of aztreonam are significantly less than those observed following aztreonam IV.

Due to its poor systemic absorption, use of aztreonam inhalation is likely acceptable for the management of cystic fibrosis in pregnant patients with Pseudomonas aeruginosa (Kroon 2018; Middleton 2019). When required, use may continue during pregnancy (Middleton 2019).

Breastfeeding Considerations

Aztreonam is present in breast milk following IV administration.

The peak plasma concentration of aztreonam following inhalation is <1% of the peak concentration seen following IV administration. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Due to its poor systemic absorption, use of aztreonam inhalation is likely acceptable for the management of cystic fibrosis in lactating women with Pseudomonas aeruginosa (Kroon 2018; Middleton 2019).

Monitoring Parameters

Consider measuring FEV1 prior to initiation of therapy

Mechanism of Action

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs), which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases), while cell wall assembly is arrested. Monobactam structure makes cross-allergenicity with beta-lactams unlikely.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Low systemic absorption.

Protein binding: ~77%.

Time to peak: ~1 hour (plasma).

Half-life elimination: Adults: 2.1 hours.

Excretion: Urine (10% [compared with 60% to 65% for injection] as unchanged drug).

  1. American Academy of Pediatrics (AAP). In: Pickering LK, Baker CJ, Kimberlin DW, Long SS, eds. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.
  2. Cayston (aztreonam) [prescribing information]. Foster City, CA: Gilead Sciences, Inc; November 2019.
  3. Cayston (aztreonam) [product monograph]. Mississauga, Ontario, Canada: Gilead Sciences Canada Inc; May 2020.
  4. Kroon MAGM, Akkerman-Nijland AM, Rottier BL, Koppelman GH, Akkerman OW, Touw DJ. Drugs during pregnancy and breast feeding in women diagnosed with cystic fibrosis - an update. J Cyst Fibros. 2018;17(1):17-25. doi: 10.1016/j.jcf.2017.11.009. [PubMed 29233472]
  5. Lahiri T, Hempstead SE, Brady C, et al. Clinical practice guidelines from the Cystic Fibrosis Foundation for preschoolers with cystic fibrosis. Pediatrics. 2016;137(4):e20151784. [PubMed 27009033]
  6. Le J, Ashley ED, Neuhauser MM, et al. Consensus summary of aerosolized antimicrobial agents: application of guideline criteria. Insights from the Society of Infectious Diseases Pharmacists. Pharmacotherapy. 2010;30(6):562-584. [PubMed 20500046]
  7. Middleton PG, Gade EJ, Aguilera C, et al. ERS/TSANZ Task Force statement on the management of reproduction and pregnancy in women with airways diseases [published online November 7, 2019]. Eur Respir J. doi: 10.1183/13993003.01208-2019. [PubMed 31699837]
  8. Refer to manufacturer's labeling.
  9. Retsch-Bogart GZ, Quittner Al, Gibson RL, et al, “Efficacy and Safety of Inhaled Aztreonam Lysine for Airway Pseudomonas in Cystic Fibrosis,” Chest, 2009, 135 (5):1223-32. [PubMed 19420195]
  10. Tiddens HA, De Boeck K, Clancy JP, et al. Open label study of inhaled aztreonam for Pseudomonas eradication in children with cystic fibrosis: The ALPINE study. J Cyst Fibros. 2015;14(1):111-119. [PubMed 25091537]
  11. Zobell JT, Young DC, Waters CD, et al. Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: I. aztreonam and carbapenems. Pediatr Pulmonol. 2012;47(12):1147-1158. [PubMed 22911974]
  12. Zobell JT, Young DC, Waters CD, et al. Optimization of anti-pseudomonal antibiotics for cystic fibrosis pulmonary exacerbations: VI. Executive Summary. Pediatr Pulmonol. 2013;48(6):525-537. [PubMed 23359557]
Topic 104067 Version 80.0

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