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Cayston aztreonam Kit — NDC 61958-0901-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cayston aztreonam Kit — NDC 61958-0901-1 (Billing 61958-0901-01)

by Gilead Sciences, Inc. · 2 CARTON in 1 PACKAGE / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE

This is a package of Cayston aztreonam Kit from Gilead Sciences, Inc., marketed since Feb 2010 and currently FDA-listed. It is this product's only package size.

NDC 61958-0901-01
🏷️ FDA NDC (as labeled) 61958-0901-1 billing pads the package segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 61958-0901-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
61958 labeler · 0901 product · 1 package
Package marketed since
Feb 22, 2010
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6195809011 7
Medicaid fills, this package
2,031 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61958-0901-1
Product NDC 61958-0901
11-digit billing NDC 61958090101
NCPDP billing unit ML — per mL (volume)
RxCUI 901610, 901614
Application # NDA050814
SPL Set ID 67300ca3-8c53-4ce4-8e86-2c03be1f9b8a
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-02-22
Dosage form KIT

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 16140010402120
GPI class Cayston
GCN Seq No 065913
GCN 28039
HICL code 036792
Ingredient (HICL) Aztreonam Lysine
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1P
Therapeutic class — specific (HIC3) Betalactams
AHFS code 08:12.07.16
AHFS class Monobactam Antibiotics
FDB label name CAYSTON 75 MG INHAL SOLUTION
FDB brand name Cayston
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 065913
  • GCN: 28039
  • GPI-14 (Medi-Span): 16140010402120
  • HICL (First Databank): 036792
  • AHFS class code: 08:12.07.16
  • RxCUI (RxNorm): 901610
Why two NDCs? The FDA registers this code as 61958-0901-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 61958-0901-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Monobactam Antibacterial class.

Pharmacologic class Monobactam Antibacterial
Drug family (ATC) Monobactams
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name CAYSTON 75 MG INHAL SOLUTION Ingredient Aztreonam Lysine
📗 Our plain-language guide HelloPharmacist
  • It treats serious infections caused by susceptible Gram-negative bacteria. That includes urinary tract, lung, skin, abdominal and gynecologic infections, plus bloodstream infection...
  • It's given as an injection into a vein or deep into a large muscle. Your prescriber decides the route and how often based on your infection and kidney function. Severe infections u...
  • The most common are soreness or swelling where you get the shot, vein irritation, diarrhea, nausea, vomiting and rash. These are usually mild. Tell your care team if they bother yo...
  • Get emergency help for swelling of the face or throat, trouble breathing or hives. Call your doctor for severe or watery diarrhea, even weeks after finishing, or for severe skin pe...
📖 Read our full Aztreonam Injection guide →
7
Nutrient depletion considerations

Aztreonam may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Aztreonam nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $154.93 —
Medicare drug plans payPart D · Q2 2026 $160.54 —
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61958-0901-01 You're viewing this Main listing 2 CARTON in 1 PACKAGE / 1 KIT in 1 CARTON * 1 mL in 1 VIAL * 1 mL in 1 AMPULE 2010-02-22 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Caystonthis 61958-0901-01 Gilead 1 kit — — FDA listed —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2010
On the market since
Feb 2010
📍
2026
Currently FDA-listed
16 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Aztreonam Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerGilead Sciences, Inc.
Application holderGILEAD SCIENCES INC
FDA applicationNDA050814 (NDA)
Labeler code61958
First marketedFeb 2010
Product typeHuman Prescription Drug
Portfolio42 products on file

More NDCs from Gilead Sciences, Inc. labeler code 61958

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 144 words ▾

1 INDICATIONS AND USAGE 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 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Administer one dose (one single use vial and one ampule of diluent) 3 times a day for 28 days. ( 2.1 ) Use dose immediately after reconstitution. ( 2.2 ) Administer only with the Altera ® Nebulizer System. Do not administer with any other type of nebulizer. ( 2.3 )

2.1Dosing Information The recommended dose of CAYSTON for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of aztreonam) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off CAYSTON therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.

CAYSTON is administered by inhalation using an Altera ® Nebulizer System. Patients should use a bronchodilator before administration of CAYSTON.

2.2Instructions for CAYSTON Reconstitution CAYSTON should be administered immediately after reconstitution. Do not reconstitute CAYSTON until ready to administer a dose. Take one amber glass vial containing CAYSTON and one diluent ampule from the carton.

To open the glass vial, carefully remove the blue cap and metal ring and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.

The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.

2.3Instructions for CAYSTON Administration CAYSTON is administered by inhalation using an Altera Nebulizer System. CAYSTON should not be administered with any other nebulizer. CAYSTON should not be mixed with any other drugs in the Altera Nebulizer Handset.

CAYSTON is not for intravenous or intramuscular administration. Patients should use a bronchodilator before administration of CAYSTON. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of CAYSTON.

Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of CAYSTON. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, CAYSTON. To administer CAYSTON, pour the reconstituted solution into the handset of the nebulizer system.

Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes.

Further patient instructions on how to administer CAYSTON are provided in the FDA-approved patient labeling. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system.

💊 Dosage Forms and Strengths 54 words ▾

3 DOSAGE FORMS AND STRENGTHS A dose of CAYSTON consists of a single-use vial of sterile, lyophilized aztreonam (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted CAYSTON is administered by inhalation. Lyophilized aztreonam (75 mg/vial) ( 3 ) Diluent (0.17% sodium chloride): 1 mL/ampule ( 3 )

⛔ Contraindications 25 words ▾

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

⚠️ Warnings and Cautions ~1 min read ▾

5 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.

5.2Bronchospasm Bronchospasm is a complication associated with nebulized therapies, including CAYSTON. Reduction of 15% or more in forced expiratory volume in 1 second (FEV 1 ) immediately following administration of study medication after pretreatment with a bronchodilator was observed in 3% of patients treated with CAYSTON.

5.3Decreases in FEV 1 After 28-Day Treatment Cycle In clinical trials, patients with increases in FEV 1 during a 28-day course of CAYSTON were sometimes treated for pulmonary exacerbations when FEV 1 declined after the treatment period. Healthcare providers should consider a patient's baseline FEV 1 measured prior to CAYSTON therapy and the presence of other symptoms when evaluating whether post-treatment changes in FEV 1 are caused by a pulmonary exacerbation.

5.4Development 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 ~1 min read ▾

6 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

🔄 Drug Interactions 15 words ▾

7 DRUG INTERACTIONS No formal clinical studies of drug interactions with CAYSTON have been conducted.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

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.

8.2Lactation Risk Summary Following intravenous administration of aztreonam for injection, aztreonam is excreted in human milk at concentrations that are less than one percent of those determined in simultaneously obtained maternal serum. Peak plasma concentrations of aztreonam following administration of CAYSTON (75 mg) are approximately 1% of peak concentrations observed following IV aztreonam (500 mg). Systemic absorption of aztreonam following inhaled administration is expected to be minimal [see Clinical Pharmacology (12.3) ].

There are no data on the effects of aztreonam on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for CAYSTON and any potential adverse effects on the breastfed infant from CAYSTON or from the underlying maternal condition.

8.4Pediatric Use Patients 7 years and older were included in clinical trials with CAYSTON. Fifty-five patients under 18 years of age received CAYSTON in placebo-controlled trials. No dose adjustments were made for pediatric patients. Pyrexia was more commonly reported in pediatric patients than in adult patients. Safety and effectiveness in pediatric patients below the age of 7 years have not been established.

8.5Geriatric Use Clinical trials of CAYSTON did not include CAYSTON-treated patients aged 65 years of age and older to determine whether they respond differently from younger patients.

8.6Use in Patients with Renal Impairment Aztreonam is known to be excreted by the kidney. 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 r… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

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.

🧒 Pediatric Use 63 words ▾

8.4Pediatric Use Patients 7 years and older were included in clinical trials with CAYSTON. Fifty-five patients under 18 years of age received CAYSTON in placebo-controlled trials. No dose adjustments were made for pediatric patients. Pyrexia was more commonly reported in pediatric patients than in adult patients. Safety and effectiveness in pediatric patients below the age of 7 years have not been established.

🧓 Geriatric Use 28 words ▾

8.5Geriatric Use Clinical trials of CAYSTON did not include CAYSTON-treated patients aged 65 years of age and older to determine whether they respond differently from younger patients.

🆘 Overdosage 79 words ▾

10 OVERDOSAGE No overdoses have been reported with CAYSTON in clinical trials to date. In clinical trials, 225 mg doses of CAYSTON via inhalation were associated with higher rates of drug-related respiratory adverse reactions, particularly cough. Since the peak plasma concentration of aztreonam following administration of CAYSTON (75 mg) is approximately 0.6 mcg/mL, compared to a serum concentration of 54 mcg/mL following administration of aztreonam for injection (500 mg), no systemic safety issues associated with CAYSTON overdose are anticipated.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Aztreonam is an antibacterial drug [see Clinical Pharmacology (12.4) ] .

12.3Pharmacokinetics Sputum Concentrations Sputum aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the first dose of CAYSTON (n = 195 patients with CF) was 726 mcg/g. Mean sputum concentrations of aztreonam in patients receiving CAYSTON 3 times a day for 28 days were 984 mcg/g, 793 mcg/g, and 715 mcg/g 10 minutes after dose administration on Days 0, 14, and 28, respectively, indicating no accumulation of aztreonam in sputum.

Plasma Concentrations Plasma aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in the clinical trials. The mean plasma concentration one hour following the first dose of CAYSTON (at approximately the peak plasma concentration) was 0.59 mcg/mL. Mean peak plasma concentrations in patients receiving CAYSTON 3 times a day for 28 days were 0.55 mcg/mL, 0.67 mcg/mL, and 0.65 mcg/mL on Days 0, 14, and 28, respectively, indicating no systemic accumulation of aztreonam.

In contrast, the serum concentration of aztreonam following administration of aztreonam for injection (500 mg) is approximately 54 mcg/mL. Absorption Evaluation of plasma and urine aztreonam concentrations following administration of CAYSTON indicates low systemic absorption of aztreonam. Approximately 10% of the total CAYSTON dose is excreted in the urine as unchanged drug, as compared to 60–65% following intravenous administration of aztreonam for injection.

Distribution The protein binding of aztreonam in plasma is approximately 77% within the clinical dose range of concentrations achieved following CAYSTON administration. Metabolism Following intramuscular administration of aztreonam for injection 500 mg every 8 hours for 7 days, approximately 6% of the dose was excreted as a microbiologically inactive open β-lactam ring hydrolysis product in an 8-hour urine collection on the last day of multiple dosing. Excretion The elimination half-life of aztreonam from plasma is approximately 2.1 hours following administration of CAYSTON to adult patients with CF, similar to what has been reported for aztreonam for injection.

Approximately 10% of the total CAYSTON dose is excreted in the urine as unchanged drug. Systemically absorbed aztreonam is eliminated about equally by active tubular secretion and glomerular filtration. Following administration of a single intravenous dose of radiolabeled aztreonam for injection, about 12% of the dose was recovered in the feces.

12.4Microbiology Mechanism of Action Aztreonam exhibits activity in vitro against Gram-negative aerobic pathogens including P. aeruginosa . Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis and death of the cell. Aztreonam activity is not decreased in the presence of CF lung secretions.

Susceptibility Testing A single sputum sample from a patient with CF may contain multiple morphotypes of P. aeruginosa and each morphotype may have a different level of in vitro susceptibility to aztreonam. There are no in vitro susceptibility test interpretive criteria for isolates of P. aeruginosa obtained from the sputum of CF patients. 1 Development of Resistance No changes in the susceptibility of P. aeruginosa to aztreonam were observed following a 28-day course of CAYSTON in the placebo-controlled trials.

Cross-Resistance 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. Other No trends in the treatment-emergent isolation of other bacterial respiratory pathogens ( Burkholderia cepacia… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 15 words ▾

12.1Mechanism of Action Aztreonam is an antibacterial drug [see Clinical Pharmacology (12.4) ] .

📦 How Supplied / Storage and Handling 197 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Each kit for a 28-day course of CAYSTON contains 84 sterile vials of CAYSTON and 88 ampules of sterile diluent packed in 2 cartons, each carton containing a 14-day supply. The four additional diluent ampules are provided in case of spillage. Package Configuration Dosage Strength NDC 28-Day Kit 75 mg 61958-0901-1 CAYSTON vials and diluent ampules should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F) until needed.

Once removed from the refrigerator, CAYSTON and diluent may be stored at room temperature (up to 25 °C/77 °F) for up to 28 days. Do not separate the CAYSTON vials from the diluent ampules. CAYSTON should be protected from light.

Do not use CAYSTON if it has been stored at room temperature for more than 28 days. Do not use CAYSTON beyond the expiration date stamped on the vial. Do not use diluent beyond the expiration date embossed on the ampule.

CAYSTON should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time. Do not use diluent or reconstituted CAYSTON if it is cloudy or if there are particles in the solution.

📦 Storage and Handling 141 words ▾

CAYSTON vials and diluent ampules should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F) until needed. Once removed from the refrigerator, CAYSTON and diluent may be stored at room temperature (up to 25 °C/77 °F) for up to 28 days. Do not separate the CAYSTON vials from the diluent ampules.

CAYSTON should be protected from light. Do not use CAYSTON if it has been stored at room temperature for more than 28 days. Do not use CAYSTON beyond the expiration date stamped on the vial.

Do not use diluent beyond the expiration date embossed on the ampule. CAYSTON should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time.

Do not use diluent or reconstituted CAYSTON if it is cloudy or if there are particles in the solution.

📋 Description 166 words ▾

11 DESCRIPTION A dose of CAYSTON consists of a 2 mL amber glass vial containing lyophilized aztreonam (75 mg) and lysine (46.7 mg), and a low-density polyethylene ampule containing 1 mL sterile diluent (0.17% sodium chloride). The reconstituted solution is for inhalation. The formulation contains no preservatives or arginine.

The active ingredient in CAYSTON is aztreonam, a monobactam antibacterial. The monobactams are structurally different from beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems) due to a monocyclic nucleus. This nucleus contains several side chains; sulfonic acid in the 1-position activates the nucleus, an aminothiazolyl oxime side chain in the 3-position confers specificity for aerobic Gram-negative bacteria including Pseudomonas spp ., and a methyl group in the 4-position enhances beta-lactamase stability.

Aztreonam is designated chemically as ( Z )-2-[[[(2-amino-4-thiazolyl)[[(2 S ,3 S )-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. The structural formula is presented below: CAYSTON is a white to off-white powder. CAYSTON is sterile, hygroscopic, and light sensitive.

Once reconstituted with the supplied diluent, the pH range is 4.5 to 6.0. Chemical Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Allergic Reactions Advise patients to tell their healthcare provider immediately if they believe they are experiencing new or worsening symptoms or believe they are having an allergic reaction to CAYSTON [see Warnings and Precautions (5.1) ]. Development of Drug-Resistant Bacteria Counsel patients that antibacterial drugs including CAYSTON should only be used to treat bacterial infections.

They do not treat viral infection (e.g., the common cold). When CAYSTON is prescribed to treat a bacterial infection, inform patients that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CAYSTON or other antibacterial drugs in the future [see Warnings and Precautions (5.4) ].

Reconstitution and Administration Advise patients that: CAYSTON is for inhalation use only and should only be administered using the Altera Nebulizer System. CAYSTON should only be reconstituted with the provided diluent. Instruct patients not to mix other drugs with CAYSTON in the Altera Nebulizer System.

Advise patients to: use a bronchodilator prior to administration of CAYSTON. complete the full 28-day course of CAYSTON even if they are feeling better. Advise patients taking several inhaled medications to use the medications in the following order: bronchodilator, mucolytics, and lastly, CAYSTON. Missed Dose Inform the patient that if they miss a dose, they should take all 3 daily doses as long as the doses are at least 4 hours apart.

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Sputum Concentrations Sputum aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in clinical trials. The mean sputum concentration 10 minutes following the first dose of CAYSTON (n = 195 patients with CF) was 726 mcg/g. Mean sputum concentrations of aztreonam in patients receiving CAYSTON 3 times a day for 28 days were 984 mcg/g, 793 mcg/g, and 715 mcg/g 10 minutes after dose administration on Days 0, 14, and 28, respectively, indicating no accumulation of aztreonam in sputum.

Plasma Concentrations Plasma aztreonam concentrations exhibited considerable variability between patients receiving CAYSTON (75 mg) in the clinical trials. The mean plasma concentration one hour following the first dose of CAYSTON (at approximately the peak plasma concentration) was 0.59 mcg/mL. Mean peak plasma concentrations in patients receiving CAYSTON 3 times a day for 28 days were 0.55 mcg/mL, 0.67 mcg/mL, and 0.65 mcg/mL on Days 0, 14, and 28, respectively, indicating no systemic accumulation of aztreonam.

In contrast, the serum concentration of aztreonam following administration of aztreonam for injection (500 mg) is approximately 54 mcg/mL. Absorption Evaluation of plasma and urine aztreonam concentrations following administration of CAYSTON indicates low systemic absorption of aztreonam. Approximately 10% of the total CAYSTON dose is excreted in the urine as unchanged drug, as compared to 60–65% following intravenous administration of aztreonam for injection.

Distribution The protein binding of aztreonam in plasma is approximately 77% within the clinical dose range of concentrations achieved following CAYSTON administration. Metabolism Following intramuscular administration of aztreonam for injection 500 mg every 8 hours for 7 days, approximately 6% of the dose was excreted as a microbiologically inactive open β-lactam ring hydrolysis product in an 8-hour urine collection on the last day of multiple dosing. Excretion The elimination half-life of aztreonam from plasma is approximately 2.1 hours following administration of CAYSTON to adult patients with CF, similar to what has been reported for aztreonam for injection.

Approximately 10% of the total CAYSTON dose is excreted in the urine as unchanged drug. Systemically absorbed aztreonam is eliminated about equally by active tubular secretion and glomerular filtration. Following administration of a single intravenous dose of radiolabeled aztreonam for injection, about 12% of the dose was recovered in the feces.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES CAYSTON was evaluated over a period of 28 days of treatment in a randomized, double-blind, placebo-controlled, multicenter trial that enrolled patients with CF and P. aeruginosa . This trial was designed to evaluate improvement in respiratory symptoms. Patients 7 years of age and older and with FEV 1 of 25% to 75% predicted were enrolled.

All patients received CAYSTON or placebo on an outpatient basis administered with the Altera Nebulizer System. All patients were required to take a dose of an inhaled bronchodilator (beta-agonist) prior to taking a dose of CAYSTON or placebo. Patients were receiving standard care for CF, including drugs for obstructive airway diseases.

The trial enrolled 164 patients with CF and P. aeruginosa . The mean age was 30 years, and the mean baseline FEV 1 % predicted was 55%; 43% were females and 96% were Caucasian. These patients were randomized in a 1:1 ratio to receive either CAYSTON (75 mg) or volume-matched placebo administered by inhalation 3 times a day for 28 days.

Patients were required to have been off antibiotics for at least 28 days before treatment with study drug. The primary efficacy endpoint was improvement in respiratory symptoms on the last day of treatment with CAYSTON or placebo. Respiratory symptoms were also assessed two weeks after the completion of treatment with CAYSTON or placebo.

Changes in respiratory symptoms were assessed using a questionnaire that asks patients to report on symptoms like cough, wheezing, and sputum production. Improvement in respiratory symptoms was noted for CAYSTON-treated patients relative to placebo-treated patients on the last day of drug treatment. Statistically significant improvements were seen in both adult and pediatric patients but were substantially smaller in adult patients.

Two weeks after completion of treatment, a difference in respiratory symptoms between treatment groups was still present, though the difference was smaller. Pulmonary function, as measured by FEV 1 (L), increased from baseline in patients treated with CAYSTON (see Figure 1 ). The treatment difference at Day 28 between CAYSTON-treated and placebo-treated patients for percent change in FEV 1 (L) was statistically significant at 10% (95% CI: 6%, 14%).

Improvements in FEV 1 were comparable between adult and pediatric patients. Two weeks after completion of drug treatment, the difference in FEV 1 between CAYSTON and placebo groups had decreased to 6% (95% CI: 2%, 9%). Figure 1 Adjusted Mean Percent Change in FEV 1 from Baseline to Study End (Days 0–42) Figure 1

🧪 Nonclinical Toxicology 159 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day. Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level.

This is approximately 12-fold higher than the average peak plasma level measured in humans following CAYSTON therapy. Genetic toxicology studies performed in vitro demonstrated that aztreonam did not induce structural chromosome aberrations in CHO cells and did not induce mutations at the TK locus in mouse lymphoma L5178Y TK +/- cells. In vivo , aztreonam was not clastogenic in mouse bone marrow cells.

Aztreonam did not impair the fertility of rats when administered parenterally at doses up to 2400 mg/kg/day that would provide systemic exposures significantly higher than peak plasma levels measured in humans following CAYSTON therapy.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 156 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day. Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level.

This is approximately 12-fold higher than the average peak plasma level measured in humans following CAYSTON therapy. Genetic toxicology studies performed in vitro demonstrated that aztreonam did not induce structural chromosome aberrations in CHO cells and did not induce mutations at the TK locus in mouse lymphoma L5178Y TK +/- cells. In vivo , aztreonam was not clastogenic in mouse bone marrow cells.

Aztreonam did not impair the fertility of rats when administered parenterally at doses up to 2400 mg/kg/day that would provide systemic exposures significantly higher than peak plasma levels measured in humans following CAYSTON therapy.

📚 References 31 words ▾

15 REFERENCES Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically—Eighth Edition; Approved Standard. CLSI Document M7-A8. CLSI, Wayne, PA 19087. January 2009.

📄 Patient Package Insert ~3 min read ▾

This Patient Information has been approved by the U.S. Food and Drug Administration Rev November 2019 PATIENT INFORMATION CAYSTON ® (kay-stun) (aztreonam for inhalation solution) for oral inhalation use What is CAYSTON? CAYSTON is a prescription medicine that is used to improve breathing symptoms in people with cystic fibrosis (CF) who have a lung infection caused by a bacterium called Pseudomonas aeruginosa.

CAYSTON contains an antibacterial medicine called aztreonam. CAYSTON is only for infections caused by bacteria. It is not for infections caused by viruses, such as the common cold.

It is not known if CAYSTON is safe and effective: in children under 7 years of age in people who have an FEV 1 less than 25% or greater than 75% predicted in people who are colonized with a bacterium called Burkholderia cepacia Do not take CAYSTON if you are allergic to aztreonam, or any of the ingredients in CAYSTON. See the end of this Patient Information for a complete list of ingredients in CAYSTON. Before you take CAYSTON, tell your healthcare provider about all of your medical conditions, including if you: are allergic to any antibiotics. are pregnant or plan to become pregnant.

It is not known if CAYSTON can harm your unborn baby. are breastfeeding or plan to breastfeed. CAYSTON can pass into your breastmilk. Talk with your healthcare provider about the best way to feed your baby while you are taking CAYSTON.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how CAYSTON works. How should I take CAYSTON?

See the step-by-step Instructions for Use about the right way to take your CAYSTON. Take CAYSTON exactly as your healthcare provider tells you. Do not change your dose or stop taking CAYSTON unless your healthcare provider tells you to.

The dose for both adults and children 7 years of age and older is: 1 single-use vial of CAYSTON, mixed with 1 ampule of saline (diluent) inhaled 3 times a day using a hand-held Altera Nebulizer System. Each dose of CAYSTON should be taken at least 4 hours apart (for example: morning, after school, and before bed). CAYSTON should be taken for 28 days.

CAYSTON is taken as a breathing treatment (inhalation) with the Altera Nebulizer System. Do not use any other nebulizer for your CAYSTON treatment. Do not mix or dilute CAYSTON with any other medicines in your Altera Nebulizer System.

Do no t mix CAYSTON with the saline until right before you are ready to use it. Do not mix more than 1 dose of CAYSTON at a time. Each treatment should take about 2 to 3 minutes.

If you miss a dose of CAYSTON, you can still take all 3 daily doses as long as they are at least 4 hours apart. You should use an inhaled bronchodilator (a type of medicine used to relax and open your airways) before taking a dose of CAYSTON. If you do not have an inhaled bronchodilator, ask your healthcare provider to prescribe one for you.

Take short-acting bronchodilators between 15 minutes and 4 hours before you take your dose of CAYSTON Take long-acting bronchodilators between 30 minutes and 12 hours before you take your dose of CAYSTON If you are taking several medicines or treatments to treat your cystic fibrosis, you should take your medicines or other treatments in this order: 1) bronchodilator 2) mucolytics (medicines to help clear mucus from your lungs) 3) CAYSTON After taking CAYSTON for 28 days, you should stop taking it and wait 28 days. Complete the full 28-day course of CAYSTON even if you are feeling better.

It is important that you keep to the 28-day on, 28 day off cycle. If you skip doses or do not finish the full 28-day course of CAYSTON, your infection may not be fully treated and CAYSTON may not work as well as a treatment for infections in the future. What are the possible side effects of CAYSTON?

CAYSTON may cause serious side effects, including: Severe allergic reactions. Stop your treatment with CAYSTO… [Excerpted — this section continues on DailyMed.]

📖 Instructions for Use ~3 min read ▾

PATIENT INSTRUCTIONS FOR USE CAYSTON ® (aztreonam for inhalation solution) for oral inhalation use Be sure that you read, understand and follow the Patient Instructions for Use below for the right way to take CAYSTON. If you have any questions, ask your healthcare provider or pharmacist. You will need the following supplies (Figure 1): 1 amber colored CAYSTON vial covered by a metal seal with a blue cap 1 ampule of saline (diluent) Altera Nebulizer System Figure 1 Check to make sure that your Altera Nebulizer System works properly before starting your treatment with CAYSTON.

See the manufacturer's instructions for use that comes with your Altera Nebulizer System. This should have complete information about how to put together (assemble), prepare, use, and care for your Altera Nebulizer System. Preparing your CAYSTON for Inhalation Step 1.

Mix (reconstitute) CAYSTON with the saline only when ready to take a dose. Take 1 amber vial of CAYSTON and 1 ampule of saline from the carton. Separate the saline ampules by gently pulling apart.

Step 2. Look at the ampule of saline. If it looks cloudy do not use it.

Throw away this ampule and get another ampule of saline. Step 3. Gently tap the vial so that the powder settles to the bottom of the vial.

This helps you get the proper dose of medicine. Follow Step A to Step D in Figure 2 below to open the vial: Step A : With the blue cap tab facing toward you, place the vial on a flat surface. Using one hand to hold the vial steady, use the other hand to slowly flip up the blue cap.

Step B : Pull the blue cap down to a flat (horizontal) position (where the bottom of the blue cap faces up), to prepare the metal seal for removal. Do not completely tear through the metal seal. Step C : While continuing to hold the vial steady with one hand, use the other hand to slowly pull the blue cap in a counterclockwise direction.

Do not twist the blue cap. Step D : When the metal seal opens, continue to slowly pull the blue cap in a counterclockwise direction until the metal seal is completely removed. Figure 2 Step 4.

Safely throw away (dispose of) the metal seal in household garbage. Carefully remove (but do not yet discard) the rubber stopper. Step 5.

Open the ampule of saline by twisting off the tip. Squeeze out the contents completely into the vial ( Figure 3 ). Next, close the vial with the rubber stopper and gently swirl the vial until the powder has completely dissolved and the liquid is clear.

Figure 3 Step 6. After mixing CAYSTON with the saline, check to make sure the diluted medicine is clear. If it is cloudy or has particles in it, do not use this medicine.

Throw away this dose of medicine and start over again with a new vial of CAYSTON and a new ampule of saline. Step 7. Use CAYSTON right away after you mix with the saline.

Taking your CAYSTON Treatment See the manufacturer's instructions for use that comes with your Altera Nebulizer System for complete instructions on taking a treatment, and how to clean and disinfect your Altera Nebulizer Handset. Step 8. Make sure the handset is on a flat, stable surface.

Step 9. Remove the rubber stopper from the vial, then pour all of the mixed CAYSTON and saline into the Medication Reservoir of the handset (Figure 4). Be sure to completely empty the vial, gently tapping the vial against the side of the Medication Reservoir if necessary.

Close the Medication Reservoir (Figure 5). Figure 4 Figure 5 Step 10. Begin your treatment by sitting in a relaxed, upright position.

Hold the handset level, and place the Mouthpiece in your mouth. Close your lips around the Mouthpiece (Figure 6). Figure 6 Step 11.

Breathe in and out normally (inhale and exhale) through the Mouthpiece. Avoid breathing through your nose . Continue to inhale and exhale comfortably until the treatment is finished.

Step 12. The empty vial, stopper and saline ampule should be disposed of in household garbage upon completion of dosing. This Instructions for Use has been approved by the U.S.

Foo… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 89 words ▾

Principal Display Panel - Cayston 28 Day Carton - Representative Label NDC 61958-0901-1 GILEAD Cayston ® (aztreonam for inhalation solution) 75 mg/vial For Oral Inhalation Only Store Refrigerated, 2 °C to 8 °C (36 °F to 46 °F) Contains: 84 Single-Use Vials of Aztreonam for Inhalation Solution 88 Diluent Ampules of Sodium Chloride 0.17%, 1 mL (4 extra ampules provided in case of spillage) For use only with the Altera ® Nebulizer System 28-Day Supply R x only Principal Display Panel - Cayston 28 Day Carton - Representative Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
2K
Units reimbursed last 4 qtrs
165.6K
Gross reimbursed last 4 qtrs
$25.66M
Avg / prescription
$12,636.08
Avg / unit
$154.93
Latest quarter Q1 2026
450Rx
Fee-for-service vs managed care ⓘ
49% FFS 51% MCO
Fee-for-service · 991 Rx Managed care · 1,040 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 7,560 units · 75.3 per 100k residents MI New York: 6,552 units · 33.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 8,400 units · 263 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 5,964 units · 47.5 per 100k residents IL Indiana: no data reported IN Ohio: 6,888 units · 58.4 per 100k residents OH Pennsylvania: 7,224 units · 55.7 per 100k residents PA New Jersey: 3,444 units · 37.1 per 100k residents NJ Massachusetts: 1,092 units · 15.6 per 100k residents MA California: 48,468 units · 124 per 100k residents CA Utah: no data reported UT Colorado: 4,116 units · 70.0 per 100k residents CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 3,528 units · 40.5 per 100k residents VA Maryland: no data reported MD Connecticut: 1,092 units · 30.2 per 100k residents CT Rhode Island: no data reported RI Arizona: 3,696 units · 49.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 4,536 units · 63.7 per 100k residents TN North Carolina: 8,064 units · 74.4 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,260 units · 11.4 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 25,704 units · 84.3 per 100k residents TX Florida: 18,060 units · 79.9 per 100k residents FL
Units reimbursed · per 100k residents
11.4263
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 263 /100k
2 California 124 /100k
3 Texas 84.3 /100k
4 Florida 79.9 /100k
5 Michigan 75.3 /100k
6 North Carolina 74.4 /100k
7 Colorado 70.0 /100k
8 Tennessee 63.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cayston — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cayston. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$11.15M
Claims incl. refills
845
Beneficiaries
613
Spend / beneficiary
$18,197.11
Spend / claim
$13,200.98
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Aztreonam — the ingredient across all brands.

Top reported reactions

Infective Pulmonary Exacerbation Of Cystic Fibrosis849
Dyspnoea440
Hospitalisation390
Cough359
Death302
Pneumonia297
Pyrexia294

Age at onset

Neonate16
Infant2
Child47
Adolescent60
Adult539
Elderly226

Reporter sex

7,148 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization3,574
Death979
Life-threatening438
Disabling64
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,221 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Finished prescription product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Gilead Sciences, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Gilead Sciences, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 61958-0802-01 · Gilead 61958-1101-01 · Gilead →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.