CAYSTON is indicated to improve respiratory symptoms in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (Pa). Read More
For answers to patients' most frequently asked questions related to CAYSTON and the ALTERA® Nebulizer System, click here.
With 3 doses a day, the total nebulization time for CAYSTON would be too long for busy patients to take.
Nebulization with CAYSTON typically requires about 2-3 minutes* for each dose. The 3 daily doses can be taken flexibly to fit within patients' daily routines when taken at least 4 hours apart.
Patients should be in an environment with a flat, stable surface to prepare their CAYSTON dose and where they can sit in a relaxed, upright position.
*This 2-3 minute estimate does not include setting up, cleaning, and disinfecting the ALTERA nebulizing equipment.
Cleaning and disinfecting instructions for the ALTERA Nebulizer System are too confusing.
There are a variety of conflicting pieces of information in the cystic fibrosis (CF) community about how to clean and disinfect the ALTERA Nebulizer System, which can be confusing to patients. Steps for cleaning and disinfecting the ALTERA Nebulizer System that have been tested and endorsed by the manufacturer and included in the product label can be found in the Cleaning and Disinfecting section.
As with other reusable nebulizers, proper cleaning and sterilization are essential with the ALTERA Nebulizer Handset. To reduce the risk of infection, illness, and/or injury from contamination and/or improper use:
The ALTERA Nebulizer Handset can be used safely with other CF medications.
It is very important NOT to use any other medications in the ALTERA Nebulizer Handset. CAYSTON is the only product to demonstrate safety and efficacy in the ALTERA Nebulizer System. The use of drugs other than CAYSTON could result in potential incorrect dosage or overdoses of medication.
Additionally, CAYSTON should not be mixed with any other drugs in the ALTERA Nebulizer Handset.
Three-times-a-day dosing with CAYSTON must be taken at the same times each day.
Dosing times with CAYSTON are flexible enough to allow patients to take it according to their individual schedules, as long as they wait at least 4 hours between each dose. For example, patients may choose to take their first CAYSTON dose in the morning, the second one after school/work, and the third dose before bed.
Patients should be in an environment with a flat, stable surface to prepare their CAYSTON dose and where they can sit in a relaxed, upright position.
Patients need to take all 3 CAYSTON doses with their ALTERA Nebulizer System at home.
Your patients can take their daily supply of CAYSTON with the ALTERA Nebulizer System away from home because the treatment is portable.
Since the ALTERA Nebulizer System is small, lightweight, and battery operated, it gives patients the flexibility to take their CAYSTON inhalation treatment away from home, as long as they can use a flat, stable surface to prepare their doses and are able to sit in a relaxed, upright position. Your patients can take their 3 doses throughout their day as long as they're taken 4 hours apart. Four new, standard AA batteries provide about 2 hours of continuous treatment. Rechargeable AA batteries may also be used. Patients should make sure to have an extra set of batteries at all times. The AC power supply provided is optional.
Patients should mix (reconstitute) CAYSTON with the saline only when ready to take a dose.
Patients need to refrigerate their CAYSTON at all times.
CAYSTON vials and diluent ampules should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F) until needed. Your patients should keep their CAYSTON refrigerated, but they may leave CAYSTON and saline at room temperature (up to 25°C/77°F) for up to 28 days.
Thus, patients can safely carry all 3 CAYSTON doses with them throughout the day, at room temperature, along with their ALTERA Nebulizer Handset. Patients should be advised to not use CAYSTON if it has been stored at room temperature for more than 28 days. CAYSTON should also be protected from light.
It is important to note that the shipment of CAYSTON to a patient's home comes with an ice pack. This is to help protect CAYSTON in the event of unusual or unexpected high temperatures during shipment.
CAYSTON is contraindicated in patients with a known allergy to aztreonam.
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.
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 (>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.
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.
Please click here to see full Prescribing Information.
The information contained on this site is intended for audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.
ALLY, CAYSTON, the CAYSTON logo, CAYSTON ACCESS PROGRAM, the CAYSTON ACCESS PROGRAM logo, GILEAD, the GILEAD logo, and MY CAYSTON COMMUNITY are trademarks of Gilead Sciences, Inc. ALTERA is a registered trademark of PARI Pharma GmbH. All other trademarks referenced herein are the property of their respective owners.
©2023 Gilead Sciences, Inc. All rights reserved. US-CAYP-0035 02/23
*Each item is summed to generate a domain score and standardized. Scores range from 0 to 100, with higher scores indicating better health.6
†These questions are from the CFQ-R version for patients 14 years and older; younger children used a different questionnaire or a parent questionnaire was used. Minimum clinically important difference was not established for the child/parent questionnaire.
X
DID YOU KNOW?
These 3 bugs represent coughing, wheezing, and mucus production; 3 of the breathing symptoms you may experience if you have Pa.
TIP:
Do not change your dose or stop taking CAYSTON unless your healthcare provider tells you to.
This is how the study was designed, before it began.
This is also referred to as a "double-blind" study.
Even though people were off treatment, they were still being monitored for the study.
People gave answers from a 4-point scale to communicate to their doctors how they were feeling.
TIP:
Track how you're feeling with a daily journal. Ask yourself these questions and talk to your doctor about symptoms you're experiencing.
"Breathing symptoms" include wheezing, coughing, and mucus production.
This means that even after people stopped taking CAYSTON, they still reported an improvement in their wheezing, coughing, and mucus production compared to placebo at Day 42, though the difference was smaller.
It’s so important for the Pa medication to improve his FEV1 —it gives you the encouragement to keep going.
Annie (caretaker for Gareth, age 8, treated with CAYSTON)
Day 28 was the predetermined timepoint used to measure improvement.
FYI:
This means how much air can be exhaled in one second in liters.
Currently taking CAYSTON and have questions for your care team?
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IMPORTANT:
Talk to your doctor if you experience new or worsening symptoms while taking CAYSTON.
This is how the study was designed, before it began.
This means that the study was not used in the evaluation and not taken into consideration for the FDA approval of CAYSTON. The information will not be found in the package insert.
The 3 numbers across each treatment course were averaged to calculate the actual change in lung function.
Considering CAYSTON and have questions for your care team?
Download a Conversation Guide
This study was set up to only look at results from one time point.
Managing CF with my care team means educating myself about treatment options and playing an active, central role as a member of my care team.
Chris Kvam
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CAYSTON is contraindicated in patients with a known allergy to aztreonam.
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.
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 (>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.
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.
Please click here to see full Prescribing Information.
