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 FEV1 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 not 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 CAYSTON and call your healthcare provider right away if you have any symptoms of an allergic reaction, including: Rash or swelling of your face Throat tightness Trouble breathing right after treatment with CAYSTON (bronchospasm). Tell your healthcare provider right away if you get any of these symptoms of bronchospasm with using CAYSTON: shortness of breath with wheezing coughing and chest tightness To decrease the chance of this happening, be sure to use your inhaled bronchodilator medicine before each treatment with CAYSTON. See "How should I take CAYSTON?"
The most common side effects of CAYSTON include:
cough nasal congestion wheezing sore throat	fever. Fever may be more common in children than in adults. chest discomfort stomach area (abdominal) pain vomiting
Other possible side effects of CAYSTON include swelling or pain in joints. Tell your healthcare provider if you have any new or worsening symptoms while taking CAYSTON. Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of CAYSTON. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store CAYSTON?
Each CAYSTON kit contains enough single-use vials of CAYSTON and ampules of saline for 28 days of treatment. There are 4 extra saline ampules in case some saline spills. Always keep your CAYSTON and saline together. Store CAYSTON and saline in the refrigerator between 36 °F to 46 °F (2 °C to 8 °C) until needed. When you remove CAYSTON and saline from the refrigerator, they may be stored at room temperature (up to 77 °F) for up to 28 days. Do not use any CAYSTON that has been stored at room temperature for more than 28 days. Keep CAYSTON away from light. Do not use CAYSTON after the expiration date on the vial. Do not use the saline after the expiration date on the ampule.
Keep CAYSTON and all medicines out of the reach of children.
General information about the safe and effective use of CAYSTON Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use CAYSTON for a condition for which it was not prescribed. Do not give CAYSTON to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about CAYSTON that is written for health professionals.
What are the ingredients in CAYSTON? Active ingredient: aztreonam Inactive ingredient: lysine, sodium chloride (diluent) Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA 94404 CAYSTON is a registered trademark of Gilead Sciences, Inc. ©2019 Gilead Sciences, Inc. All rights reserved. 50-814-GS-004 For more information, call 1-877-7CAYSTON (1-877-722-9786).

aztreonam

Product monograph

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