Cayston

What is Cayston?

• Cayston (Aztreonam) is a monobactam antibacterial used to improve breathing symptoms in people with cystic fibrosis (CF).

Aztreonam

Aztreonam ball and stick

What are the uses of this medicine?

• 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.

How does this medicine work?

• Aztreonam (az tree' oh nam) is a monocyclic beta-lactam compound (monobactam) that was originally isolated from Chromobacterium violaceum.
• It acts by binding to penicillin binding proteins inhibiting cell wall synthesis and decreasing bacterial growth.
• Aztreonam is active mostly against gram negative organisms and more closely resembles aminoglycosides rather than penicillins.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with a known allergy to aztreonam.

What drug interactions can this medicine cause?

• No formal clinical studies of drug interactions with CAYSTON have been conducted.

Is this medicine FDA approved?

• Aztreonam was approved for use in the United States in 1986 and is indicated in the treatment of various moderate-to-severe systemic or skin, intra-abdominal, genitourinary, and respiratory gram-negative infections.
• Aztreonam is available in generic forms and under the brand name Azactam as a powder or a solution for injection, and under the brand name Cayston as a powder for solution to use in inhalational therapy.

How should this medicine be used?

Recommended dosage:

• 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.

Administration:

• 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:

bronchodilator mucolytics (medicines to help clear mucus from your lungs) 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 dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As CAYSTON (aztreonam for inhalation solution), for oral inhalation use
• Lyophilized aztreonam (75 mg/vial)
• Diluent (0.17% sodium chloride): 1 mL/ampule

This medicine is available in fallowing brand namesː

• CAYSTON

What side effects can this medication cause?

The most common side effects of this medicine 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
• swelling or pain in joints

CAYSTON may cause serious side effects, including:

• Severe allergic reactions
• Trouble breathing right after treatment with CAYSTON (bronchospasm)

What special precautions should I follow?

• 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.
• Bronchospasm has been reported with CAYSTON. Stop treatment if chest tightness develops during nebulizer use.
• 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.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• drug-related respiratory adverse reactions, particularly cough.

Can this medicine be used in pregnancy?

• 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.

Can this medicine be used in children?

• It is not known if CAYSTON is safe and effective:
• in children under 7 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: aztreonam
• Inactive ingredient: lysine, sodium chloride (diluent)

Who manufactures and distributes this medicine?

• Manufactured and distributed by: Gilead Sciences, Inc. Foster City, CA

CAYSTON is a registered trademark of Gilead Sciences

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Cayston
• FDA Cayston

Cayston Resources
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