Cayston: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

CAYSTON is an inhaled antibiotic prescribed for the management of cystic fibrosis patients with chronic Pseudomonas aeruginosa (P. aeruginosa) lung infections. The safety and efficacy of CAYSTON in patients below the age of 6 years has not been established.

Antibacterial drugs like CAYSTON treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, CAYSTON should be used exactly as directed. Misuse or overuse of CAYSTON could lead to the growth of bacteria that will not be killed by CAYSTON (resistance). This means that CAYSTON may not work for you in the future. Do not share your medicine.

What it does:

When you inhale CAYSTON, it will enter your lungs and come in contact with the P. aeruginosa bacteria that are present. CAYSTON binds to certain P. aeruginosa proteins and interferes with the development of the bacterial cell wall causing the cell wall to break and killing the bacteria. By decreasing the number of P. aeruginosa bacteria living in your lungs, lung infection is reduced and your respiratory symptoms and lung function are improved.

When it should not be used:

Do not take CAYSTON if:

• you are allergic to aztreonam or to any ingredient in this formulation (See: What the important non-medicinal ingredients are).

What the medicinal ingredient is:

Aztreonam

What the important non-medicinal ingredients are:

Lysine

Sterile diluent (0.17% sodium chloride solution)

What dosage forms it comes in:

CAYSTON is available as a freeze-dried powder that needs to be reconstituted (converted to liquid form) by adding a sterile diluent (0.17% sodium chloride) before inhaling it through your Altera^® Nebulizer System manufactured by PARI Respiratory Equipment, Inc. CAYSTON is designed to be delivered specifically with the Altera Nebulizer System. A dose of CAYSTON consists of a single-use glass vial of sterile powder (75 mg aztreonam and the non-medicinal ingredient lysine) and a 1 mL ampule of sterile diluent (0.17% sodium chloride). Each kit of CAYSTON contains 84 vials of CAYSTON and 88 diluent ampules packed in 2 carton inserts each with a 14-day supply (42 vials of lyophilized CAYSTON packaged in two trays and one tray of 44 diluent ampules). The four additional diluent ampules are provided in case of spillage.

WARNINGS AND PRECAUTIONS

BEFORE you use CAYSTON tell your doctor if:

• you are allergic to any antibiotics
• you are taking certain antibiotics (cefoxitin, imipenem) as these may interfere with the action of CAYSTON

• you are pregnant or planning to become pregnant

• you are nursing or planning to nurse
• you have kidney or liver problems

Contact your doctor if the following occur while taking CAYSTON:

• you have a rash because this could mean that you have an allergic reaction to CAYSTON.

• you have difficulty in breathing

  (bronchospasm) immediately after inhalation. Bronchospasm is a potential side effect with inhalation therapies such as CAYSTON.

INTERACTIONS WITH THIS MEDICATION

Let your doctor know if you are taking any other medications.

No formal studies of drug interaction have been done with CAYSTON.

PROPER USE OF THIS MEDICATION

Usual Dose:

• The recommended dosage for both adults and

  children 6 years of age and older is one single-use vial (75 mg) of CAYSTON reconstituted with one ampule of saline diluent taken 3 times a day by inhalation for a 28-day treatment course. Each of the 3 daily doses should be taken at least 4 hours apart (e.g. morning, after school or work and before bed). The dosage of CAYSTON is the same for patients regardless of age or weight. The safety and efficacy of CAYSTON in patients below the age of 6 years has not been established.

• An inhaled bronchodilator should be used prior

  to taking a dose of CAYSTON. Short acting bronchodilators can be taken between 15 minutes and 4 hours and long acting bronchodilators can be taken between 30 minutes and 12 hours prior to each dose of CAYSTON.

• If you are receiving several respiratory therapies,

  the recommended order is: 1) bronchodilator

  1. 2) mucolytics (medicines to help clear mucus from your lungs and, 3) CAYSTON.

• CAYSTON is formulated for inhalation in your

  drug-specific Altera Nebulizer System (PARI Respiratory Equipment, Inc.). CAYSTON should only be used in your Altera Nebulizer System. Do not use aztreonam for injection in your Altera Nebulizer System, as it has not been formulated for inhalation use. Do not use any medications other than CAYSTON in your Altera Nebulizer System.

Treatment Schedule

You should take CAYSTON in prescribed courses of 28 days on CAYSTON followed by at least 28 days without CAYSTON, as directed by your physician. CAYSTON should be taken 3 times a day during the 28-day period on drug. You can take your treatments at home, school, work, or any place where you are able to carry out the steps described below. Each treatment should take approximately 2 to 3 minutes. You must complete the entire 28-day course (3 times

daily) of CAYSTON prescribed by your doctor for it to be fully effective.

Can I use my existing nebulizer with CAYSTON?

Only the Altera Nebulizer System should be used for taking CAYSTON. The Altera Nebulizer System is the only device to demonstrate safety and efficacy with CAYSTON. Other nebulizers or handsets may give a sub-optimal therapeutic result. Do not mix CAYSTON with any other medications in the Altera Nebulizer System.

Administering CAYSTON using the Altera Nebulizer System

THIS LEAFLET SUMMARIZES THE MOST IMPORTANT INFORMATION ABOUT CAYSTON. PLEASE CONSULT WITH YOUR PHYSICIAN FOR MORE

INFORMATION ABOUT PROPERLY TAKING CAYSTON OR USING YOUR ALTERA NEBULIZER SYSTEM.

You will need the following supplies (Figure 1):

• One amber colored CAYSTON vial covered by a metal seal with a blue cap
• One ampule of diluent (saline) (0.17% sodium chloride)
• Altera Nebulizer System

Check to make sure that your Altera Nebulizer System works properly before starting your treatment with CAYSTON. Refer to the manufacturer’s instructions for use provided with your Altera Nebulizer System for complete details on the assembly, preparation, use, cleaning, disinfecting, and care of your Altera Nebulizer System.

Figure 1

Step 1 Preparing your CAYSTON for Inhalation

1. 1.

   Mix (reconstitute) CAYSTON with the

   diluent (saline) only when ready to take a dose. Take one amber vial of CAYSTON and one ampule of diluent from the carton. Diluent ampules must be separated by gently pulling apart.

1. 2.

   Look at the ampule of diluent. If it looks cloudy

   do not use it. Throw away this ampule and get another ampule of diluent.

2. 3.

   Gently tap the vial so that the powder settles to

   the bottom of the vial. This helps you get the proper dose of medication. To open the vial follow Step A to Step D in Figure 2 below:

   Figure 2

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: Being careful not to completely tear through the metal seal, pull the blue cap down to a horizontal/flat 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.

1. 4.

   Safely throw away (dispose of) the metal seal in

   the household garbage. Carefully remove (but do not yet discard) the rubber stopper.

1. 5.

   Open the ampule of diluent 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

2. 6.

   After mixing CAYSTON with the diluent, 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 diluent.

3. 7.

   Use CAYSTON right away after you mix with the

   diluent.

   Step 2 Taking your CAYSTON Treatment

   Refer to the manufacturer’s instructions for use provided with your Altera Nebulizer System for complete instructions on Taking a Treatment, as well as complete details on cleaning and disinfecting your Altera Nebulizer Handset.

4. 8. Make sure the handset is on a flat, stable surface.
5. 9.

   Remove the rubber stopper from the vial, then pour all of the

   reconstituted (mixed) CAYSTON and diluent 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

   1. 10. Begin your treatment by sitting in a relaxed, upright position. Holding the handset level, place the Mouthpiece in your mouth. Close your lips around the Mouthpiece (Figure 6).

Figure 6

1. 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.

2. 12.

   The empty vial, stopper and diluent ampule should be

   disposed of in the household garbage upon completion of dosing.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

It is important that you do not miss any doses. If you miss a dose, you can still take all 3 daily doses as long as there is a period of at least 4 hours between each dose.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

The most common side effects with CAYSTON include:

• cough
• nasal congestion
• wheezing
• sore throat
• fever
• chest discomfort

• runny nose

  Less common side effects include rash, bronchospasm (difficulty in breathing) immediately after inhalation, shortness of breath, and swelling or pain of joints. Patients with cystic fibrosis can have many possible symptoms. Some of these symptoms may be related to your medications. If you have new or worsening symptoms, you should tell your doctor. If you believe you are experiencing an allergic reaction to CAYSTON, tell your doctor immediately.

Serious side effects and what to do about them

This list of side effects is not complete at this time because CAYSTON is still being studied. If you have questions about side effects, ask your doctor, nurse, or pharmacist.

HOW TO STORE IT

• Keep CAYSTON and all other medications out

  of reach and sight of children.

  • CAYSTON vials should be stored in a refrigerator at 2 to 8°C (36 to 46°F), however, vials may be stored by the patient at room temperature (up to 25°C/77°F) for up to 28 days. Diluent ampules may be refrigerated or stored at room temperature (15 to 30°C/59 to 86°F).
  • Do not use CAYSTON if it has been stored at room temperature for more than 28 days. Unused vials of CAYSTON stored at room temperature for more than 28 days should be discarded. Do not store back in the refrigerator.

  • 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.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

• Report online at: www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada;
• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting form and sending it by:

  Fax toll-free to 1-866-678-6789, or Mail to: Canada Vigilance Program

  Health Canada

  Postal Locator 1908C Ottawa, ON K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full Product Monograph prepared for health professionals can be found at: www.gilead.ca

or by contacting Gilead Sciences Canada, Inc., at: 1–866–207–4267

Last revised: May 15, 2020

Gilead Sciences Canada, Inc.

Mississauga, ON L5N 2W3

CAYSTON is a registered trademark of Gilead Sciences, Inc.

Altera is a registered trademark of PARI Pharma GmbH.

Other brands noted herein are the property of their respective owners.

©2020 Gilead Sciences, Inc. All rights reserved

e137149-GS-007