Cayston 75 mg powder and solvent for solution for inhalation by nebulizer

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Cayston 75 mg powder and solvent for solution for inhalation by nebulizer

Aztreonam

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Cayston is and what it is used for
2. What you need to know before using Cayston
3. How to use Cayston
4. Possible adverse effects
5. How to store Cayston
6. Contents of the pack and other information

1. What Cayston is and what it is used for

Cayston contains the active substance aztreonam. Cayston is an antibiotic used to treat chronic lung infections caused by the bacterium Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a potentially life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also the liver, pancreas, and digestive system. In the lungs, cystic fibrosis causes blockage with sticky mucus. This leads to difficulty breathing.

2. What you need to know before using Cayston

Do not use Cayston

• if you are allergic to aztreonam or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before starting to use Cayston:

• if you are allergic to any other antibiotic (such as penicillins, cephalosporins and/or carbapenems)
• if you do not tolerate inhaled medicines or experience chest tightness when taking other inhaled medications
• if you have kidney problems
• if you have ever coughed up blood
• if you have ever had low pulmonary function test results.

If any of the above apply to you, inform your doctor before using Cayston.

Since this is an inhaled medicine, Cayston may cause coughing, which could lead to coughing up blood. If you have ever coughed up blood, you should only use Cayston if your doctor considers that the benefit of taking this medicine outweighs the risk of coughing up blood.

During treatment with Cayston, you may experience a temporary decrease in pulmonary function test results, although this effect is generally not persistent.

Children

Cayston must not be given to children under 6 years of age.

Other medicines and Cayston

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.

There are no clinical data on the use of Cayston in pregnant women; therefore, you should not use Cayston during pregnancy unless specifically discussed with your doctor.

If you plan to breastfeed, consult your doctor before using Cayston. You may breastfeed during treatment with Cayston, as the amount of medicine likely to pass to your baby during breastfeeding will be extremely small.

Driving and using machines

Cayston is not expected to affect your ability to drive or use machines.

3. How to use Cayston

Follow exactly the administration instructions given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

• Use Cayston 3 times a day in repeated cycles of 28 days of therapy followed by 28 days without Cayston therapy. Each of the three doses should be administered by inhalation with at least a four-hour interval between doses, using a handheld Altera nebulizer device. You may use an eBase Controller or an eFlow rapid controller unit with the Altera handheld device.

• Each dose consists of one vial of Cayston mixed with the contents of the solvent ampoule. Cayston must be mixed with a solvent before inhalation using the Altera nebulizer.

Place the prepared Cayston solution into the Altera handheld nebulizer device (see below). Each treatment takes approximately 2 to 3 minutes to inhale.

Use a bronchodilator before each dose of Cayston. Short-acting bronchodilators may be used between 15 minutes and 4 hours before each Cayston dose, and long-acting bronchodilators between 30 minutes and 12 hours before.

If you are using other inhaled therapies for the treatment of cystic fibrosis, the recommended order of use is as follows:

1. bronchodilator
2. mucolytics (a medicine that helps dissolve thick mucus produced in the lungs), and finally:
3. Cayston.

Do not mix Cayston with any other medicine in the Altera handheld nebulizer device.

• Do not introduce other medicines into the Altera handheld nebulizer device.
• Do not introduce intravenous (injectable) aztreonam into the Altera handheld nebulizer device. Intravenous aztreonam is not suitable for inhalation.

How to administer Cayston using the Altera handheld nebulizer device

You will need the following items:

• One amber-colored vial of Cayston with a blue closure cap.
• One plastic solvent ampoule (0.17% w/v sodium chloride). The information on the solvent ampoule is provided in English only (see section 6).
• One Altera handheld nebulizer device with an Altera aerosol generator connected to an eFlow type 178 (eFlow rapid) or type 678 (eBase Controller) controller unit.

You must use the specific Altera handheld nebulizer device designed for Cayston, with the Altera aerosol generator. Do not attempt to use Cayston with any other type of handheld nebulizer device (even the eFlow rapid handheld device).

Check that the nebulizer is working properly before starting treatment with Cayston. Carefully read the manufacturer's instructions supplied with the Altera nebulizer system.

Preparation of Cayston for inhalation

• Do not prepare Cayston until you are ready to administer the dose.
• Do not use Cayston if you notice that the packaging has been tampered with.
• Do not use Cayston if it has been stored outside the refrigerator for more than 28 days.
• Do not use the solvent or prepared Cayston solution if it appears cloudy or if particles are visible in the solution.

1. Remove one amber-colored vial of Cayston and one solvent ampoule from the box. The solvent ampoules should be separated by gently pulling them apart.

2. Gently tap the amber-colored vial of Cayston so that the powder settles at the bottom. This helps ensure that the correct dose is administered.

3. Follow steps A to D in Figure 1 below to open the amber vial:

1. Safely discard the metal cap. Carefully remove (but do not discard yet) the rubber stopper.
2. Open the solvent ampoule by twisting off its tip. Squeeze the ampoule to transfer its entire contents into the vial (Figure 2). Then gently swirl the vial in a circular motion until the powder is completely dissolved and the liquid appears clear.

It is best to use Cayston immediately after preparing the solution. However, if you cannot use the prepared dose immediately, replace the rubber stopper on the vial and store it in the refrigerator. Use the prepared solution within 8 hours.

Preparing the Altera nebulizer for Cayston administration

1. Ensure that the Altera handheld nebulizer device is placed on a smooth, stable surface.

2. Remove the medication container cap by turning it counterclockwise.

3. Pour the entire prepared Cayston solution from the vial into the medication container of the Altera handheld nebulizer device (Figure 3a). Make sure to empty the vial completely. Gently tap the vial against the side of the medication container, if necessary.

4. Close the medication container by aligning the cap guides with the container slots. Press down and turn the cap clockwise until it stops (Figure 3b).

Using the Altera nebulizer for Cayston administration

1. Begin treatment. Sit in a relaxed position with your back straight. Hold the device horizontally, place the mouthpiece in your mouth, and close your lips around it (Figure 4).

Keep the device in a horizontal position.

1. Press and hold the On/Off button on the controller unit for a few seconds. You will hear a beep and the status light will turn green.

2. After a few seconds, a mist-like aerosol will begin flowing into the chamber of the Altera handheld nebulizer device. If the mist does not start, refer to the Altera system manual for information.

3. Breathe normally (inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue breathing comfortably until the treatment is complete.

4. When all the medication has been delivered, you will hear a "treatment complete" sound (two beeps).

5. When treatment is complete, open the medication container cap to ensure that all the medication has been used. A few drops of medication may remain in the container after treatment. If more than a few drops remain, replace the medication container cap and restart the treatment.

6. After treatment is complete, disconnect the controller unit and set aside the Altera handheld nebulizer device for cleaning and disinfection. For detailed instructions on cleaning and disinfection procedures, refer to the manufacturer's instructions supplied with the Altera handheld nebulizer device.

What if I need to interrupt the treatment before it is complete?

1. If, for any reason, you need to interrupt the treatment before completion, press and hold the On/Off button for one full second. To resume treatment, press and hold the On/Off button for one full second and restart the treatment.

Replacement of the Altera handheld nebulizer device

The Altera handheld nebulizer device is designed to last for three cycles of 28-day Cayston treatment when used according to the provided instructions. After this time, replace your Altera handheld nebulizer device, including the aerosol generator. If you notice any changes in performance before this time (for example, if it takes longer than five minutes to generate the mist), consult the Altera nebulizer instructions.

If you use more Cayston than you should

If you have used more Cayston than you should, consult a doctor or pharmacist immediately.

If you forget to use Cayston

If you miss a dose, you may continue taking your three daily doses as long as you leave at least a four-hour interval between doses. If you cannot maintain a four-hour interval, skip the missed dose.

If you stop using Cayston

Do not stop treatment with Cayston without first consulting your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you develop a rash, consult your doctor immediately, as it may mean you are experiencing an allergic reaction to Cayston.

Very common adverse effects (affect more than 1 in 10 patients)

• Cough
• Nasal congestion
• Wheezing
• Sore throat
• Feeling of breathlessness
• Fever. This may be more frequent in children than in adults.

Common adverse effects (affect between 1 and 10 in every 100 patients)

• Difficulty breathing

• Chest discomfort

• Nasal discharge

• Coughing up blood

• Rash

• Joint pain

• Lower results in lung function tests

Uncommon adverse effects (affect between 1 and 10 in every 1,000 patients)

• Swelling of the joints

The following adverse effects have been observed after the use of injectable aztreonam, but not after administration of Cayston: swelling of the face, lips, tongue or throat with difficulty swallowing or breathing, sweating, skin irritation and peeling, itchy skin rash, flushing, small red spots, and very rarely, skin blisters. All these signs may indicate an allergic reaction.

Inform your doctor if you experience any of these effects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system indicated in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cayston

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the vial label, the solvent ampoule, and the outer packaging. The expiry date refers to the last day of the month indicated.

Vial of powder and solvent ampoule:

Store in a refrigerator (between 2°C and 8°C). Unopened vials may also be stored outside the refrigerator, but at a temperature below 25°C for a maximum of 28 days.

Use this medicine immediately after reconstitution. If not used immediately, the prepared solution should be stored between 2°C and 8°C and used within 8 hours. Do not prepare more than one dose at a time.

Do not use this medicine if you notice that the packaging has been tampered with.

Do not use this medicine if it has been stored outside the refrigerator for more than 28 days.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Cayston and solvent

• The vial of powder contains 75 mg of aztreonam (as lysine).
• The solvent ampoule contains water for injections and sodium chloride. The ampoule is labelled in English only. The information appearing on the ampoule is provided below:

Appearance of the product and contents of the pack

Cayston is a white to off-white powder and solvent for inhalation solution.

Cayston is contained in a 2 ml amber glass vial with a grey rubber stopper and an aluminium seal with a blue flip-off cap.

The solvent (1 ml) is contained in a plastic ampoule.

Each 28-day pack of Cayston contains 84 vials of lyophilized Cayston and 88 solvent ampoules. The four additional solvent ampoules are provided in case of spillage.

This medicine is available in:

• 28-day pack of Cayston
• Pack containing one 28-day pack of Cayston plus a handheld Altera nebulizer device

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer:

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.