Cayston

Package leaflet: Information for the user

Cayston 75 mg powder and solvent for solution for nebuliser

aztreonam
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Cayston is and what it is used for
2. What you need to know before taking Cayston
3. How to take Cayston
4. Possible side 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 suppress 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 life-threatening inherited disease affecting the mucus glands of internal organs, particularly the lungs, but also the liver, pancreas and digestive system. Cystic fibrosis of the lungs causes airway obstruction due to thick, sticky mucus. Because of this mucus, the patient has difficulty breathing.

2. What you should know before taking Cayston

Do not take 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 taking Cayston:

• if you are allergic to other antibiotics (such as, for example, penicillins, cephalosporins and/or carbapenems)
• if you do not tolerate other inhaled medicines or experience chest tightness after using them
• if you have kidney problems
• if you have previously coughed up blood
• if you have had abnormal lung function test results If you have any of these conditions, inform your doctor before using Cayston.

As an inhaled medicine, Cayston may cause coughing, and this coughing may be accompanied by blood.
If you have previously coughed up blood, you should only use Cayston if your doctor considers that the
benefits of taking this medicine outweigh the risk of coughing up blood.
During treatment with Cayston, a temporary worsening of lung function test results may occur, but this
effect is usually not long-lasting.

Children
Cayston is not indicated for use in children under 6 years of age.

Other medicines and Cayston
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breastfeeding, consult your
doctor before taking this medicine.
There are no clinical data on the use of Cayston in pregnant women; therefore, you should not take
Cayston during pregnancy unless specifically discussed with your doctor.
If you are planning to breastfeed, consult your doctor before taking Cayston. You may breastfeed during
treatment with Cayston, as the amount of Cayston that may be passed to the infant through breast milk
is extremely low.

Driving and using machines
Cayston is not expected to affect your ability to drive vehicles or operate machinery.

3. How to take Cayston

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
The recommended dose is:

• Take Cayston 3 times a day in repeated cycles of 28 days of treatment followed by 28 days without treatment with Cayston. The three doses should be inhaled at least four hours apart using a portable nebulizer Altera. With the portable Altera nebulizer, either an eBase Controller or an eFlow rapid control unit may be used.
• Each dose consists of one vial of Cayston mixed with one vial of solvent. Cayston must be mixed with a solvent before being inhaled via the Altera nebulizer.

Place the previously prepared Cayston solution into the portable Altera nebulizer (see below). Each inhalation lasts approximately 2–3 minutes.
Use a bronchodilator before each dose of Cayston. Short-acting bronchodilators may be used from 15 minutes to 4 hours before each Cayston dose, and long-acting bronchodilators may be used from 30 minutes to 12 hours before.
If you are using other inhaled therapies for cystic fibrosis, the recommended sequence for 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 other medicines in the portable Altera nebulizer.

• Do not pour other medicines into the portable Altera nebulizer.
• Do not pour the intravenous formulation of aztreonam (injectable) into the portable Altera nebulizer. Injectable aztreonam is not suitable for inhalation.

How to take Cayston with the portable Altera nebulizer
Materials needed:

• one amber vial of Cayston with a blue closure cap.
• one plastic vial containing the solvent (sodium chloride 0.17% w/v). Information on the solvent vial is provided in English only (see section 6).
• one portable Altera nebulizer containing an Altera aerosol generator connected to a control unit of type 178 (eFlow rapid) or type 678 (eBase Controller).

You must use the specific portable Altera nebulizer for Cayston, containing an Altera aerosol
generator. Do not attempt to take Cayston with any other type of portable nebulizer (including eFlow rapid).
Check that the nebulizer is working properly before starting treatment with Cayston.
Carefully read the instructions for use provided by the manufacturer with the Altera nebulizer system.
How to prepare Cayston for inhalation

• Do not prepare Cayston until you are ready to administer a 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 previously prepared Cayston solution if it is cloudy or contains particles in suspension.

1. Remove from the box one amber vial of Cayston and one vial containing the solvent. Solvent vials should be separated from each other by gently pulling them apart.

2. Tap the amber vial containing Cayston gently so that the powder settles at the bottom. This helps ensure that the correct dose of medicine is administered.

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

Step A: With the blue closure cap facing Step B: Pull the blue closure cap downward to
toward you, place the vial on a flat surface. the horizontal position (with the bottom of the
Hold the vial firmly with one hand and with blue closure cap facing upward) to remove
the other slowly lift the blue closure cap. the metal ring. Do not completely tear off the
metal ring.

Step C: Continue holding the vial firmly Step D: As the metal ring opens, continue
with one hand and with the other slowly pulling the blue closure cap slowly in an
pull the blue closure cap counterclockwise. anticlockwise direction until the metal ring
Do not bend the blue closure cap. is completely removed.
Figure 1

4. Dispose of the metal ring safely. Carefully remove (but do not discard) the rubber stopper.
5. Open the vial containing the solvent by bending the tip. Pour the entire contents into the vial (Figure 2), then gently shake the vial until the powder is completely dissolved and the liquid is clear.

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

Figure 2
How to prepare the Altera nebulizer for taking Cayston

1. Check that the portable Altera nebulizer is placed on a stable, flat surface.
2. Remove the medicine cap by turning it counterclockwise.
3. Pour the entire previously prepared Cayston solution from the vial into the medicine reservoir of the portable Altera nebulizer (Figure 3a). Make sure you have completely emptied the vial. If necessary, gently tap the vial against the side of the medicine reservoir.
4. Close the medicine reservoir by aligning the guide tabs on the medicine cap with the grooves on the reservoir. Press and turn the cap fully clockwise (Figure 3b).

Figure 3a Figure 3b
How to use the Altera nebulizer to take Cayston

1. Start of treatment. Sit in a relaxed position with your shoulders upright. Hold the portable nebulizer upright and place the mouthpiece between your teeth, sealing your lips around it (Figure 4).

Figure 4
Keep the portable nebulizer upright.

2. Press and hold the On/Off button on the control unit for several seconds. You will hear an audible signal and the light will turn green.
3. After a few seconds, an aerosol cloud will begin to flow into the chamber of the portable Altera nebulizer. If the aerosol cloud does not appear, refer to the Altera user manual for further information.
4. Breathe normally (inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue breathing calmly until the end of the treatment.
5. When all the medicine has been delivered, you will hear an audible signal indicating the end of treatment (double beep).
6. At the end of treatment, open the medicine reservoir cap to ensure all the medicine has been used. A few drops of medicine may remain in the reservoir at the end of treatment. If more than a few drops remain, close the medicine reservoir cap and restart the treatment.
7. At the end of treatment, disconnect the control unit from the portable Altera nebulizer for cleaning and disinfection. For detailed cleaning and disinfection instructions, refer to the instructions for use provided with the portable Altera nebulizer.

What to do if you need to interrupt the treatment before completion?

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

Replacement of the portable Altera nebulizer
The portable Altera nebulizer is intended for use over three cycles of 28 days, when used correctly. After this period, replace the portable Altera nebulizer, including the aerosol generator. If you notice a change in the device's performance before completing the three cycles (for example, if the time required to produce the aerosol cloud increases to more than 5 minutes), refer to the instructions for use of the Altera nebulizer.
If you take more Cayston than you should
If you have taken more Cayston than you should, contact your doctor or pharmacist immediately.
If you forget to take Cayston
If you miss a dose, you may still take all three daily doses, provided that at least four hours elapse between doses. If you cannot allow a four-hour interval, simply skip the missed dose.
If you stop taking Cayston
Do not stop treatment with Cayston without consulting your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If a rash occurs, inform your doctor immediately, as this may be a sign of an allergic reaction to Cayston.

Very common side effects (may affect more than 1 in 10 people)

• cough
• stuffy nose
• wheezing
• sore throat
• shortness of breath
• fever. This side effect may be more common in children than in adults.

Common side effects (may affect from 1 to 10 in 100 people)

• difficulty breathing
• chest discomfort
• runny nose
• coughing up blood
• rash
• joint pain
• worsening of lung function test results

Uncommon side effects (may affect from 1 to 10 in 1,000 people)

• joint swelling

The following side effects have been observed with injectable aztreonam, but not with Cayston: swelling of the face, lips, tongue, and/or throat, with difficulty swallowing or breathing, sweating, skin irritation and peeling, itchy rash, redness, small red spots, and, very rarely, blisters on the skin. All of these may be signs of an allergic reaction.
Inform your doctor if you notice any of the symptoms described.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 vial, and the carton. The expiry date refers to the last day of that month.
Vial of powder and solvent vial:
Store in a refrigerator (2°C-8°C). The unopened vial may also be stored outside the refrigerator, at a temperature not exceeding 25°C, for up to 28 days.
Use this medicine immediately after preparation. If not used immediately, the prepared solution must be stored at 2°C-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.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cayston and the solvent contain

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

Solvent for Cayston
Sodium chloride 0.17%
For inhalation use only
1 ml
GILEAD SCIENCES

Description of the appearance of Cayston and contents of the pack
Cayston consists of a white to off-white powder and a solvent for solution for nebuliser.
Cayston is supplied in a 2 ml amber glass vial with a grey rubber stopper, aluminium flip-off seal, and blue closure cap.
The solvent (1 ml) is contained in a plastic vial.
Each 28-day pack of Cayston contains 84 vials of lyophilised Cayston and 88 vials of solvent. The four additional solvent vials are provided as a reserve in case of spillage.
The following pack sizes are available:

• 28-day pack of Cayston
• pack containing one 28-day pack of Cayston and one portable Altera nebuliser

Not all pack sizes may be marketed.

Marketing Authorisation 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 on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Gilead Sciences Belgium SRL-BV Gilead Sciences Ireland UC
Tél/Tel: + 32 (0) 2 401 35 50 Tel: + 353 (0) 1 686 1888

България Luxembourg/Luxemburg
Gilead Sciences Ireland UC Gilead Sciences Belgium SRL-BV
Teл.: + 353 (0) 1 686 1888 Tél/Tel: + 32 (0) 2 401 35 79

Česká republika Magyarország
Gilead Sciences s.r.o. Gilead Sciences Ireland UC
Tel: + 420 910 871 986 Tel: + 353 (0) 1 686 1888

Danmark Malta
Gilead Sciences Sweden AB Gilead Sciences Ireland UC
Tlf: + 46 (0) 8 5057 1849 Tel: + 353 (0) 1 686 1888

Deutschland Nederland
Gilead Sciences GmbH Gilead Sciences Netherlands B.V.
Tel: + 49 (0) 89 899890-0 Tel: + 31 (0) 20 718 36 98

Eesti Norge
Gilead Sciences Ireland UC Gilead Sciences Sweden AB
Tel: + 353 (0) 1 686 1888 Tlf: + 46 (0) 8 5057 1849

Ελλάδα Österreich
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences GesmbH
Τηλ: +30 210 8930 100 Tel: + 43 1 260 830

España Polska
Gilead Sciences, S.L. Gilead Sciences Poland Sp. z o.o.
Tel: + 34 91 378 98 30 Tel: + 48 22 262 8702

France Portugal
Gilead Sciences Gilead Sciences, Lda.
Tél: + 33 (0) 1 46 09 41 00 Tel: + 351 21 7928790

Hrvatska România
Gilead Sciences Ireland UC Gilead Sciences (GSR) S.R.L.
Tel: + 353 (0) 1 686 1888 Tel: +40 31 631 18 00

Ireland Slovenija
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: +353 (0) 214 825 999 Tel: + 353 (0) 1 686 1888

Ísland Slovenská republika
Gilead Sciences Sweden AB Gilead Sciences Slovakia s.r.o
Sími: + 46 (0) 8 5057 1849 Tel: + 421 232 121 210

Italia Suomi/Finland
Gilead Sciences S.r.l. Gilead Sciences Sweden AB
Tel: + 39 02 439201 Puh/Tel: + 46 (0) 8 5057 1849

Κύπρος Sverige
Gilead Sciences Ελλάς Μ.ΕΠΕ. Gilead Sciences Sweden AB
Τηλ: + 30 210 8930 100 Tel: + 46 (0) 8 5057 1849

Latvija United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC Gilead Sciences Ireland UC
Tel: + 353 (0) 1 686 1888 Tel: + 44 (0) 8000 113700

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