What is it and how is it used?
Cayston is an antibiotic used to suppress chronic lung infection caused by the bacteria Pseudomonas aeruginosa in adult patients with cystic fibrosis. Cystic fibrosis, also known as mucoviscidosis, is a life-threatening inherited disease that affects the mucus glands of internal organs, especially the lungs, but also of the liver, pancreas, and the digestive system. Cystic fibrosis in the lungs leads to clogging them with thick sticky mucus. This makes it hard to breathe.
What do you have to consider before using it?
Do not take Cayston
Take special care with Cayston
Your doctor needs to know:
Cayston is not for use in children under the age of 18.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
It is important to tell your doctor if you are breast-feeding, if you are pregnant or planning to become pregnant, or when you think you are pregnant. Your doctor will help you decide what is best for you and your child.
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 plan to breast-feed ask your doctor for advice before taking Cayston. You can breast-feed during treatment with Cayston because the amount of Cayston likely to be passed to your child during breast-feeding will be extremely small.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Cayston is not expected to affect your ability to drive or use machines.
How is it used?
Always take Cayston exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Put the prepared Cayston solution in the Altera Nebuliser Handset (see below). Each treatment takes about 2 to 3 minutes to inhale.
Use a bronchodilator before each 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 using other therapies to treat cystic fibrosis, the recommended order is as follows:
1. bronchodilator
2. dornase alfa (a medicine that helps to dissolve the thick mucous produced in the lungs)
3. chest physiotherapy
4. any other inhaled medicines and finally:
5. Cayston.
Do not mix Cayston with any other medicines in the Altera Nebuliser Handset.
How to take Cayston using the Altera Nebuliser Handset
You will need the following:
One amber-coloured vial of Cayston
One plastic ampoule of solvent (0.17% w/v sodium chloride)
An Altera Nebuliser Handset containing an Altera Aerosol Head connected to an Altera Control Unit (678G) or an eFlow rapid Control Unit (178G)
You must use the Cayston specific Altera Nebuliser Handset containing an Altera Aerosol Head. Do not try to take Cayston using any other type of nebuliser handset (including the eFlow rapid handset).
Check that your nebuliser works properly before starting your treatment with Cayston. Read the manufacturer’s instructions for use provided with your Altera Nebuliser System carefully.
Preparing your Cayston for inhalation
1. Take one amber vial of Cayston and one ampoule of solvent from the box. Solvent ampoules must be separated by gently pulling them apart.
2. Gently tap the amber vial containing the Cayston so that the powder settles at the bottom. This helps to ensure that you get the proper dose of medicine.
3. Open the amber vial by lifting up the metal flap on the top (Figure 1a) and pulling down (Figure 1b) to carefully remove the entire metal ring and overcap from the vial (Figure 1c). Safely dispose of the ring. Carefully remove the rubber stopper.
4. Open the ampoule of solvent by twisting off the tip. Squeeze out the contents completely into the vial (Figure 1d). Next, gently swirl the vial until the powder has completely dissolved and the liquid is clear.
It’s best to use Cayston immediately after you have made up the solution. But, if you cannot use the prepared dose straight away, replace the stopper in the vial and store in a refrigerator. Use the prepared solution within 8 hours.
Preparing the Altera Nebuliser to take your Cayston
1. Make sure the Altera Nebuliser Handset is on a flat, stable surface.
2. Remove the medicine cap by twisting anticlockwise.
3. Pour all of the prepared Cayston from the vial into the Altera Nebuliser Handset medicine reservoir (Figure 2a). Be sure to completely empty the vial. Gently tap the vial against the side of the medicine reservoir if necessary.
4. Close the medicine reservoir by aligning the tabs of the medicine cap with the slots on the reservoir. Press down and turn the cap clockwise as far as it will go (Figure 2b).
Figure 2a Figure 2b
Using the Altera Nebuliser to take your Cayston
1. Begin your treatment. Sit in a relaxed, upright position. Hold the handset level and place the mouthpiece in your mouth and close your lips around it (Figure 3).
Figure 3
Keep the handset level.
2. Press and hold the On/Off button on the Control Unit for a few seconds. You will hear one “beep” and the status light will turn green.
3. After a few seconds, an aerosol mist will begin to flow into the Aerosol Chamber of the Altera Nebuliser Handset. If aerosol mist does not begin to flow, please refer to the Altera manual for information.
4. Breathe normally (inhale and exhale) through the mouthpiece. Avoid breathing through your nose. Continue to inhale and exhale comfortably until the treatment is finished.
5. When all of the medicine has been delivered, you will hear a tone that means “treatment complete” (2 beeps).
6. When treatment is complete, open the medicine cap to ensure that all medicine has been used. A few drops of medicine may remain in the reservoir at the end of treatment. If there is more than a few drops of liquid left, replace the medicine cap and restart treatment.
7. Once treatment is complete, disconnect the Control Unit and take apart the Altera Nebuliser Handset for cleaning and disinfecting. For complete details on cleaning and disinfecting refer to the manufacturer’s instructions for use provided with your Altera Nebuliser Handset.
What if I need to stop my treatment before I’ve finished?
8. If for any reason you must stop the treatment before you have finished, press and hold the On/Off button for one full second. To re-start the treatment, press and hold the On/Off button for one full second and then restart the treatment.
Replacing the Altera Nebuliser Handset
The Altera Nebuliser Handset is designed to last for three 28-day courses of Cayston when used as directed. After this time replace your Altera Nebuliser Handset, including the aerosol head. If you notice that the performance has changed before this time (for instance, if it takes longer to produce a mist, more than 5 minutes), please refer to the Altera Nebuliser instructions for use.
If you take more Cayston than you should
If you have taken more Cayston than you should, talk to a doctor or pharmacist immediately.
If you forget to take Cayston
If you miss a dose, you can still take all 3 daily doses as long as they are at least 4 hours apart. If you can’t leave a gap of 4 hours just skip the missed dose.
If you want to stop taking Cayston
Do not stop taking Cayston without first talking to your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, Cayston can cause side effects, although not everybody gets them.
If you get a rash, tell your doctor immediately because this could mean that you have an allergic reaction to Cayston.
The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10)
common (affects 1 to 10 users in 100)
uncommon (affects 1 to 10 users in 1,000)
rare (affects 1 to 10 users in 10,000)
very rare (affects less than 1 user in 10,000)
not known (frequency cannot be estimated from the available data).
Very common side effects
Common side effects
The following side effects have been observed after the use of aztreonam for injection, but not after taking Cayston: swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing, sweating, skin irritation and flaking, itchy rash, flushing, small red spots and very rarely, blistering of the skin. All these may be signs of an allergic reaction.
Tell your doctor if you have any of these effects.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Keep out of the reach and sight of children.
Do not use Cayston after the expiry date which is stated on the vial label, solvent ampoule and the carton. The expiry date refers to the last day of that month.
Powder vial and solvent ampoule:
Store in a refrigerator (2°C - 8°C). The unopened vials may also be stored outside the refrigerator but below 25°C for up to 28 days.
Use Cayston 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 Cayston if you notice that the package has been tampered with.
Do not use Cayston if it has been stored outside a refrigerator for more than 28 days.
Do not use the solvent or prepared Cayston if it is cloudy or if there are particles in the solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
