CAYSTON Powder and solvent for nebuliser solution Ref.[6351] Active ingredients: Aztreonam

Posology

Patients should 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.

For patients taking multiple inhaled therapies, the recommended order of administration is as follows:

1. bronchodilator
2. mucolytics
3. and lastly, Cayston.

Adults and children 6 years and older

The recommended dose for adults is 75 mg three times per 24 hours for 28 days.

Doses should be taken at least 4 hours apart.

Cayston may be taken in repeated cycles of 28 days on therapy followed by 28 days off Cayston therapy.

The dosing in children aged 6 years and older is the same as for adults.

Elderly

Clinical studies of Cayston did not include Cayston-treated patients aged 65 years and older to determine whether they respond differently from younger patients. If Cayston is to be prescribed to the elderly then the posology is the same as for adults.

Renal impairment

Aztreonam is known to be excreted renally and therefore administration of Cayston in patients with renal impairment (serum creatinine >2 times upper limit of normal) should be undertaken with caution. No dose adjustment is necessary in cases of renal impairment since the systemic concentration of aztreonam following inhaled administration of Cayston is very low (approximately 1% of the concentration resulting from a dose of 500 mg aztreonam for injection).

Hepatic impairment

There are no data on the use of Cayston in patients with severe hepatic impairment (ALT or AST greater than 5 times the upper limit of normal). No dose adjustment is necessary in cases of hepatic impairment.

Paediatric population

The safety and efficacy of Cayston in children younger than 6 years of age have not been established. Currently available data are described in section 5.1 but no recommendation on posology can be given.

Method of administration

For inhalation use.

Cayston should only be used with the Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

Adverse reactions specifically associated with overdose of Cayston have not been identified. Since the plasma concentration of aztreonam following administration of Cayston (75 mg) is approximately 0.6 μg/ml, compared to serum levels of 54 μg/ml following administration of aztreonam for injection (500 mg), no safety issues associated with aztreonam overdose are anticipated.

Powder vial: 4 years.

Solvent: 3 years.

After reconstitution, immediate use of Cayston is recommended. If not used immediately, the reconstituted solution must be stored at 2°C-8°C and used within 8 hours. In-use storage times and conditions prior to use are the responsibility of the user.

Powder vial and solvent ampoule: Store in a refrigerator (2°C-8°C). May be stored outside a refrigerator but below 25°C for up to 28 days.

For storage conditions of the reconstitued medicinal product, see section 6.3.

Powder vial: Type I amber glass vial with siliconised grey rubber stopper and aluminium tear off overseal with a blue cap.

Solvent: 1 ml low density polyethylene ampoule.

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

The following pack sizes are available:

• 28-day pack of Cayston
• Pack containing one 28-day pack of Cayston plus one Altera Nebuliser Handset

Not all pack sizes may be marketed.

Reconstitution

Cayston should only be reconstituted with the solvent provided. Following reconstitution, Cayston is a clear, colourless to slightly coloured solution.

It is recommended that Cayston be administered immediately after reconstitution with solvent. Cayston should not be reconstituted until a dose is ready to be administered. One glass vial containing Cayston is opened by carefully removing the blue cap and the metal ring, and then the grey rubber stopper. The liquid is squeezed out of one solvent ampoule into the glass vial. The vial is then gently swirled until contents have completely dissolved. The reconstituted Cayston is then poured into the Altera Nebuliser Handset and the dose administered.

Cayston is administered by inhalation over a 2 to 3 minute period, using a Cayston specific Altera Nebuliser Handset and Altera Aerosol Head connected to an eBase Controller or an eFlow rapid Control Unit. Cayston should not be used with any other type of handset or aerosol head. Cayston should not be mixed with any other medicinal products in the Altera Nebuliser Handset. Do not put other medicinal products in the Altera Nebuliser Handset.

Do not reconstitute or mix Cayston with any other solvent or medicinal product. Do not reconstitute more than one dose at a time. Any unused product or waste material should be disposed of in accordance with local requirements.