Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Roche Products Limited, 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom
Management of cystic fibrosis patients with a forced vital capacity (FVC) of greater than 40% of predicted and over 5 years of age to improve pulmonary function.
2.5 mg (corresponding to 2500 U) deoxyribonuclease l by inhalation once daily.
Some patients over the age of 21 years may benefit from twice daily dosage.
Most patients gain optimal benefit from regular daily use of Pulmozyme. In studies in which Pulmozyme was given in an intermittent regimen, improvement in pulmonary function was lost on cessation of therapy. Patients should therefore be advised to take their medication every day without a break.
Patients should continue their regular medical care, including their standard regimen of chest physiotherapy.
Administration can be safely continued in patients who experience exacerbation of respiratory tract infection.
Safety and efficacy have not yet been established in patients with forced vital capacity less than 40% of predicted.
Safety and efficacy have not yet been established in patients under the age of 5 years.
Inhale the content of one ampoule (2.5 ml of solution) undiluted using a recommended nebuliser system (see section 6.6).
The effect of Pulmozyme overdosage has not been established.
In clinical studies, cystic fibrosis patients have inhaled up to 20 mg Pulmozyme twice daily (16 times the recommended daily dose) for up to 6 days and 10 mg twice daily (8 times the recommended dose) intermittently (2 weeks on/2 weeks off drug) for 168 days. Six adult non-cystic fibrosis patients received a single intravenous dose of 125 μg/kg of dornase alfa, followed 7 days later by 125 μg/kg subcutaneously for two consecutive 5-day periods, without either neutralising antibodies to DNase or any change in serum antibodies against double-stranded DNA being detected. All of these doses were well tolerated.
Systemic toxicity of Pulmozyme has not been observed and is not expected due to the poor absorption and short serum half-life of dornase alfa. Systemic treatment of overdose is therefore unlikely to be necessary (see section 5.2).
3 years.
Store in a refrigerator (2°C-8°C).
Keep the ampoule in the outer carton in order to protect from light.
A single brief exposure to elevated temperatures (less than or equal to 24 hours at up to 30°C) does not affect product stability.
2.5 ml of nebuliser solution in an ampoule (low density polyethylene plastic).
Pack sizes of 6 and 30.
Not all pack sizes may be marketed.
The contents of one 2.5 mg (2500 U) single-use ampoule of Pulmozyme sterile solution for inhalation should be inhaled once a day using a recommended nebuliser.
Pulmozyme should not be mixed with other drugs or solutions in the nebuliser (see section 6.2).
The manufacturers' instructions on the use and maintenance of the nebuliser and compressor should be followed.
Containment of the aerosol is not necessary.
Pulmozyme ampoules are for single administration only. Any unused product or waste material should be disposed of in accordance with local requirements.
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