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Pulmozyme (Dornase Alfa) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Daily administration of Pulmozyme (dornase alfa) Inhalation Solution in conjunction with standard therapies is indicated in the management of cystic fibrosis patients to improve pulmonary function. In patients with an FVC >=40% of predicted, daily administration of Pulmozyme has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.

Safety and efficacy of daily administration have not been demonstrated in patients for longer than twelve months.

DOSAGE AND ADMINISTRATION

The recommended dose for use in most cystic fibrosis patients is one 2.5 mg single-use ampule inhaled once daily using a recommended nebulizer. Some patients may benefit from twice daily administration (see Clinical Experience, Table 1). Clinical trial results and laboratory information are only available to support use of the following nebulizer/compressor systems (see Table 3).

Table 3: Recommended Nebulizer/Compressor Systems
Jet Nebulizer Compressor
Hudson T Up-draft II with Pulmo-Aide
Marquest Acorn II with Pulmo-Aide
PARI LC Jet+ with PARI PRONEB
1 PARI BABY with PARI PRONEB
Durable Sidestream with MOBILAIRE
Durable Sidestream with Porta-Neb

1 Patients who are unable to inhale or exhale orally throughout the entire nebulization period may use the PARI BABY nebulizer.

Patients who use the Sidestream Nebulizer with the MOBILAIRE compressor should turn the compressor control knob fully to the right and then turn on the compressor. At this setting, the needle on the pressure gauge should vibrate between 35 and 45 pounds per square inch (highest pressure output).

No data are currently available that support the administration of Pulmozyme with other nebulizer systems. The patient should follow the manufacturer's instructions on the use and maintenance of the equipment.

Pulmozyme should not be diluted or mixed with other drugs in the nebulizer. Mixing of Pulmozyme with other drugs could lead to adverse physicochemical and/or functional changes in Pulmozyme or the admixed compound. Patients should be advised to squeeze each ampule prior to use in order to check for leaks.

HOW SUPPLIED

Pulmozyme is supplied in single-use ampules. Each ampule delivers 2.5 mL of a sterile, clear, colorless, aqueous solution containing 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate and 8.77 mg/mL sodium chloride with no preservative. The nominal pH of the solution is 6.3.

Pulmozyme is supplied in:

  • 30 unit cartons containing 5 foil pouches of 6 single-use ampules: NDC 50242-100-40.

Storage

Pulmozyme should be stored under refrigeration (2—8C/36—46F). Ampules should be protected from strong light. Do not use beyond the expiration date stamped on the ampule. Unused ampules should be stored in their protective foil pouch under refrigeration.

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