"The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).
Daily administration of Pulmozyme® (dornase alfa) (dornase alpha) 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 (dornase alfa) 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 12 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
|Hudson T Up-draft II® with||Pulmo-Aide®|
|Marquest Acorn II® with||Pulmo-Aide®|
|PARI LC Jet+ with||PARI PRONEB®|
|*PARI BABY™ with||PARI PRONEB®|
|Durable Sidestream® with||MOBILAIRE™|
|Durable Sidestream® with||Porta-Neb®|
|* 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 (dornase alfa) with other nebulizer systems. The patient should follow the manufacturer's instructions on the use and maintenance of the equipment.
Pulmozyme (dornase alfa) should not be diluted or mixed with other drugs in the nebulizer. Mixing of Pulmozyme (dornase alfa) with other drugs could lead to adverse physicochemical and/or functional changes in Pulmozyme (dornase alfa) or the admixed compound. Patients should be advised to squeeze each ampule prior to use in order to check for leaks.
Pulmozyme (dornase alfa) 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 (dornase alfa) is supplied in:
30 unit cartons containing 5 foil pouches of 6 single-use ampules: NDC 50242-100-40.
Pulmozyme (dornase alfa) should be stored under refrigeration (2-8°C/36-46°F). 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.
Manufactured by: Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
Code Revision Date: April 2005
FDA Approval Date: January 2001
©2005 Genentech, Inc.
Last reviewed on RxList: 12/16/2008
This monograph has been modified to include the generic and brand name in many instances.
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