"The U.S. Food and Drug Administration today announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluatio"...
PULMOZYME® (dornase alfa) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
In CF 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.
DOSAGE AND ADMINISTRATION
The recommended dosage for use in most cystic fibrosis patients is one 2.5 mg single-use ampule inhaled once daily using a recommended jet nebulizer/compressor system or eRapid™ Nebulizer System.
Some patients may benefit from twice daily administration [see Clinical Studies]
Directions For Use
Administer PULMOZYME via the eRapid Nebulizer System or via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask (see Table 1). No data are currently available to support the administration of PULMOZYME with other nebulizer systems.
Do not dilute or mix PULMOZYME 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.
Table 1 : Recommended Jet Nebulizers/Compressors and
|Hudson T Up-draft II® with||Pulmo-Aide®|
|Marquest Acorn II® with||Pulmo-Aide®|
|PARI LC® Plus with||PARI PRONEB®|
|**PARI BABY™ with||PARI PRONEB®|
|Durable Sidestream® with||MOBILAIRE™|
|Durable Sidestream® with||Porta-Neb®|
|eRapid™ Nebulizer System*|
|*Consisting of the eRapid™ Nebulizer Handset with eBase™
**Patients who are unable to inhale or exhale orally throughout the entire nebulization period may use the PARI BABY™ nebulizer.
The patient should follow the manufacturer's instructions on the use and maintenance of the equipment, including cleaning and disinfection procedures.
When PULMOZYME is administered with the eRapid Nebulizer System, advise patients to replace the handset after 90 uses, regardless of whether the EasyCare cleaning aid is used. Since delivery data are not available for PULMOZYME administered with the eRapid handset beyond 90 administrations, delivery of the appropriate therapeutic dose of PULMOZYME cannot be assured beyond 90 administrations. The eRapid Nebulizer System should only be used by adults and children who can use a mouthpiece, and not by younger children who need a mask to take PULMOZYME.
Storage And Handling
Store PULMOZYME ampules in their protective foil pouch under refrigeration and protected from light. Refrigerate ampules during transport and do not expose to room temperatures for a total time of 24 hours.
Each PULMOZYME ampule should be squeezed prior to use in order to check for leaks. Discard ampules if the solution is cloudy or discolored. Once opened, the entire contents of the ampule must be used or discarded.
Dosage Forms And Strengths
Inhalation Solution: 2.5 mg/2.5 mL in single-use ampules.
PULMOZYME is supplied in:
30 unit cartons containing 5 foil pouches of 6 single-use ampules. Each 2.5 mL ampule contains 2.5 mg of dornase alpha (1 mg/mL): NDC 50242-100-40.
Storage And Handling
Store PULMOZYME under refrigeration (2°C to 8°C/36°F to 46°F) in their protective foil to protect from light. Do not use beyond the expiration date stamped on the ampule. Store unused ampules in their protective foil pouch under refrigeration. Refrigerate PULMOZYME during transport and do not expose to room temperatures for a total time of 24 hours.
Genentech, Inc., A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 US License No. 1048. Approved: December 2014
Last reviewed on RxList: 12/29/2014
This monograph has been modified to include the generic and brand name in many instances.
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