Pulmozyme

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE PULMOZYME ® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) 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. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function. ( 1 ) Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended dosage is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended nebulizer. ( 2.1 ) Some patients may benefit from twice daily administration. ( 2.1 ) See full prescribing information for the recommended nebulizers for use with PULMOZYME. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage, in most cystic fibrosis patients, is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended jet nebulizer connected to an air compressor system or via a vibrating mesh nebulizer [see Dosage and Administration (2.2) ] . Some patients may benefit from twice daily administration [see Clinical Studies (14) ] . 2.2 Administration Instructions Nebulizer Information Administer PULMOZYME via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask, or via a vibrating mesh nebulizer. Refer to Table 1 for the recommended Jet Nebulizers or Vibrating Mesh Nebulizers for use with PULMOZYME. No data are currently available to support the administration of PULMOZYME with other nebulizer systems. The eRapid Nebulizer System should only be used by adults and pediatric patients who can use a mouthpiece, and not by younger patients who need a mask to inhale PULMOZYME. Use the selected nebulizer in accordance with the manufacturer's instruction manual. Refer to the manufacturer's instruction manual on the use, maintenance, and replacement of the equipment, including cleaning and disinfection procedures for the selected nebulizer. For additional information, refer to the selected nebulizer manufacturer's instruction manual. Table 1. Recommended Jet Nebulizers or Vibrating Mesh Nebulizers for Use with PULMOZYME Jet Nebulizer Follow the selected nebulizer manufacturer's instruction manual. Compressor Hudson T Up-draft II ® Pulmo-Aide ® or legally marketed compressor of identical pressure and flow rate (maximum 30 psi, 12 LPM). Marquest Acorn II ® PARI LC ® Plus PARI PRONEB ® or legally marketed compressor of identical pressure and flow rate (maximum 24 psi, 9 LPM). PARI BABY™ Patients who are unable to inhale or exhale orally throughout the entire nebulization period may use the PARI BABY™ nebulizer. Durable Sidestream ® MOBILAIRE™, Porta-NEB ® or legally marketed compressor of identical pressure and flow rate (maximum 45 psi, 7 LPM). Vibrating Mesh Nebulizers eRapid ® Nebulizer System Consisting of the eRapid ® Nebulizer Handset with eBase™ Controller. Avoid use in patients who need a mask to inhale PULMOZYME. Innospire Go Pulmogine Vibrating Mesh Nebulizer AireHealth Nebulizer™ Intelligent Mesh Nebulizer PULMOZYME Information 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. 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. Warnings and cautions 5 WARNINGS AND PRECAUTIONS None. None. ( 5 ) Drug interactions 7 DRUG INTERACTIONS Available data indicate there are no clinically important drug-drug interactions with PULMOZYME. Pregnancy 8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies with PULMOZYME in pregnant women. However, animal reproduction studies have been conducted with dornase alfa. In these studies, no evidence of fetal harm was observed in rats and rabbits at doses of dornase alfa up to approximately 600 times the maximum recommended human dose (MRHD). The background risk of major birth defects and miscarriage for the cystic fibrosis population is unknown. However, the background risk in the U.S. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. Data Animal Data Reproductive studies have been performed in rats and rabbits at intravenous doses of dornase alfa up to 10 mg/kg/day (approximately 600 times the MRHD in adults). In a combined embryo-fetal development and pre- and post-natal development study, no evidence of maternal toxicity, embryotoxicity, or teratogenicity was observed when dornase alfa was administered to dams throughout organogenesis (Gestation days 6 to 17). Dornase