NEBULIZERS AND COMPRESSORS
Nebulizer options for Pulmozyme dosing
FDA recommends the following nebulizer and compressor combinations for the administration of Pulmozyme for cystic fibrosis (CF) treatments
*Patients who are unable to inhale or exhale orally through the
entire nebulization period may use the PARI BABY™ nebulizer.
†Consisting of the eRapid® Nebulizer Handset with eBase™ Controller.
‡The average nebulization time for the eRapid Nebulizer System is approximately 2-3 minutes compared to the LC® Plus Jet Nebulizer, which is 6-10 minutes.
Questions to consider when helping patients choose a nebulizer and compressor combination
What is your patient's lifestyle like?
Patients may want to consider what conveniences they need. For example, nebulizers/compressors may have different delivery times and cleaning instructions.
Will a child use it?
Certain nebulizers are designed especially for younger children and have features such as a mask instead of a mouthpiece.
How much will it cost?
Costs, out-of-pocket expenses, and insurance coverage can vary.
Which specialty pharmacies distribute eRapid?
- If you are considering eRapid for your patient, visit www.PARI.com to locate specialty pharmacies that distribute eRapid.
Important Safety Information & Indication
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.
Important Safety Information
Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.
The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. There have been no reports of anaphylaxis attributed to the administration of Pulmozyme. Mild to moderate urticaria and mild skin rash have been observed and have been transient.
The safety and effectiveness of Pulmozyme have been established in pediatric patients 5 years of age and older. The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with cystic fibrosis aged 3 months to < 5 years. While clinical trial data are limited in pediatric patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in pulmonary function or who may be at risk of respiratory tract infection.
The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABY™ reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger; and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials in older patients. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45%; compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37%; compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35%; compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33, 0%).