Pulmozyme as a Preventive Treatment Plan
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On this page you'll find useful information about Pulmozyme as part of a preventive treatment plan for patients with mild cystic fibrosis and as a consideration for patients under 5. For further information watch this video about assessing risk factors for disease progression, and read about the indication and important safety information.
As part of a preventive treatment plan for patients with mild CF lung disease, prescribe Pulmozyme before lung function loss
In a pivotal 6-month study, Pulmozyme significantly reduced the risk of pulmonary exacerbations requiring parenteral antibiotics in patients with CF
Study design: In this prospective trial, 968 clinically stable CF patients over 5 years of age were randomized to treatment with Pulmozyme 2.5 mg once daily, Pulmozyme 2.5 mg twice daily, or placebo over a 6-month time period. Primary efficacy end points were reduction in infections requiring parenteral antibiotics and improvement in lung function (FEV1).
Pulmozyme also significantly improved lung function by 5.8%
Pulmonary damage can precede persistent symptoms in patients under 5
Structural damage is evident of HRCT in this patient with intermittent symptoms*
As part of a preventive treatment plan, consider Pulmozyme for appropriate patients under 5
4-year-old male
- Patient clinically stable on no regular therapy
- Intermittent wheezing and recent onset of cough
- Unremarkable chest radiograph
Because of the limited experience with Pulmozyme in patients under 5, Pulmozyme should be considered when there is potential for benefit in lung function or risk of pulmonary infection based on early risk assessment
Adverse events were generally similar in infants and toddlers, as compared to older children. (Ref: 3)
Adapted with permission from Wagener JS et al. J Pediatr. 1998;133(4):486-491.
*Includes fever potentially related to bronchoscopy.
Study design: This prospective study compared Pulmozyme drug delivery levels and adverse effects in children with cystic fibrosis in 2 age groups: 3 months to less than 5 years of age (n=65) and 5 years to 10 years of age (n=33). All patients received 2.5 mg of Pulmozyme once daily for 2 weeks.
Delivery of Pulmozyme in the airways of younger patients (aged 3 months to 5 years) was similar to that of older pediatric patients. (Ref: 3)
- Pulmozyme was successfully administered via nebulizer to infants, young children, and older children.
Adapted with permission from Wagener JS et al. J Pediatr. 1998;133(4):486-491.
Because of the limited experience with the administration of Pulmozyme to patients younger than 5 years, its use should be considered only for those patients in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.
Study design: This prospective study compared Pulmozyme drug delivery levels and adverse effects in children with cystic fibrosis in 2 age groups: 3 months to less than 5 years of age= (n=65) and 5 years to 10 years of age (n=33). All patients received 2.5 mg of Pulmozyme once daily for 2 weeks.
Video Assessing Risk Factors for Disease Prevention
Indication and Important Safety Information
Indication
Daily administration of Pulmozyme® (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 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.
Important Safety Information
Pulmozyme should be used in conjunction with standard therapies for CF. The most common adverse events reported include voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis. Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese hamster ovary cell products, or any component of the product.
Pediatric Use
Because of the limited experience with the administration of Pulmozyme to patients younger than 5 years, its use should be considered only for those patients in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.
The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 patients with cystic fibrosis (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). 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% as compared to 6/33, 18%). Other events tended to be of mild to moderate severity. 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). The nature of adverse events was similar to that seen in the larger trials of Pulmozyme.
Please see important safety information and accompanying full prescribing information.
