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Indication Statement:

Daily administration of Pulmozyme (dornase alfa) in conjunction with standard therapies is indicated in the management of cystic fibrosis (CF) 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 twelve months.

Important Safety Information

  • Pulmozyme should not be used in patients with known hypersensitivity to dornase alfa, or any ingredients of the product.
  • Pulmozyme should be used in conjunction with standard therapies for CF.
  • Most common reported adverse events associated with the use of Pulmozyme include: voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis.

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Research Contracts and Reagents Program

Genentech is well-known for its world-class research. In addition to the research done at Genentech, we also support investigators in academic institutions throughout the world by supplying key reagents for their research. The Research Contracts and Reagents Program at Genentech coordinates the interface with outside institutions.
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Epidemiologic Study of Cystic Fibrosis

The Epidemiologic Study of Cystic Fibrosis (ESCF) was designed to monitor patients receiving routine clinical care for cystic fibrosis. It was a multicenter, prospective, observational study in adult and pediatric patients with cystic fibrosis (CF). Enrollment began in February 1994 and concluded December 31, 2005. During the first phase of data collection, roughly 1994 to 2001, data collection focused on patient information such as clinical characteristics, the use of routine therapies, the results of pulmonary function tests, respiratory cultures, information on growth and nutrition and details of antibiotic treatments. From 2001 to study closure in 2005, information on risk factors, measures of pulmonary function and pulmonary exacerbations requiring specific therapy was also collected. During the latter collection period, the primary intent was to describe existing practice patterns, changes in practice patterns over time, and clinical outcomes over time, such as lung function, growth and nutrition, pulmonary exacerbations, and quality of life.

This encounter-based database covers over 832,000 patient encounters on a total of 32,414 patients. Detailed data is available on lung-function, growth, microbiology, medical conditions, exacerbations and hospitalizations as well as chronic and acute therapies.

Information on the safety and effectiveness of long-term Pulmozyme® (dornase alfa) Inhalation Solution treatment of CF patients in clinical practice was collected in the study. Information on patients treated with other therapies was also collected.

Access to the database is overseen by Genentech ESCF Team and the North American Scientific Advisory Group.

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ESCF Abstracts

2006

  • Quittner AL, Schechter M, Rasouliyan LH, et al. Effects of socioeconomic status, race and ethnicity on quality of life in a national database. J Cyst Fibros. 2007;5(suppl 1):S102.
  • Konstan MW, Wagener, JS, Pasta DJ, et al. Pulmozyme (Dornase alfa) use is associated with a slower rate of lung function decline in patients with cystic fibrosis. Pediatr Pulmonol. 2006; (suppl 29):337.

2007

  • Moskowitz SM, Silva SJ, Mayer-Hamblett N, et al. Inhaled antibiotic use among North American cystic fibrosis patients. Am J Respir Crit Care Med. 2007;suppl.
  • Sawicki GS, et al. The impact of methicillin-resistant Staphylococcus aureus (MRSA) acquisition on pulmonary function in cystic fibrosis patients.
  • Wagener JS, VanDevanter DR, Rasouliyan LH, et al. Change in the clinical appearance of the cystic fibrosis patient population over time. Pediatr Pulmonol. 2007;(suppl).

2008

  • Wagener JS, Rasouliyan LH, Pasta DJ, et al. Practice patterns for treating respiratory exacerbations in cystic fibrosis. Pediatr Pulmonol. 2008;(suppl).
  • Sawicki GS, Rasouliyan LH, Pasta DJ, et al. Longitudinal assessment of changes in health status and health-related quality of life in cystic fibrosis. Pediatr Pulmonol. 2008;(suppl 31):401.
  • Liou TG, Elkin EP, Pasta DJ, et al. Year-to-year changes in lung function in individuals with cystic fibrosis. J Cyst Fibros. 2010;9(4):250-256.
  • Konstan MW, VanDevanter DR, Rasouliyan LH, et al. Trends in the use of routine therapies in cystic fibrosis: 1995-2005. Pediatr Pulmonol. 2010;45(12):1167-1172.
  • VandenBranden SL, et al. Characteristic changes in lung function decline during the period of transition from adolescence to young adulthood.

2009

  • VanDevanter DR, et al. A tool for predicting future lung function in CF children aged 2 to 5 years.
  • Konstan MW, et al. Ranibizumab in ischemic central retinal vein occlusion (iCRVO): long-term results of the RAVE (Rubeosis Anti-VEGF) trial.
  • Quittner AL, et al. Changes in respiratory and nutritional indices predict changes in health-related quality of life in cystic fibrosis.
  • Quittner AL, et al. Construct validity of the CFQ-R in a national database.
  • Wagener JS, et al. Evaluating cystic fibrosis care site outcomes with single-year versus longitudinal data. Pediatr Pulmonol. 2009;(suppl).
  • McColley S, Regelmann W, Schechter M, et al. Risk factors for onset of symptoms in children with cystic fibrosis. Am J Respir Crit Care Med. 2009;(179):A1204.

2010

  • Ren CL, et al. Relationship between multiple antibiotic-resistant Pseudomonas aeruginosa (MARPA) acquisition and lung function decline in patients with cystic fibrosis (CF).
  • Schechter M, et al. Long-term outcomes following pregnancy in women with cystic fibrosis.
  • VanDevanter DR, et al. Incidence and characteristics of pulmonary exacerbations, 1995-2005.
  • Morgan WJ, et al. Relationship between decline in FEF25-75 and FEV1 in cystic fibrosis patients 6-24 years old.
  • Konstan MW, et al. Rate of lung function decline as an outcome for randomized controlled trials in cystic fibrosis.
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ERSF Publications

1999-2005

  • Morgan WJ, Butler SM, Johnson CA, et al. Epidemiologic study of cystic fibrosis: design and implementation of a prospective, multicenter, observational study of patients with cystic fibrosis in the U.S. and Canada. Pediatr Pulmonol. 1999;28(4):231-241.
  • Konstan MW, Butler SM, Schidlow DV, et al. Patterns of medical practice in cystic fibrosis: part 1. Evaluation and monitoring of health status of patients. Pediatr Pulmonol. 1999;28(4):242-247.
  • Konstan MW, Butler SM, Schidlow DV, et al. Patterns of medical practice in cystic fibrosis: part II. Use of therapies. Pediatr Pulmonol. 1999;28(4):248-254.
  • Johnson CA, Butler SM, Konstan MW, et al. Estimating effectiveness in an observational study: A case study of dornase alfa in cystic fibrosis. J Pediatr. 1999;134(6):734-739.
  • Geller DE, Kaplowitz HJ, Light MJ, et al. Allergic bronchopulmonary aspergillosis in cystic fibrosis: reported prevalence, regional distribution, and patient characteristics. Chest. 1999;116(3):639-646.
  • Shreve MR, Butler SM, Kaplowitz HJ, et al. Impact of microbiology practice on cumulative prevalence of respiratory tract bacteria in patients with cystic fibrosis. J Clin Microbiol. 1999;37(3):753-757.
  • Johnson CA, Butler SM, Konstan MW, et al. Factors influencing outcomes in cystic fibrosis: a center-based analysis. Chest. 2003;123(1):20-27.
  • Konstan MW, Butler SM, Wohl ME, et al. Growth and nutritional indexes in early life predict pulmonary function in cystic fibrosis. J Pediatr. 2003;142(6):624-630.
  • Rabin HR, Butler SM, Wohl, ME, et al. Pulmonary exacerbations in cystic fibrosis. Pediatr Pulmonol. 2004;37(5):400-406.
  • Marshall BC, Butler SM, Stoddard M, et al. Epidemiology of cystic fibrosis-related diabetes. J Pediatr. 2005;146(5):681-687.

2006-2008

  • McMullen AH, Pasta DJ, Frederick PD, et al. Impact of pregnancy on women with cystic fibrosis. Chest. 2006;129(3);706-711.
  • Padman R, McColley SA, Miller DP, et al. Infant care patterns at epidemiologic study of cystic fibrosis sites that achieve superior childhood lung function. Pediatrics. 2007;119(3): e531-537.
  • Ren CL, Morgan WJ, Konstan MW, et al. Relationship between methicillin-resistant Staphylococcus aureus in cystic fibrosis respiratory cultures and clinical status. Pediatr Pulmonol. 2007;42(6):513-518.
  • Konstan, MW, Morgan WJ, Butler SM, et al. Risk factors for rate of decline in forced expiratory volume in one second in children and adolescents with cystic fibrosis. J Pediatr. 2007;151(2):134-139.
  • Moskowitz SM, Silva SJ, Mayer-Hamblett N, et al. Shifting patterns of inhaled antibiotic use in cystic fibrosis. Pediatr Pulmonol. 2008;43(9):874-881.
  • VanDevanter DR, Rasouliyan LH, Murphy TM, et al. Trends in the clinical characteristics of the U.S. cystic fibrosis patient population from 1995 to 2005. Pediatr Pulmonol. 2008;43(8):739-744.
  • Ren CL, Pasta DJ, Rasouliyan LH, et al. Relationship between inhaled corticosteroid therapy and rate of lung function decline in children with cystic fibrosis. J Pediatr. 2008;153(6):746-751.
  • Sawicki GS, Rasouliyan LH, Pasta DJ, et al. The impact of incident methicillin-resistant Staphylococcus aureus detection on pulmonary function in cystic fibrosis. Pediatr Pulmonol. 2008;43(11):1117-1123.

2009

  • Schechter MS, McColley SA, Silva S, et al. Association of socioeconomic status with the use of chronic therapies and healthcare utilization in children with cystic fibrosis. J Pediatr. 2009;155(5):634-639.e1-4.
  • Quittner AL, Schechter MS, Rasouliyan LH, et al. Impact of socioeconomic status, race, and ethnicity on quality of life in patients with cystic fibrosis in the United States. Chest. 2009; 137(3):642-650. Epub 2009 Oct 9.

2010

  • Konstan MW, Wagener JS, Yegin A, et al. Design and powering of cystic fibrosis clinical trials using rate of FEV(1) decline as an efficacy endpoint. J Cyst Fibros. 2010;9(5):332-338. Epub 2010 Jun 19.
  • Liou TG, Elkin EP, Pasta DJ, et al. Year-to-year changes in lung function in individuals with cystic fibrosis. J Cyst Fibros. 2010;9(4):250-256. Epub 2010 May 14.
  • VanDevanter DR, Wagener JS, Pasta DJ, et al. Pulmonary outcome prediction (POP) tools for cystic fibrosis patients. Pediatr Pulmonol. 2010;45(12):1156-1166. doi: 10.1002/ppul.21311. Epub 2010 Aug 17.
  • Konstan MW, VanDevanter DR, Rasouliyan LH, et al. Trends in the use of routine therapies in cystic fibrosis: 1995-2005. Pediatr Pulmonol. 2010;45(12):1167-1172. doi: 10.1002/ppul.21315. Epub 2010 Aug 17.
  • Sawicki GS, Rasouliyan LH, McMullen AH, et al. Longitudinal assessment of health-related quality of life in an observational cohort of patients with cystic fibrosis. Pediatr Pulmonol. 2011;46(1):36-44. doi: 10.1002/ppul.21325. Epub 2010 Sep 16.
  • Konstan MW, Wagener JS, Pasta DJ, et al. Clinical use of dornase alfa is associated with a slower rate of FEV(1) decline in cystic fibrosis. Pediatr Pulmonol. 2011;in press. doi: 10.1002/ppul.21388 [Epub ahead of print].
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Links to information for you and your patients

Genentech does not recommend and does not endorse the content on any third-party websites. Genentech is not responsible for the content of linked third-party sites and does not make any representations regarding their content or accuracy. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites.

  • Blooming Rose Foundation: The Blooming Rose Foundation (BRF) was created to give hope to families immediately following Cystic Fibrosis diagnosis. BRF offers an online resource for individuals, families, and friends to find up to date research, links, and ways to connect with other families and adults with CF.
  • Boomer Esiason Foundation: This Foundation is committed to raising awareness about CF and funding CF research, and it provides numerous ways to get involved in the fight against CF.
  • CF Living: This online community is a place for CF patients and caregivers to get advice, share stories and connect with others fighting this disease.
  • Cystic Fibrosis Foundation: The Cystic Fibrosis Foundation is the leading organization in the United States devoted to cystic fibrosis, and its website provides a wealth of information. The mission of this nonprofit, donor-supported organization is to assure the development of the means to cure and control cystic fibrosis and to improve the quality of life for those with the disease.
  • Cystic Fibrosis Research, Inc.: CFRI is a nonprofit organization founded in 1975. CFRI's mission is to fund research, provide educational and personal support, and spread awareness of cystic fibrosis (CF), a life-threatening genetic disease.
  • Cystic Fibrosis Resources for Daily Living and Information: A community for people concerned with cystic fibrosis. Contains interactive forums and blogs to find support and share information; celebrate and remember with the community.
  • Cystic Fibrosis Services Pharmacy: This one-stop pharmacy is a subsidiary of the Cystic Fibrosis Foundation, letting you order and refill your prescriptions online.
  • Cystic-L: Cystic Fibrosis Information and Support: CYSTIC-L is a free email service dedicated to the exchange of information and support specific to cystic fibrosis. Members include those with cystic fibrosis, as well as family members, medical professionals, researchers and more.
  • CysticLife Community: CysticLife.org is a social network just for the cystic fibrosis community. This positive, uplifting website is the central location for the CF community to share tips, questions, ideas, experiences and encouragement.
  • Mayo Clinic: The CF section of the Mayo Clinic website can provide your patients with a full overview of the disease, along with information about symptoms, causes, risk factors and what to expect during the treatment process.
  • Pulmozyme Access Solutions: This program can help eligible patients receive financial support for covering the cost of Pulmozyme.
  • WebMD Video: WebMD hosts information and videos, including this video about a program for people with CF that is being run at one California CF Care Center.
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