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Important Safety Information

Indication and Usage

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.

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.

Pediatric Use

The safety and effectiveness of Pulmozyme in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients. Use of Pulmozyme in pediatric patients is supported by evidence in the following age groups:

  • Patients 5 to 17 years of age: A randomized, placebo-controlled trial of 303 of clinically stable cystic fibrosis patients 5 to 17 years of age who received Pulmozyme.
  • Patients less than 5 years: Extrapolation of efficacy data in patients 5 years of age and older with additional safety data in 65 pediatric patients aged 3 months to less than 5 years who received Pulmozyme 2.5 mg daily by inhalation for 2 weeks.

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 BABYTM 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%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see Pulmozyme full Prescribing Information for additional Important Safety Information.

    • Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

      Pulmozyme (dornase alfa) [package insert]. South San Francisco, CA: Genentech, Inc; 2024.

    • Harms HK, Matouk E, Tournier G, et al; DNase International Study Group. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. Pediatr Pulmonol. 1998;26(3):155-161.

      Harms HK, Matouk E, Tournier G, et al; DNase International Study Group. Multicenter, open-label study of recombinant human DNase in cystic fibrosis patients with moderate lung disease. Pediatr Pulmonol. 1998;26(3):155-161.

    • Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4(4):255-273.

      Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4(4):255-273.

    • Puchelle E, de Bentzmann S, Zahm JM. Physical and functional properties of airway secretions in cystic fibrosis—therapeutic approaches. Respiration. 1995;62(suppl 1):2-12.

      Puchelle E, de Bentzmann S, Zahm JM. Physical and functional properties of airway secretions in cystic fibrosis—therapeutic approaches. Respiration. 1995;62(suppl 1):2-12.

    • King M. Mucolytics and mucus clearance. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.

      King M. Mucolytics and mucus clearance. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.

    • Flume PA, Van Devanter DR. State of progress in treating cystic fibrosis respiratory disease. BMC Med. 2012;10:88.

      Flume PA, Van Devanter DR. State of progress in treating cystic fibrosis respiratory disease. BMC Med. 2012;10:88.

    • Drug development pipeline. Cystic Fibrosis Foundation website. https://www.cff.org/trials/pipeline. Accessed August 17, 2020.

      Drug development pipeline. Cystic Fibrosis Foundation website. https://www.cff.org/trials/pipeline. Accessed August 17, 2020.

    • Research milestones. Cystic Fibrosis Foundation website. https://www.cff.org/about-us/our-history. August 17, 2020.

      Research milestones. Cystic Fibrosis Foundation website. https://www.cff.org/about-us/our-history. August 17, 2020.

    • Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994;331(10):637-642.

      Fuchs HJ, Borowitz DS, Christiansen DH, et al. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis. N Engl J Med. 1994;331(10):637-642.

    • Data on file. Genentech, a member of the Roche Group.

      Data on file. Genentech, a member of the Roche Group.

    • Cystic Fibrosis Foundation Patient Registry 2016 Annual Data Report. Bethesda, MD. ©2017 Cystic Fibrosis Foundation.

      Cystic Fibrosis Foundation Patient Registry 2016 Annual Data Report. Bethesda, MD. ©2017 Cystic Fibrosis Foundation.

    • Sly PD, Brennan S, Gangell C, et al. Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009;180(2):146-152. 

      Sly PD, Brennan S, Gangell C, et al. Lung disease at diagnosis in infants with cystic fibrosis detected by newborn screening. Am J Respir Crit Care Med. 2009;180(2):146-152. 

    • Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368(21):1963-1970.

      Sly PD, Gangell CL, Chen L, et al. Risk factors for bronchiectasis in children with cystic fibrosis. N Engl J Med. 2013;368(21):1963-1970.

    • Bakker EM, Volpi S, Salonini E, et al. Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial. Pediatr Pulmonol. 2020;49(2):154-161.

      Bakker EM, Volpi S, Salonini E, et al. Small airway deposition of dornase alfa during exacerbations in cystic fibrosis; a randomized controlled clinical trial. Pediatr Pulmonol. 2020;49(2):154-161.

    • Trikafta [Package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2021. 

      Trikafta [Package insert]. Boston, MA: Vertex Pharmaceuticals Incorporated; 2021. 

    • Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019;394(10212)1940-1948. 

      Heijerman HGM, McKone EF, Downey DG, et al. Efficacy and safety of the elexacaftor plus tezacaftor plus ivacaftor combination regimen in people with cystic fibrosis homozygous for the F508del mutation: a double-blind, randomised, phase 3 trial. Lancet. 2019;394(10212)1940-1948. 

    • Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med. 2019;381(19):1809-1819. 

      Middleton PG, Mall MA, Dřevínek P, et al. Elexacaftor–tezacaftor–ivacaftor for cystic fibrosis with a single Phe508del allele. N Engl J Med. 2019;381(19):1809-1819. 

    • Pulmozyme Instructions for Use. South San Francisco, CA: Genentech, Inc; 2024.

      Pulmozyme Instructions for Use. South San Francisco, CA: Genentech, Inc; 2024.

    • Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187:680-689.

      Mogayzel PJ, Naureckas ET, Robinson KA, et al. Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health. Am J Respir Crit Care Med. 2013;187:680-689.

    • Clancy JP. Ongoing research into CFTR modulation. Adv Stud Med. 2010;10(1):14-18.

      Clancy JP. Ongoing research into CFTR modulation. Adv Stud Med. 2010;10(1):14-18.

    • Treatments and therapies. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/. Accessed July 22, 2021. 

      Treatments and therapies. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/. Accessed July 22, 2021. 

    • Medications. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Medications/. Accessed July 22, 2021.

      Medications. Cystic Fibrosis Foundation website. https://www.cff.org/Life-With-CF/Treatments-and-Therapies/Medications/. Accessed July 22, 2021.

    Non-US Residents visit: Pulmozyme.global