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Indication

Daily administration of Pulmozyme 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 12 months.

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
  • 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

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.

For further information, please see the Pulmozyme full Prescribing Information.

 
Indication

Daily administration of Pulmozyme 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 12 months.

Important Safety Information
  1. Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese hamster ovary cell products, or any component of the product
  2. Pulmozyme should be used in conjunction with standard therapies for CF
  3. Most common reported adverse events associated with the use of Pulmozyme include: voice alteration, pharyngitis, laryngitis, rash, chest pain, and conjunctivitis

Treat with Pulmozyme to reduce exacerbation risk

In patients with FVC ≥40% of predicted
Pulmozyme reduced the risk of exacerbations*

Proportion of patients remaining exacerbation-free over 6 months1
Older patients (>21 years of age) may require twice-daily dosing
More patients remained exacerbation-free on Pulmozyme than on placebo
*An exacerbation is defined as a respiratory tract infection requiring parenteral antibiotics

Patients with early disease (FVC >85%) also benefited from Pulmozyme
  • 1.
    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;331:637-642.

Pulmozyme significantly improved lung function

Pulmozyme provided rapid and sustained lung function improvement1†
FEV1 change from baseline over 6 months in patients with FVC ≥40%1
Within 8 days of the start of treatment:
Mean FEV1 increased 7.9% in patients taking Pulmozyme 2.5 mg once daily
Safety and efficacy of daily administration have not been demonstrated in patients for longer than 12 months
  • 1.
    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;331:637-642.

Pulmozyme is a cornerstone of CF treatment

Pulmozyme, a mucolytic, plays an essential role in affecting the inflammation-obstruction-infection cycle
Before Pulmozyme: Neutrophils involved in the inflammatory response degenerate, leaving behind extracellular DNA,2 which increases the viscosity and adhesive properties of mucus3

After Pulmozyme: In vitro, Pulmozyme cleaves neutrophil-derived DNA, which has been shown to reduce sputum viscoelasticity3,4
  • 2.
    Chmiel JF, Konstan MW. Anti-inflammatory medications for cystic fibrosis lung disease: selecting the most appropriate agent. Treat Respir Med. 2005;4:255-273.
  • 3.
    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.
  • 4.
    King M. In: Rubin BK, van der Schans CP, eds. Therapy for Mucus-Clearance Disorders. New York, NY: Marcel Dekker Inc; 2004:201-224.
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Indication

Daily administration of Pulmozyme 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 12 months.

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
  • 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

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.

For further information, please see the Pulmozyme full Prescribing Information.