Important Safety Information

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Pulmozyme Safety Information

When taking any treatment, it's important to understand the possible side effects and potential risks. Be sure to talk with your doctor about any questions and concerns you have about taking Pulmozyme.

Who is Pulmozyme for?

Pulmozyme (dornase alfa) is indicated for daily administration along 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 injectable antibiotics.

Who should not take Pulmozyme?

Pulmozyme should not be used in patients who are allergic to any of its ingredients.

What are the most common side effects of Pulmozyme?

Based on studies, patients may experience the following when using Pulmozyme: 

  • Change in or loss of voice
  • Throat discomfort
  • Rash
  • Chest pain
  • Red watery eyes
  • Runny nose
  • Lowering of lung function
  • Fever
  • Indigestion
  • Shortness of breath

Mild to moderate hives and mild skin rash have been observed and have been short-lived. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Pulmozyme should not be used in patients who are allergic to any of its ingredients.

You should call your doctor if you experience any of these side effects or if any of these side effects are severe, get worse, or do not go away.

Can Pulmozyme be taken by patients younger than 5?

The safety and effectiveness of Pulmozyme have been established in patients 5 years of age and older. While clinical trial data are limited in patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in lung function or who may be at risk of respiratory tract infection.

The safety of Pulmozyme given by daily inhalation for 2 weeks has been studied using 98 CF patients with 65 of them aged 3 months to <5 years (younger group) and 33 aged 5 years to <10 years (older group). The PARI BABY reusable nebulizer (which uses a face mask instead of a mouthpiece) was used in patients who were unable to show that they could breathe in or out using their mouth throughout the entire treatment period. Overall, the kind of side effects observed in children was similar to those seen in larger trials in older patients.

 

Report Side Effects

You are encouraged to report side effects to Genentech and the FDA. 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 full Pulmozyme Prescribing Information  for additional Important Safety Information. If you have questions, please discuss them with your CF Care Team.