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, along with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) 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 along with standard therapies for cystic fibrosis have been established in pediatric patients. The use of Pulmozyme in pediatric patients at 5 to 17 years of age is supported by evidence from a randomized, controlled trial. The use of Pulmozyme in patients less than 5 years of age is supported by the efficacy data from the same randomized, controlled trial and additional safety data in pediatric patients aged 3 months to less than 5 years who received Pulmozyme.

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.

For further information, please see the Pulmozyme full Prescribing Information. If you have questions, please discuss them with your CF Care Team.