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Indication

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.

Important Safety Information

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

Patients may experience the following when using Pulmozyme: change in or loss of their voice, discomfort in the throat, rash, chest pain, red watery eyes, runny nose, lowering of lung function, fever, indigestion and shortness of breath. There have been no reports of severe allergic reactions caused by the administration of Pulmozyme. Mild to moderate hives and mild skin rash have been observed and have been short-lived.

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.

Pediatric Use

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.

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How Pulmozyme Works

Pulmozyme is a commonly prescribed cystic fibrosis (CF) medicine that is unique in the way it works.

CF is a complicated disease that causes your body to produce extra-thick, sticky mucus. Pulmozyme uniquely targets one of the causes of this thick, sticky mucus - extracellular DNA - to help keep mucus thin and loose. In this innovative animation, you will learn about the roles Pulmozyme and some other common treatment options help play in a treatment plan.

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Please see Important Safety Information

Pulmozyme uniquely targets extracellular DNA to help keep mucus thin and loose.

You may know DNA as the code used to build the cells in the body. So you might be wondering how DNA can be a problem for mucus in the lungs.

Because of CF, bacteria can build up in extra thick mucus.

  • After white blood cells fight the bacteria, they leave behind extracellular DNA that can make mucus more thick and sticky.
  • Cutting up the extracellular DNA can help thin mucus.

Understanding how a pair of scissors can be used to cut something into smaller pieces can help show how Pulmozyme works.

  • Laboratory studies have shown that Pulmozyme cuts apart extracellular DNA to help thin mucus by acting like an enzyme* found naturally in the body.
  • By cutting up the extracellular DNA, Pulmozyme uniquely works to help keep mucus thin and loose.

*Enzymes are proteins created by the body to help speed up chemical reactions (such as the breakdown of molecules).

Pulmozyme may be an essential partner in your fight against cystic fibrosis.

Pulmozyme may help improve lung function and reduce the risk of respiratory tract infection in mild to moderate disease.*

Research has shown that patients treated with Pulmozyme can experience fewer lung infections and improved lung function. In a study of patients 5 years and older taking Pulmozyme daily, those with mild to moderate disease* had 27% fewer lung infections that required injectible antibiotics. Patients also had a 5.8% improvement in lung function compared to those not taking Pulmozyme.

* Patients had an FVC ≥40% predicted. FVC stands for forced vital capacity, a test that shows how well the lungs work. To do the test, patients usually take the deepest breath they can. Then they exhale into a sensor for as long as they can. The amount of air they exhale is their FVC score.

What do other CF medicines do?

CF is a complex disease. Your doctor will prescribe other medicines to take in addition to Pulmozyme. These medicines can include:

Other CF Medicines Before image

Antibiotics

Help to prevent and
treat infections

Bronchodilators

Help to relax
the air wall lining

Hydrators

Help to restore
airway surface liquid

Airway Clearance
Techniques

Help physically loosen
and move mucus
out of the way

Other CF Medicines After image

Do you have questions about what you are taking? Your CF Care Team can help.

Pulmozyme is an essential part of a cystic fibrosis treatment plan.

Pulmozyme has been a standard part of CF care for over 17 years. The Cystic Fibrosis Foundation recommends Pulmozyme for patients six years of age and older to:

  • Improve lung function, regardless of how sick the patient may be.
  • Reduce serious infections in mild to moderate disease.

Pulmozyme is approved by the FDA to be used with other standard CF treatments, and it has a safety profile in children, adolescents and adults.*

For answers to common questions about how Pulmozyme works, please visit our FAQ page.

* Because of the limited experience with the administration of Pulmozyme to patients younger than five years of age, its use should be considered only for those patients for whom there is a potential benefit in lung function or a risk of respiratory infections.