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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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Pulmozyme Access Solutions®

How the Lungs Work

Cystic fibrosis is a genetic disease that can drastically affect lung function. Here, you can get an overview of how each part of the respiratory system works, so you can better understand the disease.

  1. What the lungs do

    • How lungs work
    • Healthy lungs take in fresh oxygen and get rid of carbon dioxide and other gaseous waste products so that other parts of the body can function properly.
  2. Trachea and bronchi

    • Trachea and bronchi
    • When you breathe in, the mucus membranes in your mouth and nose warm and moisten the air that passes through your throat and into your trachea or windpipe.

      Your trachea divides into the left and right bronchi, like a tree branch. Each bronchus divides again and again, becoming narrower and narrower.
  3. Alveoli expanded

    • Alveoli explanded
    • These branches lead to millions of alveoli, which are small, thin air sacs that look like clusters of balloons. When you breathe in, the "balloons" expand. When you breathe out, the "balloons" relax and air is released.
  4. Alveoli relaxed

    • Alveoli relaxed
    • The oxygen you breathe in binds to hemoglobin, a protein in your blood that gives red blood cells their color, and is carried from your lungs to body tissues. Hemoglobin also has carbon dioxide bound to it, which it passes into the alveoli within a fraction of a second each time you inhale.

      When you exhale, the carbon dioxide leaves the alveoli, and the oxygen-rich blood returns to your heart. This exchange of gases allows your body to release carbon dioxide as a waste product and retain the oxygen necessary for your tissues and organs to function properly.

Feeling well is only part of the story.

Even if you (or your child) feels well, cystic fibrosis may still be active in the lungs and can cause damage. That is because CF affects the small airways deep in the lungs at first and may not immediately affect lung function. As the effects of CF reach the larger airways, symptoms such as coughing or difficulty breathing may increase.

Pulmozyme may be an essential part of your fight against CF — in those with mild to moderate CF*, Pulmozyme may help improve lung function and reduce the risk of respiratory tract infection.

* 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.