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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®

Glossary

Resource Center

If you or a member of your family has cystic fibrosis (CF), you'll want to learn all you can about the disease and its treatment. To make your task easier, we've compiled a glossary to help acquaint you with the terms and concepts that are central to understanding CF and CF therapy—and getting the most out of the Pulmozyme® website.

  • Airway clearance techniques (ACTs):
    Different methods to loosen thick, sticky mucus in the lungs. Examples include coughing, huffing (forcefully pushing air out through the mouth), chest physical therapy, high-frequency chest wall oscillation, intrapulmonary percussive ventilation, oscillating positive expiratory pressure, percussion, and positive expiratory pressure therapy.
  • Alveoli:
    The millions of tiny air sacs at the end of the bronchioles in the lungs where oxygen is exchanged for carbon dioxide from the blood. In CF, mucus can clog alveoli and interfere with oxygen-carbon dioxide exchange.
  • Bacteria:
    Tiny, one-celled organisms. Some bacteria normally live in the body and others can cause infections. People with CF are prone to bacterial lung infections (often caused by Staphylococcus aureus or Pseudomonas aeruginosa).
  • Bronchus:
    The large airways that move air from the trachea to the lungs. The bronchi (more than one bronchus) branch into smaller airways called bronchioles. These lead to the alveoli. In CF, mucus can clog the bronchi and interfere with breathing.
  • Deoxyribonucleic acid (DNA):
    The chemical coding for a gene. DNA decides the "genetic message" in each cell, organ, and organism.
  • Enzymes:
    Proteins that help initiate or accelerate certain chemical processes in the body. People with CF have thick mucus that often blocks the ducts or tubes through which pancreatic enzymes flow. This can make it difficult to break down and absorb food/nutrients properly.
  • Hemoglobin:
    The oxygen-carrying protein that gives red blood cells their color.
  • Inflammation:
    Swelling in CF airways or surrounding tissue due to irritation, infection, or disease.
  • Mucus membrane:
    Tissue that contains mucus-making epithelial cells. Mucus membranes are found in the nose, mouth, lungs, esophagus, stomach, pancreas, and intestines.
  • Nebulizer:
    A device that delivers a mist when attached to an air compressor.
  • Neutrophil:
    A type of white blood cell filled with tiny sacs of enzymes that help the cell to destroy bacteria.
  • Obstruction:
    Process in which thick mucus accumulates in CF lungs and can be hard to remove, making breathing difficult.
  • Protein:
    A large molecule required for the structure, function, and regulation of the body's cells, tissues, and organs. Each protein has unique functions. Proteins are essential components of muscles, skin, bones, and the body as a whole.
  • Pulmonary:
    Relating to the lungs.
  • Respiratory Tract Infection:
    Infection occurs when bacteria or other organisms (for example, fungus) grow in airways and cause illness.
  • Trachea:
    Also known as the windpipe, the largest central airway, the trachea connects the upper respiratory tract to the lower respiratory tract.

Please see Important Safety Information and accompanying full
Prescribing Information.