FREQUENTLY ASKED QUESTIONS

Talking with your CF patients

Topics and frequently asked questions to discuss throughout cystic fibrosis (CF) treatment

The following are questions that your patients or their caregivers may ask and applicable responses you can use when discussing their treatment.

About Pulmozyme

  • You have been diagnosed with CF and Pulmozyme is a mucolytic, an important part of a multitherapy treatment approach. In clinical studies, Pulmozyme has been shown to improve lung function. Pulmozyme has been shown to reduce the risk of exacerbations in CF patients with an FVC ≥ 40% of predicted (mild to moderate disease).*

Indication

Pulmozyme (dornase alfa) is indicated for daily administration in conjunction 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 parenteral antibiotics.

*Patients had an FVC ≥ 40% of 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.

  • Pulmozyme (dornase alfa) is indicated for daily administration along with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
  • Pulmozyme is approved by the FDA to be used with other standard CF treatments. Pulmozyme also has a demonstrated safety profile in children over 5 years of age, adolescents, and adults.
  • Pulmozyme should not be used if you have a hypersensitivity to dornase alfa, or any ingredients of the product.
  • The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. Mild to moderate urticaria and mild skin rash have been observed and have been transient.
  • Based on studies, patients taking Pulmozyme may experience change in or loss of voice, discomfort in the throat, chest pain, red watery eyes, rash, dizziness, fever, or runny nose. In most cases, these side effects are mild and short-lived and were similar for patients on Pulmozyme compared with those taking placebo. Patients should call their doctor if any of these side effects are severe, get worse, or do not go away.

    To learn more about the possible side effects that can happen with Pulmozyme, please talk to your doctor and read the Adverse Reactions (section 6) of the Prescribing information.
  • Pulmozyme is a standard part of CF care, and has been a part of CF treatment for over 25 years.
  • The Cystic Fibrosis Foundation Guidelines recommend Pulmozyme in CF patients 6 years of age and older.†

    †Adapted from Mogayzel. Cystic Fibrosis Pulmonary Guidelines. Am J Respir Crit Care Med. 2013.

Taking Pulmozyme

  • The recommended dose of Pulmozyme for most CF patients is 2.5 mg once daily; however, some patients over the age of 21 may benefit from twice-daily dosing. Learn more about the potential benefits of BID dosing. 
  • Each daily Pulmozyme treatment requires the following items:
    • One ampule of Pulmozyme
    • One jet nebulizer approved for use with Pulmozyme that can be connected to an air compressor OR a nebulizer system
    • Tubing and other components that come with the nebulizer
    • A mouthpiece or a face mask (for younger patients unable to inhale or exhale consistently using a mouthpiece)
    • Step-by-step instructions on administering Pulmozyme are located on the Pulmozyme Patient site. 
  • CF is a complicated disease that leads to the body producing extra thick, sticky mucus. In laboratory studies, Pulmozyme has been shown to target one of the contributors to extra thick mucus: extracellular DNA.
  • Pulmozyme mimics an enzyme naturally found in the body. It is designed to make mucus thinner and looser even though you may not feel it.
  • Cutting up extracellular DNA can break up mucus, making it thinner and looser.
  • You may know DNA as the code used to build the cells in your 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, sticky mucus. White blood cells fight the bacteria, leaving behind a substance called extracellular DNA. The extracellular DNA can make mucus more thick and sticky. Cutting it up can help break up mucus, making it thinner and looser.
  • Pulmozyme is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
  • Fighting CF often requires a multitherapy approach. CF is a complicated disease, and you may be prescribed different medicines in addition to Pulmozyme. These medicines may include:
    • Bronchodilators help open airways
    • Hydrators help increase moisture in thick mucus
    • Airway clearance techniques help physically loosen and move mucus out of the way
    • Antibiotics help prevent and treat infections
    • Cystic fibrosis transmembrane conductance regulator (CFTR) modulators help keep a balance of salt and water in the lungs
  • In clinical studies of patients over 5 years of age, Pulmozyme has been shown to improve lung function. Pulmozyme has also been shown to reduce the risk of exacerbations (CF patients with an FVC ≥ 40% of predicted), in patients with mild to moderate disease. See the full clinical study results here.
  • While you may not feel the process happening in your body, it is important to remember that Pulmozyme works to target CF mucus, even if you don't feel its effects.

INDICATION AND USAGE

Pulmozyme (dornase alfa) is indicated for daily administration in conjunction 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 parenteral antibiotics.

  • It's important to remind patients to take their CF treatments as they have been prescribed. Each medicine in their treatment plan plays a role, and a mucolytic, like Pulmozyme, is an important component.
  • For more information, view these tips for patients about staying on track with their CF treatment. You can also review a list of topics to discuss throughout treatment.
  • Each sterile, single-use ampule of Pulmozyme (2.5 mg) is packaged in a protective foil pouch.
  • Pulmozyme ampules should be left in their foil package and stored in the refrigerator. They should also be kept away from light.
  • No. Pulmozyme comes in sterile, single-use ampules that should be used completely. Because Pulmozyme has no preservatives, the entire contents must be used or discarded.
  • Yes. There are expiration dates stamped on each ampule. It is important to follow the stamped date and discard any ampules that expire.
  • The following nebulizer systems and nebulizers/compressors are recommended for use with Pulmozyme:
    • eRapid® (PARI) Nebulizer System
    • Durable Sidestream® with MOBILAIRE™
    • Durable Sidestream® with Porta-Neb®
    • Hudson “T” Up-draft II® with Pulmo-Aide®
    • Marquest Acorn II® with Pulmo-Aide®
    • PARI LC® PLUS Reusable with PARI PRONEB®
    • PARI BABY™ with PARI PRONEB®

Financial Support

Genentech Access Solutions may be able to help you understand how to get the medicine you need. We can find out:

  • If your health insurance plan covers your Genentech medicine
  • How much your co-pay will be

Even if you have health insurance, you might feel concerned about the cost of your treatment. We can refer you to patient assistance options.

To learn more about how we can help, contact us. Call (800) 690-3023 or visit Genentech-Access.com/Pulmozyme/patients.

Important Safety Information & Indication

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Indication

Pulmozyme (dornase alfa) is indicated for daily administration in conjunction 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 parenteral antibiotics.

Important Safety Information

Pulmozyme is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

The most common adverse reactions associated with the use of Pulmozyme include: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥ 10%, fever, dyspepsia, and dyspnea. There have been no reports of anaphylaxis attributed to the administration of Pulmozyme. Mild to moderate urticaria and mild skin rash have been observed and have been transient.

Pediatric Use

The safety and effectiveness of Pulmozyme have been established in pediatric patients 5 years of age and older. The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 65 patients with cystic fibrosis aged 3 months to < 5 years. While clinical trial data are limited in pediatric patients younger than 5 years of age, the use of Pulmozyme should be considered for pediatric CF patients who may experience potential benefit in pulmonary function or who may be at risk of respiratory tract infection.

The safety of Pulmozyme, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABY™ reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger; and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials in older patients. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45%; compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37%; compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35%; compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33, 0%).

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.