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
Why would I be prescribed Pulmozyme?
What is Pulmozyme?
What are the possible side effects of Pulmozyme?
Is Pulmozyme recommended for CF treatment?
Taking Pulmozyme
How do I take Pulmozyme?
How does Pulmozyme work?
What is extracellular DNA? How does it affect my mucus?
Will Pulmozyme work with my other CF treatments?
How will I know if Pulmozyme is working?
Can I stop taking Pulmozyme when prescribed a new CF treatment?
How should I store Pulmozyme?
Can I use just part of my Pulmozyme ampule and save the rest for later?
Does Pulmozyme expire?
Can I use the nebulizer/compressor I already have to take Pulmozyme?
Financial Support
I have questions about paying for Pulmozyme. Is it covered by my insurance?
Important Safety Information & Indication
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.