Medical Editor: John P. Cunha, DO, FACOEP
What Is Pulmozyme?
Pulmozyme (dornase alfa) Inhalation Solution is a synthetic protein used to improve lung function in people with cystic fibrosis by thinning pulmonary secretions and reducing the risk of respiratory tract infections.
What Are Side Effects of Pulmozyme?
Common side effects of Pulmozyme include:
- sore/dry throat and hoarseness,
- eye redness and irritation,
- eye inflammation, or
- runny or stuffy nose.
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives),
- increased difficulty breathing,
- chest pain, or
Dosage for Pulmozyme
The recommended dose of Pulmozyme for use in most cystic fibrosis patients is one 2.5 mg single-use ampule inhaled once daily using a recommended nebulizer. Some patients may benefit from twice daily administration.
What Drugs, Substances, or Supplements Interact with Pulmozyme?
There are no known interactions between Pulmozyme and other medicines. Tell your doctor all other prescription or over-the-counter medicines or supplements you use.
Pulmozyme During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant before using Pulmozyme. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Our Pulmozyme (dornase alfa) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
If you experience any of the following serious side effects while taking dornase alfa, seek emergency medical attention or contact your doctor immediately:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- increased difficulty breathing;
- chest pain; or
Less serious side effects may be more likely to occur with the use of dornase alfa. Talk to your doctor if you experience any of the following side effects:
- voice alteration;
- sore throat;
- eye redness, irritation, or inflammation; or
- nasal stuffiness or discharge.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Pulmozyme (Dornase alfa)
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to PULMOZYME in 902 patients, with exposures ranging from 2 weeks of daily administration up to once or twice daily administration for six months. PULMOZYME was studied in both placebo-controlled and uncontrolled trials (n=804 and n=98). The population of patients in placebo-controlled trials was with FVC ≥ 40% of predicted (n=643) or with more advanced pulmonary disease, FVC < 40% of predicted (n=161). The population in the uncontrolled trial included 98 pediatric patients with CF ranging from 3 months to 10 years of age. More than half of the patients received PULMOZYME 2.5 mg by inhalation once a day (n=581), while the rest of patients (n=321) received PULMOZYME 2.5 mg by inhalation twice a day.
Trial 1: Trial 1 was a randomized, placebo-controlled clinical trial in patients with FVC ≥ 40% of predicted. In this trial, over 600 patients received PULMOZYME once or twice daily for six months. The most common adverse reaction (risk difference ≥5%) was voice alteration. The proportion of most adverse events was similar for patients on PULMOZYME and on placebo, probably reflecting the sequelae of the underlying lung disease. In most cases reactions that were increased were mild, transient in nature, and did not require alterations in dosing. Few patients experienced adverse reactions resulting in permanent discontinuation from PULMOZYME, and the proportion of discontinuations were similar for placebo (2%) and PULMOZYME (3%). Adverse reactions occurring in a higher proportion (greater than 3%) of PULMOZYME treated patients than in placebo-treated patients are listed in Table 2.
Trial 2: Trial 2 was a randomized, placebo-controlled trial in patients with more advanced pulmonary disease (FVC < 40% of predicted) who were treated for 12 weeks. In this trial, the safety profile of PULMOZYME was similar to that reported in patients with less advanced pulmonary disease (FVC ≥ 40% of predicted). Adverse reactions that were reported in this trial with a higher proportion (greater than 3%) in the PULMOZYME treated patients are listed in Table 2.
Table 2: Adverse Reactions Increased 3% or More in PULMOZYME Treated Patients Over Placebo in CF Clinical Trials
|Adverse Reactions (of any severity or seriousness)||Trial 1 CF Patients with FVC ≥ 40% of predicted treated for 24 weeks||Trial 2 CF Patients with FVC <40% of predicted treated for 12 weeks|
|FVC decrease of ≥ 10% of predicted*||Differences were less than 3%||17%||22%|
|Dyspnea (when reported as serious)||Differences were less than 3%||12%†||17%†|
|*Single measurement only, does not reflect overall FVC changes.|
† Total reports of dyspnea (regardless of severity or seriousness) had a difference of less than 3% in Trial 2.
Mortality rates observed in controlled trials were similar for the placebo and PULMOZYME treated patients. Causes of death were consistent with progression of cystic fibrosis and included apnea, cardiac arrest, cardiopulmonary arrest, cor pulmonale, heart failure, massive hemoptysis, pneumonia, pneumothorax, and respiratory failure.
Trial 3: 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. 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% as 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).
There have been no reports of anaphylaxis attributed to the administration of PULMOZYME. Urticaria, mild to moderate, and mild skin rash have been observed and have been transient. Within all of the studies, a small percentage (average of 2-4%) of patients treated with PULMOZYME developed serum antibodies to PULMOZYME. None of these patients developed anaphylaxis, and the clinical significance of serum antibodies to PULMOZYME is unknown.
Postmarketing spontaneous reports and prospectively collected safety data from observational studies confirm the safety profile to be as described in clinical trials [see ADVERSE REACTIONS].
Read the entire FDA prescribing information for Pulmozyme (Dornase alfa)
© Pulmozyme Patient Information is supplied by Cerner Multum, Inc. and Pulmozyme Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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