"The U.S. Food and Drug Administration today approved TOBI Podhaler (tobramycin inhalation powder) for the management of cystic fibrosis
Cystic fibrosis is a genetic disease that affects about 30,000 pediatric and adult patients in the United "...
Pulmozyme Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Pulmozyme (dornase alfa) Inhalation Solution is used to improve lung function in people with cystic fibrosis by thinning pulmonary secretions and reducing the risk of respiratory tract infections. It is a synthetic protein. Common side effects include sore/dry throat and hoarseness. Eye redness/irritation may also infrequently occur.
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. 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. Tell your doctor if you are pregnant before using Pulmozyme. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Pulmozyme in Detail - Patient Information: Side Effects
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Pulmozyme Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if this unlikely but serious side effect occurs: chest pain.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, unusual trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Pulmozyme (Dornase alfa)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Pulmozyme FDA Prescribing Information: Side Effects
Patients have been exposed to Pulmozyme (dornase alfa) for up to 12 months in clinical trials.
In a randomized, placebo-controlled clinical trial in patients with FVC ≥ 40% of predicted, over 600 patients received Pulmozyme (dornase alfa) once or twice daily for six months; most adverse events were not more common on Pulmozyme (dornase alfa) than on placebo and probably reflected the sequelae of the underlying lung disease. In most cases events that were increased were mild, transient in nature, and did not require alterations in dosing. Few patients experienced adverse events resulting in permanent discontinuation from Pulmozyme (dornase alfa) , and the discontinuation rate was similar for placebo (2%) and Pulmozyme (dornase alfa) (3%). Events that were more frequent (greater than 3%) in Pulmozyme (dornase alfa) treated patients than in placebo-treated patients are listed in Table 2.
In a randomized, placebo-controlled trial of patients with advanced disease (FVC < 40% of predicted) the safety profile for most adverse events was similar to that reported for the trial in patients with mild to moderate disease. For this study, adverse events that were reported with a higher frequency (greater than 3%) in the Pulmozyme (dornase alfa) treated patients, are also listed in Table 2.
Table 2: Adverse Events Increased 3% or More in Pulmozyme (dornase alfa) Treated
Patients Over Placebo in CF Clinical Trials
|Adverse Event (of any severity or seriousness)||Trial in Mild to Moderate CF Patients (FVC ≥ 40% of predicted) treated for 24 weeks||Trial in Advanced CF Patients (FVC < 40% of predicted) treated for 12 weeks|
|FVC decrease of ≥ 10% of predicted°||Differences were less than 3% for these adverse events in the Trial in mild to moderate CF patients.||17%||22%|
|Dyspnea (when reported as serious)||Difference was less than 3% for this adverse event in the Trial in mild to moderate CF patients.||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% for the Trial in advanced CF patients.|
Events Observed at Similar Rates in Pulmozyme® (dornase alfa) Inhalation Solution and Placebo Treated Patients with FVC ≥ 40% of predicted
|Body as a Whole||Abdominal pain, Asthenia, Fever, Flu syndrome, Malaise, Sepsis|
|Digestive System||Intestinal Obstruction, Gall Bladder disease, Liver disease, Pancreatic disease|
|Metabolic Nutritional System||Diabetes Mellitus, Hypoxia, Weight Loss|
|Respiratory System||Apnea, Bronchiectasis, Bronchitis, Change in Sputum, Cough Increase, Dyspnea, Hemoptysis, Lung Function Decrease, Nasal Polyps, Pneumonia, Pneumothorax, Rhinitis, Sinusitis, Sputum Increase, Wheeze|
Mortality rates observed in controlled trials were similar for the placebo and Pulmozyme (dornase alfa) 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.
The safety of Pulmozyme (dornase alfa) , 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 patients with cystic fibrosis (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). 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%). Other events tended to be of mild to moderate severity. 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). The nature of adverse events was similar to that seen in the larger trials of Pulmozyme (dornase alfa) .
There have been no reports of anaphylaxis attributed to the administration of Pulmozyme (dornase alfa) to date. 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 (dornase alfa) developed serum antibodies to Pulmozyme (dornase alfa) . None of these patients developed anaphylaxis, and the clinical significance of serum antibodies to Pulmozyme (dornase alfa) is unknown.
Read the entire FDA prescribing information for Pulmozyme (Dornase alfa) »
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