ADVERSE REACTIONS
Patients have been exposed to Pulmozyme 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 once or twice daily for six months; most adverse events were not more common on Pulmozyme 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, and the discontinuation rate was similar for placebo (2%) and Pulmozyme (3%). Events that were more frequent (greater than 3%) in Pulmozyme 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 treated patients, are also listed in Table 2.
Table 2: Adverse Events Increased 3% or More in Pulmozyme Treated Patients Over Placebo in CF Clinical Trials
| |
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 |
Adverse Event
(of any severity or seriousness) |
Placebo
n=325 |
Pulmozyme
QD
n=322 |
Pulmozyme
BID
n=321 |
Placebo
n=159 |
Pulmozyme
QD
n=161 |
| Voice alteration |
7% |
12% |
16% |
6% |
18% |
| Pharyngitis |
33% |
36% |
40% |
28% |
32% |
| Rash |
7% |
10% |
12% |
1% |
3% |
| Laryngitis |
1% |
3% |
4% |
1% |
3% |
| Chest Pain |
16% |
18% |
21% |
23% |
25% |
| Conjunctivitis |
2% |
4% |
5% |
0% |
1% |
| Rhinitis |
Differences were less than 3% for these adverse events in the Trial in mild to moderate CF patients |
24% |
30% |
| FVC decrease of ≥10% of predicted
|
17% |
22% |
| Fever |
28% |
32% |
| Dyspepsia |
0% |
3% |
Dyspnea
(when reported as serious) |
Differences were less than 3% for this adverse event in the Trial in mild to moderate CF patients |
12%
|
17%
|
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 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, 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.
Allergic Reactions
There have been no reports of anaphylaxis attributed to the administration of Pulmozyme 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 developed serum antibodies to Pulmozyme. None of these patients developed anaphylaxis, and the clinical significance of serum antibodies to Pulmozyme is unknown.
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REPORTS OF SUSPECTED PULMOZYME SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Pulmozyme. The information is not vetted and should not be considered as verified clinical evidence.
Possible Pulmozyme side effects / adverse reactions in 9 year old female
Reported by a physician from United States on 2011-10-14
Patient: 9 year old female
Reactions: Pituitary-Dependent Cushing's Syndrome, Asthma, Cystic Fibrosis Related Diabetes, Adrenal Insufficiency, Vulvovaginal Candidiasis
Suspect drug(s):
Propranolol
Indication: Portal Hypertension
Fluconazole
Administration route: Oral
Indication: Vulvovaginal Candidiasis
Start date: 2009-07-21
End date: 2009-07-29
Fluticasone Propionate
Dosage: 440 mcg
Indication: Asthma
Start date: 2009-06-02
End date: 2009-06-29
Prednisone
Indication: Asthma
Pulmozyme
Indication: Cystic Fibrosis
Start date: 2008-12-16
Azithromycin
Indication: Cystic Fibrosis
Start date: 2008-12-16
Fluticasone Propionate
Dosage: 880 mcg
Start date: 2009-06-30
End date: 2009-09-25
Albuterol
Indication: Cystic Fibrosis
Start date: 2008-12-16
Possible Pulmozyme side effects / adverse reactions in 16 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-11-03
Patient: 16 year old female
Reactions: Dysphonia, Oropharyngeal Pain
Suspect drug(s):
Pulmozyme
Other drugs received by patient: Cefixime; Tobramycin; Levemir; Ventolin; Creon; Vitamins A, D and E; Fluticasone Propionate; Ceftazidime; Acetaminophen; Azithromycin; Omeprazole; Vitamin E
Possible Pulmozyme side effects / adverse reactions in 32 year old male
Reported by a pharmacist from United States on 2011-11-14
Patient: 32 year old male weighing 56.7 kg (124.7 pounds)
Reactions: Death
Adverse event resulted in: death
Suspect drug(s):
Pulmozyme
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