Pulmozyme Side Effects

Please note - some side effects for Pulmozyme may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Pulmozyme - for the Consumer

Pulmozyme

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Pulmozyme:

Changes in voice; fever; indigestion; itching; mild sore throat; redness around the eyes; sinus inflammation; temporary loss of voice or hoarseness; throat inflammation.

Seek medical attention right away if any of these SEVERE side effects occur when using Pulmozyme:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Pulmozyme Side Effects - for the Professional

Pulmozyme

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
* 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.
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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Side Effects by Body System - for Healthcare Professionals

General

Dornase alfa has been generally well tolerated. Dose ranging studies employing daily dosages as high as 40 mg revealed no significant adverse effects. The most common adverse reactions have been respiratory in nature and included pharyngitis (36% to 40% versus 33% with placebo, n=968), voice alteration or hoarseness (12% to 16% versus 7%), laryngitis (3% to 4% versus 1%), dyspnea and increase in cough. Rash has also occurred frequently (10% to 12% versus 7%).

Many of these adverse reactions have been difficult to distinguish from symptoms of the underlying disease. Hoarseness and pharyngitis have been shown to be dose-related in one study. The hoarseness was transient and regressed after a 3 week period. Withdrawal rates in clinical trials have been similar between active and placebo groups.

Cardiovascular

Cardiovascular side effects have included chest pain, which has been reported in 18% to 21% of patients receiving dornase alfa versus 16% with placebo.

Ocular

Ocular side effects have included conjunctivitis which has been reported in 4% to 5% of patients receiving dornase alfa versus 2% with placebo.

Hypersensitivity

Hypersensitivity side effects have included a small percentage of patients who developed serum antibodies to the drug, but no anaphylaxis or severe allergic reactions have been reported. The clinical relevance of the rhDNase antibodies is presently unknown. No immunoglobulin E antibodies have been detected. exposed to the drug during clinical trials

Other

Special face masks are not needed for caregivers involved with the administration of dornase alfa. Studies have shown that the passive airborne exposure is well below the clinical dose during administration and nondetectable 15 to 45 minutes after treatment.

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