Pulmozyme Side Effects
Generic Name: dornase alfa
Note: This page contains side effects data for the generic drug dornase alfa. It is possible that some of the dosage forms included below may not apply to the brand name Pulmozyme.
It is possible that some side effects of Pulmozyme may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to dornase alfa: inhalation solution
As well as its needed effects, dornase alfa (the active ingredient contained in Pulmozyme) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking dornase alfa, check with your doctor or nurse as soon as possible:Rare
- Hives or welts
- redness of skin
- skin rash
Some dornase alfa side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:More common
- Chest pain or discomfort
- sore throat
- Difficulty breathing
- redness, itching, pain, swelling, or other irritation of eyes
- runny or stuffy nose
- upset stomach
For Healthcare Professionals
Applies to dornase alfa: inhalation solution
Dornase alfa (the active ingredient contained in Pulmozyme) 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%).[Ref]
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.[Ref]
Cardiovascular side effects have included chest pain, which has been reported in 18% to 21% of patients receiving dornase alfa (the active ingredient contained in Pulmozyme) versus 16% with placebo.[Ref]
Ocular side effects have included conjunctivitis which has been reported in 4% to 5% of patients receiving dornase alfa (the active ingredient contained in Pulmozyme) versus 2% with placebo.[Ref]
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[Ref]
Special face masks are not needed for caregivers involved with the administration of dornase alfa (the active ingredient contained in Pulmozyme) Studies have shown that the passive airborne exposure is well below the clinical dose during administration and nondetectable 15 to 45 minutes after treatment.[Ref]
1. Bryson HM, Sorkin EM "Dornase alfa. A review of its pharmacological properties and therapeutic potential in cystic fibrosis." Drugs 48 (1994): 894-906
2. "Product Information. Pulmozyme (dornase alfa)." Genentech, South San Francisco, CA.
3. Fuchs HJ, Borowitz DS, Christiansen DH, et al. "Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis." N Engl J Med 331 (1994): 637-42
4. Witt DM, Anderson L "Dornase alfa: a new option in the management of cystic fibrosis." Pharmacotherapy 16 (1996): 40-8
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