Pulmozyme Side Effects

Generic name: dornase alfa

Note: This document contains side effect information about dornase alfa. Some of the dosage forms listed on this page may not apply to the brand name Pulmozyme.

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

For the Consumer

Applies to dornase alfa: inhalation solution

If you experience any of the following serious side effects while taking dornase alfa (the active ingredient contained in Pulmozyme) 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

• fever.

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;

• rash;

• laryngitis;

• 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.

For Healthcare Professionals

Applies to dornase alfa: inhalation solution

General

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%).

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 (the active ingredient contained in Pulmozyme) versus 16% with placebo.

Ocular

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.

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 (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.

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