Dornase alfa Side Effects

Please note - some side effects for Dornase alfa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dornase alfa - for the Consumer

Dornase Alfa

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 Dornase Alfa:

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

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

Side Effects by Body System

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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