Side Effects of Pulmozyme (dornase alpha)

Pulmozyme is an inhaled synthetic protein used to treat cystic fibrosis, a common fatal genetic disease in developed countries.

Cystic fibrosis causes the lungs to secrete thickened fluid, blocking the airways and promoting infection. Pulmozyme breaks down the DNA in the fluid, reducing its thickness.

Common side effects of Pulmozyme include voice changes, sore throat, laryngitis, rash, red eyes, cough, nasal congestion, shortness of breath, and stomach upset.

Serious side effects include allergic reactions, increased difficulty breathing, chest pain, and fever.

Pulmozyme is compatible with standard cystic fibrosis therapies including oral, inhaled, and parenteral antibiotics, bronchodilators, enzyme supplements, vitamins, oral or inhaled corticosteroids, and analgesics.

There are no studies of Pulmozyme in women during pregnancy. Caution should be exercised when considering its use in breastfeeding women.

Important Side Effects of Pulmozyme (dornase alpha)

The most common side effects of dornase alpha include voice alteration, sore throat, laryngitis, rash, chest pain, red eyes, cough, nasal congestion, shortness of breath, stomach upset, and fever.

Pulmozyme (dornase alpha) Side Effects for Healthcare Professionals

Clinical Trials Experience

Adverse reaction rates observed in clinical trials varied due to different conditions. Pulmozyme was studied in placebo-controlled and uncontrolled trials in patients with varying degrees of lung disease.

Most adverse events were similar between Pulmozyme and placebo, reflecting the lung disease. Few patients discontinued Pulmozyme due to adverse reactions.

Adverse reactions occurring in a higher proportion of Pulmozyme-treated patients included voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, FVC decrease, fever, and dyspepsia.

Mortality rates were similar between placebo and Pulmozyme-treated patients.

Uncontrolled Trial

The safety profile of Pulmozyme in pediatric patients was similar to that seen in placebo-controlled trials.

Pulmozyme-treated patients reported more cough, rhinitis, and rash compared to placebo.

Allergic Reactions

No reports of anaphylaxis were attributed to Pulmozyme administration. Urticaria, mild to moderate, and mild skin rash were observed and transient. Some patients developed serum antibodies to Pulmozyme, but no anaphylaxis occurred.

Postmarketing Experience

Postmarketing data confirm the safety profile observed in clinical trials.

Drug Interactions with Pulmozyme (dornase alpha)

No clinically important drug-drug interactions have been reported with Pulmozyme.

Summary

Pulmozyme is an inhaled protein used to treat cystic fibrosis. The common side effects include voice changes, sore throat, laryngitis, rash, red eyes, cough, nasal congestion, shortness of breath, and stomach upset. The effects of Pulmozyme during pregnancy and breastfeeding are unknown.