What are the adverse reactions of pulmozyme?

pulmozyme

Clinical trials have shown that the main adverse reactions of pulmozymede include voice change, pharyngitis, rash, FVC decrease ≥10%, laryngitis, chest pain, conjunctivitis, rhinitis, fever, indigestion, and dyspnea.

There have been no reports of allergic reactions caused by taking pulmozyme. Urticaria, mild to moderate rash, and mild rash have been observed and are transient. Across studies, a small proportion (average 2-4%) of patients treated with pulmozyme developed serum antibodies against pulmozyme. None of these patients experienced allergic reactions, and the clinical significance of serum anti-pulmozyme antibodies is unknown.

In clinical trials, patients treated with pulmozyme experienced an increase in adverse reactions of 3% or more compared to placebo. Mortality rates were similar in placebo- and pulmozyme-treated patients observed in controlled trials. 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.

Mechanism of action

Pulmozyme is recombinant human deoxyribonuclease I (rhDNase), an enzyme that selectively cleaves DNA. In preclinical in vitro studies, pulmozyme hydrolyzed DNA in the sputum of patients with cystic fibrosis and reduced the viscoelasticity of the sputum.

In patients with cystic fibrosis, retention of viscous purulent secretions in the airways can lead to reduced lung function and worsening of infections. Purulent lung secretions contain very high concentrations of extracellular DNA, released by degenerating leukocytes and accumulated in response to infection.

Pharmacokinetics

After inhaling 2.5 mg of pulmozyme in 18 patients with cystic fibrosis, an average sputum concentration of 3g/mL DNase could be measured within 15 minutes. Two hours after inhalation, the average sputum concentration dropped to an average of 0.6g/mL. Four patients with cystic fibrosis inhaled up to 10 mg of pulmozyme three times a day for 6 consecutive days, which did not result in significant increases in serum levels.

If patients with cystic fibrosis experience severe adverse reactions such as difficulty breathing while using pulmozyme, they should stop taking the drug in time and consult a doctor to avoid adverse drug reactions.