Pulmozyme

— THERAPEUTIC CATEGORIES —
  • Lung surfactants/mucolytics

Pulmozyme Generic Name & Formulations

General Description

Dornase alfa (recombinant human DNase) 1mg/mL; soln for inh; preservative-free.

How Supplied

Ampules (2.5mL)—30

Storage

Store ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat. Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat.

Manufacturer

Generic Availability

NO

Mechanism of Action

Pulmozyme is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, it hydrolyzes the DNA in sputum of cystic fibrosis patients and reduces sputum viscoelasticity. In CF patients, retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to infection.

Pulmozyme Indications

Indications

Management of cystic fibrosis in conjunction with standard therapies to improve pulmonary function.

Pulmozyme Dosage and Administration

Adults and Children

<3months: not recommended. Use appropriate nebulizer (jet or vibrating mesh). Do not dilute. >5yrs: 2.5mg once daily via nebulization; may increase to 2.5mg twice daily (see full labeling).

Pulmozyme Contraindications

Not Applicable

Pulmozyme Boxed Warnings

Not Applicable

Pulmozyme Warnings/Precautions

Warnings/Precautions

For patients <5yrs of age, use only if there is a potential for benefit in pulmonary function or in risk of respiratory tract infection. Use only with recommended nebulizers. Pregnancy. Nursing mothers.

Pulmozyme Pharmacokinetics

Elimination

Half-life: 3–4 hours.

Pulmozyme Interactions

Interactions

Do not mix with other drugs in nebulizer.

Pulmozyme Adverse Reactions

Adverse Reactions

Pharyngitis, voice alteration, laryngitis, rash, chest pain, conjunctivitis.

Pulmozyme Clinical Trials

See Literature

Pulmozyme Note

Not Applicable

Pulmozyme Patient Counseling

See Literature