(DOOR nase AL fa)
- Recombinant Human Deoxyribonuclease
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Pulmozyme: 1 mg/mL (2.5 mL)
Brand Names: U.S.
- Mucolytic Agent
The hallmark of cystic fibrosis lung disease is the presence of abundant, purulent airway secretions composed primarily of highly polymerized DNA. The principal source of this DNA is the nuclei of degenerating neutrophils, which is present in large concentrations in infected lung secretions. The presence of this DNA produces a viscous mucous that may contribute to the decreased mucociliary transport and persistent infections that are commonly seen in this population. Dornase alfa is a deoxyribonuclease (DNA) enzyme produced by recombinant gene technology. Dornase selectively cleaves DNA, thus reducing mucous viscosity and as a result, airflow in the lung is improved and the risk of bacterial infection may be decreased.
Onset of Action
Nebulization: Enzyme levels are measured in sputum in ~15 minutes and decline rapidly thereafter
Duration of Action
Sputum concentrations decline within 2 hours of inhalation
Use: Labeled Indications
Cystic fibrosis: Management of cystic fibrosis patients, in conjunction with standard therapies, to improve pulmonary function; reduce the risk of respiratory tract infections requiring parenteral antibiotics in patients with a forced vital capacity (FVC) ≥40% of predicted.
Off Label Uses
Parapneumonic pleural effusions and empyemas (adults)
Use of dornase alfa with alteplase in the treatment of complicated parapneumonic effusions or empyemas in adults has been evaluated in controlled and noncontrolled settings, demonstrating reductions in effusion volume, the need for surgical intervention, and hospital stay.
British Thoracic Society guidelines state that there is no indication for the routine use of intrapleural fibrinolytics in the management of pleural infection. However, fibrinolytics may be considered for use in patients with pleural infection refractory to traditional therapy and who are not candidates for surgery. The guidelines mention the potential use of alteplase in combination with dornase but provide no recommendations, as the guidelines were published prior to full publication of the controlled trial evaluating the combination.
Hypersensitivity to dornase alfa, Chinese hamster ovary cell products, or any component of the formulation
Cystic fibrosis: Inhalation: 2.5 mg daily through selected jet nebulizers in conjunction with a Pulmo-Aide, Pari-Proneb, Mobilaire, or Porta-Neb compressor system or eRapid Nebulizer System
Patients unable to inhale or exhale orally throughout the entire treatment period may use Pari-Baby nebulizer. Some patients may benefit from twice daily administration.
Parapneumonic pleural effusions and empyemas (off-label use): Intrapleural: 5 mg (diluted in 30 mL of sterile water) administered twice daily >2 hours after each intrapleural alteplase dose (with a 1-hour dwell time for each drug) for a total of 3 days (Rahman, 2011). Some clinicians suggest consideration of fibrinolytic use in patients in whom treatment with at least 24 hours of chest tube drainage has failed and who are poor surgical candidates (Hamblin, 2010).
Refer to adult dosing.
Cystic fibrosis: Inhalation:
Infants and Children ≤5 years: Not approved for use; however, studies using this therapy in small numbers of children as young as 3 months of age have reported efficacy and similar side effects.
Children >5 years: Refer to adult dosing
Dosing: Renal Impairment
There are no dosage adjustment provided in manufacturer’s labeling.
Dosing: Hepatic Impairment
There are no dosage adjustment provided in manufacturer’s labeling.
Nebulization: Prior to use, squeeze each ampul to check for leaks. Should not be diluted or mixed with any other drugs in the nebulizer, this may inactivate the drug. When administered with the eRapid Nebulizer System, replace handset after 90 uses to ensure delivery of appropriate dose; the eRapid Nebulizer System should only be used by patients who can use a mouthpiece. Follow the manufacturer’s instructions on use and maintenance of the equipment.
Parapneumonic pleural effusions and empyemas (off-label use): Intrapleural: Note: Each dose must be diluted in 30 mL of sterile water. Stability of dornase alfa diluted in sterile water has not been formally evaluated; use immediately after preparation. Instill dose into chest tube and clamp drain. After 1 hour dwell time, release clamp and connect chest tube to continuous suction (Rahman, 2011).
Store at 2°C to 8°C (36°F to 46°F) in protective foil to protect from light. Refrigerate during transport and do not expose to room temperatures for ≥24 hours.
There are no known significant interactions.
Adverse events were similar in children using the PARI BABY nebulizer (facemask as opposed to mouthpiece) with the addition of cough.
Cardiovascular: Chest pain (18% to 25%)
Central nervous system: Voice disorder (12% to 18%)
Dermatologic: Skin rash (3% to 12%)
Respiratory: Cough (PARI-BABY nebulizer facemask: children 3 months to <5 years: 45%; children 5 to ≤10 years: 30%), pharyngitis (32% to 40%), rhinitis (30%; in patients with FVC: <40%), decrease in forced vital capacity (≥10% decrease of predicted: 22%; in patients with FVC: <40%), dyspnea (17%; in patients with FVC: <40%)
Miscellaneous: Fever (32% in patients with FVC <40%)
1% to 10%:
Gastrointestinal: Dyspepsia (≤3%)
Immunologic: Antibody development (to dornase alfa: 2% to 4%)
Ophthalmic: Conjunctivitis (1% to 5%)
Respiratory: Laryngitis (3% to 4%)
<1%, postmarketing and/or case reports: Headache, urticaria
• Decreased pulmonary function: In patients with pulmonary function <40% of normal, dornase alfa does not significantly reduce the risk of respiratory infections that require parenteral antibiotics.
• Pediatric: Safety studies included children ≥3 months, however experience is limited in children <5 years of age.
Adverse events have not been observed in animal reproduction studies.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience change in voice, rhinorrhea, pharyngitis, or eye irritation. Have patient report immediately to prescriber angina or shortness of breath (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about dornase alfa
- Side Effects
- During Pregnancy
- Dosage Information
- Drug Interactions
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- Drug class: miscellaneous respiratory agents
Other brands: Pulmozyme