Medically reviewed by Drugs.com. Last updated on Mar 16, 2020.
(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
Data from controlled and noncontrolled studies support the use of dornase alfa in combination with alteplase for the treatment of complicated parapneumonic effusion or empyema. Effusion volume, need for surgical intervention, and duration of hospital stay were reduced in patients treated with combination therapy [Piccolo 2014], [Rahman 2011].
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 twice daily. Administer >2 hours after each intrapleural alteplase dose (with a 1-hour dwell time for each drug) for a total of 3 days (Rahman 2011). Data from a single center study suggest that concurrent administration of alteplase and dornase alfa (with a 2-hour dwell time) is safe and effective (Majid 2016).
Refer to adult dosing.
Infants and Children <2 years; Symptomatic patients: Limited data available (Borowitz 2009; McKenzie 2007): Inhalation: Nebulization: 2.5 mg/day through selected nebulizers in conjunction with Pulmo-Aide, Pari-Proneb, Mobilaire, Porta-Neb, or Pari Baby compressor system or eRapid Nebulizer System (Berge 2003)
Children 2 to <5 years; Acute exacerbations or chronic use in select patients: Limited data available (Lahiri 2016; McKenzie 2007): Inhalation: Nebulization: 2.5 mg/day through selected nebulizers in conjunction with Pulmo-Aide, Pari-Proneb, Mobilaire, Porta-Neb, or Pari Baby compressor system or eRapid Nebulizer System (Nasr 2001)
Children ≥5 years and Adolescents; Chronic therapy: Inhalation: Nebulization: 2.5 mg/day through selected nebulizers in conjunction with a Pulmo-Aide, Pari-Proneb, Mobilaire, Porta-Neb, or Pari Baby compressor system or the eRapid Nebulizer System; chronic daily use in cystic fibrosis patients ≥6 years of age (Mogayzel 2013). Some patients may benefit from twice daily dosing.
Rhinosinusitis, chronic; secondary to cystic fibrosis: Limited data available: Children ≥5 years and Adolescents: Inhalation: Intranasal: 2.5 mg/day nebulized intranasal with the Pari Sinus; dosing based in double-blind, placebo-controlled cross-over trial in 23 subjects (age range: 5 to 67 years) which showed improvement of primary nasal symptoms compared to placebo (isotonic saline); treatments were well tolerated, nasal bleeding reported in two patients (Mainz 2014).
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: For sequential administration of alteplase and dornase alfa, dilute each dose in 30 mL 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). For concurrent administration of alteplase and dornase alfa, using separate syringes, dilute each dose in 50 mL normal saline. Instill each dose into chest tube, one immediately after the other, followed by a 60 mL normal saline flush. Clamp drain; after 2-hour dwell time, release clamp (Majid 2016).
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 a total time of 60 hours.
There are no known significant interactions.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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.
What is this drug used for?
• It is used to lower the number of lung infections and help lung function in cystic fibrosis.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Change in voice
• Runny nose
• Sore throat
• Eye irritation
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Chest pain
• Shortness of breath
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
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More about dornase alfa
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Interactions
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- Drug class: miscellaneous respiratory agents
Other brands: Pulmozyme