Dornase Alfa (Oral Inhalation) (Monograph)

Brand name: Pulmozyme
Drug class: Mucolytic Agents

Medically reviewed by Drugs.com on Oct 26, 2023. Written by ASHP.

Introduction

Mucolytic agent; biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I).

Uses for Dornase Alfa (Oral Inhalation)

Cystic Fibrosis

Adjunctive therapy in pediatric and adult patients with cystic fibrosis to improve pulmonary function.

Reduces the frequency of respiratory infections requiring parenteral anti-infective therapy in patients with forced vital capacity (FVC) ≥40%.

Designated an orphan drug by FDA for this use.

Guidelines recommend the use of dornase alfa for patients with asymptomatic, mild, moderate, or severe cystic fibrosis to improve lung function and reduce exacerbations.

Parapneumonic Effusions and Empyema

Although safety and efficacy not established, limited data suggest dornase alfa may be used intrapleurally in conjunction with alteplase for complicated parapneumonic effusions and empyema^{† [off-label]}.

Chronic Rhinosinusitis Secondary to Cystic Fibrosis

Although safety and efficacy not established, limited data suggest dornase alfa may be used for the treatment of chronic rhinosinusitis secondary to cystic fibrosis in pediatric patients^{† [off-label]} .

Related/similar drugs

azithromycin, Zithromax, gentamicin, Creon, tobramycin

Dornase Alfa (Oral Inhalation) Dosage and Administration

General

Other General Considerations

• Only administer dornase alfa with specific jet nebulizers and nebulizer systems listed in the manufacturer’s product labeling. Data are not available to support the administration of dornase alfa with other nebulizer systems.

Administration

Oral Inhalation

Administer by oral inhalation via nebulization.

Administer using a recommended jet nebulizer/compressor system (see Table) or using the eRapid™ Nebulizer System (consisting of the eRapid™ Nebulizer Handset with eBase™ Controller); safety and efficacy of dornase alfa inhalation solution administered via other nebulizer systems not established. If using the eRapid™ Nebulizer System, the handset should be replaced after 90 uses.

Do not dilute or mix the oral inhalation solution with any other drugs in the nebulizer.

Clean the nebulizer after use according to the manufacturer’s instructions. Consult Instructions for Use provided by the manufacturer for detailed information on proper administration techniques via various nebulization systems.

Oral inhalation solution contains no preservatives; once the single-use ampule is opened, use the entire contents or discard the remainder.

Dosage

Each single-use ampule delivers 2.5 mg of dornase alfa (2.5 mL of undiluted solution).

Pediatric Patients

Cystic Fibrosis

Oral Inhalation

2.5 mg once daily. Some patients may benefit from twice daily administration.

Adults

Cystic Fibrosis

Oral Inhalation

2.5 mg once daily. Some patients may benefit from twice daily administration.

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.

Renal Impairment

No specific dosage recommendations at this time.

Geriatric Use

No specific dosage recommendations at this time.

Cautions for Dornase Alfa (Oral Inhalation)

Contraindications

Known hypersensitivity to dornase alfa, Chinese hamster ovary cell products, or any ingredient in the formulation.

Warnings/Precautions

Specific Populations

Pregnancy

No adequate and well-controlled studies in pregnant women. Animal reproductive data have shown no evidence of fetal harm at doses up to 600 times the maximum recommended human dose.

Lactation

Not known whether dornase alfa distributed into human milk. Consider developmental and health benefits of breastfeeding along with mother’s clinical need for the drug and the potential for adverse effects to the breast-fed child.

Pediatric Use

Safety and efficacy established in pediatric patients. Use of dornase alfa in pediatric patients 5–17 years of age supported by evidence from a clinical trial. Use of dornase alfa in pediatric patients <5 years of age supported by extrapolated efficacy data from pediatric patients ≥5 years of age and additional safety data.

Geriatric Use

Clinical studies did not include sufficient numbers of patients ≥65 years of age.

Hepatic Impairment

Not evaluated in hepatic impairment.

Renal Impairment

Not evaluated in renal impairment.

Common Adverse Effects

Adverse effects (≥3%): voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC ≥10%, fever, dyspnea.

Drug Interactions

Manufacturer states no clinically significant drug-drug interactions.

Dornase Alfa (Oral Inhalation) Pharmacokinetics

Absorption

Bioavailability

Following oral inhalation, serum DNase concentrations were not increased above normal endogenous levels.

Onset

After oral inhalation, sputum concentrations measurable within 15 minutes.

Distribution

Extent

Not known whether distributed into human milk.

Elimination

Metabolism

Expected to undergo metabolism via proteases in biological fluids.

Half-life

3-4 hours after IV administration.

Stability

Storage

Oral Inhalation

Solution for nebulization

Store in protective foil at 2-8ºC; keep refrigerated during transport, and do not expose to room temperature for ≥24 hours total.

Actions

• Selectively cleaves extracellular DNA (e.g., in purulent pulmonary secretions); does not appear to affect sputum in the absence of an inflammatory response to infection (i.e., in those with nonpurulent sputum) nor does it affect pulmonary function in healthy individuals.

• Reduces sputum viscosity and viscoelasticity.

• Mechanism of action not fully elucidated; appears to improve the transportability of purulent mucus via ciliary activity and cough.

• Reduces airflow obstruction, improves pulmonary function (increased FVC and forced expiratory volume at 1 second [FEV₁]), and improves mucociliary clearance in patients with cystic fibrosis.

Advice to Patients

• Advise patients and caregivers on the proper storage of dornase alfa; must be stored in the refrigerator and protected from heat and light. Refrigerate dornase alfa during transport, and do not allow it to be exposed to room temperature for more than 24 hours total.

• Instruct patients and caregivers to squeeze ampules prior to each use to check for leaks, and to discard the ampule if the solution appears cloudy or discolored. Once the ampule is opened, the contents must be used immediately or discarded.

• Inform patients and caregivers that dornase alfa must not be diluted or mixed with other drugs in the nebulizer.

• Advise patients and caregivers to perform proper maintenance of the jet nebulizer/compressor system or eRapid™ Nebulizer System.

• Instruct patients and caregivers to read and follow the dornase alfa Instructions for Use and the Manufacturer’s eRapid™ Nebulizer System Instruction Booklet.

• Instruct patients and caregivers to replace the eRapid™ handset after 90 uses; data are not available for the administration of dornase alfa with the eRapid™ handset beyond 90 administrations.

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary and herbal supplements, as well as any concomitant illnesses.  

• Advise patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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