Dornase Alfa (Monograph)

Brand name: Pulmozyme
Drug class: Mucolytic Agents
ATC class: R05CB13
VA class: RE900
Chemical name: Deoxyribonuclease
CAS number: 9003-98-9

Medically reviewed by Drugs.com on Mar 22, 2023. Written by ASHP.

Introduction

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

Uses for Dornase Alfa

Cystic Fibrosis

Adjunctive therapy in patients with cystic fibrosis to reduce mucus viscosity and enable the clearance of airway secretions to improve pulmonary function (designated an orphan drug by FDA for this use).

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

Dornase Alfa Dosage and Administration

Administration

Oral Inhalation

Administer by oral inhalation via nebulization once daily.

Administer using a recommended nebulizer system; safety and efficacy of dornase alfa inhalation solution administered by a nebulizer system other than those listed below not established.

Use in patients unable to inhale or exhale orally throughout the entire nebulization period.

Oral inhalation solution should not be diluted nor mixed with any other drugs in the nebulizer.

Empty the entire contents of the single-use ampul of solution into the nebulizer cup; attach the cup to the inhalation apparatus according to the manufacturer’s instructions.

Place the mouthpiece of the nebulizer in the mouth and turn on the compressor. Breathe calmly and evenly through the mouth until the nebulizer stops producing a mist (duration of treatment for full dose is approximately 10–15 minutes).

Clean the nebulizer after use according to the manufacturer’s instructions.

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

Dosage

Each single-use ampul delivers 2.5 mg (2.5 mL of undiluted solution) to the nebulizer cup.

Pediatric Patients

Cystic Fibrosis

Oral Inhalation

Children ≥5 years of age: 2.5 mg once daily. Some patients (e.g., those with FVC >85%) may benefit from 2.5 mg twice daily.

Adults

Cystic Fibrosis

Oral Inhalation

2.5 mg once daily. Some patients (e.g., ≥21 years of age, those with FVC >85%) may benefit from 2.5 mg twice daily.

Prescribing Limits

Pediatric Patients

Cystic Fibrosis

Oral Inhalation

In clinical studies, dosages >2.5 mg twice daily did not provide additional improvement in pulmonary function (e.g., FEV₁).

Safety and efficacy of daily administration for >12 months of continuous therapy not established.

Adults

Cystic Fibrosis

Oral Inhalation

In clinical studies, dosages >2.5 mg twice daily did not provide additional improvement in pulmonary function (e.g., FEV₁).

Safety and efficacy of daily administration for >12 months of continuous therapy not established.

Special Populations

No special population dosage recommendations at this time.

Cautions for Dornase Alfa

Contraindications

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

Warnings/Precautions

General Precautions

Adjunct to and not a replacement for standard therapies (e.g., chest physical therapy, anti-infectives, bronchodilators, oral enzyme supplements, vitamins, oral and/or inhaled corticosteroids, analgesics); continue such therapies during enzyme therapy.

Specific Populations

Pregnancy

Category B.

Lactation

Not known whether dornase alfa is distributed into milk; caution if used in nursing women.

Pediatric Use

Limited experience in patients <5 years of age; use only in those in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.

Increased incidence of cough, rhinitis, and rash in children <5 years of age compared with children ≥5 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Common Adverse Effects

Pharyngitis, chest pain, voice alteration (e.g., hoarseness), rash, conjunctivitis.

Interactions for Dornase Alfa

No formal drug interaction studies to date; however, the manufacturer states that concomitant administration of dornase alfa and other standard therapies for cystic fibrosis is safe and effective.

Dornase Alfa Pharmacokinetics

Absorption

Bioavailability

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

Onset

Following oral inhalation, mean sputum DNase concentrations measurable within 15 minutes. Improvement in pulmonary function (FEV₁) evident within 8 days.

Distribution

Extent

Not known whether dornase alfa crosses the placenta or is distributed into milk.

Stability

Storage

Oral

Inhalation Solution

2–8°C; protect from light and excessive heat. Store ampuls in protective foil pouch to protect from light until used. Discard if left at room temperature for ≥24 hours.

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 forced vital capacity and forced expiratory volume at 1 second [FEV₁]), and improves mucociliary clearance in patients with cystic fibrosis.

Advice to Patients

• Importance of providing patient a copy of manufacturer’s patient information.

• Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the nebulization delivery system.

• Importance of thoroughly washing hands with soap and water before handling drug and nebulizer to avoid microbial contamination.

• Importance of adhering to daily dosing schedule and concomitant therapies, including not exceeding the recommended dose or frequency of use unless otherwise instructed by a clinician.

• Importance of not diluting or mixing with other drugs in the nebulizer.

• Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

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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