Pulmozyme (dornase alfa)
Mucolytics Inhalation Solution, Non-Oral
Last reviewed · Source: First Databank (FDB) drug data
Overview
Dornase alfa is a biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I), an enzyme that selectively cleaves extracellular DNA (e.g., in purulent pulmonary secretions).
Dornase alfa is a biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I, pancreatic DNase, human DNase, thymonuclease), an enzyme that selectively cleaves DNA. Deoxyribonuclease I is present in a variety of animal and plant tissues. Dornase alfa is prepared from cultures of genetically modified Chinese hamster ovary cells using recombinant DNA technology.
These cells have been modified by the addition of plasmids that incorporate the human deoxyribonuclease gene, which was isolated from human pancreas cells.
Deoxyribonuclease I is an enzyme involved in endonucleolytic cleavage of extracellular DNA to 5'-phosphodinucleotide and 5'-phosphooligonucleotide end products; deoxyribonuclease I has no effect on DNA within intact cells. In patients with cystic fibrosis, retention of viscous purulent secretions in the airways contributes to both reduced pulmonary function and exacerbations of infection. Purulent pulmonary secretions contain high concentrations of extracellular DNA, an extremely viscous polyanion, which is released by degeneration of leukocytes that accumulate during the inflammatory response to infection.
In vitro, dornase alfa hydrolyzes the DNA in sputum of patients with cystic fibrosis; optimal enzymatic activity depends on the presence of divalent cations (e.g., calcium, magnesium). The enzyme 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. While most evidence suggests that this effect on extracellular DNA reduces sputum viscosity and viscoelasticity, limited evidence indicates that the enzyme may instead reduce the adhesiveness and elasticity of purulent sputum with little effect on its viscosity per se.
Trypsin, chymotrypsin, and/or other proteolytic contaminants, which were present in early formulations of bovine DNase I, do not appear to contribute to the viscosity-reducing effect of deoxyribonuclease I, including dornase alfa.
Although the mechanism of dornase alfa has not been elucidated fully, the enzyme appears to improve the transportability of purulent mucus via ciliary activity and cough. Alteration of purulent sputum by dornase alfa is associated with reduced airflow obstruction, improved pulmonary function (increased forced vital capacity and forced expiratory volume at 1 second (FEV1)), and more effective mucociliary clearance in patients with cystic fibrosis. The beneficial effects of dornase alfa in these patients involve a mechanism(s) distinct from the mucolytic action of acetylcysteine.
After administration of dornase alfa 2.5 mg by inhalation to cystic fibrosis patients, sputum concentrations were measurable within 15 minutes. When up to 10 mg of dornase alfa was inhaled 3 times daily in patients with cystic fibrosis for 6 consecutive days, significant elevations in DNase above normal endogenous levels were not observed. When 2.5 mg of dornase alfa was administered 2 times daily to patients with cystic fibrosis for 6 months, no accumulation of serum DNase was observed.
Dornase alfa is expected to undergo metabolism via proteases present in biological fluids. The elimination half-life of IV administered dornase alfa is 3-4 hours.
USES: This medication is used to improve breathing and reduce the risk of lung infections in people with cystic fibrosis. It is used along with other treatments for this disease (such as chest physical therapy, medications, nutritional supplements). Dornase alfa is the same as a substance (DNase I enzyme) that is naturally produced by the body.
It works in the airways by decreasing stickiness/thickness of mucus so that it can be cleared from the lungs more easily.
Generic name: dornase alfa
Pronunciation: (DOOR-naze AL-fa)
Drug class: Mucolytics
Therapeutic class: Respiratory Therapy Agents
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Pulmozyme
Indications
The following indications are listed for Pulmozyme:
- Respiratory Cystic Fibrosis
Also known as: Respiratory Complications Of Cystic Fibrosis.
Dosing
Each single-use ampule delivers 2.5 mg of dornase alfa (2.5 mL of undiluted solution).
Dornase alfa is administered by oral inhalation via a jet nebulizer or a vibrating mesh nebulizer.
The manufacturer states that recommended jet nebulizers for use with dornase alfa include: the disposable jet nebulizer Hudson T Up-draft II(R) or the disposable jet nebulizer Marquest Acorn II(R), in conjunction with a Pulmo-Aide(R) compressor or a legally marketed compressor of identical pressure and flow rate; the reusable PARI LC(R) Plus or PARI BABY(TM) nebulizer, in conjunction with the PARI PRONEB(R) compressor or a legally marketed compressor of identical pressure and flow rate; and the Durable Sidestream(R) nebulizer with either the MOBILAIRE(R) or Porta-Neb(R) compressor or a legally marketed compressor of identical pressure and flow rate. The manufacturer states that recommended vibrating mesh nebulizers for use with dornase alfa include the eRapid(TM) Nebulizer System, consisting of the eRapid(TM) Nebulizer Handset with eBase(TM) Controller, Innospire Go, Pulmogine Vibrating Mesh Nebulizer, AireHealth Nebulizer, and Intelligent Mesh Nebulizer.
The eRapid(TM) Nebulizer System should only be used by adults and pediatric patients who can use a mouthpiece, and not by younger patients who need a mask for dornase alfa inhalation. Patients and clinicians should refer to the manufacturer's instruction manual on the use, maintenance, and replacement of equipment,including cleaning and disinfection procedures for the selected nebulizer.
Dornase alfa oral inhalation solution should not be diluted nor should it be admixed with any other drugs in the nebulizer. The manufacturer states that patients or their caregivers should be advised to squeeze each ampule prior to use to check for leaks.
Store ampules of dornase alfa at 2-8degreesC and in their protective foil to protect from light and heat; once protective foil pouch is opened, unused ampules must be refrigerated in the foil pouch to protect from light and heat. Keep ampules refrigerated during transport in their protective foli pouch and do not expose to room temperature for longer than 60 hours in total. Dornase alfa oral inhalation solution contains no preservatives; once the single-use ampule is opened, the manufacturer states that the entire contents must be used or the remainder discarded.
| Drug label | Dosing type | Instructions |
|---|---|---|
| Pulmozyme 1 Mg/Ml Ampul | Maintenance | Inhale 2.5 mg by inhalation route once daily via nebulizer. |
No dosing information is available for this tab.
Drug interactions
The manufacturer states that there are no clinically significant drug-drug interactions with dornase alfa.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*Known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any ingredient in the formulation.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- Bronchiectasis
Adverse reactions
Adverse effects in clinical studies of dornase alfa occurring in >=3% of patients and more commonly than with placebo include voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, a decrease in forced vital capacity >=10%, fever, and dyspnea.
There are no severe adverse reactions for this drug.
More Frequent
- Chest pain
- Conjunctivitis
- Decrease in forced vital capacity
- Dyspnea
- Fever
- Hoarseness
- Laryngitis
- Pharyngitis
- Rhinitis
- Skin rash
- Sore throat
- Voice change
Less Frequent
- Dyspepsia
Precautions
No enhanced messaging available.
Safety and efficacy of dornase alfa as adjunctive therapy in cystic fibrosis have been established in pediatric patients. The use of dornase alfa in pediatric patients 5-17 years of age is supported by evidence from a trial including 303 clinically stable patients with cystic fibrosis; use of dornase alfa in pediatric patients <5 years of age is supported by extrapolated efficacy data from pediatric patients >=5 years of age, and additional safety data in 65 patients, 3 months to 5 years of age, who received dornase alfa 2.5 mg daily via inhalation for a 2-week period.
There are no adequate and well-controlled studies of dornase alfa in pregnant women. Animal reproductive data have shown no evidence of fetal harm at doses up to 600 times the maximum recommended human dose.
It is not known whether dornase alfa is distributed into human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for dornase alfa and the potential for adverse effects on the breast-fed child.
The manufacturer makes no specific dosage recommendations in geriatric patients.
Because cystic fibrosis is a condition that primarily affects children and young adults, clinical studies of dornase alfa did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently from younger patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Respiratory cystic fibrosis | ||
| E84.0 | ICD10CM | Cystic fibrosis with pulmonary manifestations |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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