Pulmozyme

Drug overview for PULMOZYME (dornase alfa):

Generic name: DORNASE ALFA (DOOR-naze AL-fa)
Drug class: Mucolytics
Therapeutic class: Respiratory Therapy Agents

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).

No enhanced Uses information available for this drug.

DRUG IMAGES

PULMOZYME 1 MG/ML AMPUL

The following indications for PULMOZYME (dornase alfa) have been approved by the FDA:

Indications:
Respiratory cystic fibrosis

Professional Synonyms:
Respiratory complications of cystic fibrosis

The following dosing information is available for PULMOZYME (dornase alfa):

Dosing
Administration
PULMOZYME
Generic

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.

Dosing information for PULMOZYME
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
PULMOZYME 1 MG/ML AMPUL	Maintenance	Adults inhale 2.5 mg by inhalation route once daily via nebulizer

No generic dosing information available.

Moderate List
Bronchiectasis

The following adverse reaction information is available for PULMOZYME (dornase alfa):

Overview
Severe
Less Severe

Adverse reaction overview.

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 0 severe adverse reactions.

There are 13 less severe adverse reactions.

More Frequent	Less Frequent
Chest pain Conjunctivitis Decrease in forced vital capacity Dyspnea Fever Hoarseness Laryngitis Pharyngitis Rhinitis Skin rash Sore throat Voice change	Dyspepsia

Rare/Very Rare
None.

The following precautions are available for PULMOZYME (dornase alfa):

Pediatric
Pregnant
Lactation
Geriatric

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.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

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.

Respiratory cystic fibrosis
E84.0	Cystic fibrosis with pulmonary manifestations