Pulmozyme

PULMOZYME- dornase alfa solution
Genentech, Inc.

1 INDICATIONS AND USAGE

PULMOZYME® is indicated, in conjunction with standard therapies, for the management of pediatric and adult patients with cystic fibrosis (CF) to improve pulmonary function.

In CF patients with an FVC ≥ 40% of predicted, daily administration of PULMOZYME has also been shown to reduce the risk of respiratory tract infections requiring parenteral antibiotics.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage, in most cystic fibrosis patients, is one 2.5 mg single-dose ampule inhaled once daily using a recommended jet nebulizer connected to an air compressor system or eRapid™ Nebulizer System.

Some patients may benefit from twice daily administration [see Clinical Studies (14)].

2.2 Administration Instructions

Nebulizer Information

Administer PULMOZYME via the eRapid Nebulizer System or via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask (see Table 1). No data are currently available to support the administration of PULMOZYME with other nebulizer systems.

When PULMOZYME is administered with the eRapid Nebulizer System, replace the handset after 90 uses, regardless of whether the EasyCare cleaning aid is used. Since delivery data are not available for PULMOZYME administered with the eRapid handset beyond 90 administrations, delivery of the appropriate therapeutic dose of PULMOZYME cannot be assured beyond 90 administrations. The eRapid 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 to take PULMOZYME.

The patient should follow the manufacturer’s instructions on the use and maintenance of the equipment, including cleaning and disinfection procedures.

For additional information, refer to recommended nebulizer manufacturers’ Instructions for Use.

Table 1 Recommended Jet Nebulizers and Nebulizer Systems
Jet Nebulizer * Compressor
*
Follow Manufacturer’s Instructions for Use
Patients who are unable to inhale or exhale orally throughout the entire nebulization period may use the PARI BABY™ nebulizer.
Consisting of the eRapid™ Nebulizer Handset with eBase™ Controller.
Hudson T Up-draft II® Pulmo-Aide® or legally marketed compressor of identical pressure and flow rate (maximum 30 psi, 12 LPM).
Marquest Acorn II®
PARI LC® Plus PARI PRONEB® or legally marketed compressor of identical pressure and flow rate (maximum 24 psi, 9 LPM).
PARI BABY™
Durable Sidestream® MOBILAIRE™, Porta-NEB® or legally marketed compressor of identical pressure and flow rate (maximum 45 psi, 7 LPM).
Nebulizer System
eRapid™ Nebulizer System

PULMOZYME Information

Each PULMOZYME ampule should be squeezed prior to use in order to check for leaks. Discard ampules if the solution is cloudy or discolored. Once opened, the entire contents of the ampule must be used or discarded.

Do not dilute or mix PULMOZYME with other drugs in the nebulizer. Mixing of PULMOZYME with other drugs could lead to adverse physicochemical and/or functional changes in PULMOZYME or the admixed compound.

3 DOSAGE FORMS AND STRENGTHS

Inhalation solution: 2.5 mg/2.5 mL clear, colorless solution in single-dose ampules.

4 CONTRAINDICATIONS

PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product.

5 WARNINGS AND PRECAUTIONS

None.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to PULMOZYME in 902 patients, with exposures ranging from 2 weeks of daily administration up to once or twice daily administration for six months. PULMOZYME was studied in both placebo-controlled and uncontrolled trials (n=804 and n=98). The population of patients in placebo-controlled trials was with FVC ≥ 40% of predicted (n=643) or with more advanced pulmonary disease, FVC < 40% of predicted (n=161). The population in the uncontrolled trial included 98 pediatric patients with CF ranging from 3 months to 10 years of age. More than half of the patients received PULMOZYME 2.5 mg by inhalation once a day (n=581), while the rest of patients (n=321) received PULMOZYME 2.5 mg by inhalation twice a day.

Placebo-Controlled Trials

Trial 1: Trial 1 was a randomized, placebo-controlled clinical trial in patients with FVC ≥ 40% of predicted. In this trial, over 600 patients received PULMOZYME once or twice daily for six months. The most common adverse reaction (risk difference ≥5%) was voice alteration. The proportion of most adverse events was similar for patients on PULMOZYME and on placebo, probably reflecting the sequelae of the underlying lung disease. In most cases reactions that were increased were mild, transient in nature, and did not require alterations in dosing. Few patients experienced adverse reactions resulting in permanent discontinuation from PULMOZYME, and the proportion of discontinuations were similar for placebo (2%) and PULMOZYME (3%). Adverse reactions occurring in a higher proportion (greater than 3%) of PULMOZYME treated patients than in placebo-treated patients are listed in Table 2.

Trial 2: Trial 2 was a randomized, placebo-controlled trial in patients with more advanced pulmonary disease (FVC < 40% of predicted) who were treated for 12 weeks. In this trial, the safety profile of PULMOZYME was similar to that reported in patients with less advanced pulmonary disease (FVC ≥ 40% of predicted). Adverse reactions that were reported in this trial with a higher proportion (greater than 3%) in the PULMOZYME treated patients are listed in Table 2.

Table 2. Adverse Reactions Increased 3% or More in PULMOZYME Treated Patients Over Placebo in CF Clinical Trials
Adverse Reactions(of any severity or seriousness) Trial 1CF Patients with FVC ≥ 40% of predicted treated for 24 weeks Trial 2CF Patients with FVC <40% of predicted treated for 12 weeks
Placebon=325 Pulmozyme QDn=322 Pulmozyme BIDn=321 Placebon=159 Pulmozyme QDn=161
*
Single measurement only, does not reflect overall FVC changes.
Total reports of dyspnea (regardless of severity or seriousness) had a difference of less than 3% in Trial 2.
Voice alteration 7% 12% 16% 6% 18%
Pharyngitis 33% 36% 40% 28% 32%
Rash 7% 10% 12% 1% 3%
Laryngitis 1% 3% 4% 1% 3%
Chest Pain 16% 18% 21% 23% 25%
Conjunctivitis 2% 4% 5% 0% 1%
Rhinitis Differences were less than 3% 24% 30%
FVC decrease of ≥ 10% of predicted * 17% 22%
Fever 28% 32%
Dyspepsia 0% 3%
Dyspnea (when reported as serious) Differences were less than 3% 12% 17%

Mortality rates observed in controlled trials were similar for the placebo and PULMOZYME treated patients. Causes of death were consistent with progression of cystic fibrosis and included apnea, cardiac arrest, cardiopulmonary arrest, cor pulmonale, heart failure, massive hemoptysis, pneumonia, pneumothorax, and respiratory failure.

Uncontrolled Trial

Trial 3: The safety of PULMOZYME, 2.5 mg by inhalation, was studied with 2 weeks of daily administration in 98 pediatric patients with cystic fibrosis 3 months to 10 years of age (65 aged 3 months to < 5 years, 33 aged 5 to ≤ 10 years). The PARI BABY™ reusable nebulizer (which uses a facemask instead of a mouthpiece) was utilized in patients unable to demonstrate the ability to inhale or exhale orally throughout the entire treatment period (54/65, 83% of the younger and 2/33, 6% of the older patients). Overall, the nature of adverse reactions was similar to that seen in the placebo-controlled trials. The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45% compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37% as compared to 6/33, 18%). The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35% compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33).

Allergic Reactions

There have been no reports of anaphylaxis attributed to the administration of PULMOZYME. Urticaria, mild to moderate, and mild skin rash have been observed and have been transient. Within all of the studies, a small percentage (average of 2-4%) of patients treated with PULMOZYME developed serum antibodies to PULMOZYME. None of these patients developed anaphylaxis, and the clinical significance of serum antibodies to PULMOZYME is unknown.

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