Pulmozyme inhalation

Pulmozyme inhalation® (Pulmozyme inhalation) is indicated for daily administration in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.

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

Pulmozyme inhalation inhalation solution is used together with other medicines (eg, antibiotics, bronchodilators, and steroids) to control symptoms of cystic fibrosis. Cystic fibrosis is a condition in which a thick mucus is formed in the lungs and breathing passages. The mucus blocks the airways and increases the chance of lung infections. The infections then cause the mucus to become even thicker, making it more difficult to breathe.

Pulmozyme inhalation will not cure cystic fibrosis. However, when it is used every day, it helps make breathing easier and reduces the number of serious lung infections that require treatment with antibiotics.

Pulmozyme inhalation is available only with your doctor's prescription.

Recommended Dosage

The recommended dosage for use in most cystic fibrosis patients is one 2.5 mg single-use ampule inhaled once daily using a recommended jet nebulizer/compressor system or eRapid™ Nebulizer System.

Some patients may benefit from twice daily administration

Directions For Use

Administer Pulmozyme inhalation 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. No data are currently available to support the administration of Pulmozyme inhalation with other nebulizer systems.

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

Table 1 : Recommended Jet Nebulizers/Compressors and Nebulizer Systems

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

When Pulmozyme inhalation is administered with the eRapid Nebulizer System, advise patients to replace the handset after 90 uses, regardless of whether the EasyCare cleaning aid is used. Since delivery data are not available for Pulmozyme inhalation administered with the eRapid handset beyond 90 administrations, delivery of the appropriate therapeutic dose of Pulmozyme inhalation cannot be assured beyond 90 administrations. The eRapid Nebulizer System should only be used by adults and children who can use a mouthpiece, and not by younger children who need a mask to take Pulmozyme inhalation.

Storage And Handling

Store Pulmozyme inhalation ampules in their protective foil pouch under refrigeration and protected from light. Refrigerate ampules during transport and do not expose to room temperatures for a total time of 24 hours.

Each Pulmozyme inhalation 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.

How supplied

Dosage Forms And Strengths

Inhalation Solution: 2.5 mg/2.5 mL in single-use ampules.

Pulmozyme inhalation is supplied in:

30 unit cartons containing 5 foil pouches of 6 single-use ampules. Each 2.5 mL ampule contains 2.5 mg of dornase alpha (1 mg/mL): NDC 50242-100-40.

Storage And Handling

Store Pulmozyme inhalation under refrigeration (2°C to 8°C/36°F to 46°F) in their protective foil to protect from light. Do not use beyond the expiration date stamped on the ampule. Store unused ampules in their protective foil pouch under refrigeration. Refrigerate Pulmozyme inhalation during transport and do not expose to room temperatures for a total time of 24 hours.

Genentech, Inc., A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990 US License No. 1048. Approved: December 2014

See also:
What is the most important information I should know about Pulmozyme inhalation?

Do not dilute or mix the Pulmozyme inhalation solution with any other drugs in the nebulizer. Mixing of Pulmozyme inhalation with other drugs could lead to changes in the actions of the medications.

Ampules of Pulmozyme inhalation do not contain a preservative. Once opened, the entire contents of the ampule must be used or discarded.

Pulmozyme inhalation must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Pulmozyme inhalation should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

Use Pulmozyme inhalation exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Pulmozyme inhalation is administered by inhalation using a recommended nebulizer. Your doctor or other healthcare provider will give you detailed instructions on the use and maintenance of the nebulizer.

Do not dilute or mix the Pulmozyme inhalation solution with any other drugs in the nebulizer. Mixing of Pulmozyme inhalation with other drugs could lead to changes in the actions of the medications.

If you are also taking other respiratory medications, use them in the order directed by your doctor (e.g., a bronchodilator, followed by chest physiotherapy, then Pulmozyme inhalation, etc.) Do not dilute or mix Pulmozyme inhalation with other agents in the nebulizer at the same time.

Ampules of Pulmozyme inhalation do not contain a preservative. It is intended for one-time use only. Once opened, the entire contents of the ampule must be used or discarded.

Do not use any Pulmozyme inhalation solution that is cloudy or discolored. Throw away any unused Pulmozyme inhalation on the expiration date stamped on the ampule.

Pulmozyme inhalation should be used on a regular basis to get the most benefit.

Pulmozyme inhalation must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Pulmozyme inhalation should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

Use: Labeled Indications

Cystic fibrosis: Management of cystic fibrosis patients, in conjunction with standard therapies, to improve pulmonary function; reduce the risk of respiratory tract infections requiring parenteral antibiotics in patients with a forced vital capacity (FVC) ≥40% of predicted.

Off Label Uses

Parapneumonic pleural effusions and empyemas

Data from controlled and noncontrolled studies support the use of Pulmozyme inhalation in combination with alteplase for the treatment of complicated parapneumonic effusion or empyema. Effusion volume, need for surgical intervention, and duration of hospital stay were reduced in patients treated with combination therapy.

See also:
What other drugs will affect Pulmozyme inhalation?

Available data indicate there are no clinically important drug-drug interactions with Pulmozyme inhalation.

See also:
What are the possible side effects of Pulmozyme inhalation?

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 inhalation in 902 patients, with exposures ranging from 2 weeks of daily administration up to once or twice daily administration for six months. Pulmozyme inhalation 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 inhalation 2.5 mg by inhalation once a day (n=581), while the rest of patients (n=321) received Pulmozyme inhalation 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 inhalation 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 inhalation 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 inhalation, and the proportion of discontinuations were similar for placebo (2%) and Pulmozyme inhalation (3%). Adverse reactions occurring in a higher proportion (greater than 3%) of Pulmozyme inhalation 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 inhalation 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 inhalation treated patients are listed in Table 2.

Table 2: Adverse Reactions Increased 3% or More in Pulmozyme inhalation Treated Patients Over Placebo in CF Clinical Trials

Mortality rates observed in controlled trials were similar for the placebo and Pulmozyme inhalation 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 inhalation, 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 inhalation. 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 inhalation developed serum antibodies to Pulmozyme inhalation. None of these patients developed anaphylaxis, and the clinical significance of serum antibodies to Pulmozyme inhalation is unknown.

Postmarketing Experience

Postmarketing spontaneous reports and prospectively collected safety data from observational studies confirm the safety profile to be as described in clinical trials.