Recombinant Human Deoxyribonuclease 1Prescription OnlyPregnancy Cat. Not classifiedFDA Yes
Pulmozyme
DORNASE ALFA
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. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cysti...
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Brand names:Pulmozyme
Quick Reference
Medicine ClassRecombinant Human Deoxyribonuclease 1
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- DORNASE ALFA
- Medicine class
- Recombinant Human Deoxyribonuclease 1
- Brand names
- Pulmozyme
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of 3-4 hours for dornase alfa
- FDA approved
- Yes
What Is Pulmozyme?
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. PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cysti...
Pulmozyme (DORNASE ALFA) belongs to the Recombinant Human Deoxyribonuclease 1 class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Pulmozyme. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Pulmozyme with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Pulmozyme is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
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.
PULMOZYME is a recombinant DNase enzyme indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function.
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended nebulizer. ( 2.1 ) Some patients may benefit from twice daily administration. ( 2.1 ) See full prescribing information for the recommended nebulizers for use with PULMOZYME. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage, in most cystic fibrosis patients, is 2.5 mg (one single-dose ampule) inhaled once daily using a recommended jet nebulizer connected to an air compressor system or via a vibrating mesh nebulizer [see Dosage and Administration (2.2) ] . Some patients may benefit from twice daily administration [see Clinical Studies (14) ] . 2.2 Administration Instructions Nebulizer Information Administer PULMOZYME via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask, or via a vibrating mesh nebulizer. Refer to Table 1 for the recommended Jet Nebulizers or Vibrating Mesh Nebulizers
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The most common adverse reactions (occurring in ≥3% of patients treated with PULMOZYME over placebo) seen in clinical trials in CF patients were: voice alteration, pharyngitis, rash, laryngitis, chest pain, conjunctivitis, rhinitis, decrease in FVC of ≥10%, fever, and dyspnea.
- ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
- 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 (n=804) and uncontrolled trials (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.
Serious
- 5 WARNINGS AND PRECAUTIONS None.
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS None. None. ( 5 )
How Pulmozyme Works
12.1 Mechanism of Action PULMOZYME is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, PULMOZYME hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity. In CF patients, retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to infection.
Pharmacokinetics
Half-Life
half-life of 3-4 hours for dornase alfa
Metabolism
metabolized by proteases present in biological fluids
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Pulmozymewhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Storage and Handling Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat. Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from li
Frequently Asked Questions
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Pulmozyme side effects
Complete adverse effect profile including common, serious, and rare reactions
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Pulmozyme
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
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Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.