Dornase Alfa
Dornase alfa is an inhaled enzyme used to help manage cystic fibrosis by thinning thick mucus in the airways and improving lung function.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Dornase Alfa: Patient Information Guide
A plain-language walkthrough of Dornase Alfa — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Dornase alfa (Pulmozyme) is an inhaled enzyme approved to help manage cystic fibrosis alongside other standard treatments.
- Pulmozyme is indicated to improve pulmonary function in adults and children with cystic fibrosis (CF).
- Pulmozyme has been shown to reduce the risk of respiratory tract infections that require IV (parenteral) antibiotics — specifically in CF patients whose lung function (FVC) is at or above 40% of the predicted normal value.
⚙️How it works▾
In cystic fibrosis, the airways fill with thick, infected mucus. When white blood cells arrive to fight infection and then break down, they release high concentrations of DNA into the airway secretions. That DNA makes mucus extremely viscous (thick and sticky). Pulmozyme is a lab-engineered copy of a naturally occurring human enzyme called DNase I. It works by selectively cutting and breaking down that extracellular DNA, which dramatically thins the mucus — making it easier to cough out and clearing the airways so air can move more freely.
💊How it's taken▾
Pulmozyme is inhaled through a nebulizer once daily in most patients; a prescriber may recommend twice-daily use for some individuals. It is breathed in as a mist through a mouthpiece or face mask connected to a recommended jet nebulizer or vibrating mesh nebulizer system.
- Use only with a nebulizer system recommended for Pulmozyme — no data support other systems.
- Do not mix Pulmozyme with other drugs in the nebulizer.
- Use the entire ampule contents once opened, or discard the rest.
- Follow your prescriber's instructions closely — do not adjust how often you use it without their guidance.
🤒Side effects — in detail▾
Most side effects from Pulmozyme are mild and temporary. The most commonly reported ones include:
- Voice changes or hoarseness
- Sore throat (pharyngitis)
- Laryngitis (inflammation of the voice box)
- Skin rash
- Chest pain
- Red or irritated eyes (conjunctivitis)
- Runny or stuffy nose (rhinitis)
- Shortness of breath (dyspnea)
- Fever
Call your doctor right away if you develop signs of a serious allergic reaction (such as hives, swelling, or difficulty breathing) or if your breathing noticeably worsens after starting Pulmozyme.
⚠️Warnings & precautions▾
- Allergy/contraindication: Do not use Pulmozyme if you have a known allergy to dornase alfa, to products made with Chinese Hamster Ovary (CHO) cells, or to any component of the product.
- Mild, temporary side effects: Most adverse reactions seen in trials were mild and did not lead to stopping treatment — rates of discontinuation were similar to placebo.
- Nebulizer compatibility: Pulmozyme should only be used with recommended nebulizer systems; no safety or effectiveness data exist for other systems.
🔀What it interacts with▾
According to available data, Pulmozyme does not have any clinically important interactions with other drugs. That said, always tell your health care team about everything you take.
- Other nebulized drugs: Do not mix Pulmozyme with any other medicine in the nebulizer — doing so can cause chemical changes that may harm the medicine or the other drug.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to dornase alfa or CHO-cell products: Pulmozyme is contraindicated — do not use it if you have this type of allergy.
- Pregnancy: No adequate human studies exist. Animal studies did not show fetal harm, but talk to your doctor to weigh the benefits and risks.
- Breastfeeding: It is not known if Pulmozyme passes into human breast milk. Discuss with your doctor before using it while breastfeeding.
- Children under 5: Use in children as young as 3 months is supported by safety data and extrapolation of effectiveness data from older children.
- Older adults (65+): Limited data are available for this age group, as CF is primarily a disease of children and young adults.
📡Pharmacodynamics — effects in the body▾
When inhaled, Pulmozyme reaches the sputum in the airways within 15 minutes, where it breaks down extracellular DNA and reduces the thick, sticky quality (viscoelasticity) of CF mucus. This thinner mucus is easier to clear from the lungs. The drug works mainly at the airway surface — after inhalation, blood levels of DNase do not rise significantly above the body's normal baseline levels, even with repeated dosing.
🔬Pharmacokinetics — how your body processes it▾
After inhalation, Pulmozyme acts quickly in the airways — measurable levels appear in sputum within 15 minutes and begin to decline over the following two hours. Despite daily or twice-daily use over months, the medicine does not meaningfully build up in the bloodstream. Dornase alfa is expected to be broken down by naturally occurring enzymes (proteases) in body fluids. An IV study in humans suggested an elimination half-life of roughly 3 to 4 hours.
📦How to store it▾
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. refrigerated in the protective foil pouch to protect from light and heat.
📄 Written from Dornase Alfa’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Dornase Alfa — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Pulmozyme do for cystic fibrosis? ▾
How do I use Pulmozyme — do I swallow it or breathe it in? ▾
Can I mix Pulmozyme with my other nebulized medicines to save time? ▾
What side effects should I expect, and when should I call my doctor? ▾
Is Pulmozyme safe for my child? ▾
I'm pregnant — is it safe to keep using Pulmozyme? ▾
Is Dornase Alfa available over the counter? ▾
When was Dornase Alfa first available? ▾
Who makes Dornase Alfa? ▾
💬 Answers drafted from Dornase Alfa’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Dornase Alfa comes
Dornase Alfa is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Inhalation solution (nebulizer)
How this form is used
- Pulmozyme is used to improve lung function in adults and children with cystic fibrosis, alongside standard CF therapies.
- Pulmozyme is used to reduce the risk of serious respiratory infections requiring IV antibiotics in CF patients with lung function at or above 40% of predicted normal.
- Pulmozyme should be inhaled using a recommended jet nebulizer connected to an air compressor, or a recommended vibrating mesh nebulizer — do not use other nebulizer systems.
- Pulmozyme is typically inhaled once daily; some patients may be prescribed twice-daily use.
- Do not dilute Pulmozyme or mix it with other drugs in the nebulizer — this can damage the medicine.
- Squeeze each Pulmozyme ampule before use to check for leaks; discard it if the solution looks cloudy or discolored, and use or discard the full contents once opened.
Oral solution
📊 Dornase Alfa across the U.S. market
How Dornase Alfa appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Dornase Alfa is used
A general measure of how commonly Dornase Alfa is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Dornase Alfa is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Dornase Alfa prescribed? Of the 1,596 medications we measure, Dornase Alfa ranks #665 by Medicaid prescriptions — more than 58% of them.
Utilization by Dornase Alfa product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
dornase alfa 1 MG/ML Inhalation Solution
Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310014
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Dornase Alfa, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 2 listed Dornase Alfa NDCs with Medicaid activity.
🔍 Compare Dornase Alfa products
A representative set of FDA-listed product records for Dornase Alfa — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Inhalation solution (nebulizer) | ||||
| 1 mg/mL | Respiratory (inhalation) | Genentech, Inc. × 2 listings | BLA | View NDC → |
| 💊Oral solution | ||||
| 14 g/L | — | Genentech, Inc. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 8 mg/mL | — | Lonza Biologics Tuas Pte Ltd. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Dornase Alfa NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Dornase Alfa — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Dornase Alfa in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Dornase Alfa went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 337623 1 dose form · 1 strength
-
Dose form (SCDF) Inhalation Solution RxCUI 2108354In current FDA listingsClinical drug / strength (SCD) 1 MG/MLRxCUI 310014
Look up RxCUI 337623 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Dornase Alfa is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Dornase Alfa belongs to the Recombinant Human Deoxyribonuclease 1 class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Genentech, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.