pulmozyme
Pharmaranks rates Pulmozyme 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Pulmozyme (Dornase Alfa) is a recombinant human deoxyribonuclease 1 used to treat Bronchitis, Cystic Fibrosis.
Dornase Alfa · by Genentech Inc
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Dornase Alfa
- Drug class
- Recombinant Human Deoxyribonuclease 1
- Form
- Solution
- Strength
- Dornase Alfa 1MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- bronchitis, cystic fibrosis
- Manufacturer
- Genentech Inc
- FDA application
- BLA103532
What is Pulmozyme?
From the FDA label:Dornase alfa is a recombinant human deoxyribonuclease I (rhDNase) an enzyme which selectively cleaves DNA. The protein is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the native human protein, deoxyribonuclease I (DNase). The product is purified by column chromatography and tangential flow filtration. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons. The primary amino acid sequence is identical to that of the native human enzyme. PULMOZYME (dornase alfa) inhalation solution is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer or a recommended nebulizer system [see Clinical Studies (14) and Dosage and Administration (2.2) ] . PULMOZYME is a sterile, clear, colorless, highly purified solution in single-dose ampules. Each ampule delivers 2.5 mL of the solution to the nebulizer bowl. Each mL of aqueous solution contains 1 mg dornase alfa, calcium chloride dihydrate (0.15 mg) and sodium chloride (8.77 mg). The solution contains no preservative. The nominal pH of the solution is 6.3.
How to use
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 for use with PULMOZYME. No data are currently available to support the administration of PULMOZYME with other nebulizer systems. 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 inhale PULMOZYME. Use the selected nebulizer in accordance with the manufacturer's instruction manual. Refer to the manufacturer's instruction…
Side effects
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. More than half of the patients received PULMOZYME 2.5 mg by inhalation once a day (n=581), while the rest of patients…
Warnings
Important safety information
None. None. ( 5 )
Who should not take Pulmozyme
PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. PULMOZYME is contraindicated in patients with known hypersensitivity to dornase alfa, Chinese Hamster Ovary cell products, or any component of the product. ( 4 )
Interactions
Available data indicate there are no clinically important drug-drug interactions with PULMOZYME.
Storing Pulmozyme, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “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.”
- “Instruct patients on the proper techniques to store and handle PULMOZYME [see How Supplied/Storage and Handling (16) ].”
Drug class
May treat (source: NIH RxClass)
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Pulmozyme treat?
- Pulmozyme (Dornase Alfa) may be used to treat bronchitis, cystic fibrosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Pulmozyme rated?
- pharmaranks gives Pulmozyme a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Pulmozyme?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Pulmozyme. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Pulmozyme?
- Pulmozyme is marketed by Genentech Inc. You can see Genentech Inc's full profile, rating, and other products on pharmaranks.
- Is Pulmozyme a brand-name or generic drug?
- Pulmozyme is a brand-name product with the active ingredient Dornase Alfa.
- Is Pulmozyme available over the counter?
- No. Pulmozyme is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Pulmozyme come in?
- Pulmozyme is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Pulmozyme?
- Pulmozyme is classified as recombinant human deoxyribonuclease 1, per the FDA's Established Pharmacologic Class.
- Is Pulmozyme FDA-registered?
- Pulmozyme is on record with the U.S. FDA under application number BLA103532. You can verify this on its official FDA label.
- Has Pulmozyme been recalled by the FDA?
- Pulmozyme has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Pulmozyme safe?
- There's no single safe-or-not verdict. pharmaranks gives Pulmozyme a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Pulmozyme?
- Pulmozyme's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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pulmozyme
70/100