Dornase alfa
دورناز آلفا
🌬️ Respiratory SystemMucolytic enzyme (DNase)
Market / country: 🇺🇸 USA
Pulmozyme (US)
🧮 Dose calculator
Cystic fibrosis · Regimen source: FDA Pulmozyme · 2.1
- • Some patients may benefit from twice daily. Do not mix with other drugs in the nebulizer. FDA Pulmozyme · 2.1FDA Pulmozyme · 2.2
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity to dornase alfa or Chinese hamster ovary cell products. FDA Pulmozyme · 4
Formulations
- 2.5 mg/2.5 mL ampule for nebulizer — solution 🇺🇸 USA FDA Pulmozyme · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Pulmozyme · 8.1
“Risk Summary There are no adequate and well-controlled studies with PULMOZYME in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Pulmozyme · 8.2
“In a pharmacokinetic study in Cynomolgus monkeys, levels of dornase alfa detected in milk were less than 0.1% of the maternal serum concentration at 24 hours after dosing [intravenous bolus dose (0.1 mg/kg) of dornase alfa followed by an intravenous infusion (0.080 mg/kg/hr) over a 6-hour period] on post-partum day 14.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Pulmozyme · 8.4
“The safety and effectiveness of PULMOZYME in conjunction with standard therapies for cystic fibrosis have been established in pediatric patients.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Pulmozyme · 8.5
“Cystic fibrosis is primarily a disease of children and young adults.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)BLA103532
- DailyMed (FDA label)FDA Pulmozyme
- MedlinePlus (NIH)Dornase Alfa
- WHO ATC/DDDR05CB13
- Darooyab (Iran)Dornase-Alfa
🇮🇷 Registered in Iran Darooyab · G-2162/Dornase-Alfa
Dosage forms with Iranian generic codes, per Darooyab.
- 08081 · DORNASE ALFA 2500IU AMP · آمپول دورناس آلفا ۲۵۰۰ واحد بینالمللی
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Pulmozyme · 3FDA Pulmozyme · 2.1FDA Pulmozyme · 2.2FDA Pulmozyme · 4FDA Pulmozyme · SPL approval / marketing categoryFDA Pulmozyme · 8.1FDA Pulmozyme · 8.2FDA Pulmozyme · 8.4FDA Pulmozyme · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-2162/Dornase-Alfa
- Clinical review⚠ Unverified