actually [5:<5 years of age compared with children 5 years of age. 1 Geriatric Use Insufficient experience in patients 65 years of age to determine whether geriatric patients respond differently than younger adults. a Common Adverse Effects Pharyngitis, chest pain, voice alteration (e.g., hoarseness), rash, conjunctivitis. a Interactions for Dornase Alfa No formal drug interaction studies to date; however, the manufacturer states that concomitant administration of dornase alfa and other standard therapies for cystic fibrosis is safe and effective. a Dornase Alfa Pharmacokinetics Absorption Bioavailability Following oral inhalation, serum DNase concentrations were not increased above normal endogenous levels. a Onset Following oral inhalation, mean sputum DNase concentrations measurable within 15 minutes. a Improvement in pulmonary function (FEV 1 ) evident within 8 days. a Distribution Extent Not known whether dornase alfa crosses the placenta or is distributed into milk. a Stability Storage Oral Inhalation Solution 2 8 C; protect from light and excessive heat. a b Store ampuls in protective foil pouch to protect from light until used. a Discard if left at room temperature for 24 hours. b Actions Selectively cleaves extracellular DNA (e.g., in purulent pulmonary secretions); 1 2 5 33 does not appear to affect sputum in the absence of an inflammatory response to infection (i.e., in those with nonpurulent sputum) 2 5 8 35 nor does it affect pulmonary function in healthy individuals. 8 Reduces sputum viscosity and viscoelasticity. 1 2 3 15 20 Mechanism of action not fully elucidated; 6 7 appears to improve the transportability of purulent mucus via ciliary activity and cough. 3 19 Reduces airflow obstruction, improves pulmonary function (increased forced vital capacity and forced expiratory volume at 1 second [FEV 1 ]), and improves mucociliary clearance in patients with cystic fibrosis. 1 5 8 9 10 11 12 14 27 29 Advice to Patients Importance of providing patient a copy of manufacturer s patient information. b Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the nebulization delivery system. b Importance of thoroughly washing hands with soap and water before handling drug and nebulizer to avoid microbial contamination. b Importance of adhering to daily dosing schedule and concomitant therapies, including not exceeding the recommended dose or frequency of use unless otherwise instructed by a clinician. b Importance of not diluting or mixing with other drugs in the nebulizer. 1 Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing patients of other important precautionary information. a (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Dornase Alfa Routes Dosage Forms Strengths Brand Names Manufacturer Oral Inhalation Solution, for nebulization 1 mg/mL (2.5 mg) Pulmozyme Genentech AHFS DI Essentials. Copyright 2017, Selected Revisions April 1, 2010. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution prescribing information. South San Francisco, CA; 2001 Jan. 2. Shak S, Capon DJ, Hellmiss R et al. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum. Proc Natl Acad Sci USA . 1990; 87:9188-92. [PubMed 2251263] 3. Zahm JM, de Bentzmann S, Deneuville E et al. Recombinant human DNase I improves the transport of cystic fibrosis respiratory mucus ex vivo. Pediatr Pulmonol . 1993; Suppl 9:250. 4. Collins FS. Cystic fibrosis: molecular biology and therapeutic implications. Science . 1992; 256:774-9. [PubMed 1375392] 5. Hubbard RC, McElvaney NG, Birrer P et al. A preliminary study of aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med . 1992; 326:812-5. [PubMed 1538726] 6. Rubin BK. Aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med . 1992; 327:571. [PubMed 1635583] 7. Hubbard RC, Shak S, Crystal RG. Aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med . 1992; 327:571. 8. Aitken ML, Burke W, McDonald G et al. Recombinant human DNase inhalation in normal subjects and patients with cystic fibrosis: a phase 1 study. JAMA . 1992; 267:1947-51. [PubMed 1548827] 9. Fuchs HJ, Borowitz D, Christiansen D et al. Aerosolized recombinant human DNase reduces pulmonary exacerbations and improves pulmonary function in patients with cystic fibrosis. Presented at the 36th Annual Conference on Chest Disease, Intermountain Thoracic Society. Snowbird, UT: 1993 Jan 26. 10. Ramsey BW, Astley SJ, Aitken ML et al. Efficacy and safety of short-term administration of aerosolized recombinant human deoxyribonuclease in patients with cystic fibrosis. Am Rev Respir Dis . 1993; 148:145-51. [PubMed 8317790] 11. Ranasinha C, Assoufi B, Shak S et al. Efficacy and safety of short-term administration of aerosolised recombinant human DNase I in adults with stable stage cystic fibrosis. Lancet . 1993; 342:199-202. [PubMed 8100928] 12. Ramsey B for the Pulmozyme (rhDNase) Study Group. A summary of the results of the phase III multicenter clinical trial: aerosol administration of recombinant human DNase reduces the risk of respiratory tract infections and improves pulmonary function in patients with cystic fibrosis. Pediatr Pulmonol . 1993; Suppl 9:152-3. 13. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to August 31, 1993. Rockville, MD; 1993 September. 14. Quan MP. Manufacturer letter regarding product information on Pulmozyme (dornase alfa). South San Francisco, CA: Genentech, Inc; 1993 Aug 6. 15. Boucher RC. Drug therapy in the 1990s: what can we expect for cystic fibrosis? Drugs . 1992; 43:431-9. 16. Wallace CS, Hall M, Kuhn RJ. Pharmacologic management of cystic fibrosis. Clin Pharm . 1993; 12:657-74. [PubMed 8306566] 17. Fiel SB. Clinical management of pulmonary disease in cystic fibrosis. Lancet . 1993; 341:1070-4. [PubMed 8096969] 18. Gibaldi M. Understanding and treating some genetic diseases. Ann Pharmacother . 1992; 26:1589-94. [PubMed 1482818] 19. Rubin BK, Ramirez OE, Baharav AL. The physical and transport properties of CF sputum after treatment with rhDNase. Pediatr Pulmonol . 1993; Suppl 9:251. 20. Shak S, King M. Effects of rhDNase on cystic fibrosis sputum viscoelasticity in vitro. Pediatr Pulmonol . 1993; Suppl 9:251. 21. Mucolytics. In: Goodman LS, Gilman A, Gilman AG et al, eds. Goodman and Gilman s the pharmacological basis of therapeutics. 5th ed. New York: Macmillan Publishing Company; 1975:955-6. 22. Lieberman J. Dornase aerosol effect on sputum viscosity in cases of cystic fibrosis. JAMA . 1968; 205:114-5. [PubMed 5694890] 23. Lieberman J. The appropriate use of mucolytic agents. Am J Med . 1970; 49:1-4. [PubMed 4246985] 24. Puckett WH Jr. The pharmacist and inhalation therapy. Am J Hosp Pharm . 1972; 29:556-63. [PubMed 5052020] 25. Raskin P. Bronchospasm after inhalation of pancreatic dornase. Am Rev Respir Dis . 1968; 98:697-8. [PubMed 4877872] 26. Morice AH. Which DNase in cystic fibrosis? Lancet . 1993; 342:624-5. Letter. 27. Shah PL, Scott S, Geddes D et al. A preliminary report on using aerosolised recombinant human DNase I in the treatment of patients with stable stage cystic fibrosis for six months. Pediatr Pulmonol . 1993; Suppl 9:247. 28. Wilmott R, DNase Multicenter Study Group, Genentech Staff. A phase II, double-blind, multicenter study of the safety and efficacy of aerosolized recombinant human DNase I (rhDNase) in hospitalized patients with CF experiencing acute pulmonary exacerbations. Pediatr Pulmonol . 1993; Suppl 9:154. 29. Laube BL, Auci RM, Shields DE et al. A randomized, placebo-controlled trial of the effect of recombinant human DNase I (rhDNase) on the deposition homogeneity and mucociliary clearance of radioaerosol in patients with cystic fibrosis. Pediatr Pulmonol . 1993; Suppl 9:155-6. 30. Shah PL, Scott SF, Hodson ME. Report on a multicentre study using aerosolised recombinant human DNase I in the treatment of cystic fibrosis patients with severe pulmonary disease. Pediatr Pulmonol . 1993; Suppl 9:157. 31. Magnuson DE. Dear hospital pharmacist letter regarding the use of Pulmozyme in the management of patients with cystic fibrosis. South San Francisco, CA: Genentech, Inc; 1994 Jan 5. 32. Genentech, Inc. Patient information booklet: your guide to Pulmozyme (dornase alfa) therapy for cystic fibrosis (CF). South San Francisco, CA; 1994. 33. Webb EC, preparer. Enzyme nomenclature 1992: recommendations of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology on the nomenclature and classification of enzymes. San Diego, CA: Academic Press, Inc; 1992:339. ECC 3.1.21.1. 34. Armstrong JB, White JC. Liquefaction of viscous purulent exudates by deoxyribonuclease. Lancet . 1950; 1:739-42. 35. Genentech, South San Francisco, CA: Personal communication. 36. Genentech, Inc. Pulmozyme (dornase alfa) recombinant inhalation solution prescribing information. South San Francisco, CA; 1996 Nov. 37. McCoy K, Hamilton S, Johnson C. Effects of 12-week administration of dornase alfa in patients with advanced cystic fibrosis lung disease. Chest . 1996; 110:889-95. [PubMed 8874241] 38. Kanga JF. Dornase alfa therapy in cystic fibrosis: who should get it? Chest . 1996; 110:871-2. Editorial. a. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution prescribing information. South San Francisco, CA; 2005 Apr. b. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution information for the patient/parent. South San Francisco, CA; 2001 Jan. Next Interactions Print this page Add to My Med List More about dornase alfa Side Effects During Pregnancy Dosage Information Drug Interactions Support Group En Español 1 Review Add your own review/rating Drug class: miscellaneous respiratory agents Consumer resources Dornase alfa inhalation Dornase Alfa Dornase alfa Inhalation, oral/nebulization (Advanced Reading) Professional resources Dornase Alfa (Wolters Kluwer) Other brands: Pulmozyme Related treatment guides Cystic Fibrosis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Miscellaneous respiratory agents Related Drugs Cystic Fibrosis azithromycin , Zithromax , vitamin e , Creon , gentamicin , tobramycin , Zenpep , pancrelipase , amikacin , aztreonam , Garamycin , Azactam , Pulmozyme , Pancreaze , Orkambi , Amikin , pancreatin , Tobi , Cayston , Kalydeco , Alpha E , TOBI Podhaler , More... 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