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Statements

Subject Item
n2:DB00003
rdf:type
n3:Drug
n3:description
Dornase alfa is a biosynthetic form of human deoxyribunuclease I (DNase I) enzyme. It is produced in genetically modified Chinese hamster ovary (CHO) cells using recombinant DNA technology. The 260-amino acid sequence of dornase alfa is identical to the endogenous human enzyme. Dornase alfa cleaves extracellular DNA to 5´-phosphodinucleotide and 5´-phosphooligonucleotide end products without affecting intracellular DNA. In individuals with cystic fibrosis, extracellular DNA, which is an extremely viscous anion, is released by degenerating leukocytes that accumulate during inflammatory responses to infections. Enzymatic breakdown of this extracellular DNA appears to reduce sputum viscosity and viscoelasticity.
n3:dosage
n10:271B3E9D-363D-11E5-9242-09173F13E4C5
n3:generalReferences
# Cramer GW, Bosso JA: The role of dornase alfa in the treatment of cystic fibrosis. Ann Pharmacother. 1996 Jun;30(6):656-61. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/8792953 # Jones AP, Wallis C: Dornase alfa for cystic fibrosis. Cochrane Database Syst Rev. 2010 Mar 17;3:CD001127. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/20238314 # Riethmueller J, Kumpf M, Borth-Bruhns T, Brehm W, Wiskirchen J, Sieverding L, Ankele C, Hofbeck M, Baden W: Clinical and in vitro effect of dornase alfa in mechanically ventilated pediatric non-cystic fibrosis patients with atelectases. Cell Physiol Biochem. 2009;23(1-3):205-10. Epub 2009 Feb 18. "Pubmed":http://www.ncbi.nlm.nih.gov/pubmed/19255515 # Roche Products Limited. Pulmozyme. 1st ed. Newmarket, Auckland: N.p., 2014. Web. 11 Nov. 2014. #Glowm.com,. 'Dornase Alfa'. N.p., 2014. Web. 11 Nov. 2014.
n3:group
approved
n3:indication
Used as adjunct therapy in the treatment of cystic fibrosis.
n3:manufacturer
n6:271B3E94-363D-11E5-9242-09173F13E4C5
owl:sameAs
n18:DB00003 n19:DB00003
dcterms:title
Dornase alfa
adms:identifier
n21:P24855 n22:M55983 n23:Dornase_alfa n24:PA10318 n26:DB00003
n3:mechanismOfAction
Dornase alfa is a biosynthetic form of human DNase I. The enzyme is involved in endonucleolytic cleavage of extracellular DNA to 5´-phosphodinucleotide and 5´-phosphooligonucleotide end products. It has no effect on intracellular DNA. Optimal activity is dependent on the presence of divalent cations such as calcium and magnesium. Extracellular DNA is a viscous anionic polymer and its breakdown appears to improve the viscosity and viscoelasticity of purulent sputum of individuals with CF, thus reducing airflow obstruction. Dornase alfa does not seem to have any effect on non-purulent sputum.
n3:packager
n6:271B3E90-363D-11E5-9242-09173F13E4C5 n6:271B3E91-363D-11E5-9242-09173F13E4C5 n6:271B3E8E-363D-11E5-9242-09173F13E4C5 n6:271B3E8F-363D-11E5-9242-09173F13E4C5 n6:271B3E92-363D-11E5-9242-09173F13E4C5 n6:271B3E93-363D-11E5-9242-09173F13E4C5
n3:patent
n4:2184581 n4:2137237
n3:synonym
DNase rhDNase DNase I Deoxyribonuclease I Deoxyribonuclease-1 precursor
n3:toxicity
Adverse reactions occur at a frequency of < 1/1000 and are usually mild and transient in nature. Reported adverse effects include chest pain (pleuritic/non-cardiac), fever, dyspepsia, voice alteration (hoarseness), pharyngitis, dyspnea, laryngitis, rhinitis, decreased lung function, rash, urticaria, and conjunctivitis. There is no evidence of carcinogenic or mutagenic properties. The safety of dornase alfa has not been studied in pregnant women, nursing women and children under the age of 5 years old.
n3:volumeOfDistribution
In studies in rats and monkeys, the initial volume of distribution is similar to the serum volume. Concentrations in sputum decline rapidly after inhalation.
n15:hasAHFSCode
n16:44-00
n3:mixture
n11:271B3E8D-363D-11E5-9242-09173F13E4C5 n11:271B3E8B-363D-11E5-9242-09173F13E4C5 n11:271B3E8C-363D-11E5-9242-09173F13E4C5 n11:271B3E89-363D-11E5-9242-09173F13E4C5 n11:271B3E8A-363D-11E5-9242-09173F13E4C5 n11:271B3E87-363D-11E5-9242-09173F13E4C5 n11:271B3E88-363D-11E5-9242-09173F13E4C5 n11:271B3E86-363D-11E5-9242-09173F13E4C5
n12:hasConcept
n13:M0227369
foaf:page
n8:pulmozyme.htm n14:dornase-alfa.html
n3:Molecular-Formula
n5:271B3EA2-363D-11E5-9242-09173F13E4C5
n3:Molecular-Weight
n5:271B3EA1-363D-11E5-9242-09173F13E4C5
n3:absorption
Studies in rats and monkeys after inhalation of dornase alfa shows very little systemic absorption (less than 15% for rats and less than 2% for monkeys). The results were also witnessed in patients. Dornase alfa is also associated with very low accumulation with no serum concentration greater than 10ng/mL observed no matter the dose administered. Bioavailability: mean sputum concentrations of dornase alfa can be measured after 15 minutes. Onset is achieved within 3 to 7 days. Peak concentrations are achieved after 9 days.
n3:affectedOrganism
Humans and other mammals
n3:casRegistryNumber
9003-98-9
n3:category
n3:clearance
Studies in rats indicate that, following aerosol administration, the disappearance half-life of dornase alfa from the lungs is 11 hours. In humans, sputum DNase levels declined below half of those detected immediately post-administration within 2 hours but effects on sputum rheology persisted beyond 12 hours.
n3:containedIn
n9:271B3E9A-363D-11E5-9242-09173F13E4C5 n9:271B3E96-363D-11E5-9242-09173F13E4C5 n9:271B3E97-363D-11E5-9242-09173F13E4C5 n9:271B3E95-363D-11E5-9242-09173F13E4C5 n9:271B3E9B-363D-11E5-9242-09173F13E4C5 n9:271B3E9C-363D-11E5-9242-09173F13E4C5 n9:271B3E98-363D-11E5-9242-09173F13E4C5 n9:271B3E99-363D-11E5-9242-09173F13E4C5
n3:Hydrophobicity
n5:271B3E9F-363D-11E5-9242-09173F13E4C5
n3:Isoelectric-Point
n5:271B3EA0-363D-11E5-9242-09173F13E4C5
n3:Melting-Point
n5:271B3E9E-363D-11E5-9242-09173F13E4C5