Dornase Alpha

Table of contents

  • Brand Names
  • Chemistry
  • Pharmacologic Category
  • Mechanism of Action
  • Therapeutic Use
  • Pregnancy and Lactation Implications
  • Contraindications
  • Warnings and Precautions
  • Adverse Reactions
  • Genes that may be involved
  • Drug Interactions
  • Dosage

Brand Names

Europe

Austria: Pulmozyme; Belgium: Pulmozyme; Bulgaria: Pulmozyme; Cyprus: Pulmozyme; Czech Republic: Pulmozyme; Denmark: Pulmozyme; Estonia: Pulmozyme; Finland: Pulmozyme; France: Pulmozyme; Germany: Pulmozyme; Greece: Pulmozyme; Hungary: Pulmozyme; Ireland: Pulmozyme; Italy: Pulmozyme; Latvia: Pulmozyme; Lithuania: Pulmozyme; Luxembourg: Pulmozyme; Malta: Pulmozyme; Netherlands: Pulmozyme; Poland: Pulmozyme; Portugal: Pulmozyme; Romania: Pulmozyme; Slovakia: Pulmozyme; Slovenia: Pulmozyme; Spain: Pulmozyme; Sweden: Pulmozyme; UK: Pulmozyme.

North America

Canada: Pulmozyme; USA: Pulmozyme.

Latin America

Brazil: Pulmozyme.

Drug combinations

Chemistry

Dornase Alpha: C~1321~H~1995~N~339~O~396~S~9~ (protein moiety). Mw: 29,249.62. Deoxyribonuclease (human clone 18-1 protein moiety). CAS-143831-71-4 (1997).

Pharmacologic Category

Enzymes. Mucolytic Agents. (ATC-Code: R05CB13).

Mechanism of action

Dornase alpha is a biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I), an enzyme that selectively cleaves extracellular DNA (e.g. in purulent pulmonary secretions), thus reducing mucous viscosity and as a result, airflow in the lung is improved and the risk of bacterial infection may be decreased.

Therapeutic use

Management of cystic fibrosis patients to reduce the frequency of respiratory infections which require parenteral antibiotics in FVC≥40%. In conjunction with standard therapies, to improve pulmonary function in cystic fibrosis.

Pregnancy and lactiation implications

Teratogenic effects not observed in animal studies. There are no adequate, well-controlled studies in pregnant women. Use with caution during lactation.

Unlabeled use

Contraindications

Hypersensitivity to dornase alpha, Chinese hamster ovary cell products, or any component of the formulation.

Warnings and precautions

In decreased pulmonary function, dornase alpha does not significantly reduce the risk of respiratory infections which require parenteral antibiotics. Increased incidence of cough, rhinitis, and rash in children <5 years of age compared with children ≥5 years of age.

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