Dornase Alfa

Registered South African indications:

• Cystic fibrosis

Contraindications

• Hypersensitivity to active ingredient or to any of its excipients
• Children younger than 5 years

Cautions

• Pregnancy
• Breastfeeding
• Pulmonary function <40%

Forms avail. in SA and covered in this monograph: neb

Cystic Fibrosis

• Inhaled (neb): 2.5mg, daily

Patients older than 21 years may benefit from a 12hrly dose

Do not dilute or mix with other drugs in nebuliser bowl

See Additional Prescribing Points

Forms avail. in SA and covered in this monograph: neb 

Cystic Fibrosis

Younger than 5 years

• Not established for use

Older than 5 years
-  FVC >40%

• See adult dosage

Do not dilute or mix with other drugs in nebuliser bowl

See Additional Prescribing Points

Pregnancy

• Caution; no evidence of risk  
• The safety of dornase alfa has not been established in pregnant women
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, or embryofoetal development. Caution should be exercised when prescribing dornase alfa to pregnant women

Breastfeeding

• Caution
• When dornase alfa is administered to humans according to the dosage recommendation, there is minimal systemic absorption; therefore no measurable concentrations of dornase alfa would be expected in human milk

• Nevertheless, dornase alfa should be used with caution in breastfeeding women

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warning

Respiratory Disorders

• Dyspnoea
• Pharyngitis
• Cough
• Laryngitis
• Rhinitis
• Dysphonia
• Chest pain (pleuritic/non-cardiac)
• Increased sputum expectoration (upon treatment initiation)
• Decreased pulmonary function (upon treatment initiation)

Gastrointestinal Disorders

• Dyspepsia  

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria

Immune, Blood and Lymphatic Disorders

• Antibody development
• Fever

Sensory Disorders

• Conjunctivitis

None known

None routine.Specific cases may require

• Pulmonary function tests

Special prescribing points

• Most patients gain optimal benefit from regular daily use. In studies in which dornase alfa was given in an intermittent regimen, improvement in pulmonary function was lost on cessation of therapy. Patients should therefore be advised to take their medication every day without a break
• Patients should continue their regular medical care, including their standard regimen of chest physiotherapy
• Administration can be safely continued in patients who experience exacerbation of respiratory tract infection

Dornase alfa is a genetically engineered version of a naturally occurring human enzyme which cleaves extracellular DNA. Retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent secretions contain very high concentrations of extracellular DNA, a viscous polyanion released by degenerating leukocytes, which accumulate in response to infection. In vitro, dornase alfa hydrolyses DNA in sputum and greatly reduces the viscoelasticity of cystic fibrosis sputum.

Nebuliser solution (per 2.5ml) 2.5mg

• Pulmozyme  (Roche) originator