Dornase Alfa Dosage

Usual Adult Dose for Cystic Fibrosis

2.5 mg (1 single-use ampule) inhaled orally once daily using a recommended nebulizer/compressor system

Comment:
-Some patients may benefit from twice daily administration.

Use:
-Coadministration with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function
-To reduce the risk of respiratory tract infections requiring parenteral antibiotics in CF patients with a Force Vital Capacity (FVC) of 40% or more

Usual Pediatric Dose for Cystic Fibrosis

5 years or older:
2.5 mg (1 single-use ampule) inhaled orally once daily using a recommended nebulizer/compressor system

Comment:
-Some patients may benefit from twice daily administration.

Uses:
-Coadministration with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function
-To reduce the risk of respiratory tract infections requiring parenteral antibiotics in CF patients with a Force Vital Capacity (FVC) of 40% or more

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 5 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-For oral inhalation only.
-Administer via nebulizer system or via a jet nebulizer connected to an air compressor with an adequate air flow and equipped with a mouthpiece or suitable face mask.
-Do not dilute or mix with other drugs in the nebulizer.
-The manufacturer's instructions on the use and maintenance of the equipment, including cleaning and disinfection procedures should be followed.

Storage requirements:
-Store ampules in their protective foil pouch under refrigeration and protected from light.
-Refrigerate ampules during transport and do not expose to room temperatures for a total time of 24 hours.
-Each ampule should be squeezed prior to use in order to check for leaks.
-Discard if the solution is cloudy or discolored. Once opened, the entire contents of the ampule should be used or discarded.