Dornase Alfa

Dornase Alfa is a prescription medication used along with standard medicines for managing cystic fibrosis to improve pulmonary function. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Before taking dornase alfa, tell your doctor about all of your medical conditions.

Especially tell your doctor if you are allergic to dornase alfa, Chinese Hamster Ovary cell products, or any component of this medication.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Do not use dornase alfa if you have had an allergic reaction to it or to other Chinese Hamster Ovary cell products.

Before using dornase alfa, tell your doctor if you have any other medical conditions or if you take other prescription or over-the-counter medicines. You may require a dosage adjustment or special monitoring during your treatment.

Dornase alfa is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether dornase alfa passes into breast milk. Do not use dornase alfa without first talking to your doctor if you are breast-feeding a baby.

Your pharmacist has more information about dornase alfa written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Storage

Oral

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

• 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 [FEV1]), and improves mucociliary clearance in patients with cystic fibrosis.1 5 8 9 10 11 12 14 27 29

• If you have an allergy to dornase alfa or any other part of dornase alfa.
• If you are allergic to hamsters, talk with the doctor.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Fever.
• Shortness of breath.

Cystic fibrosis: Management of cystic fibrosis patients, in conjunction with standard therapies, to improve pulmonary function; reduce the risk of respiratory tract infections requiring parenteral antibiotics in patients with a forced vital capacity (FVC) ≥40% of predicted.

Cystic fibrosis: Inhalation: 2.5 mg daily through selected jet nebulizers in conjunction with a Pulmo-Aide, Pari-Proneb, Mobilaire, or Porta-Neb compressor system or eRapid Nebulizer System

Patients unable to inhale or exhale orally throughout the entire treatment period may use Pari-Baby nebulizer. Some patients may benefit from twice daily administration.

Parapneumonic pleural effusions and empyemas (off-label use): Intrapleural: 5 mg (diluted in 30 mL of sterile water) administered twice daily >2 hours after each intrapleural alteplase dose (with a 1-hour dwell time for each drug) for a total of 3 days (Rahman, 2011). Some clinicians suggest consideration of fibrinolytic use in patients in whom treatment with at least 24 hours of chest tube drainage has failed and who are poor surgical candidates (Hamblin, 2010).

Disease-related concerns:

• Decreased pulmonary function: In patients with pulmonary function <40% of normal, dornase alfa does not significantly reduce the risk of respiratory infections that require parenteral antibiotics.

Special populations:

• Pediatric: Safety studies included children ≥3 months, however experience is limited in children <5 years of age.