Dornase alfa is used in people with cystic fibrosis to thin mucus in the airways. This may help improve lung function and lower the risk of infections.

Dornase alfa may also be used for purposes not listed in this medication guide.

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Use dornase alfa regularly to get the most benefit.

Read and follow all Instructions for Use. Ask your doctor or pharmacist if you need help.

To use the solution with most nebulizers:

• Pour the medicine into the nebulizer chamber. Attach the mouthpiece or face mask, then attach the chamber to the compressor. Sit upright and place the mouthpiece into your mouth or put on the face mask. Turn on the compressor.

• Breathe slowly and evenly until there is no more mist and the drug chamber is empty.

• Clean the nebulizer after each use. On certain nebulizer systems, you may need to change the handset after 90 uses. Follow the directions that came with your nebulizer.

Do not dilute or mix dornase alfa with any other drugs in the nebulizer.

Tell the doctor if your child has trouble breathing in or out while using the nebulizer.

Each ampule is for one use only. Throw it away after one use, even if there is still medicine left inside.

Store dornase alfa ampules in the refrigerator, protected from light. Keep unused ampules in the protective foil pouch.

If needed, you may store an ampule at room temperature for short periods of time (up to a total of 60 hours). Protect from heat and light.

Call your pharmacist if the medicine looks cloudy or has changed colors.

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

You should not use dornase alfa if you are allergic to dornase alfa or other Chinese Hamster Ovary cell products.

Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Overdose is unlikely when used as directed, and is not expected to cause harmful effects.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have worsened breathing problems.

Common side effects of dornase alfa may include:

• sore throat;

• chest pain, trouble breathing;

• changes in the sound of your voice;

• rash;

• eye redness; or

• fever.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect dornase alfa, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.