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|Dornase Alfa

Dornase Alfa

Dornase Alfa is used for:

Improving lung function and reducing the risk of respiratory tract infections in patients with cystic fibrosis.

Dornase Alfa is an enzyme. It works by decreasing the thickness and stickiness of mucus secretions in the airways of cystic fibrosis patients.

Do NOT use Dornase Alfa if:

• you are allergic to any ingredient in Dornase Alfa
• you are allergic to Chinese hamster ovary cell products

Contact your doctor or health care provider right away if any of these apply to you.

Before using Dornase Alfa :

Some medical conditions may interact with Dornase Alfa . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Dornase Alfa . However, no specific interactions with Dornase Alfa are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dornase Alfa may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Dornase Alfa :

Use Dornase Alfa as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Discuss with your doctor what type of nebulizer is appropriate to use with Dornase Alfa . Follow the directions provided by your doctor or other health care provider for using your nebulizer.
• Do not mix Dornase Alfa with any other medicine in the nebulizer. Do not use Dornase Alfa if it is cloudy or discolored.
• Before each use, squeeze the vial you will be using to make sure that it is not leaking.
• To use Dornase Alfa , twist open the top of the vial and pour the entire contents into the nebulizer reservoir, unless directed otherwise by your doctor.
• Connect the nebulizer reservoir to the mouthpiece or face mask. Connect the nebulizer to the compressor.
• Sit in a comfortable, upright position. Place the mouthpiece in your mouth (or put on the face mask) and turn on the compressor.
• Breathe as calmly, deeply, and evenly as possible until no more mist is formed in the nebulizer chamber (about 5 to 15 minutes).
• Use the contents of the vial as soon as it is opened. Discard any unused medicine.
• Clean the nebulizer according to the instructions. Failure to properly clean the nebulizer could lead to bacterial contamination and you may get an infection. To avoid contamination, throw away any unused medicine after the vial has been opened.
• If you miss a dose of Dornase Alfa , use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Dornase Alfa .

Important safety information:

• Do not dilute or mix Dornase Alfa with other medicines before using it.
• Dornase Alfa should be used in combination with standard therapies for cystic fibrosis.
• Use Dornase Alfa with extreme caution in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Dornase Alfa , discuss with your doctor the benefits and risks of using Dornase Alfa during pregnancy. It is unknown if Dornase Alfa is excreted in breast milk. If you are or will be breast-feeding while you are using Dornase Alfa , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Dornase Alfa :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in voice; fever; indigestion; itching; mild sore throat; redness around the eyes; sinus inflammation; temporary loss of voice or hoarseness; throat inflammation.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Dornase Alfa in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Keep Dornase Alfa out of the reach of children and away from pets.

General information:

• If you have any questions about Dornase Alfa , please talk with your doctor, pharmacist, or other health care provider.
• Dornase Alfa is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Dornase Alfa . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.