Dornase Alfa, Inhalation

________________________________________________________________________

KEY POINTS

• This medicine is inhaled through your mouth to help prevent lung infections in people with cystic fibrosis. Use it exactly as directed.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: mucolytic enzyme

Generic and brand names: dornase alfa, inhalation; Pulmozyme

What is this medicine used for?

This medicine is inhaled to improve lung function and to help prevent lung infections in people with cystic fibrosis.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had an allergic reaction to any medicine or to hamsters.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

You must use this medicine in a power-operated nebulizer. A nebulizer provides a precise amount of medicine as an aerosol mist that you breathe through your mouth and into your lungs. Use only the nebulizer that is prescribed by your healthcare provider. If you are not sure how to use the nebulizer, ask your healthcare provider or pharmacist to explain.

Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 5 years.

Do not use this medicine if it has become cloudy or discolored. Throw out any part of a vial that is not used right away.

Do not dilute this medicine or mix it with any other medicine in the nebulizer. Do not stop taking this medicine without your healthcare provider's approval.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

Use all other medicines exactly as prescribed your healthcare provider.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Rash, wheezing, chest pain that continues or gets worse, fever.

Other: Stomach pain, muscle or joint pain, cough, wheezing, runny nose, sore throat, mild itching, red or watery eyes, change in voice, hoarseness, dizziness

What products might interact with this medicine?

No significant drug interactions have been identified.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator until you use it. Do not let it reach room temperature for more than 24 hours. Also, refrigerate it during transport. Keep this medicine in its original foil pouch and away from strong light.

---

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.