Pulmozyme inhalation

Do not dilute or mix the dornase alfa solution with any other drugs in the nebulizer. Mixing of dornase alfa with other drugs could lead to changes in the actions of the medications.

Ampules of dornase alfa do not contain a preservative. Once opened, the entire contents of the ampule must be used or discarded.

Dornase alfa must be stored in the refrigerator between 36 and 46 degrees Fahrenheit (2 and 8 degrees Celsius) and protected from strong light. Keep unused ampules in the protective foil pouch. Dornase alfa should be kept refrigerated during transport. Combined lengths of exposure of the medication to room temperature should not exceed 24 hours.

An overdose of dornase alfa is unlikely to threaten life. If an overdose is suspected, contact your doctor, a hospital emergency room, or a poison control center.

Symptoms of a dornase alfa overdose are not known.

There are no known interactions between dornase alfa and other medicines. Talk to your doctor or pharmacist before taking any other prescription or over-the-counter medicines, including herbal products, during treatment with dornase alfa.

This medication is used to improve breathing and reduce the risk of lung infections in people with cystic fibrosis. It is used along with other treatments for this disease (e.g., chest physical therapy, medications, nutritional supplements). Dornase alfa is the same as a substance (DNase I enzyme) that is naturally produced by the body. It works in the airways by decreasing stickiness/thickness of mucus so that it can be cleared from the lungs more easily.

How to use Pulmozyme Solution, Non-

This medication is inhaled into the lungs using special breathing equipment, usually once or twice daily or as directed by your doctor. A health care professional will show you the proper way to prepare the medication and use the equipment. If you are unclear about any of the instructions, ask your health care professional.

Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more frequently than prescribed. Your condition will not improve faster and the risk for side effects may be increased.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Sore/dry throat and hoarseness may occur. Eye redness/irritation may also rarely occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if this unlikely but serious side effect occurs: chest pain.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, unusual trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using dornase alfa, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Tell your doctor if you are pregnant before using this medication.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

Pulmozyme is a synthetic protein that breaks down excess DNA in the pulmonary secretions of people with cystic fibrosis.

Pulmozyme is used to improve lung function in people with cystic fibrosis by thinning pulmonary secretions and reducing the risk of respiratory tract infections.

Pulmozyme may also be used for purposes other than those listed in this medication guide.