Pulmozyme

DRUG DESCRIPTION

Pulmozyme® (dornase alfa) Inhalation Solution is a sterile, clear, colorless,
highly purified solution of recombinant human deoxyribonuclease I (rhDNase),
an enzyme which selectively cleaves DNA. The protein is produced by genetically
engineered Chinese Hamster Ovary (CHO) cells containing DNA encoding for the
native human protein, deoxyribonuclease I (DNase). Fermentation is carried out
in a nutrient medium containing the antibiotic gentamicin, 100-200 mg/L. However,
the presence of the antibiotic is not detectable in the final product. The product
is purified by tangential flow filtration and column chromatography. The purified
glycoprotein contains 260 amino acids with an approximate molecular weight of
37,000 daltons¹. The primary amino acid sequence is identical to
that of the native human enzyme.

Pulmozyme (dornase alfa) is administered by inhalation of an aerosol mist produced by a compressed
air driven nebulizer system (see Clinical Experience,
DOSAGE AND ADMINISTRATION). Each Pulmozyme (dornase alfa)
single-use ampule will deliver 2.5 mL of the solution to the nebulizer bowl.
The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride
dihydrate and 8.77 mg/mL sodium chloride. The solution contains no preservative.
The nominal pH of the solution is 6.3.

What are the possible side effects of dornase alfa (Pulmozyme)?

If you experience any of the following serious side effects while taking dornase alfa, seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);


• increased difficulty breathing;


• chest pain; or


• fever.

Less serious side effects may be more likely to occur with the use of dornase alfa. Talk to your doctor if you experience any of the following side...

Read All Potential Side Effects and See Pictures of Pulmozyme »

What are the precautions when taking dornase alfa (Pulmozyme)?

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...

Read All Potential Precautions of Pulmozyme »

Pulmozyme Consumer (continued)

SIDE EFFECTS: Sore/dry throat and hoarseness may occur. Eye redness/irritation may also infrequently 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 immediately 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.

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

PRECAUTIONS: 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.

Pulmozyme Patient Information Including Side Effects

Brand Names: Pulmozyme

Generic Name: dornase alfa (inhalation) (Pronunciation: DOOR nase AL fa)

• What is dornase alfa (Pulmozyme)?


• What are the possible side effects of dornase alfa (Pulmozyme)?


• What is the most important information I should know about dornase alfa (Pulmozyme)?


• What should I discuss with my healthcare provider before using dornase alfa (Pulmozyme)?


• How should I use dornase alfa (Pulmozyme)?


• What happens if I miss a dose (Pulmozyme)?


• What happens if I overdose (Pulmozyme)?


• What should I avoid while using dornase alfa (Pulmozyme)?


• What other drugs will affect dornase alfa (Pulmozyme)?


• Where can I get more information?

What is dornase alfa (Pulmozyme)?

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

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

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

What are the possible side effects of dornase alfa (Pulmozyme)?

If you experience any of the following serious side effects while taking dornase alfa, seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);


• increased difficulty breathing;


• chest pain; or


• fever.

Less serious side effects may be more likely to occur with the use of dornase alfa. Talk to your doctor if you experience any of the following side effects:

• voice alteration;


• sore throat;


• rash;


• laryngitis;


• eye redness, irritation, or inflammation; or


• nasal stuffiness or discharge.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about dornase alfa (Pulmozyme)?

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.

Related Drug Centers

• Pulmozyme