Pulmozyme

What is Pulmozyme used for?

Pulmozyme is a prescription medicine that is used to lower the number of lung infections and help lung function in cystic fibrosis.

Description

Dornase alfa is a 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). The product is purified by column chromatography and tangential flow filtration. The purified glycoprotein contains 260 amino acids with an approximate molecular weight of 37,000 daltons. The primary amino acid sequence is identical to that of the native human enzyme.

PULMOZYME (dornase alfa) inhalation solution is administered by inhalation of an aerosol mist produced by a compressed air driven nebulizer or an approved nebulizer system  and  PULMOZYME is a sterile, clear, colorless, highly purified solution in single-dose ampules. Each ampule delivers 2.5 mL of the solution to the nebulizer bowl. Each mL of aqueous solution contains 1 mg dornase alfa, calcium chloride dihydrate (0.15 mg) and sodium chloride (8.77 mg). The solution contains no preservative. The nominal pH of the solution is 6.3.

 Mechanism of Action

PULMOZYME is recombinant human deoxyribonuclease I (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, PULMOZYME hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity. In CF patients, retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to infection.

Before taking Pulmozyme, tell your doctor:

• If you are allergic to hamsters, talk with the doctor.
• If you are allergic to Pulmozyme; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Pulmozyme with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Pulmozyme?

• Tell all of your health care providers that you take Pulmozyme. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine is used with other drugs. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Pulmozyme while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is Pulmozyme best taken?

Use Pulmozyme as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• You will use by breathing in from the mouth with a special machine (nebulizer). Your doctor will teach you the right way to use.
• Only use the type of nebulizer that you have been told to use. If you are not sure what type of nebulizer to use, talk with the doctor.
• Do not mix other drugs in nebulizer.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Use right after opening.
• Throw away any part not used after use.
• Keep using Pulmozyme as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Pulmozyme that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Chest pain or pressure.
• Fever.
• Shortness of breath.

What are some other side effects of Pulmozyme?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Change in voice.
• Runny nose.
• Sore throat.
• Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Pulmozyme?

• Store in a refrigerator. Do not freeze.
• Protect from light.
• Store unused containers in foil pouch until use.
• Throw away unopened drug if left at room temperature for more than 24 hours.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 2.5 ML AMPULE POUCH CARTON