dornase alfa (Rx)

Brand and Other Names:Pulmozyme
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution, inhalation

  • 1mg/mL (2.5mL)

Cystic Fibrosis

Indicated in conjunction with standard therapies, for the improvement of pulmonary function in cystic fibrosis (CF) patients

2.5 mg via nebulizer qDay; some patients may benefit from twice daily administration

Patients with an FVC ≥40% of predicted, daily administration showed a risk reduction in respiratory tract infections requiring parenteral antibiotics

Sarcoidosis (Orphan)

Orphan designation for treatment of sarcoidosis

Orphan sponsor

  • SarcoMedUSA, LLC; 1300 Post Oak Boulevard, Suite 760; Houston, Texas 77056

Dosage Forms & Strengths

solution, inhalation

  • 1mg/mL (2.5mL)

Cystic Fibrosis

Indicated in conjunction with standard therapies, for the improvement of pulmonary function in cystic fibrosis (CF) patients

2.5 mg via nebulizer qDay; some patients may benefit from twice daily administration

Patients with an FVC ≥40% of predicted, daily administration showed a risk reduction in respiratory tract infections requiring parenteral antibiotics

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Adverse Effects

>10%

Chest pain (18-25%)

Pharyngitis (32-40%)

Rash (3-12%)

Voice alteration (12-18%)

Rhinitis (30% in patients with FVC <40%)

Fever (32% in patients with FVC <40%)

1-10%

Dyspepsia (3%)

Conjunctivitis (1-5%)

Dornase alfa serum antibodies (2-4%)

Laryngitis (3-4%)

<1%

Headache

Urticaria

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Warnings

Contraindications

Hypersensitivity to dornase alfa or Chinese hamster ovary cell products

Cautions

Use in conjunction with standard CF therapies

Dornase alfa therapy does not reduce the risk of respiratory infections that require parenteral antibiotics in patient with pulmonary function <40% of normal

Experience with therapy in children < 5 years is limited

Safety and efficacy not established for therapy lasting > 12 months

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant females

Lactation

Unknown whether dornase alfa is present in human milk

Levels of dornase alfa in cynomolgus monkeys detected in milk were <1% of maternal serum concentration at 24 hr after dosing (IV bolus dose (0.1 mg/kg) of dornase alfa followed IV infusion [0.08 mg/kg/hr] over a 6 hr period) on postpartum day 14

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Recombinant human DNase 1, digests neutrophil DNA deposited in the pulmonary mucosa thereby reducing mucosal viscoelasticity

Pharmacokinetics

Onset of action: Enzyme activity measured in sputum in 15 min

Duration: Activity declines rapidly

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Administration

Oral Inhalation Administration

Oral inhalation use only

Squeeze each ampule before use to check for leaks

Discard ampules if solution is cloudy or discolored

Once opened, discard entire contents of ampule

Do not dilute or mix with other drugs in the nebulizer

Mixing with other drugs could lead to adverse physicochemical and/or functional changes or admixed compound

Administer via eRapid Nebulizer System or jet nebulizer connected to an air compressor with an adequate air flow with a mouthpiece or suitable face mask

No data are available to support administration with other nebulizer systems

eRapid Nebulizer System

  • Replace handset after 90 uses regardless of whether EasyCare cleaning aid is used
  • Delivery data are unavailable with eRapid handset beyond 90 administrations; therefore, delivery of appropriate therapeutic dose cannot be ensured beyond 90 administrations
  • Only use in adults and children who are able to use a mouthpiece; do not use in patients who require a mask to administer

Refer to prescribing information for other recommended jet nebulizers and compressors

Follow manufacturer's instructions on use and maintenance of the equipment, including cleaning and disinfection procedures

For additional information, refer to recommended nebulizer manufacturers’ Instructions for Use

Storage

Refrigerate at 2-8ºC (36-46ºF)

Protect from light and heat

Keep refrigerated during transport; do not expose to room temperature for a total time of 24 hr

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Pulmozyme inhalation
-
1 mg/mL solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
dornase alfa inhalation

DORNASE ALFA SOLUTION - INHALATION

(DOOR-naze AL-fa)

COMMON BRAND NAME(S): Pulmozyme

USES: 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: Read the Instructions for Use if available from your pharmacist before you start using dornase alfa and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is inhaled into the lungs using special breathing equipment as directed by your doctor, usually once or twice daily. 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.The 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 time(s) each day.

SIDE EFFECTS: 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 this medication has been prescribed because your doctor 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 you have any serious side effects, including: chest pain.A very serious allergic reaction to this drug is rare. However, get medical help right away 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.

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.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: 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. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store in the refrigerator away from light and heat. Do not freeze. Keep all medications 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.

Information last revised September 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.