dornase alfa (Rx)

Brand and Other Names:Pulmozyme
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution, inhalation

  • 1mg/mL (2.5mL)
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Cystic Fibrosis

2.5 mg nebulizer qDay or twice daily if needed

Dosage Forms & Strengths

solution, inhalation

  • 1mg/mL (2.5mL)
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Cystic Fibrosis

2.5 mg nebulizer qDay or twice daily if needed

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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 Category: B

Lactation: Not known whether secreted in milk, use caution

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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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.
  • Manage and view all your plans together – even plans in different states.
  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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