Adult Dosing

Management of cystic fibrosis

• 2.5 mg qd oral inhalation via nebulizer
• Patients >21 yrs and those with baseline forced vital capacity >85% may benefit from administration of 2.5 mg bid

Note:

• Do not dilute or mix with other drugs in the nebulizer

Pediatric Dosing

Management of cystic fibrosis

• Child >5 years: 2.5 mg qd oral inhalation via nebulizer
• Child < 5years: Safety and effectiveness in pediatric patients <5 yrs of age have not been established
• Patients with baseline FVC >85% may benefit from administration of 2.5 mg bid

Note:

• Do not dilute or mix with other drugs in the nebulizer

[Outline]

• Adult Dosing
• Pediatric Dosing

• Indicated in conjunction with standard therapies for the management of cystic fibrosis (CF) patients to improve pulmonary function

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to Chinese hamster ovary cell products

• N/A

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Dornase alfa should be used in conjunction with standard therapies for cystic fibrosis
• Should not be diluted or mixed with other drugs in the nebulizer, as it could lead to adverse physicochemical and/or functional changes in dornase alfa or the admixed compound
• Contains no preservative; use the entire contents of the ampule once opened or discard the remaining

Supplemental Patient Information

• Advise patients to squeeze each ampule prior to use in order to check for leaks

Pregnancy Category:B

Breastfeeding: Safety unknown. Manufacturer advises caution when administered to a nursing woman.

• EENT: Voice alteration, conjunctivitis, rhinitis
• CNS: Malaise
• NEURO: Asthenia
• CV: Chest pain
• RESP: Pharyngitis, laryngitis, dyspnea, apnea, bronchiectasis, bronchitis, sputum changes, increased cough, dyspnea, hemoptysis, decreased lung function, nasal polyps, pneumonia, pneumothorax, rhinitis, sinusitis, increased sputum, wheeze
• GI: Dyspepsia, abdominal pain, intestinal obstruction, gall bladder disease, liver disease, pancreatic disease
• METABOLIC: Diabetes mellitus, hypoxia, weight loss
• DERM: Rash, urticaria
• MISC: Fever, flu syndrome, sepsis

• Recombinant human deoxyribonuclease I (rhDNase) enzyme; breaks down excessive amounts of extracellular DNA found in the respiratory tract, which reduces sputum viscosity and viscoelasticity of purulent sputum in patients with CF
• Metabolism: Unknown
• Excretion: Unknown
• Half-life: Unknown

US Trade Name(s)

• Pulmozyme

US Availability

Pulmozyme

• SOLN for INH: 1 mg/mL (2.5 mL amp)

Canadian Trade Name(s)

• Pulmozyme

Canadian Availability

Pulmozyme

• SOLN for INH: 1 mg/mL (2.5 mL amp)

UK Trade Name(s)

• Pulmozyme

UK Availability

Pulmozyme

• SOLN for INH: 1 mg/mL (2.5 mL amp)

Australian Trade Name(s)

• Pulmozyme

Australian Availability

Pulmozyme

• SOLN for INH: 1 mg/mL (2.5 mL amp)

[Outline]

Pulmonary

Mucolytics

Deoxyribonuclease I Enzyme

Pricing data from www.DrugStore.com in U.S.A.

• Pulmozyme 1 MG/ML SOLN [Plas Cont] (GENENTECH)
  75 ml = $2325.11
  150 ml = $4546.85

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.