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PULMOZYME is a brand name for Dornase Alfa, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General PULMOZYME (dornase alfa) should be used in conjunction with standard therapies for cystic fibrosis (CF). Patients should be instructed in the proper use and maintenance of the nebulizer and compressor system used in its delivery.
Carcinogenesis and Mutagenesis There is no evidence of oncogenic or mutagenic potential (see TOXICOLOGY: Carcinogenesis, Mutagenesis for discussion on animal data). Sexual Function/Reproduction Fertility and reproductive performance were not affected in animal studies (see TOXICOLOGY: Reproduction/Development Studies).
Special Populations Pregnant Women:
The safety of PULMOZYME has not been established in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, or embryofoetal development (see TOXICOLOGY: Reproduction/Developmental Studies).
Caution should be exercised when prescribing PULMOZYME to pregnant women.
Nursing Women:
As it is not known whether dornase alfa is excreted in human milk, caution should be exercised when PULMOZYME is administered to a nursing woman (see DETAILED PHARMACOLOGY: Pharmacokinetics).
Pediatrics (<5 years of age):
There is limited experience in the use of PULMOZYME in patients under the age of 5 years. The clinical efficacy in patients under the age of 5 years is not established. ADVERSE REACTIONS Adverse Drug Reaction Overview The adverse event data reflect the clinical trial and post-marketing experience of using PULMOZYME (dornase alfa) at the recommended dose regimen.
Adverse reactions attributed to PULMOZYME are rare (<1/1000). In most cases, the adverse reactions are mild and transient in nature and do not require alterations in the dosing of PULMOZYME.
Page 5 of 23 Body as a Whole:
Chest pain (pleuritic/non-cardiac), fever Gastrointestinal System: Dyspepsia Respiratory System: Voice alteration (hoarseness), pharyngitis (inflammation of the throat), dyspnea, laryngitis, rhinitis, decreased lung function Skin and Appendages: Rash, urticaria Special Senses: Conjunctivitis Patients who experience adverse events common to cystic fibrosis can, in general, safely continue administration of PULMOZYME as evidenced by the high percentage of patients completing clinical trials with PULMOZYME.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Upon initiation of therapy with PULMOZYME, as with any aerosol, pulmonary function may decline and expectoration of sputum may increase. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. In clinical trials, few patients experienced adverse events resulting in permanent discontinuation from PULMOZYME, and the discontinuation rate was observed to be similar between placebo (2%) and PULMOZYME (3%).
Mortality rates observed in a controlled trial were similar for the placebo (1%) and PULMOZYME (1%). Causes of death were consistent with progression of cystic fibrosis and included apnea, cardiac arrest, cardiopulmonary arrest, cor pulmonale, heart failure, massive hemoptysis, pneumonia, pneumothorax, and respiratory failure.
10 The number of patients reporting cough was higher in the younger age group as compared to the older age group (29/65, 45% compared to 10/33, 30%) as was the number reporting moderate to severe cough (24/65, 37% as compared to 6/33, 18%).
Other events tended to be of mild to moderate severity. The number of patients reporting rhinitis was higher in the younger age group as compared to the older age group (23/65, 35% compared to 9/33, 27%) as was the number reporting rash (4/65, 6% as compared to 0/33).
Adverse events were common in this Page 6 of 23 study and some were considered to be due to bronchoalveolar lavage. The nature of adverse drug reactions was similar to that seen in the larger trials of PULMOZYME. 5 mg (the recommended dose).
Data presented in Table 1 are based on adverse drug reactions reported in Study Z0644g. 1 Allergic Reactions There have been no reports of anaphylaxis attributed to the administration of PULMOZYME to date. Skin rash and urticaria have been observed, and were mild and transient in nature.
Less than 5% of patients treated with PULMOZYME have developed antibodies to the drug and none Page 7 of 23 of these patients have developed IgE antibodies to PULMOZYME. Improvement in pulmonary function tests has still occurred even after the development of antibodies to PULMOZYME.
DRUG INTERACTIONS Clinical trials have indicated that PULMOZYME can be effectively and safely used in conjunction with standard cystic […]