Pulmozyme® [Dornase Alfa]
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Pulmozym - mucolytic agent. It is a phosphorylated glycosylated recombinant deoxyribonuclease I, or dornase alpha, identical to the human DNase isolated from human urine. Dornase alpha is a genetically engineered version of the natural human enzyme that cleaves extracellular DNA.
The accumulation of a viscous purulent secretion in the respiratory tract plays a role in impaired respiratory function and in exacerbations of the infectious process in patients with cystic fibrosis. The purulent secretion contains very high concentrations of extracellular DNA, a viscous polyanion released from decaying white blood cells that accumulate as a result of the infection. In vitro, dornase alfa hydrolyzes DNA in sputum and markedly reduces sputum viscosity in cystic fibrosis.
To improve respiratory function in patients with cystic fibrosis over the age of 5 years, with an FVC index of at least 40% of the norm.
Pulmozyme can be used to treat patients with certain chronic lung diseases (bronchiectasis, chronic obstructive pulmonary disease, congenital lung malformations in children, chronic pneumonia, immunodeficiency conditions with lung damage, etc.), if the doctor estimates the mucolytic effect of dornase alpha benefits to patients.
1 vial (2.5 ml) of the solution for inhalation contains:
active substance: Dornase Alfa 2.5 mg
Excipients: sodium chloride, calcium chloride dihydrate, water for injection.
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Dosage and Administration
Inhalation, using a jet nebulizer (see instructions for handling the drug). From each vial of Pulmozyme containing a single dose of the drug, 2500 units (2.5 mg) of dornase alfa will fall into the nebulizer chamber.
The recommended dose is 2500 units (2.5 mg) of dornase alfa once a day, which corresponds to the inhalation of the contents of 1 ampoule (2.5 ml of undiluted solution). In some patients over the age of 21, the best effect of treatment can be achieved with the use of the drug 2 times a day.
In most patients, the optimal effect can be achieved with continuous daily use of Pulmozyme. Studies in which dornase alfa was prescribed intermittently show that after cessation of therapy, the improvement of lung function quickly disappears. Therefore, patients should be advised to take the drug daily. Currently, there are no recommendations on the optimal time of day for receiving Pulmozyme.
With the exacerbation of respiratory tract infections during the treatment with Pulmozim its use can be continued without any risk for the patient.
Adverse reactions in the treatment of pulmosis are rare (% 26lt% 3B 1/1000), in most cases, weakly expressed, are transient in nature and do not require dose adjustment.
From the side of blood-forming organs: acute lymphocytic leukemia, aplastic anemia.
From the nervous system: epileptic seizures, migraine.
From the senses: conjunctivitis, imbalance.
Since the cardiovascular system: tachycardia, bradycardia, cardiac arrest.
On the part of the respiratory system: pneumonia, bronchitis, respiratory tract infections, including those caused by Pseudomonas, pharyngitis, laryngitis, voice change (hoarseness), shortness of breath, rhinitis, deterioration of lung function, reduced respiratory function, respiratory failure, hemoptysis, pneumothorax, pulmonary hemorrhage, laryngeal polyp , cough, increased bronchial secretions, alveolitis, hypoxia, bronchospasm, productive cough.
From the gastrointestinal tract: dyspepsia, abdominal pain, bloody vomiting, liver failure.
From the skin and its appendages:rash, pruritus, urticaria, dermatitis, purpura, angioedema.
Pregnancy, postpartum period: preterm labor, pregnancy complications, spontaneous abortion, medical abortion.
On the part of the body as a whole: pleural chest pain, fever, weakness, malaise, death.
Patients who develop adverse events that coincide with the symptoms of cystic fibrosis can usually continue with Pulmozyme. Adverse events that led to the complete cessation of treatment with Pulmozim were observed in a very small number of patients, and the frequency of interruption of therapy was the same when prescribing placebo (2%) and dornase alpha (3%).
Antibodies to dornase alpha were found in less than 5% of patients, but none of them belonged to the IgE class. Improvement in lung function was observed even after the appearance of antibodies to dornase alpha.
Hypersensitivity to the drug or its components.
Compatible with standard drugs for the treatment of cystic fibrosis: antibiotics, bronchodilators, digestive enzymes, vitamins, inhaled and systemic glucocorticosteroids and analgesics.
Pulmozyme is an aqueous solution without buffer properties and should not be diluted or mixed with other drugs or solutions in the nebulizer tank. Mixing the drug with other drugs can lead to undesirable structural and / or functional changes in Pulmozyme or another component of the mixture.
Pregnancy and Lactation
Safety Pulmozyme for pregnant women has not been established. Studies of dornase alpha did not indicate a violation of fertility, teratogenicity, or the effect of the drug on fetal development in animals.Pulmosis should be prescribed during pregnancy with caution and only if the benefit to the mother outweighs the potential risk to the fetus.
Whether Pulmosis penetrates breast milk in women is unknown. Assign Pulmozym to nursing mothers with caution. In lactating cynomolgus macaques that received high doses of dornase alfa IV, low concentrations of dornase alfa were found in human milk (% 26lt% 3B 0.1% of serum concentrations). Given the minimal systemic absorption of dornase alfa, one should not expect measurable concentrations of dornase alfa in breast milk in women.
With Pulmozim therapy, it is necessary to continue regular medical observation of the patient. After the start of therapy with the Pulmozim, as with any aerosol, the function of the lungs may slightly decrease, and the discharge of sputum will increase.
Experience with Pulmozyme in children under 5 years of age is limited.
There were no differences in the safety profile of children under 5 years of age and the older age group from 5 to 9 years. After the end of treatment, there was no increase in the incidence of serious adverse events in children under 5 years of age who received Pulmozim.
Pulmosis should be prescribed to children under 5 years of age only if the potential advantage of improving lung function is greater than the risk of an infection of the respiratory tract.
The efficacy and safety of dornase alfa in patients with FVC less than 40% of the norm has not been established.
A single short action of elevated temperatures (no more than 24 hours at temperatures up to 30 ° C) does not affect the stability of the drug.
Cases of overdose have not been reported. Single inhalations of the drug to animals in doses exceeding those commonly used in humans, up to 180 times, were well tolerated. Oral administration of dornase alpha to rats at doses up to 200 mg / kg was also well tolerated. In clinical studies, patients with cystic fibrosis received up to 20 mg of dornase alfa 2 times a day for 6 days and 10 mg 2 times a day according to a discontinuous schedule (two weeks intake, two weeks break) for 168 days. Both dosing regimens were well tolerated.
- Brand name: Pulmozyme
- Active ingredient: Dornase Alfa
- Dosage form: Solution for inhalation.
- Manufacturer: Hoffmann la roch
- Country of Origin: Switzerland
- Aerosolized dornase alfa in cystic fibrosis: Is there a role in the management of patients with early obstructive lung disease?
- Effect of smaller droplet size of dornase alfa on lung function in mild cystic fibrosis
- A technical feasibility study of dornase alfa delivery with eflow® vibrating membrane nebulizers: Aerosol characteristics and physicochemical stability
- Dornase alfa in early cystic fibrosis lung disease
- Dornase alfa in the treatment of cystic fibrosis in Europe: A report from the Epidemiologic Registry of Cystic Fibrosis
- Dornase alfa is well tolerated: Data from the Epidemiologic Registry of Cystic Fibrosis
- Is a longer time interval between recombinant human deoxyribonuclease (dornase alfa) and chest physiotherapy better?: A multi-center, randomized crossover trial
- Successful mucolysis in pertussis using bronchoscopically applied dornase alfa
- Dornase alfa and progression of lung disease in cystic fibrosis
- Physicochemical compatibility of mixtures of dornase alfa and tobramycin containing nebulizer solutions
- Dornase alfa improves the health-related quality of life among Brazilian patients with cystic fibrosis—A one-year prospective study
- Clinical use of dornase alfa is associated with a slower rate of FEV1 decline in cystic fibrosis
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- Rekombinante humane DNase (Dornase alfa) bei Mukoviszidose
- Use of dornase alfa in the management of ARDS
- Dornase Alfa in Premature Infants With Severe Respiratory Distress and Early Bronchopulmonary Dysplasia
- Dornase Alfa: A New Option in the Management of Cystic Fibrosis
- Improvements in Lung Function Outcomes in Children with Cystic Fibrosis are Associated with Better Nutrition, Fewer Chronic Pseudomonas aeruginosa Infections, and Dornase Alfa Use
- Dornase-Alfa (DNase, Pulmozyme) for cystic fibrosis
- Sinonasal inhalation of dornase alfa in CF: A double-blind placebo-controlled cross-over pilot trial
- Effect Of Nebulized Dornase Alfa On Pulmonary Gas Exchange In Critically Ill Stem Cell Transplant Recipients
- Effect of dornase alfa on inflammation and lung function: Potential role in the early treatment of cystic fibrosis
- Editorial for effect of dornase alfa on inflammation and lung function: Potential role in the early treatment of cystic fibrosis
- Estimating effectiveness in an observational study: A case study of dornase alfa in cystic fibrosis