Pulmozyme, 2.5 mg/2.5 ml 2.5 ml 6 pcs.

Pulmozyme has a mucolytic effect.

Pharmacodynamics

The recombinant human DN-ase (dornase alfa) is a genetically engineered version of a natural human enzyme that cleaves extracellular DNA.

The accumulation of viscous purulent secretion in the respiratory tract plays a role in impaired airway function and in exacerbations of the infection process in cystic fibrosis patients. Purulent secretion contains very high concentrations of extracellular DNA, a viscous polyanion released from destructive leukocytes that accumulate in response to infection. In vitro dornase alfa hydrolyzes DNA in sputum and significantly reduces sputum viscosity in cystic fibrosis.

Pharmacokinetics

The systemic absorption of dornase alfa after aerosol inhalation in humans is low.

The dor-aza is normally present in human serum. Inhalation of dornase alfa at doses up to 40 mg for 6 days resulted in no significant increase in serum DN-ase concentration compared with normal endogenous levels. Serum DN-ase concentration did not exceed 10 ng/ml.

After administration of dornase alfa at 2500 IU (2.5 mg) 2 times daily for 24 weeks, mean serum concentrations of DN-aza did not differ from the pre-treatment mean of 3.5±0.1 ng/mL, indicating little systemic absorption or cumulation.

In cystic fibrosis patients, the mean concentration of dornase alfa in sputum 15 min after inhalation of 2500 units (2.5 mg) is approximately 3 µg/mL. After inhalation, serum dornase alfa concentration decreases rapidly.

Indications

Symptomatic therapy in combination with standard cystic fibrosis therapy in patients with a forced vital capacity (FVC) of at least 40% of normal; treatment of patients with some chronic lung diseases (bronchiectatic disease, COPD, congenital lung malformation in children, chronic pneumonia, immunodeficiency states, occurring with lung damage, etc.) if in the opinion of the physician the mucolytic effect of dorza alfa provides advantages for patients.), if in the doctor’s opinion the mucolytic effect of dornase alfa provides benefits for patients.

Active ingredient

Dornase alpha

Composition

Active ingredient:

dornase alfa 2.5 mg;

Associates:

Sodium chloride;

calcium chloride dihydrate;

water for injection

How to take, the dosage

Inhaled.

Pulmozyme must not be diluted or mixed with other drugs or solutions in the nebulizer tank. Mixing the product with other medications may result in undesirable structural and/or functional changes to Pulmozyme or another component of the mixture.

2.5 mg dornase alfa (corresponding to the contents of 1 ampoule – 2.5 mL of undiluted solution, 2500 units) once daily, inhaled, without dilution, using a Jet Nebulizer (see “Instructions for Use”).

In some patients over 21 years of age, a daily dose of 2 times a day may have a better treatment effect. In most patients, optimal effect is achieved with continuous daily use of Pulmozyme. Studies in which dornase alfa has been administered in an intermittent regimen show that once therapy is discontinued, the improvement in lung function disappears. Consequently, patients should be advised to take the drug daily without interruption.

Patients should continue comprehensive therapy, including chest physiotherapy.

If respiratory tract infection worsens during treatment with Pulmozyme, its use can be continued without any risk to the patient.

Interaction

Compatible with standard cystic fibrosis medications: antibiotics, bronchodilators, digestive enzymes, vitamins, inhaled and systemic GCS and analgesics.

Pulmozyme is an aqueous solution without buffering properties and should not be diluted or mixed with other drugs or solutions in the nebulizer tank. Mixing the medication with other medications may result in undesirable structural and/or functional changes to Pulmozyme or another component of the mixture.

Special Instructions

The patient should continue to be monitored regularly during Pulmozyme therapy.

After initiation of Pulmozyme therapy, as with any aerosol, lung function may decrease slightly and sputum flow may increase.

Pulmozyme has limited experience in children under 5 years of age.

There is no difference in the safety profile in children under 5 years of age and in the older age group of 5 to 9 years. No increase in the incidence of serious adverse events in children under 5 years of age receiving Pulmozyme has been found after treatment.

Pulmozyme should only be administered to children under 5 years of age if the potential benefit of improved lung function outweighs the risk of respiratory tract infection.

The efficacy and safety of dornase alfa in patients with FEL less than 40% of normal have not been established.

A single brief exposure to elevated temperatures (no more than 24 hours at temperatures up to 30 °C) does not affect the stability of the drug.

Impact on the ability to drive and operate machinery. There have been no reports about the effect of dornase alfa on the patient’s ability to drive vehicles and operate mechanisms.

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Contraindications

Hypersensitivity to the drug or its components.

With caution:

• pregnancy;
• breastfeeding period;
• children under 5 years.

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Side effects

Blood organs: acute lympholeukemia, aplastic anemia.

Nervous system disorders: epileptic seizures, migraine.

Sensory system disorders: conjunctivitis, balance disorders.

Cardiovascular system: tachycardia, bradycardia, cardiac arrest.

Respiratory system: pneumonia, bronchitis, respiratory tract infections, including those caused by Pseudomonas.caused by Pseudomonas, pharyngitis, laryngitis, voice changes (hoarseness), dyspnea, rhinitis, worsening of lung function, decreased respiratory function, respiratory failure, hemoptysis, pneumothorax, pulmonary bleeding, lary polyp, cough, increased bronchial secretion, alveolitis, hypoxia, bronchospasm, productive cough.

Gastrointestinal disorders: dyspepsia, abdominal pain, bloody vomiting, liver failure.

Skin and its appendages: rash, itching, urticaria, dermatitis, purpura, angioedema.

Pregnancy, postpartum period: premature delivery, complications of pregnancy, spontaneous abortion, medical abortion.

Body in general: pleural chest pain, fever, weakness, malaise, death.