Dornase Alpha (Dornasum alfa *)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
Read on
Clinical and pharmacological group: & nbsp

Mucolytics and stimulators of motor function of the respiratory tract

Included in the formulation
  • Pulmozim®
    solution d / inhal. 
    Hoffmann-La Roche Ltd.     Switzerland
    • Included in the list (Order of the Government of the Russian Federation No. 2782-r of 30.12.2014):

    VED

    7 nosologies

    АТХ:

    R.05.C.B.13   Dornase alpha (deoxyribonuclease)

    Pharmacodynamics:

    Recombinant human DNase (dornase alpha) is a genetically engineered version of a natural human enzyme that cleaves extracellular DNA.

    The accumulation of a viscous purulent secretion in the airways plays a role in the disturbance of the function of external respiration 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 collapsing leukocytes, which accumulate in response to infection. In vitro dornase alpha hydrolyzes DNA in sputum and expresses reduces the viscosity of sputum in cystic fibrosis.

    Pharmacokinetics:

    Systemic absorption of dornase alpha after inhalation of aerosol in humans is low. Half-life from lungs after inhalation - 11 hours.

    Indications:

    Symptomatic therapy in combination with standard cystic fibrosis therapy in patients with a forced vital capacity of at least 40% of normal.

    Treatment of patients with certain chronic lung diseases (bronchiectasis, chronic obstructive pulmonary disease, congenital malformation of the lungs in children, chronic pneumonia, immunodeficiency states that occur with lung damage), if the doctor estimates that the mucolytic effect of dornase alpha provides benefits for patients.

    ICD-10

    IV.E70-E90.E84.0   Cystic fibrosis with pulmonary manifestations

    X.J10-J18.J18   Pneumonia without clarification of the pathogen

    X.J40-J47.J44.9   Chronic obstructive pulmonary disease, unspecified

    X.J40-J47.J47   Bronchoectasia

    X.J80-J84.J84.1   Other interstitial lung diseases with mention of fibrosis

    X.J95-J99.J99.8 *   Respiratory disorders in other diseases classified elsewhere

    XVII.Q30-Q34.Q33   Congenital malformations of the lung

    XVIII.R00-R09.R09.3   Sputum

    Contraindications:

    Hypersensitivity to the drug or its components. Allergic reactions to preparations from ovarian cells of Chinese hamsters.

    Carefully:

    With caution: pregnancy; the period of breastfeeding; children under 5 years. Patients with an index of forced vital capacity of the lungs are less than 40%.

    Pregnancy and lactation:

    The action category for the fetus was FDA-B. Dornase alpha studies did not indicate a violation of fertility, teratogenicity, or the effect of the drug on fetal development in animals.When pregnancy should be prescribed only on absolute indications, if the benefit for the mother exceeds the risk for the child (adequate and strictly controlled studies in humans are not carried out).

    It is not known whether it penetrates into breast milk. It is not recommended to administer breastfeeding mothers.

    Dosing and Administration:

    Inhalation. The solution in ampoules is intended only for a single inhalation application, it is introduced with the help of a compressor air nebulizer (jet nebulizer); the recommended dose is 2,500 ED (2.5 mg) of Dornase Alpha once a day, which corresponds to 1 ampoule (2.5 mg of undiluted solution). In some patients older than 21 years, 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 the constant daily use of dornase alpha. Studies in which dornase alpha was administered in intermittent mode show that after the cessation of therapy, the improvement in lung function quickly disappears, therefore a daily intake of the drug is recommended. Currently, there is no recommendation for the optimal time of day for taking the drug.

    The safety and efficacy of daily use for a period of more than 12 months are not established.

    During exacerbation of respiratory tract infection during treatment with use of the drug can be continued without any risk for the patient.

    Side effects:

    From the hematopoiesis: acute lymphocytic leukemia, aplastic anemia.

    From the nervous system: epileptic seizures, migraines.

    From the sense organs: conjunctivitis, imbalance.

    From 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), dyspnea, rhinitis, impaired lung function, decreased respiratory function, respiratory failure, hemoptysis, pneumothorax, pulmonary hemorrhage, laryngeal polyps, cough, bronchial secretion, alveolitis, hypoxia, bronchospasm, productive cough.

    From the digestive tract: dyspepsia, abdominal pain, bloody vomiting, liver failure.

    From the skin and its appendages: rash, itching, urticaria, dermatitis, purpura, angioedema.

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

    On the part of the body as a whole: pleural pain in the chest, fever, weakness, malaise, death.

    Antibodies to dornase alfa were found in less than 5% of patients, but in none of them, they did not belong to the class IgE. Improvement in lung function was noted even after the appearance of antibodies to dornase alpha.

    Overdose:

    There have been no cases of overdose.

    Interaction:

    Compatible with standard drugs for the treatment of cystic fibrosis: antibiotics, bronchodilators, digestive enzymes, vitamins, inhalation and systemic glucocorticosteroids and analgesics.

    Pharmaceutical incompatibility: The aqueous solution of dornase alpha does not have buffer properties and should not be diluted or mixed in inhalation systems with other drugs (undesirable structural and / or functional changes are possible).

    Special instructions:

    Exacerbation of the infectious disease during the period of dornase alpha use is not a basis for discontinuing therapy.

    Do not mix in an inhaler with other medicines.

    It is necessary to monitor the blood glucose level.

    Instructions
    Up